Fewer-doses daratumumab added to VRd for newly diagnosed multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm Phase 2 trial evaluating a modified, less-frequent daratumumab schedule combined with standard VRd induction for newly diagnosed multiple myeloma. Patients receive four 28-day induction cycles with daratumumab on days 1, 15, 29, 50, 71, and 92, plus weekly bortezomib, lenalidomide, and dexamethasone. The study looks at MRD negativity after induction, overall response, depth of response, progression-free survival, safety, daratumumab pharmacokinetics, stem-cell yield, and engraftment timing after ASCT where applicable. Exploratory endpoints include immune cell subset analyses to understand potential immunologic effects.

Why it matters

Who can join: the full rules

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

Where it's running

• Actrec Tmc
  Navi Mumbai, Maharashtra, India Recruiting
• Dr.Sumeet Mirgh
  Navi Mumbai, Maharashtra, India Not yet recruiting

Study contacts

• Study coordinator: Dr.Sumeet Mirgh, MBBS MD DM Clinical Hematology
• Email: drsumeetmirgh@gmail.com
• Phone: +91 8130140245

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.