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Daratumumab
Source: Plasma Cell Neoplasms (Including Multiple Myeloma) Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: April 25, 2025 · Captured 2026-09-09.
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Daratumumab is a monoclonal antibody targeting CD38 that can be given on its own but is usually given in combination with other drugs. Although it is given as an infusion, the subcutaneous formulation has equivalent efficacy and fewer adverse events.[3]
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Evidence (daratumumab):
In the prospective CASTOR trial (NCT02136134), 498 previously treated patients were randomly assigned to receive either daratumumab, bortezomib, and dexamethasone (DVd) or bortezomib and dexamethasone (Vd).[4]
In the prospective CASTOR trial (NCT02136134), 498 previously treated patients were randomly assigned to receive either daratumumab, bortezomib, and dexamethasone (DVd) or bortezomib and dexamethasone (Vd).[4]
With a median follow-up of 72.6 months, the median overall survival (OS) was 49.6 months for patients in the DVd group and 38.5 months for patients in the Vd group (hazard ratio [HR], 0.74; 95% confidence interval [CI], 0.59–0.92; P = .0075).[4][Level of evidence A1]
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In the prospective POLLUX trial (NCT02076009), 569 previously treated patients were randomly assigned to receive either daratumumab, lenalidomide, and dexamethasone (DRd) or lenalidomide and dexamethasone (Rd).[5,6]
In the prospective POLLUX trial (NCT02076009), 569 previously treated patients were randomly assigned to receive either daratumumab, lenalidomide, and dexamethasone (DRd) or lenalidomide and dexamethasone (Rd).[5,6]
With a median follow-up of 79.7 months, the median OS was 67.6 months for patients in the DRd group and 51.8 months for patients in the Rd group (HR, 0.73; 95% CI, 0.58–0.91; P = .0044).[6][Level of evidence A1]
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In a prospective trial (NCT03158688), 466 previously treated patients were randomly assigned in a 2:1 ratio to receive either daratumumab, carfilzomib, and dexamethasone or carfilzomib and dexamethasone.[7]
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In a prospective trial (NCT03158688), 466 previously treated patients were randomly assigned in a 2:1 ratio to receive either daratumumab, carfilzomib, and dexamethasone or carfilzomib and dexamethasone.[7]
With a median follow-up of 27.8 months, the median progression-free survival (PFS) was 28.6 months (95% CI, 25.6–29.5) in the daratumumab group and 15.2 months (11.1–19.9) in the control arm (log-rank P < .0001).[8][Level of evidence B1]
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In a prospective randomized trial, 1,304 previously treated patients received either daratumumab plus pomalidomide and dexamethasone (DPd) or pomalidomide and dexamethasone (Pd) alone.[9]
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In a prospective randomized trial, 1,304 previously treated patients received either daratumumab plus pomalidomide and dexamethasone (DPd) or pomalidomide and dexamethasone (Pd) alone.[9]
With a median follow-up of 16.9 months, the median PFS was 12.4 months (95% CI, 8.3–19.3) for patients who received DPd and 6.9 months (95% CI, 5.5–9.3) for patients who received Pd (HR, 0.63; 95% CI, 0.47–0.85; P = .0018).[9][Level of evidence B1]
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Several phase I and phase II trials evaluated daratumumab as a single agent for relapsed or refractory multiple myeloma.[10-12]
Several phase I and phase II trials evaluated daratumumab as a single agent for relapsed or refractory multiple myeloma.[10-12]
With a median follow-up of 12 to 17 months, the overall response rate was 31% and 36%, with minimal response or stable disease in about 40% of patients.[10-12][Level of evidence C3]
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In every prospective randomized trial to date, adding daratumumab to other active myeloma combination therapies improved responses and PFS when compared with the combination therapies alone.
Studies cited in this source section
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Preserved source evidence · Not medical advice