N=~1590
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Key eligibility criteria*:
- MM diagnosis according to IMWG criteria
- Newly diagnosed and not considered a candidate for high-dose chemotherapy with ASCT
- ECOG PS 0–2
- No history of stroke, transient ischemic attack, or seizure within 6 months prior to randomization
- Have not received cumulative dose of systemic corticosteroids ≥20 mg of dexamethasone within 14 days prior to randomization
Primary outcomes:
- PFS
- 12-month MRD-negative CR
Secondary outcomes†:
- ≥VGPR
- ≥CR
- Sustained MRD-negative CR
- PFS2
- OS
- AEs
- ADAs
- Abnormal laboratory parameters
- Abnormal ECG
*Not a complete list of inclusion and exclusion criteria. †Not a complete list of secondary outcomes.
Ab, antibody; ADA, antidrug antibody; AE, adverse event; ASCT, autologous stem cell transplant; BCMA, B-cell maturation antigen; CD, cluster of differentiation; CR, complete response; DR, daratumumab and lenalidomide; DRd, daratumumab, lenalidomide, and dexamethasone; ECG, electrocardiogram; ECOG PS, Eastern Cooperative Oncology Group performance status; IMWG, International Myeloma Working Group; GPRC5D, G protein–coupled receptor class C group 5 member D; IV, intravenously; MM, multiple myeloma; MRD, minimal residual disease; OS, overall survival; PFS, progression-free survival; PFS2, progression-free survival on next-line therapy; PO, orally; R, randomized; SC, subcutaneous; VGPR, very good partial response.