6 mg PO once daily for up to 10 days or until hospital discharge, whichever comes first is recommended by the National Institutes of Health (NIH) COVID-19 treatment guidelines for use in hospitalized patients who require supplemental oxygen, including those on high-flow oxygen, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). This recommendation also applies to pregnant women, as the potential benefit of decreased maternal mortality justifies the low risk of fetal adverse effects with the short course of therapy. The NIH advises clinicians to review the patient's medical history and assess the potential risks and benefits before starting dexamethasone.[65314] The World Health Organization (WHO) strongly recommends the use of systemic corticosteroids for 7 to 10 days in patients with severe or critical COVID-19.[65876]

0.15 mg/kg/dose (Max: 6 mg/dose) PO once daily for up to 10 days, although data are limited. The National Institutes of Health (NIH) COVID-19 treatment guidelines recommend dexamethasone (with or without remdesivir) for hospitalized pediatric patients who require high-flow oxygen or noninvasive ventilation. Dexamethasone (without remdesivir) is also recommended for pediatric patients requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO). The addition of baricitinib or tocilizumab may be considered for patients who do not have rapid (e.g., within 24 hours) improvement in oxygenation after initiation of dexamethasone. Corticosteroids are not routinely recommended for pediatric patients who require only conventional oxygen, but corticosteroids can be considered in combination with remdesivir for patients with increasing oxygen needs, particularly adolescents. The use of dexamethasone for treatment of severe COVID-19 in pediatric patients who are profoundly immunocompromised has not been evaluated and may be harmful; in such cases, treatment should be considered on a case-by-case basis.[65314]

6 mg IV once daily for up to 10 days or until hospital discharge, whichever comes first is recommended by the National Institutes of Health (NIH) COVID-19 treatment guidelines for use in hospitalized patients who require supplemental oxygen, including those on high-flow oxygen, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). This recommendation also applies to pregnant women, as the potential benefit of decreased maternal mortality justifies the low risk of fetal adverse effects with the short course of therapy. The NIH advises clinicians to review the patient's medical history and assess the potential risks and benefits before starting dexamethasone.[65314] The World Health Organization (WHO) strongly recommends the use of systemic corticosteroids for 7 to 10 days in patients with severe or critical COVID-19.[65876]

0.15 mg/kg/dose (Max: 6 mg/dose) IV once daily for up to 10 days, although data are limited. The National Institutes of Health (NIH) COVID-19 treatment guidelines recommend dexamethasone (with or without remdesivir) for hospitalized pediatric patients who require high-flow oxygen or noninvasive ventilation. Dexamethasone (without remdesivir) is also recommended for pediatric patients requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO). The addition of baricitinib or tocilizumab may be considered for patients who do not have rapid (e.g., within 24 hours) improvement in oxygenation after initiation of dexamethasone. Corticosteroids are not routinely recommended for pediatric patients who require only conventional oxygen, but corticosteroids can be considered in combination with remdesivir for patients with increasing oxygen needs, particularly adolescents. The use of dexamethasone for treatment of severe COVID-19 in pediatric patients who are profoundly immunocompromised has not been evaluated and may be harmful; in such cases, treatment should be considered on a case-by-case basis.[65314]

0.15 to 0.3 mg/kg/dose (Max: 6 mg/dose) PO once daily for up to 10 days is recommended as first-line immunomodulatory treatment in patients with persistent oxygen requirements due to COVID-19.[65707]

0.15 to 0.3 mg/kg/dose (Max: 6 mg/dose) IV once daily for up to 10 days is recommended as first-line immunomodulatory treatment in patients with persistent oxygen requirements due to COVID-19.[65707]

0.5 mg PO every 6 hours for 48 hours. 24-hour urine collections are made for determination of 17-hydroxycorticosteroid excretion. Alternatively, 1 mg PO at 11:00 p.m. with plasma cortisol concentration measured at 8:00 a.m. the following morning.

25 to 30 mcg/kg/dose PO (Max: 2 mg/dose PO) given at 11:00 p.m. with a plasma cortisol concentration measured at 8:00 a.m. the following morning. A plasma cortisol concentration of less than 5 mcg/dL occurs in normal individuals but not those with Cushing's syndrome. Measure a dexamethasone concentration concurrently with the cortisol concentration to ensure adequacy of the dexamethasone dose.[54499]

2 mg PO every 6 hours for 48 hours. 24-hour urine collections are made for determination of 17-hydroxycorticosteroid excretion.

120 mcg/kg/dose PO (Max: 8 mg/dose PO) given at 11:00 p.m. with a plasma cortisol concentration measured at 8:00 a.m. the following morning. A decrease in the morning cortisol of 20% or more from baseline had a 97.5% sensitivity and 100% specificity in distinguishing patients with Cushing's disease from those with primary adrenal disorders in a retrospective study (n = 125, age 3 to 18 years). Measure a dexamethasone concentration concurrently with the cortisol concentration to ensure adequacy of the dexamethasone dose.[54501] Alternatively, a 2 day test consisting of 30 mcg/kg/day PO on day 1 and 120 mcg/kg/day PO on day 2, each given in 4 divided doses, has been recommended. Cortisol concentrations are suppressed in patients with pituitary Cushing's syndrome after the larger dose but not the smaller dose; cortisol concentrations are not suppressed after dexamethasone in patients with adrenocorticotropic hormone-independent Cushing syndrome.[54499]

Various dosage regimens have been used. 1 to 6 mg/kg IV or 40 mg IV every 4 to 6 hours while shock persists. Alternatively, 20 mg IV injection followed by an IV infusion of 3 mg/kg over 24 hours.[60760] Corticosteroids are given as adjunctive therapy to epinephrine.[66106] [64564]

Initially, 0.5 to 9 mg/day IV or IM, in 2 to 4 divided doses. Adjust according to patient response.[60760] Corticosteroids are not indicated as initial treatment for anaphylaxis, but can be given as adjunctive therapy after the administration of epinephrine.[66106] [64564]

0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m²/day IV or IM given in 3 to 4 divided doses is the FDA-approved general dosage range.[60760] [54286] Adjust according to patient response. Corticosteroids are not indicated as initial treatment for anaphylaxis, but can be given as adjunctive therapy after the administration of epinephrine.[66106] [64564]

Initially, 0.75 to 9 mg/day PO, given in 2 to 4 divided doses. Adjust according to patient response.[54286]

0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m²/day PO given in 3 to 4 divided doses is the FDA-approved general dosage range.[54286] Adjust according to patient response.

4 to 8 mg IM as a single dose on day 1. Then change to oral therapy, 1.5 mg PO twice daily on days 2 and 3; then 0.75 mg PO twice daily on day 4; then 0.75 mg PO once daily on days 5 and 6, then discontinue.[54286] [54285]

Initially, 1 to 1.5 mg/kg/dose IV, then 1 to 1.5 mg/kg/day IV in divided doses every 3 to 4 hours was used in conjunction with hyperventilation, control of body temperature, barbiturates, and continuous intracranial and arterial pressure monitoring in pediatric patients with severe head injury (n = 24, age 3 months to 14 years).[54512] 0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m²/day IV or IM given in 3 to 4 divided doses is the FDA-approved dosage range. Adjust according to patient response. Use is not a substitute for neurosurgical evaluation and definitive management such as neurosurgery, etc.[54285] [54286]

0.02 to 0.3 mg/kg/day PO or 0.6 to 9 mg/m²/day PO given in 3 to 4 divided doses is the FDA-approved general dosage range.[54286] Adjust according to patient response. Use is not a substitute for neurosurgical evaluation and definitive management such as neurosurgery, etc.

1 to 2 mg/kg IV load followed by 0.25 to 0.5 mg/kg/dose IV every 6 hours. Max: 16 mg/dose.[64934]

0.3 mg/kg/dose PO once daily and taper by 0.1 mg/kg/dose weekly until 0.1 mg/kg/dose, then 3 mg PO once daily and taper by 1 mg/dose weekly for a total duration of 6 weeks. Guidelines recommend as adjunct therapy for meningitis. Routine use outside of CNS involvement is not recommended; however, select patients may benefit.[60760] [61094] [69585] [69587] [69589]

0.3 to 0.6 mg/kg/dose PO once daily for 4 to 6 weeks, then taper dose over 2 to 4 weeks. Guidelines recommend as adjunct therapy for meningitis. Routine use outside of CNS involvement is not recommended; however, select patients may benefit.[54286] [61094] [66745] [69585] [69587] [69589]

0.3 mg/kg/dose IV or IM once daily and taper by 0.1 mg/kg/dose weekly until 0.1 mg/kg/dose, then 3 mg IV or IM once daily and taper by 1 mg/dose weekly for a total duration of 6 weeks. Switch to oral therapy when possible. Guidelines recommend as adjunct therapy for meningitis. Routine use outside of CNS involvement is not recommended; however, select patients may benefit.[60760] [61094] [69585] [69587] [69589]

0.3 to 0.6 mg/kg/dose IV or IM once daily for 4 to 6 weeks, then taper dose over 2 to 4 weeks. Guidelines recommend as adjunct therapy for meningitis. Routine use outside of CNS involvement is not recommended; however, select patients may benefit.[54286] [60760] [61094] [66745] [69585] [69586] [69587] [69589]

0.4 mg/kg/dose PO once daily and taper by 0.1 mg/kg/dose weekly until 0.1 mg/kg/dose, then 4 mg PO once daily and taper by 1 mg/dose weekly for a total duration of 8 weeks. Guidelines recommend as adjunct therapy for meningitis. Routine use outside of CNS involvement is not recommended; however, select patients may benefit.[54286] [61094] [69585] [69587] [69589]

0.3 to 0.6 mg/kg/dose PO once daily for 4 to 6 weeks, then taper dose over 2 to 4 weeks. Guidelines recommend as adjunct therapy for meningitis. Routine use outside of CNS involvement is not recommended; however, select patients may benefit.[54286] [61094] [66745] [69585] [69587] [69589]

0.4 mg/kg/dose IV or IM once daily and taper by 0.1 mg/kg/dose weekly until 0.1 mg/kg/dose, then 4 mg IV or IM once daily and taper by 1 mg/dose weekly for a total duration of 8 weeks. Switch to oral therapy when possible. Guidelines recommend as adjunct therapy for meningitis. Routine use outside of CNS involvement is not recommended; however, select patients may benefit.[60760] [61094] [69585] [69587] [69589]

0.3 to 0.6 mg/kg/dose IV or IM once daily for 4 to 6 weeks, then taper dose over 2 to 4 weeks. Guidelines recommend as adjunct therapy for meningitis. Routine use outside of CNS involvement is not recommended; however, select patients may benefit.[54286] [60760] [61094] [66745] [69585] [69586] [69587] [69589]

0.3 to 0.4 mg/kg/dose PO once daily for 2 to 4 weeks, then taper by 0.1 mg/kg/dose weekly until 0.1 mg/kg/dose, and then 4 mg PO once daily and taper by 1 mg/dose weekly for a total duration of 12 weeks. Guidelines recommend as adjunct therapy for meningitis. Routine use outside of CNS involvement is not recommended; however, select patients may benefit.[34362] [54286] [61094] [69585][69587] [69589]

0.3 to 0.4 mg/kg/dose PO once daily for 2 to 4 weeks, then taper by 0.1 mg/kg/dose weekly until 0.1 mg/kg/dose, and then 4 mg PO once daily and taper by 1 mg/dose weekly for a total duration of 12 weeks. Guidelines recommend as adjunct therapy for meningitis. Routine use outside of CNS involvement is not recommended; however, select patients may benefit.[34362] [54286] [61094] [69585] [69587] [69589]

0.3 to 0.6 mg/kg/dose PO once daily for 4 to 6 weeks, then taper dose over 2 to 4 weeks. Guidelines recommend as adjunct therapy for meningitis. Routine use outside of CNS involvement is not recommended; however, select patients may benefit.[34361] [54286] [61094] [66745] [69585] [69586] [69587] [69589]

0.3 to 0.4 mg/kg/dose IV or IM once daily for 2 to 4 weeks, then taper by 0.1 mg/kg/dose weekly until 0.1 mg/kg/dose, and then 4 mg IV or IM once daily and taper by 1 mg/dose weekly for a total duration of 12 weeks. Guidelines recommend as adjunct therapy for meningitis. Routine use outside of CNS involvement is not recommended; however, select patients may benefit.[34362] [60760] [61094] [69585] [69587] [69589]

0.3 to 0.4 mg/kg/dose IV or IM once daily for 2 to 4 weeks, then taper by 0.1 mg/kg/dose weekly until 0.1 mg/kg/dose, and then 4 mg IV or IM once daily and taper by 1 mg/dose weekly for a total duration of 12 weeks. Guidelines recommend as adjunct therapy for meningitis. Routine use outside of CNS involvement is not recommended; however, select patients may benefit.[34362] [60760] [61094] [69585] [69587] [69589]

0.3 to 0.6 mg/kg/dose IV or IM once daily for 4 to 6 weeks, then taper dose over 2 to 4 weeks. Guidelines recommend as adjunct therapy for meningitis. Routine use outside of CNS involvement is not recommended; however, select patients may benefit.[34361] [54286] [60760] [61094] [66745] [69585] [69586] [69587] [69589]

0.75 to 9 mg/day PO in 2 to 4 divided doses. Adjust dose according to response.[30011]

0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m²/day PO in 3 to 4 divided doses, initially. Adjust dose according to response.[54286]

0.5 to 9 mg/day IV or IM in 2 to 4 divided doses. Adjust dose according to response.[60760]

0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m²/day IV or IM in 3 to 4 divided doses. Adjust dose according to response.[54286] [60760]

8 to 16 mg or 0.1 to 0.3 mg/kg/dose IV or IM once daily, then taper dose over 7 to 10 days.[68070] [68102]

0.1 to 0.3 mg/kg/dose IV or IM once daily, then taper dose over 7 to 10 days.[68070] [68102]

100 mg or 1 to 1.5 mg/kg/dose IV or IM once daily for 3 days.[68070] [68100] [68101]

1 to 1.5 mg/kg/dose IV or IM once daily for 3 days.[68070] [68100] [68101]

2 to 6 mg by intralesional injection; may repeat dose every 3 to 5 days to every 2 to 3 weeks. Dosage dependent upon degree of inflammation, size, disease state, and location of affected area. Usually employed when condition to be treated is limited to 1 or 2 sites.[60760]

0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m²/day PO given in 3 to 4 divided doses is the FDA-approved general dosage range.[54286] Adjust according to patient response.

0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m²/day IV or IM given in 3 to 4 divided doses is the FDA-approved general dosage range.[54285] [54286] Adjust according to patient response.

initial, 0.75 to 9 mg orally daily; dose is dependent on the disease being treated and should be individualized based on patient response. Maintenance therapy may be given; use the lowest dose that produces an adequate clinical response. Taper dexamethasone gradually in patients on long-term therapy; do not abruptly stop therapy in these patients.[60761]

initial, 0.02 to 0.3 mg/kg (0.6 mg to 9 mg/m²) orally daily in 3 or 4 divided doses. Dose is dependent on the disease being treated and should be individualized based on patient response. Maintenance therapy may be given; use the lowest dose that produces an adequate clinical response. Taper dexamethasone gradually in patients on long-term therapy; do not abruptly stop therapy in these patients.[60761]

initial, 0.5 to 9 mg IV daily; dose is dependent on the disease being treated and should be individualized based on patient response. Maintenance therapy may be given; use the lowest dose that produces an adequate clinical response. Taper dexamethasone gradually in patients receiving IV therapy for more than a few days; do not abruptly stop therapy in these patients.[60760]

40 mg orally daily on days 1, 2, 3, and 4 in combination with gemcitabine 1,000 mg/m² IV on days 1 and 8 and cisplatin 75 mg/m² IV on day 1 (GDP regimen) every 21 days for 2 cycles was evaluated in a randomized, phase III trial (NCIC-CTG LY.12 trial). In patients with CD20-positive lymphoma, rituximab 375 mg/m² IV was added on day 1 of each treatment cycle (R-GDP regimen). Patients in the trial could receive a third cycle of therapy if they did not achieve a complete or partial response after the second cycle. Patients with CD20-positive lymphoma who received an autologous stem-cell transplant (ASCT) were randomized to receive either rituximab 375 mg/m² IV every 2 months for 6 cycles or observation starting 28 days post ASCT.[60756]

40 mg orally or IV on days 1, 2, 3, and 4 as part of the DHAP regimen with cisplatin 100 mg/m² as a continuous IV infusion over 24 hours on day 1 and cytarabine 2 grams/m² IV over 3 hours every 12 hours for 2 doses on day 2 in combination with ofatumumab 1,000 mg IV on days 1 and 8 of cycle 1 then ofatumumab 1,000 mg IV on day 1 of cycles 2 and 3 was evaluated in a randomized, phase III trial (n = 445; the ORCHARRD trial). Cycles were repeated every 21 days for a total of 3 cycles of therapy. Premedication with acetaminophen, diphenhydramine, and an IV glucocorticoid was administered prior to each ofatumumab infusion. If dexamethasone from the DHAP chemotherapy was dosed on the same day as ofatumumab, then the glucocorticoid premedication was omitted and substituted with the 40-mg dose of dexamethasone. Granulocyte colony-stimulating factor use was recommended as follows: filgrastim 5 micrograms (mcg)/kg on days 6 to 13 or pegfilgrastim 6 mg on day 6 on cycles of therapy with no stem-cell mobilization and filgrastim 5 to 10 mcg/kg on days 6 to 13 on cycles of therapy that were followed by stem-cell mobilization. Central nervous system prophylaxis using intrathecal therapy was permitted. Supportive care during treatment consisted of irradiated blood products, oral antibiotics, and antifungal prophylaxis as clinically indicated.[61715]

40 mg orally on days 1, 8, 15, and 22; administer in combination with lenalidomide (25 mg orally daily for 21 days followed by 7 days off treatment). Continue 28-day treatment cycles until disease progression in patients who are ineligible for an autologous stem-cell transplantation (ASCT); hematopoietic stem-cell mobilization should occur within four 28-day treatment cycles in patients who are eligible for an ASCT.[65868] [58806]

20 mg orally on days 1, 8, 15, and 22; administer in combination with lenalidomide (25 mg orally daily for 21 days followed by 7 days off treatment). Continue 28-day treatment cycles until disease progression.[65868] [58806]

40 mg orally daily on days 1 to 4, 9 to 12, and 17 to 20 every 28 days for the first 4 cycles of therapy, and then 40 mg orally daily on days 1 to 4 every 28 days starting with cycle 5. Given in combination with lenalidomide (25 mg orally daily on days 1 to 21 of each cycle). Continue or modify dosing based on clinical and laboratory findings.[65868] [58806]

40 mg orally daily on days 1 to 4, days 9 to 12, and days 17 to 20 of every 28-day treatment cycle plus thalidomide 200 mg orally daily (given at bedtime and at least 1 hour after the evening meal).[65868] [49713]

40 mg PO or IV on days 1, 8, 15, and 22 in combination with lenalidomide (25 mg orally daily for 21 days) and carfilzomib as specified in the protocol.[65868] Treatment cycles are repeated every 28 days until disease progression or unacceptable toxicity; maximum of 18 cycles for carfilzomib only. CYCLE 1: carfilzomib 20 mg/m² IV over 10 minutes on days 1 and 2; if tolerated, increase to a target dose of 27 mg/m² IV over 10 minutes on days 8, 9, 15, and 16. CYCLES 2 to 12: carfilzomib 27 mg/m² IV over 10 minutes on days 1, 2, 8, 9, 15, and 16. CYCLES 13 to 18: carfilzomib 27 mg/m² IV over 10 minutes on days 1, 2, 15, and 16. Dose carfilzomib at a maximum body surface area (BSA) of 2.2 m²; dose adjustment is not necessary for patients with a weight change of 20% or less. Give dexamethasone 30 minutes to 4 hours prior to the carfilzomib (on carfilzomib dosing days only). Give hydration with both oral fluids and IV fluids prior to each carfilzomib dose in cycle 1. Additional IV hydration may be given after the carfilzomib infusion in cycle 1. Oral and/or IV hydration may be continued as needed in subsequent cycles; adjust hydration to individual patient needs. Thromboprophylaxis is recommended. Consider giving an antiviral agent and an antacid medication.[51306] In a prespecified interim analysis of a multinational, randomized, open-label, phase 3 trial (n = 792; the ASPIRE trial), the median progression-free survival time (primary endpoint) was significantly increased with carfilzomib plus lenalidomide/dexamethasone (26.3 months) compared with lenalidomide/dexamethasone alone (17.6 months; hazard ratio (HR) = 0.69; 95% CI, 0.57 to 0.83; p = 0.0001) in patients with relapsed multiple myeloma who had received 1 to 3 prior therapies (age range, 31 to 91 years; median of 2 prior therapies). In this study, some patients had previously received bortezomib (65.8%) and/or lenalidomide (19.8%). The median overall survival (OS) time had not been reached in either study arm at the time of the interim analysis (median follow-up: carfilzomib arm, 32.3 months; lenalidomide/dexamethasone alone, 31.5 months). The estimated 24-month OS rates were 73.3% and 65% in the carfilzomib/lenalidomide/dexamethasone and lenalidomide/dexamethasone arms, respectively (HR = 0.79; 95% CI, 0.63 to 0.99; p = 0.04); prespecified criteria for stopping the study due to OS benefit was not met and this study is ongoing.[60044]

20 mg orally on days 1, 2, 4, 5, 8, 9, 11, and 12 during cycles 1 to 8, then dexamethasone 20 mg orally on days 1, 2, 8, and 9 during cycles 9 to 16.[65868] Administer in combination with bortezomib (1.3 mg/m² IV bolus over 3 to 5 seconds on days 1, 4, 8, and 11 in cycles 1 to 8) then bortezomib (1.3 mg/m² on days 1 and 8 in cycles 9 to 16) and panobinostat (20 mg orally on days 1, 3, 5, 8, 10, and 12). Continue every 21-day treatment cycles for up to 8 cycles; consider giving up to an additional 8 cycles (maximum of 16 treatment cycles) in patients who experience clinical benefit without unresolved severe or medically significant toxicity.[58821] Treatment with panobinostat, bortezomib, and dexamethasone (n = 387; median therapy duration of 5 months) was compared with placebo, bortezomib, and dexamethasone (n = 381; median therapy duration of 6.1 months) in patients with relapsed or relapsed and refractory multiple myeloma who had received 1 to 3 prior therapies in a multinational, randomized, phase 3 trial (the PANORAMA1 trial). The median patient age was 63 years (range, 56 to 69 years), about 51% of patients had received 1 prior therapy, and approximately 57% of patients had previously received a stem-cell transplantation. Patients with primary refractory or bortezomib-refractory disease were ineligible for this study. At a median follow-up time of 6.47 months (interquartile range, 1.81 to 13.47 months), the median progression-free survival time (primary endpoint) was significantly improved in the panobinostat arm (11.99 months) compared with the placebo arm (8.08 months; hazard ratio (HR) = 0.63; 95% CI, 0.52 to 0.76; p less than 0.0001). The overall survival (OS) time was not significantly improved in the panobinostat arm (33.64 months vs. 30.39 months; HR = 0.87; 95% CI, 0.69 to 1.1); however, OS data are not mature. Crossover from the placebo arm to the panobinostat arm was not permitted.[58822]

20 mg orally or IV on days 1, 2, 4, 5, 8, 9, 11, and 12 (or 20 mg orally/IV once weekly in patients with a body-mass index less than 18.5, poorly controlled diabetes mellitus, or a prior intolerance to glucocorticoid therapy) repeated every 3 weeks for 8 cycles in combination with daratumumab and bortezomib.[65868] The bortezomib dosage is 1.3 mg/m² as a subcutaneous injection or IV infusion on days 1, 4, 8, and 11 repeated every 3 weeks for 8 cycles. The daratumumab dosage is 16 mg/kg (actual body weight) IV weekly on weeks 1 to 9 (9 doses), 16 mg/kg IV every 3 weeks on weeks 10 to 24 (5 doses), and then 16 mg/kg IV every 4 weeks starting on week 25 until disease progression. Administer standard pre-and post-infusion medications with daratumumab infusions. Give dexamethasone prior to the daratumumab infusion when these drugs are scheduled on the same day.[61207] [60311]

20 mg orally or IV once weekly repeated every 3 weeks for 8 cycles in combination with daratumumab and bortezomib.[65868] The bortezomib dosage is 1.3 mg/m² as a subcutaneous injection or IV infusion on days 1, 4, 8, and 11 repeated every 3 weeks for 8 cycles. The daratumumab dosage is 16 mg/kg (actual body weight) IV weekly on weeks 1 to 9 (9 doses), 16 mg/kg IV every 3 weeks on weeks 10 to 24 (5 doses), and then 16 mg/kg IV every 4 weeks starting on week 25 until disease progression. Administer standard pre-and post-infusion medications with daratumumab infusions. Give dexamethasone prior to the daratumumab infusion when these drugs are scheduled on the same day.[61207] [60311]

40 mg orally or IV once weekly (or 20 mg orally or IV once weekly for patients with a body-mass index less than 18.5) in combination with lenalidomide and daratumumab until disease progression or unacceptable toxicity.[65868] The lenalidomide dosage is 25 mg orally daily on days 1 to 21 repeated every 28 days in patients with creatinine clearance (CrCl) greater than 60 mL/min and 10 mg orally daily on days 1 to 21 repeated every 28 days in patients with a CrCl of 30 to 60 mL/min. The daratumumab dosage is 16 mg/kg (actual body weight) IV weekly on weeks 1 to 8 (8 doses), 16 mg/kg IV every other week on weeks 9 to 24 (8 doses), and then 16 mg/kg IV every 4 weeks starting on week 25 until disease progression. Administer standard pre-and post-infusion medications with daratumumab infusions. In patients receiving full dose dexamethasone, administer as 20 mg IV prior to the daratumumab infusion and then 20 mg PO the next day when these drugs are scheduled on the same week; patients receiving a 20 mg/week dexamethasone dose should receive the entire dose administered prior to the daratumumab infusion.[61407] [60311]

20 mg orally or IV once weekly in combination with lenalidomide and daratumumab until disease progression or unacceptable toxicity.[65868] The lenalidomide dosage is 25 mg orally daily on days 1 to 21 repeated every 28 days in patients with creatinine clearance (CrCl) greater than 60 mL/min and 10 mg orally daily on days 1 to 21 repeated every 28 days in patients with a CrCl of 30 to 60 mL/min. The daratumumab dosage is 16 mg/kg (actual body weight) IV weekly on weeks 1 to 8 (8 doses), 16 mg/kg IV every 2 weeks on weeks 9 to 24 (8 doses), and then 16 mg/kg IV every 4 weeks starting on week 25 until disease progression. Administer standard pre-and post-infusion medications with daratumumab infusions. Give dexamethasone prior to the daratumumab infusion when these drugs are scheduled on the same week.[61407] [60311]

40 mg orally or IV once weekly (or 20 mg orally or IV once weekly for patients with a body-mass index less than 18.5) in combination with lenalidomide and daratumumab until disease progression or unacceptable toxicity.[65868] Give dexamethasone IV prior to the first infusion; oral administration may be considered thereafter. Give the treatment dexamethasone dose as the daratumumab premedication steroid when these drugs are scheduled on the same day. Consider giving a low-dose oral corticosteroid (equivalent to methylprednisolone 20 mg or less) on the day after every infusion. The lenalidomide dosage is 25 mg orally daily on days 1 to 21 repeated every 28 days in patients with creatinine clearance (CrCl) greater than 50 mL/min and 10 mg orally daily on days 1 to 21 repeated every 28 days in patients with a CrCl of 30 to 50 mL/min. The daratumumab dosage is 16 mg/kg (actual body weight) IV weekly on weeks 1 to 8 (8 doses), 16 mg/kg IV every 2 weeks on weeks 9 to 24 (8 doses), and then 16 mg/kg IV every 4 weeks starting on week 25 until disease progression. Administer standard pre-and post-infusion medications with daratumumab infusions.[60311] In the MAIA trial (median follow-up, 56.2 months), the median progression-free survival (time not reached vs. 34.4 months; hazard ratio (HR) = 0.53; 95% CI, 0.43 to 0.66, p less than 0.0001) and overall survival (time not reached in either arm; HR = 0.68; 95% CI, 0.53 to 0.86) times were significantly improved in the daratumumab plus lenalidomide and dexamethasone arm compared with the lenalidomide and dexamethasone arm in patients (median age, 73 years; range, 45 to 90 years) with newly diagnosed multiple myeloma who were ineligible for a stem-cell transplant.[67219]

20 mg orally or IV once weekly in combination with lenalidomide and daratumumab until disease progression or unacceptable toxicity.[65868] Give dexamethasone IV prior to the first infusion; oral administration may be considered thereafter. Give the treatment dexamethasone dose as the daratumumab premedication steroid when these drugs are scheduled on the same day. Consider giving a low-dose oral corticosteroid (equivalent to methylprednisolone 20 mg or less) on the day after every infusion. The lenalidomide dosage is 25 mg orally daily on days 1 to 21 repeated every 28 days in patients with creatinine clearance (CrCl) greater than 50 mL/min and 10 mg orally daily on days 1 to 21 repeated every 28 days in patients with a CrCl of 30 to 50 mL/min. The daratumumab dosage is 16 mg/kg (actual body weight) IV weekly on weeks 1 to 8 (8 doses), 16 mg/kg IV every 2 weeks on weeks 9 to 24 (8 doses), and then 16 mg/kg IV every 4 weeks starting on week 25 until disease progression. Administer standard pre-and post-infusion medications with daratumumab infusions. Give dexamethasone prior to the daratumumab infusion when these drugs are scheduled on the same week.[60311] In the MAIA trial (median follow-up, 56.2 months), the median progression-free survival (time not reached vs. 34.4 months; hazard ratio (HR) = 0.53; 95% CI, 0.43 to 0.66, p less than 0.0001) and overall survival (time not reached in either arm; HR = 0.68; 95% CI, 0.53 to 0.86) times were significantly improved in the daratumumab plus lenalidomide and dexamethasone arm compared with the lenalidomide and dexamethasone arm in patients (median age, 73 years; range, 45 to 90 years) with newly diagnosed multiple myeloma who were ineligible for a stem-cell transplant.[67219]

40 mg IV/PO (or 20 mg PO/IV in patients with a body-mass index less than 18.5) once weekly plus lenalidomide 25 mg PO daily on days 1 to 21 repeated every 28 days in combination with 1,800 mg daratumumab and 30,000 units hyaluronidase subcutaneously weekly on weeks 1 to 8 (8 doses), 1,800 mg daratumumab and 30,000 units hyaluronidase every other week on weeks 9 to 24 (8 doses), and then 1,800 mg daratumumab and 30,000 units hyaluronidase every 4 weeks starting on week 25 until disease progression was evaluated in a single-arm cohort (n = 65) of a multicohort, open-label trial (the PLEIADES trial). The overall response rate was 91% in patients with relapsed or refractory multiple myeloma who received daratumumab/hyaluronidase, lenalidomide, and dexamethasone.[65868] [65366]

20 mg PO/IV once weekly plus lenalidomide 25 mg PO daily on days 1 to 21 repeated every 28 days in combination with 1,800 mg daratumumab and 30,000 units hyaluronidase subcutaneously weekly on weeks 1 to 8 (8 doses), 1,800 mg daratumumab and 30,000 units hyaluronidase every other week on weeks 9 to 24 (8 doses), and then 1,800 mg daratumumab and 30,000 units hyaluronidase every 4 weeks starting on week 25 until disease progression was evaluated in a single-arm cohort (n = 65) of a multicohort, open-label trial (the PLEIADES trial). The overall response rate was 91% in patients with relapsed or refractory multiple myeloma who received daratumumab/hyaluronidase, lenalidomide, and dexamethasone.[65868] [65366]

40 mg orally or IV once weekly (or 20 mg IV/PO once weekly for patients with a body-mass index less than 18.5) in combination with pomalidomide (4 mg orally daily on days 1 to 21 repeated every 28 days) and daratumumab (16 mg/kg of actual body weight IV weekly on weeks 1 to 8 (8 doses), 16 mg/kg IV every other week on weeks 9 to 24 (8 doses), and then 16 mg/kg IV every 4 weeks starting on week 25) until disease progression was evaluated in a nonrandomized, phase 1b trial (n = 103; EQUULEUS trial). Administer standard pre-and post-infusion medications with daratumumab infusions. In patients receiving full dose dexamethasone, administer as 20 mg IV prior to the daratumumab infusion and then 20 mg orally the next day when these drugs are scheduled on the same week; patients receiving a 20 mg/week dexamethasone dose should receive the entire dose administered prior to the daratumumab infusion.[65868] [60311]

20 mg orally or IV once weekly in combination with pomalidomide (4 mg orally daily on days 1 to 21 repeated every 28 days) and daratumumab (16 mg/kg of actual body weight IV weekly on weeks 1 to 8 (8 doses), 16 mg/kg IV every other week on weeks 9 to 24 (8 doses), and then 16 mg/kg IV every 4 weeks starting on week 25) until disease progression was evaluated in a nonrandomized, phase 1b trial (n = 103; EQUULEUS trial). Administer standard pre-and post-infusion medications with daratumumab infusions. Give dexamethasone prior to the daratumumab infusion when these drugs are scheduled on the same week. [65868] [60311]

28 mg orally (taken 3 to 24 hours prior to elotuzumab) on days 1, 8, 15, and 22 on cycles 1 and 2 and on days 1 and 15 of subsequent cycles in combination with lenalidomide 25 mg orally daily on days 1 through 21 and elotuzumab 10 mg/kg IV once weekly on cycles 1 and 2 (on days 1, 8, 15, and 22), then 10 mg/kg IV every 2 weeks (on days 1 and 15) thereafter. Give dexamethasone 40 mg orally on days 8 and 22 of cycles 3 and beyond. Repeat treatment cycles every 28 days until disease progression.[65868] Administer the following premedications 45 to 90 minutes prior to each elotuzumab infusion: acetaminophen 650 to 1,000 mg PO, diphenhydramine 25 to 50 mg PO or IV (or equivalent), ranitidine 50 mg IV or 150 mg PO (or equivalent), and dexamethasone 8 mg IV.[60354] At a median follow-up time of 24.5 months, the median progression-free survival time was significantly improved with elotuzumab plus lenalidomide and dexamethasone (median duration of therapy, 17 months) compared with lenalidomide and dexamethasone alone (19.4 months vs. 14.9 months; hazard ratio (HR) = 0.7; 95% CI, 0.57 to 0.85; p less than 0.001) in patients with relapsed and/or refractory multiple myeloma in a planned interim analysis of a multicenter, randomized, open-label, phase 3 trial (n = 646; the ELOQUENT-2 trial). In this study, patients had received a median of 2 prior therapies (range, 1 to 4 therapies); 35% of patients had refractory disease to the last therapy and 54% of patients had previously received an autologous stem cell transplantation.[60353] The overall survival time was improved in the elotuzumab-containing arm (48.3 months vs. 39.6 months; HR = 0.82; 95% CI, 0.68 to 1) at the final analysis (minimum follow-up time of 70.6 months). In subgroup analyses, the median OS times were significantly improved in elotuzumab-treated patients who had received 2 or 3 prior therapies (51 months vs. 33.6 months; HR = 0.71; 95% CI, 0.54 to 0.92), were refractory to their most recent therapy (40.4 months vs. 25.9 months; HR = 0.67; 95% CI, 0.49 to 0.91), or were less than 65 years of age (63.5 months vs. 47.7 months; HR = 0.7; 95% CI, 0.52 to 0.96).[65918]

28 mg orally (at 3 to 24 hours prior to elotuzumab) on days 1, 8, 15, and 22 on cycles 1 and 2 and on day 1 of subsequent cycles in combination with elotuzumab 10 mg/kg IV once weekly on cycles 1 and 2 (on days 1, 8, 15, and 22) followed by 20 mg/kg IV every 4 weeks (on day 1) starting on cycle 3 and pomalidomide 4 mg orally daily on days 1 through 21. Additionally, give dexamethasone 40 mg (at 3 to 24 hours prior to elotuzumab) on days 8, 15, and 22 of cycles 3 and beyond. Repeat treatment cycles every 28 days until disease progression.[65868] Administer the following premedications 45 to 90 minutes prior to each elotuzumab infusion: acetaminophen 650 to 1,000 mg orally, diphenhydramine 25 to 50 mg orally or IV (or equivalent), ranitidine 50 mg IV or 150 mg orally (or equivalent), and dexamethasone 8 mg IV. At a minimum follow-up time of 9.1 months, the median investigator-assessed progression-free survival time was significantly improved with elotuzumab plus pomalidomide and dexamethasone (median number of treatment cycles, 9) compared with pomalidomide and dexamethasone alone (10.25 months vs. 4.67 months; hazard ratio (HR) = 0.54; 95% CI, 0.34 to 0.86; p = 0.0078) in patients with relapsed or refractory multiple myeloma in a randomized, phase 2 trial (n = 117; the ELOQUENT-3 trial). In this study, patients had received a median of 3 prior therapies; 70% of patients had refractory disease after both lenalidomide and a proteasome inhibitor and 55% of patients had previously received an autologous stem cell transplantation.[60354]

8 mg orally (at 3 to 24 hours prior to elotuzumab) on days 1, 8, 15, and 22 on cycles 1 and 2 and on day 1 of subsequent cycles in combination with elotuzumab 10 mg/kg IV once weekly on cycles 1 and 2 (on days 1, 8, 15, and 22) followed by 20 mg/kg IV every 4 weeks (on day 1) starting on cycle 3 and pomalidomide 4 mg orally daily on days 1 through 21. Additionally, give dexamethasone 20 mg orally (at 3 to 24 hours prior to elotuzumab) on days 8, 15, and 22 of cycles 3 and beyond. Repeat treatment cycles every 28 days until disease progression.[65868] Administer the following premedications 45 to 90 minutes prior to each elotuzumab infusion: acetaminophen 650 to 1,000 mg orally, diphenhydramine 25 to 50 mg orally or IV (or equivalent), ranitidine 50 mg IV or 150 mg orally (or equivalent), and dexamethasone 8 mg IV. At a minimum follow-up time of 9.1 months, the median investigator-assessed progression-free survival time was significantly improved with elotuzumab plus pomalidomide and dexamethasone (median number of treatment cycles, 9) compared with pomalidomide and dexamethasone alone (10.25 months vs. 4.67 months; hazard ratio (HR) = 0.54; 95% CI, 0.34 to 0.86; p = 0.0078) in patients with relapsed or refractory multiple myeloma in a randomized, phase 2 trial (n = 117; the ELOQUENT-3 trial). In this study, patients had received a median of 3 prior therapies; 70% of patients had refractory disease after both lenalidomide and a proteasome inhibitor and 55% of patients had previously received an autologous stem cell transplantation.[60354]

20 mg orally on days 1, 2, 4, 5, 8, 9, 11, and 12 repeated every 21 days for 8 cycles (SWOG S0777 trial); 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, and 12 repeated every 21 days for 3 cycles prior to stem-cell transplantation (SCT) followed by 10 mg orally on days 1, 2, 4, 5, 8, 9, 11, and 12 repeated every 21 days for 2 cycles after SCT (IFM 2009 trial); and 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, and 12 repeated every 21 days for 4 cycles, 10 mg orally on days 1, 2, 4, 5, 8, 9, 11, and 12 on cycles 5 to 9, and then 10 mg orally on days 1, 2, 8, and 9 on cycles 9 to 12 (ENDURANCE trial) in combination with bortezomib and lenalidomide (VRd regimen) have been evaluated in 3 randomized, phase 3 trials. Maintenance therapy consisted of lenalidomide and dexamethasone or lenalidomide only.[61788] [65843] [65899]

40 mg orally daily on days 1 to 4 during all cycles and on days 9 to 12 for cycles 1 and 2 only plus bortezomib (1.3 mg/m² IV on days 1, 4, 8, and 11) repeated every 3 weeks for 4 cycles as induction therapy prior to autologous stem-cell transplantation has been evaluated in newly diagnosed multiple myeloma patients in randomized, phase 3 studies.[49477] [49745]

40 mg orally on days 1, 2, 4, 5, 8, 9, 11, and 12 plus bortezomib (1.3 mg/m² IV on days 1, 4, 8, and 11) and thalidomide (100 mg orally daily for the first 14 days during cycle 1 only, and then 200 mg orally daily thereafter). Regimen is known as the VTD regimen. Repeated every 21 days for 3 cycles prior to a double (tandem) autologous stem-cell transplant (ASCT). This regimen was studied in a multicenter, randomized, phase 3 study. Patients randomized to induction therapy with VTD also received two 35-day consolidation cycles with VTD (bortezomib 1.3 mg/m² on days 1, 8, 15, and 22 plus thalidomide 100 mg orally daily and dexamethasone 40 mg orally on days 1, 2, 8, 9, 15, 16, 22, and 23) following the second transplantation. Patients also received maintenance therapy with dexamethasone 40 mg orally on days 1 to 4 every 28 days until relapse or disease progression.[49746] Additionally in a randomized, phase 3 study, dexamethasone 40 mg orally daily on days 1 to 4 and 9 to 12 plus bortezomib (1.3 mg/m² on days 1, 4, 8, and 11) and thalidomide (200 mg orally daily after dose escalation as follows in the first cycle: thalidomide 50 mg/day on days 1 to 14 and 100 mg/day on days 15 to 28) repeated every 4 weeks for 6 cycles prior to an ASCT was studied. In this study, patients who received up to 3 years of maintenance therapy (starting 3 months after ASCT) with bortezomib (1.3 mg/m² IV on days 1, 4, 8, and 11 repeated every 3 months) plus thalidomide (100 mg/day) had significantly improved 2-year progression-free survival compared with thalidomide or interferon alfa-2b maintenance therapy.[49747]

40 mg orally daily on days 1 to 4, days 9 to 12, and days 17 to 20 or dexamethasone 40 mg orally daily on days 1 to 4 on all cycles and days 9 to 12 and days 17 to 20 of cycles 1 and 2 only, plus doxorubicin 9 mg/m² IV daily and vincristine 0.4 mg IV daily on days 1 to 4 (VAD regimen) has been studied. Doxorubicin and vincristine were administered as a continuous IV infusion over 24 hours/day [49477] or as a daily IV infusion. Cycles were repeated every 4 weeks for 3 to 4 cycles as induction therapy prior to autologous stem-cell transplantation.[49477] [49478]

20 mg orally on days 1, 2, 4, 5, 8, 9, 11, and 12 repeated every 21 days on cycles 1 to 8 and then 20 mg orally on days 1, 2, 8, and 9 starting on cycle 9 in combination with pomalidomide (4 mg orally daily on days 1 to 14) and bortezomib was evaluated in a randomized, phase 3 trial (n = 559; the OPTIMISMM trial). Bortezomib was administered as follows: 1.3 mg/m² IV or subcutaneously on days 1, 4, 8, and 11 on cycles 1 to 8 then 1.3 mg/m² IV or subcutaneously on days 1 and 8 starting on cycle 9. Treatment cycles were repeated every 21 days until disease progression.[64412]

10 mg orally on days 1, 2, 4, 5, 8, 9, 11, and 12 repeated every 21 days on cycles 1 to 8 and then 10 mg orally on days 1, 2, 8, and 9 starting on cycle 9 in combination with pomalidomide (4 mg orally daily on days 1 to 14) and bortezomib. Bortezomib was administered as follows: 1.3 mg/m² IV or subcutaneously on days 1, 4, 8, and 11 on cycles 1 to 8 then 1.3 mg/m² IV or subcutaneously on days 1 and 8 starting on cycle 9. Treatment cycles were repeated every 21 days until disease progression.[64412]

40 mg orally or IV on days 1, 2, 8, 9, 15, 16, 22, and 23 in induction cycles 1 and 2; 40 mg orally or IV on days 1 and 2 and 20 mg PO or IV on days 8, 9, 15, and 16 in induction cycles 3 and 4; and 20 mg orally or IV on days 1, 2, 8, 9, 15, and 16 for 2 consolidation cycles in combination with daratumumab, bortezomib, and thalidomide was evaluated in a multicenter, randomized, phase 3 trial (n = 1,085; the CASSIOPEIA trial).[65868] In this trial, dexamethasone was administered for up to four 28-day induction therapy cycles and two 28-day consolidation therapy cycles with daratumumab (16 mg/kg IV weekly in induction cycles 1 and 2 then 16 mg/kg IV every 2 weeks in induction cycles 3 and 4 and for both consolidation cycles; bortezomib 1.3 mg/m² subcutaneously on days 1, 4, 8, and 11 in each induction and consolidation cycle; and thalidomide 100 mg orally daily. Consolidation therapy was begun after hematopoietic reconstitution but not earlier than 30 days after transplant.[64528]

40 mg IV or orally on days 1, 8, 15, and 22 repeated every 28 days until disease progression. Give in combination with isatuximab 10 mg/kg (actual body weight) IV on days 1, 8, 15, and 22 on cycle 1 and isatuximab 10 mg/kg (actual body weight) IV on days 1 and 15 starting on cycle 2 and pomalidomide 4 mg orally daily on days 1 to 21. The scheduled dexamethasone dose should be given prior to isatuximab and pomalidomide on days these drugs are given together.[65868] [65066] At a median follow-up time of 11.6 months, the median progression-free survival time (evaluated by an independent response committee) was significantly improved in patients with relapsed or refractory multiple myeloma who received isatuximab, pomalidomide, and low-dose dexamethasone compared with pomalidomide and low-dose dexamethasone alone (11.5 months vs. 6.5 months; hazard ratio (HR) = 0.596; 95% CI, 0.44 to 0.81; p = 0.001) in a multinational, randomized, phase 3 trial (the ICARIA-MM trial; n = 307). Patients (median age, 67 years) in this study had received a median of 3 prior therapies including lenalidomide and a proteasome inhibitor; 56% of patients had previously received an autologous stem-cell transplantation.[65070] At a second interim analysis (median follow-up, 35.3 months), the median overall survival time was 24.6 months in patients who received isatuximab, pomalidomide, and dexamethasone compared with 17.7 months in patients who received pomalidomide and dexamethasone (HR = 0.76; 95% CI, 0.57 to 1.01). Subsequent therapy was given at disease progression in 60% and 72% of patients in the isatuximab-containing and control arms, respectively. Of patients who received subsequent therapy, fewer patients received daratumumab in the isatuximab-containing arm (24% vs. 58%).[67409]

20 mg IV or orally on days 1, 8, 15, and 22 repeated every 28 days until disease progression. Give in combination with isatuximab 10 mg/kg (actual body weight) IV on days 1, 8, 15, and 22 on cycle 1 and isatuximab 10 mg/kg (actual body weight) IV on days 1 and 15 starting on cycle 2 and pomalidomide 4 mg orally daily on days 1 to 21. The scheduled dexamethasone dose should be given prior to isatuximab and pomalidomide on days these drugs are given together.[65868] [65066] At a median follow-up time of 11.6 months, the median progression-free survival was significantly improved in patients with relapsed or refractory multiple myeloma who received isatuximab, pomalidomide, and low-dose dexamethasone compared with pomalidomide and low-dose dexamethasone alone (11.5 months vs. 6.5 months; hazard ratio = 0.596; 95% CI, 0.44 to 0.81; p = 0.001) in a multinational, randomized, phase 3 trial (the ICARIA-MM trial; n = 307). Patients (median age, 67 years) in this study had received a median of 3 prior therapies including lenalidomide and a proteasome inhibitor; 56% of patients had previously received an autologous stem-cell transplantation.[65070]

20 mg PO/IV on days 1, 2, 8, 9, 15, and 16 and 40 mg PO/IV on day 22 repeated every 28 days in combination with IV carfilzomib (20 mg/m² and 56 mg/m² twice weekly regimen) and IV daratumumab until disease progression or unacceptable toxicity. Alternatively, dexamethasone may be given as follows: 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, and 23 in cycles 1 and 2; 20 mg PO/IV on days 1, 2, 15, and 16 and 40 mg PO/IV on days 8 and 22 in cycles 3, 4, 5, and 6; and 20 mg PO/IV on days 1 and 2 and 40 mg PO/IV on days 8, 15, and 22 in cycles 7 and beyond in combination with IV carfilzomib (20 mg/m² and 70 mg/m² once weekly regimen) and IV daratumumab until disease progression or unacceptable toxicity. Treatment cycles are repeated every 28 days. Give dexamethasone 30 minutes to 4 hours prior to the carfilzomib dose and 1 to 3 hours prior to daratumumab.[65868] [51306] At a median follow-up time of about 17 months, the median progression-free survival was significantly improved in patients with relapsed or refractory multiple myeloma who received carfilzomib 20 mg/m² and 56 mg/m² twice weekly regimen, daratumumab, and dexamethasone compared with carfilzomib and dexamethasone alone (median time not reached vs. 15.8 months; hazard ratio = 0.63; 95% CI, 0.46 to 0.85; p = 0.0027) in a multicenter, randomized (2:1), open-label, phase 3 trial (n = 466; the CANDOR trial).[65854] At a median follow-up time of 16.6 months (range, 0.5 to 27.4 months), the overall response rate was 84% (complete response rate, 33%) in patients with relapsed or refractory multiple myeloma who received carfilzomib 20 mg/m² and 70 mg/m² once weekly regimen, daratuzumab, and dexamethasone in a multicenter, multi-arm, phase 1b trial (n = 85; EQUULEUS trial).[65855]

20 mg PO/IV on days 1 and 2 of cycle 1 only and then 20 mg PO/IV weekly in combination with IV carfilzomib and IV daratumumab until disease progression or unacceptable toxicity. Treatment cycles are repeated every 28 days. Give dexamethasone 30 minutes to 4 hours prior to the carfilzomib dose and 1 to 3 hours prior to daratumumab.[65868] [51306] At a median follow-up time of about 17 months, the median progression-free survival was significantly improved in patients with relapsed or refractory multiple myeloma who received carfilzomib 20 mg/m² and 56 mg/m² twice weekly regimen, daratumumab, and dexamethasone compared with carfilzomib and dexamethasone alone (median time not reached vs. 15.8 months; hazard ratio = 0.63; 95% CI, 0.46 to 0.85; p = 0.0027) in a multicenter, randomized (2:1), open-label, phase 3 trial (n = 466; the CANDOR trial).[65854] At a median follow-up time of 16.6 months (range, 0.5 to 27.4 months), the overall response rate was 84% (complete response rate, 33%) in patients with relapsed or refractory multiple myeloma who received carfilzomib 20 mg/m² and 70 mg/m² once weekly regimen, daratuzumab, and dexamethasone in a multicenter, multi-arm, phase 1b trial (n = 85; EQUULEUS trial).[65855]

20 mg on days 1, 2, 8, 9, 15, and 16 repeated every 21 days on cycles 1, 2, 3, and 4 followed by high-dose chemotherapy and an autologous stem-cell transplant and then 2 additional cycles of dexamethasone 20 mg on days 1, 2, 8, 9, 15, and 16 repeated every 21 days (cycles 5 and 6) plus lenalidomide 25 mg orally daily on days 1 to 14 and bortezomib 1.3 mg/m² subcutaneously on days 1, 4, 8, and 11 repeated every 21 days for 6 cycles (VRd regimen) with daratumumab was evaluated in a randomized, phase 2 trial (the GRIFFIN trial; n = 207). Daratumumab treatment consisted of 16 mg/kg IV on days 1, 8, and 15 repeated every 21 days on cycles 1, 2, 3, and 4 and 16 mg/kg IV day 1 repeated every 21 days on cycles 5 and 6. Maintenance therapy was given for up to 2 years and consisted of daratumumab 16 mg/kg IV on day 1 repeated every 4 or 8 weeks and lenalidomide 10 mg orally daily on days 1 to 21 (increased to 15 mg after 3 cycles if tolerated) repeated every 28 days.[66069]

20 mg PO on days 1 and 2 in combination with selinexor 100 mg orally on day 1 once weekly and bortezomib 1.3 mg/m2 subcutaneously on day 1 once weekly for 4 weeks followed by 1 week off; repeat cycles until disease progression.[64399] Treatment with a once-weekly regimen of selinexor plus bortezomib, and dexamethasone (SVd regimen) led to a significantly improved median progression-free survival time compared with bortezomib and dexamethasone (13.93 months vs. 9.46 months; hazard ratio (HR) = 0.7; 95% CI, 0.53 to 0.93) in a randomized, phase 3 trial (n = 402; the Boston trial). At a median follow-up of 17.3 months, the median overall survival (OS) time was not significantly improved in the SVd arm (HR = 0.84; 95% CI, 0.57 to 1.23); however, OS data was not mature at the time of this analysis. Patients (median age, 67 years) in this trial had received a median of 2 prior regimens (range, 1 to 2 regimens) and approximately 70% of patients had received prior bortezomib therapy; 35% of patients had previously received a stem-cell transplant.[66186]

40 mg orally or IV on days 1, 8, 15, and 22 in combination with melphalan flufenamide 40 mg IV on day 1 repeated every 28 days until disease progression. Treatment with melphalan flufenamide plus dexamethasone resulted in an overall response rate of 23.7% in 97 patients with multiple myeloma who had received 4 or more previous lines of therapy and were refractory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and a CD38-directed monoclonal antibody in a nonrandomized phase 2 trial (the HORIZON trial). No patient achieved a complete response. In this trial, the median duration of response was 4.2 months. Patients (median age, 65 years; range, 35 to 86 years) had received a median of 6 prior regimens (range, 4 to 12 regimens); 75% of patients had alkylator refractory disease and 70% of patients had previously received a stem-cell transplant.[66471]

20 mg orally or IV on days 1, 8, 15, and 22 in combination with melphalan flufenamide 40 mg IV on day 1 repeated every 28 days until disease progression. Treatment with melphalan flufenamide plus dexamethasone resulted in an overall response rate of 23.7% in 97 patients with multiple myeloma who had received 4 or more previous lines of therapy and were refractory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and a CD38-directed monoclonal antibody in a nonrandomized phase 2 trial (the HORIZON trial). No patient achieved a complete response. In this trial, the median duration of response was 4.2 months. Patients (median age, 65 years; range, 35 to 86 years) had received a median of 6 prior regimens (range, 4 to 12 regimens); 75% of patients had alkylator refractory disease and 70% of patients had previously received a stem-cell transplant.[66471]

20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 in combination with isatuximab (cycle 1: 10 mg/kg IV on days 1, 8, 15, and 22; cycle 2 and beyond: 10 mg/kg IV on days 1 and 15) and carfilzomib (cycle 1: 20 mg/m² IV on days 1 and 2 and then 56 mg/m² on days 8, 9, 15, and 16; cycle 2 and beyond: 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16). Repeat treatment cycles every 28 days until disease progression. Give IV dexamethasone prior to isatuximab and/or carfilzomib on days these agents are given on the same day and then give dexamethasone orally for other scheduled doses.[65066] [51306] At a median follow-up time of 44 months, the median progression-free survival time (evaluated by an independent review committee) was significantly improved in patients with relapsed or refractory multiple myeloma who received isatuximab, carfilzomib, and dexamethasone compared with carfilzomib and dexamethasone alone (35.7 months vs. 19.2 months; hazard ratio (HR) = 0.58; 95% CI, 0.42 to 0.79) in a prespecified interim analysis of a multinational, randomized, phase 3 trial (the IKEMA trial; n = 302). Median overall survival (OS) was not significantly improved in isatuximab-treated patients (HR = 0.78; 95% CI, 0.54 to 1.12); however, OS data were not mature at this analysis. Patients (median age, 65 years) in the isatuximab-treated arm had received a median of 2 (range, 1 to 4) prior therapies and 49.7% of patients were refractory to the last regimen.[69167]

40 mg orally on days 1, 8, 15, and 22 in combination with ixazomib 4 mg orally on days 1, 8, and 15 and lenalidomide 25 mg orally daily on days 1 through 21. Repeat treatment cycles every 28 days until disease progression.[60335] The median progression-free survival time was significantly improved with ixazomib plus lenalidomide and dexamethasone compared with placebo plus lenalidomide and dexamethasone (20.6 months vs. 14.7 months; hazard ratio (HR) = 0.74; 95% CI, 0.59 to 0.94; p = 0.01) in patients with relapsed and/or refractory multiple myeloma who had received 1 to 3 prior therapies in a multinational, randomized, double-blind, phase 3 trial (n = 722; TOURMALINE-MM1 trial). At a median follow-up time of 85 months, the median overall survival time was not significantly improved in the ixazomib-containing arm (53.6 months vs. 51.6 months; HR = 0.939; 95%CI, 0.784 to 1.125). In this trial, subsequent lines of therapy were given in 71.7% and 69.9% of patients who received ixazomib plus lenalidomide and dexamethasone (median, 2 subsequent therapies; range, 1 to 9) and lenalidomide and dexamethasone (median, 3 subsequent therapies; range, 1 to 12), respectively. The median age of patients in this study was 66 years (range, 30 to 91 years); prior therapy included a stem-cell transplant in 57% of patients, proteasome inhibitor therapy in 70% of patients, and immunomodulatory drug therapy in 55% of patients. Thromboprophylaxis was recommended for all patients.[60856] [66762]

40 mg orally once weekly (on days 1, 8, 15, and 22) repeated every 28 days until disease progression; give in combination with daratumumab/hyaluronidase (1,800 mg daratumumab and 30,000 units hyaluronidase subcutaneously weekly on weeks 1 to 8 (8 doses), every other week on weeks 9 to 24 (8 doses), and then every 4 weeks starting on week 25 until disease progression) and pomalidomide (4 mg PO daily on days 1 to 21 repeated every 28 days).[65366] At a median follow-up time of 16.9 months, the median progression-free survival time was significantly improved in patients with relapsed or refractory multiple myeloma who received daratumumab/hyaluronidase plus pomalidomide and dexamethasone compared with pomalidomide and dexamethasone alone (12.4 months vs. 6.9 months; hazard ratio (HR) = 0.63; 95% CI, 0.47 to 0.85) in a randomized, phase 3 (APOLLO) trial (n = 304). At a median follow-up of 39.6 months, the median overall survival time was not significantly improved in the daratumumab/hyaluronidase-containing arm (34.4 months vs. 23.7 months; HR = 0.82; 95% CI, 0.61 to 1.11). In this trial, eligible patients had received at least 1 previous line of therapy with both lenalidomide and a proteasome inhibitor, had a partial response or better to one or more previous lines of anti-myeloma therapy, and were refractory to lenalidomide if they had received only 1 previous line of treatment. Patients (median age, 67 years; range, 42 to 86 years) in the daratumumab/hyaluronidase arm had received a median of 2 (range, 1 to 5) prior therapies; 60% of patients had received a prior autologous stem-cell transplantation.[66809] [70310]

20 mg orally once weekly (on days 1, 8, 15, and 22) repeated every 28 days until disease progression; give in combination with daratumumab/hyaluronidase (1,800 mg daratumumab and 30,000 units hyaluronidase subcutaneously weekly on weeks 1 to 8 (8 doses), every other week on weeks 9 to 24 (8 doses), and then every 4 weeks starting on week 25 until disease progression) and pomalidomide (4 mg PO daily on days 1 to 21 repeated every 28 days).[65366] At a median follow-up time of 16.9 months, the median progression-free survival time was significantly improved in patients with relapsed or refractory multiple myeloma who received daratumumab/hyaluronidase plus pomalidomide and dexamethasone compared with pomalidomide and dexamethasone alone (12.4 months vs. 6.9 months; hazard ratio (HR) = 0.63; 95% CI, 0.47 to 0.85) in a randomized, phase 3 (APOLLO) trial (n = 304). At a median follow-up of 39.6 months, the median overall survival time was not significantly improved in the daratumumab/hyaluronidase-containing arm (34.4 months vs. 23.7 months; HR = 0.82; 95% CI, 0.61 to 1.11). In this trial, eligible patients had received at least 1 previous line of therapy with both lenalidomide and a proteasome inhibitor, had a partial response or better to one or more previous lines of antimyeloma therapy, and were refractory to lenalidomide if they had received only 1 previous line of treatment. Patients (median age, 67 years; range, 42 to 86 years) in the daratumumab/hyaluronidase arm had received a median of 2 (range, 1 to 5) prior therapies; 60% of patients had received a prior autologous stem-cell transplantation.[66809] [70310]

40 mg PO or IV per week in combination with carfilzomib and daratumumab/hyaluronidase; treatment cycles are repeated every 28 days until disease progression or unacceptable toxicity. Dexamethasone dosing day(s)/schedule differ with twice weekly or once weekly carfilzomib regimens. Give dexamethasone 30 minutes to 4 hours prior to the carfilzomib. Give the treatment dexamethasone dose as the premedication steroid when these drugs are scheduled on the same day as daratumumab; hyaluronidase. With carfilzomib 20 mg/m² and 56 mg/m² twice weekly regimen, give dexamethasone 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22 and 23 on cycles 1 and 2 and then 20 mg PO/IV on days 1, 2, 8, 9, 15, and 16 and 40 mg PO/IV on day 22 on subsequent cycles. With carfilzomib 20 mg/m² and 70 mg/m² once weekly regimen, give dexamethasone 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, and 23 on cycles 1 and 2; 20 mg PO/IV on days 1, 2, 15, and 16 and 40 mg PO/IV on days 8 and 22 on cycles 3, 4, 5, and 6; and 20 mg PO/IV on days 1 and 2 and 40 mg PO/IV on days 8, 15, and 22 on cycles 7 and beyond. In patients with a BMI of less than 18.5 who received the carfilzomib once weekly regimen, give a reduced dexamethasone dosage of 20 mg PO/IV on days 1 and 2 of cycle 1 then 20 mg PO/IV weekly. Daratumumab; hyaluronidase is administered as follows: 1,800 mg daratumumab and 30,000 units hyaluronidase subcutaneously weekly on weeks 1 to 8 (8 doses), 1,800 mg daratumumab and 30,000 units hyaluronidase every 2 weeks on weeks 9 to 24 (8 doses), and then 1,800 mg daratumumab and 30,000 units hyaluronidase every 4 weeks starting on week 25 until disease progression. The overall response rate was 84.8% in 66 patients with relapsed or refractory multiple myeloma who received carfilzomib (20 mg/m² and 70 mg/m² once weekly regimen), daratumumab/hyaluronidase, and dexamethasone in a multicohort, phase 2 trial (the PLEIADES trial). The stringent complete response rate was 16.7% and the complete response rate was 21.2%. At a median follow-up time of 9.2 months, the median duration of response was not reached. Patients (median age, 61 years; range, 42 to 84 years) in this trial had received at least 1 previous therapy line that contained lenalidomide; 79% of patients had a prior stem-cell transplant.[51306] [65366]

20 mg PO/IV on days 1 and 2 of week 1 and then 20 mg PO/IV once weekly in combination with carfilzomib and daratumumab/hyaluronidase; treatment cycles are repeated every 28 days until disease progression or unacceptable toxicity. Give dexamethasone 30 minutes to 4 hours prior to the carfilzomib. Carfilzomib is administered as either a 20 mg/m² and 56 mg/m² twice weekly or a 20 mg/m² and 70 mg/m² once weekly regimen. Give the treatment dexamethasone dose as the premedication steroid when these scheduled on the same day as daratumumab; hyaluronidase. Daratumumab; hyaluronidase is administered as follows: 1,800 mg daratumumab and 30,000 units hyaluronidase subcutaneously weekly on weeks 1 to 8 (8 doses), 1,800 mg daratumumab and 30,000 units hyaluronidase every 2 weeks on weeks 9 to 24 (8 doses), and then 1,800 mg daratumumab and 30,000 units hyaluronidase every 4 weeks starting on week 25 until disease progression. The overall response rate was 84.8% in 66 patients with relapsed or refractory multiple myeloma who received carfilzomib (20 mg/m² and 70 mg/m² once weekly regimen), daratumumab/hyaluronidase, and dexamethasone in a multicohort, phase 2 trial (the PLEIADES trial). The stringent complete response rate was 16.7% and the complete response rate was 21.2%. At a median follow-up time of 9.2 months, the median duration of response was not reached. Patients (median age, 61 years; range, 42 to 84 years) in this trial had received at least 1 previous therapy line that contained lenalidomide; 79% of patients had a prior stem-cell transplant.[51306] [65366]

20 mg (IV on days of isatuximab infusions and PO on the other days) on days 1, 2, 4, 5, 8, 9, 11, 12, 15, 22, 23, 25, 26, 29, 30, 32, and 33 of cycles 1 to 4 (42-day cycles) and on days 1, 8, 15, and 22 starting on cycle 5 (28-day cycles). Give in combination with isatuximab 10 mg/kg (actual body weight) IV on days 1, 8, 15, 22, and 29 of cycle 1 (42-day cycle), on days 1, 15, and 29 of cycles 2, 3, and 4 (42-day cycles), on days 1 and 15 of cycles 5 to 17 (28-day cycles), and on day 1 of cycles 18 and beyond (28-day cycles); bortezomib 1.3 mg/m² subcutaneously on days 1, 4, 8, 11, 22, 25, 29, and 32 of cycles 1 to 4 (42-day cycles); lenalidomide 25 mg PO daily on days 1 to 14 and on days 22 to 35 of cycles 1 to 4 (42-day cycles) and on days 1 to 21 starting on cycle 5 (28-day cycles). Administer dexamethasone (as part of isatuximab premedication and as part of the scheduled regimen dose) before isatuximab, bortezomib, and lenalidomide.[65066] [65868] At a median follow-up of 60 months, the median progression-free survival (PFS) time was significantly improved in patients with newly diagnosed multiple myeloma not eligible for autologous stem cell transplant who received isatuximab, bortezomib, lenalidomide, and dexamethasone compared with bortezomib, lenalidomide, and dexamethasone alone (not reached vs. 54.3 months) in a randomized, phase 3 study (IMROZ); the improvement in PFS represented a 40% reduction in the risk of disease progression or death. Crossover from the control arm to the experimental arm was allowed after cycle 4 at the investigator's discretion.[65066] [71276]

1 to 2 drops into affected eye(s) every hour during the day and every 2 hours during the night, initially. Reduce dose to 1 drop into affected eye(s) every 4 hours when a favorable response occurs, and then to 1 drop into affected eye(s) 3 to 4 times daily.[54348]

1 to 2 drops into affected eye(s) every hour for severe disease and every 4 to 6 hours for mild disease. Taper dose to discontinuation as inflammation subsides.[61633]

1 to 2 drops into affected eye(s) every hour for severe disease and every 4 to 6 hours for mild disease. Taper dose to discontinuation as inflammation subsides.[61633]

0.75 to 9 mg/day PO in 2 to 4 divided doses, initially. Adjust according to individual response.[54286]

0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m²/day PO in 3 to 4 divided doses, initially. Adjust according to individual response.[54286]

0.5 to 9 mg/day IV or IM in 2 to 4 divided doses, initially. Adjust according to individual response.[54285] [54286]

0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m²/day IV or IM in 3 to 4 divided doses. Adjust according to individual response.[54285] [54286]

0.4 mg in the lower lacrimal punctum into the canaliculus as a single dose. A single insert releases a 0.4 mg dose od dexamethasone for up to 30 days after insertion.[63796]

0.7 mg implant by intravitreal injection into affected eye(s).[41921] [71021]

0.7 mg implant by intravitreal injection into affected eye(s).[71021] [71024]

1 to 2 drops into both eyes 4 times daily, initially. Reduce dose to 1 to 2 drops into both eyes twice daily after 1 to 2 weeks if positive response in signs and/or symptoms and start cyclosporine, then taper or discontinue steroid therapy after 2 to 4 weeks. Consider extending duration to 4 weeks if no response at 2 weeks, especially in individuals with moderate to severe disease.[68206] [71210]

Place the insert containing 0.4 mg of dexamethasone into the lower lacrimal canaliculus, just below the punctal opening. A single insert releases a 0.4 mg dose for up to 30 days following insertion.[63796]

4 mg PO every 6 hours until symptoms resolve.[56782] [67542]

0.15 mg/kg/dose (Max: 4 mg/dose) PO every 6 hours until symptoms resolve.[56398] [56782] [67542]

4 mg IV or IM every 6 hours until symptoms resolve.[56782] [67542]

0.15 mg/kg/dose (Max: 4 mg/dose) IV or IM every 6 hours until symptoms resolve.[56398] [56782] [67542]

8 mg PO once, then 4 mg PO every 6 hours until symptoms resolve. May add acetazolamide.[56782] [67542]

0.15 mg/kg/dose (Max: 4 mg/dose) PO every 6 hours until symptoms resolve. May add acetazolamide.[56398] [56782] [67542]

8 mg IV or IM once, then 4 mg IV or IM every 6 hours until symptoms resolve. May add acetazolamide.[56782] [67542]

0.15 mg/kg/dose (Max: 4 mg/dose) IV or IM every 6 hours until symptoms resolve. May add acetazolamide.[56398] [56782] [67542]

20 mg IV on day 1 in combination with rituximab 375 mg/m² IV on day 1 and cyclophosphamide 100 mg/m² orally twice daily on days 1 to 5 (total dose of 1,000 mg/m²/cycle) repeated every 21 days for 6 cycles was evaluated in a single-arm, phase II trial.[61073]

40 mg IV on days 1, 8, 15, and 22 in cycles 2 and 5 in combination with bortezomib and rituximab was evaluated in a nonrandomized phase II trial. Bortezomib was given as follows: 1.3 mg/m² IV on days 1, 4, 8, and 11 for the first 21-day cycle (cycle 1) then 1.6 mg/m² IV on days 1, 8, 15, and 22 repeated every 35 days for 4 additional cycles (cycles 2, 3, 4, and 5). Rituximab was given as 375 mg/m² IV on days 1, 8, 15, and 22 in cycles 2 and 5 (for 8 total doses). All patients received premedication with acetaminophen 1,000 mg PO and diphenhydramine 50 mg IV prior to rituximab and herpes zoster prophylaxis with valacyclovir or acyclovir.[61131]

Dexamethasone in combination with lenalidomide (15 mg PO daily on days 1 to 21) and cyclophosphamide repeated every 28 days has been evaluated in nonrandomized, phase II studies. Treatment duration, drug dosages of cyclophosphamide and dexamethasone, and thromboprophylaxis agents/recommendations varied in these studies.[61321] [61322] [61323] In one study, 12 cycles of dexamethasone (20 mg PO on days 1, 2, 3, 4, 9, 10, 11, and 12 for 6 cycles; then 20 mg PO on days 1, 2, 3, and 4 for an additional 6 cycles), lenalidomide, and cyclophosphamide (300 mg/m² IV on days 1 and 8 for 6 cycles; then 300 mg/m² IV on day 1 for an additional 6 cycles) were given and then maintenance therapy with lenalidomide and dexamethasone was administered for 3 additional years or until disease progression. Patients with cardiac stage III had an upfront dose modification of dexamethasone.[61321] In another study, dexamethasone (40 mg PO on days 1, 8, 15, and 22), lenalidomide, and cyclophosphamide (500 mg PO on days 1, 8, and 15) therapy was given for a maximum of 9 cycles; treatment was discontinued after cycle 6 if a complete response or partial response/very good partial response plus organ response was obtained. In this study, patients with fluid retention over 3% of body weight despite optimal diuretic use received a lower dose of dexamethasone (20 mg once weekly).[61322] In a third study, cycles of dexamethasone (40 mg PO on days 1, 8, 15, and 22), lenalidomide, and cyclophosphamide (300 mg/m² PO on days 1, 8, and 15) were continued until disease progression, unacceptable toxicity, or up to 2 years; however, cyclophosphamide was given for up to a maximum of 12 cycles only.[61323]

40 mg orally on days 1, 8, 15, and 22 in combination with lenalidomide (10 mg PO daily on days 1 to 21) and melphalan repeated every 28 days has been evaluated in nonrandomized studies. Treatment duration, the melphalan dosage, and thromboprophylaxis agents/recommendations varied in these studies.[61331] [61332] In one study, melphalan (0.18 mg/kg PO daily on days 1, 2, 3, and 4), lenalidomide, and dexamethasone therapy was given for a maximum of 9 cycles; single-agent lenalidomide was continued in responding patients.[61331] In another study, lenalidomide, melphalan (5 mg/m² PO daily on days 1, 2, 3, and 4), and dexamethasone were continued until disease progression, unacceptable toxicity, or up to 12 cycles.[61332]

40 mg orally daily on days 1, 2, 3, and 4 repeated every 28 days on cycles 1 and 2 and then 40 mg orally daily on days 1, 2, 3, and 4 repeated every 35 days up to a maximum of 8 cycles in combination with bortezomib and melphalan (BMdex regimen) was evaluated in a multicenter, randomized, open-label, phase 3 trial (n = 109). Patients were evaluated for response after 3 and 6 cycles of therapy; patients with a partial response (PR) or better after cycle 3 received an additional 3 cycles of therapy. Patients with a complete response (CR) or a PR and organ response stopped treatment after cycle 6.[65948]

40 mg IV or PO in combination with bortezomib 1.3 mg/m² subcutaneously and cyclophosphamide 300 mg/m² (Max dose of 500 mg) IV or PO each given weekly on days 1, 8, 15, and 22 repeated every 28 days for a maximum of 6 cycles (VCd) plus up to 2 years of subcutaneous daratumumab; hyaluronidase (D-VCd) was evaluated in transplant eligible, newly diagnosed light-chain amyloidosis patients in a randomized, phase 3 trial (n = 388; the ANDROMEDA trial). The dose of dexamethasone was reduced to 20 mg in patients older than 70 years or who had a body mass index less than 18.5, hypervolemia, poorly controlled diabetes mellitus, or prior intolerance to steroid therapy. Daratumumab; hyaluronidase was administered as follows: 1,800 mg daratumumab and 30,000 units hyaluronidase subcutaneously weekly on weeks 1 to 8 (8 doses), 1,800 mg daratumumab and 30,000 units hyaluronidase every 2 weeks on weeks 9 to 24 (8 doses), and then 1,800 mg daratumumab and 30,000 units hyaluronidase every 4 weeks starting on week 25 until disease progression or for a maximum of 2 years.[65366] At a median follow-up time of 11.4 (range, 0.03 to 21.3) months, the hematologic complete response rate was significantly improved (53.3% vs. 18.1%; relative risk ratio = 2.9; 95% CI, 2.1 to 4.1; p less than 0.001) in patients who received D-VCd compared with VCd in the ANDROMEDA trial. The median time to hemCR was 60 and 85 days in the D-VCd and VCd arms, respectively.[66968]