NCT07891923
Less Doses of Daratumumab Are Adequate to Achieve Response in Newly Diagnosed Multiple Myeloma
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Record History
All 2 versions: 2 with changes below.
- Minor Interventions modified
- Study First Submitted
- Minor: routine updates
Endpoints
Primary
Post-induction MRD negativity rate
Timeframe: At the end of Cycle 4 (each induction cycle is 28 days; MRD assessed within 2 weeks after completion of Cycle 4 [approximately Days 113-127]
Secondary (9)
Overall Response Rate (ORR) and ≥Complete Response (≥CR) Rate After Four Cycles of Induction
Overall Response Rate (ORR) and ≥Complete Response (≥CR) Rate Day 100 (±15 days) post-transplant
Progression-Free Survival (PFS)
Incidence of Grade ≥3 Adverse Events
Minimal residual disease (MRD)Negativity at Day 100 (±15 Days) Post-Autologous Stem Cell Transplantation (ASCT)
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Sustained MRD negativity
pharmacokinetics (pK) of daratumumab
Stem-cell yield after mobilization
Time to Engraftment Following Autologous Stem Cell Transplantation (ASCT)
Arms and interventions
Daratumumab with VRd (Bortezomib, Lenalidomide, and Dexamethasone)Experimental
This arm includes patients with newly diagnosed multiple myeloma (NDMM) who meet all the inclusion and exclusion criteria. Eligible patients will receive four cycles of Dara-VRd induction therapy, with each cycle lasting 28 days. The regimen comprises daratumumab, bortezomib, lenalidomide, and dexamethasone, administered according to the specified dosing schedule.
Drugs: Daratumumab (Intravenously), Bortezomib (BTZ), Len (lenalidomide), Dexamethasone
Sites
2 sites in 1 country