NCT07891923 Less Doses of Daratumumab Are Adequate to Achieve Response in Newly Diagnosed Multiple Myeloma

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 52 participants in total. It began in 2025-10-28 with a primary completion date of 2029-05-05.

Brief Summary

The goal of this clinical trial is to evaluate whether a modified (less frequent) dosing schedule of daratumumab, when added to standard VRd therapy, can be an effective induction regimen for treating newly diagnosed multiple myeloma (NDMM). The main questions it aims to answer are: 1. Does the modified (less frequent) daratumumab dosing regimen increase the rate of MRD (minimal residual disease) negativity after 4 cycles of induction therapy (as compared to standard VRd therapy)? 2. Is the modified less-frequent dosing schedule safe and does it achieve adequate drug levels 3. What is the clinical response of patients to the treatment? Treatment regimen Daratumumab (Dara), Bortezomib, Lenalidomide, and Dexamethasone will be given together for four cycles of induction therapy Duration of each cycle will be 28 days 1. Daratumumab will be given at standard dose of 16mg/kg - Day 1, 15, 29, 50, 71, and 92 (First three doses every 2 weeks, followed by the next three doses every 3 weeks). This will be given intravenously in saline 2. Bortezomib: 1.3 mg/m2 - Given once weekly subcutaneously (similar to insulin) 3. Lenalidomide: 15-25 mg orally for 21 days, followed by a 7-day gap. 4. Dexamethasone: 40mg given once weekly Response Assessment * Response assessment - A bone marrow test will be done within two weeks of end of cycle 4 in order to assess the cancer burden via a special test called MRD (minimal residual disease) in the bone marrow. * Blood tests will be performed to assess your response to treatment (serum protein electrophoresis, immunofixation electrophoresis and serum free light chain assay) after cycle 2 (between day 51-day 56) and cycle 4 (between 107-112). These blood tests are routinely done for all myeloma patients during their treatment to assess response.

Eligibility Criteria

Inclusion Criteria 1. Newly diagnosed multiple myeloma 2. ECOG performance status 0-2 3. Age ≥18 years of age 4. Acceptable liver functions, as specified below: Total bilirubin \<2 times upper limit of normal (ULN), Aspartate transaminase (AST; SGOT), alanine transaminase (ALT; SGPT) \<3 ULN 5. Acceptable hematological parameters: Hemoglobin \>7g/dl, Absolute neutrophil count (ANC) ≥500/mm3, platelet count ≥50,000/mm3 6. Creatinine clearance ≥30ml/minute (by Cockcroft-Gault formula) 7. Treatment naive or received ≤ 1 cycle (≤28 days) of bortezomib based triplet therapy Exclusion Criteria 1. Other plasma cell dyscrasias - Plasma cell leukemia (\>=5% circulating plasma cells in peripheral blood), AL Amyloidosis, POEMS syndrome 2. Patients with symptomatic central nervous system involvement (as per assessing clinician) 3. Patients with symptomatic obstructive airway disease, as per assessing clinician 4. New York Heart Association (NYHA) Class III or IV cardiac disease, or left ventricular ejection fraction \<40% 5. Human immunodeficiency virus (HIV) positive or HBsAg positive 6. Pregnant or breastfeeding female

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