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

RecruitingPhase 2Ages 18 Years - anyAllTata Memorial Centre
NCT07891923 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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,

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📋 Eligibility rules (as published)
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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What it tests

  • Daratumumab (Intravenously) with VRd (Bortezomib, Lenalidomide, and Dexamethasone)
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Where

2 sites
Actrec Tmc
Navi Mumbai, India
Dr.Sumeet Mirgh
Navi Mumbai, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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