Less Frequent Daratumumab Dosing for Newly Diagnosed Multiple Myeloma
Tests fewer daratumumab doses, with other myeloma drugs, in adults newly diagnosed with multiple myeloma.
Plain-language title generated from the registry record
Registry title: Less Doses of Daratumumab Are Adequate to Achieve Response in Newly Diagnosed Multiple Myeloma
Key facts
- Where
- Navi Mumbai, IndiaSee the 2 sites
- Phase
- Phase 2
Where in India
- Actrec TmcNavi Mumbai, IndiaTaking people
- Dr.Sumeet MirghNavi Mumbai, IndiaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tata Memorial Centre
- Trial code
- NCT07891923
- Record updated
- 27 October 2026
- Original description
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).Read full original descriptionShow less
Less is Adequate - A Phase 2 Study of Less Frequent Dosing of Daratumumab in Newly Diagnosed Multiple Myeloma
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.
Inclusion: Newly diagnosed multiple myeloma; ECOG performance status 0-2; Age ≥18 years of age; 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; Acceptable hematological parameters: Hemoglobin >7g/dl, Absolute neutrophil count (ANC) ≥500/mm3, platelet count ≥50,000/mm3; Creatinine clearance ≥30ml/minute (by Cockcroft-Gault formula); Treatment naive or received ≤ 1 cycle (≤28 days) of bortezomib based triplet therapy.
Exclusion: Other plasma cell dyscrasias - Plasma cell leukemia (>=5% circulating plasma cells in peripheral blood), AL Amyloidosis, POEMS syndrome; Patients with symptomatic obstructive airway disease, as per assessing clinician; Human immunodeficiency virus (HIV) positive or HBsAg positive; New York Heart Association (NYHA) Class III or IV cardiac disease, or left ventricular ejection fraction <40%; Patients with symptomatic central nervous system involvement (as per assessing clinician); Pregnant or breastfeeding female.