Project Title

Study comparing Daratumumab, Lenalidomide, and Dexamethasone with Lenalidomide and Dexamethasone in participants with previously untreated Multiple Myeloma.

Official Title

A Phase III Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy.

Project Summary

The purpose of this study is to compare the efficacy of daratumumab in combination with lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of progression-free survival (PFS) in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT).

This is a Phase III, randomized (study drug assigned by chance), open-label (participants and researchers are aware about the treatment, participants are receiving), active-controlled (study in which the experimental treatment or procedure is compared to a standard treatment or procedure), parallel-group (each group of participants will be treated at the same time), and multicenter (when more than one hospital or medical school team work on a medical research study) study in participants with newly diagnosed multiple myeloma and who are not candidates for high dose chemotherapy and ASCT.

All the eligible participants will be randomly assigned to receive either daratumumab in combination with lenalidomide and dexamethasone (DRd) or lenalidomide and dexamethasone (Rd). Daratumumab (16 milligram per kilogram [mg/kg]) will be administered weekly for first 8 weeks (Cycles 1 to 2) of treatment and then every other week for 16 weeks (Cycles 3 to 6), then every 4 weeks (from Cycle 7 and beyond) until progression of disease or unacceptable toxicity. Lenalidomide will be administered at a dose of 25 mg orally on Days 1 through 21 of each 28-day cycle, and dexamethasone will be administered at a dose of 40 mg once a week for both treatment arms. Participants in both treatment arms will continue lenalidomide and dexamethasone until disease progression or unacceptable toxicity. Participants in Arm B (Rd) who had discontinued treatment with Rd at 24 months may re-start treatment. Participants in lenalidomide and dexamethasone (Rd) Arm who have sponsor-confirmed disease progression may have the option to receive daratumumab provided by the sponsor (in any subsequent line of therapy) in the Follow-up phase.

The study consists of 3 phases:

  • Screening Phase (within 21 days prior to the first dose administration on Day 1);
  • Treatment Phase (Day 1 up to discontinuation of all study treatment); and
  • Follow-up Phase (from discontinuation of all study treatment up to death, lost to follow up, consent withdrawal, or study end, whichever occurs first).

The maximum duration of study will be 7 years after last participant is randomized. Efficacy will primarily be evaluated by PFS. Participants' safety will be monitored throughout the study.

Blood Disorder

  • Multiple Myeloma 

Patient Recruitment Details

Patient recruitment status: Closed

Number of Patients (Globally)

737 participants.