A Study to Assess A Change in Disease Activity and Adverse Events of Intravenous Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Adult Participants With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant
Phase 2/3
660
about 16 years
18+
13 sites in AZ, CO, IN +7
What this study is about
This trial is testing a treatment with etentamig and daratumumab compared to daratumumab, lenalidomide, and dexamethasone. This study will evaluate the adverse events, change in disease activity, and how well the treatment works (pharmacokinetics) in adults who have newly diagnosed multiple myeloma and cannot undergo a transplant.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Daratumumab
- 2.Take Dexamethasone
- 3.Take Etentamig
- +1 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You are randomly assigned, but you will know your treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
daratumumab, dexamethasone, lenalidomide (Immunomodulatory drug; affects immune system and cancer cells (exact mechanism unclear))
infusion, injection, ocular, oral (Oral Capsule)
Primary: Phase 2 and 3: Percentage of Participants with Adverse Events (AE)s, Phase 3: Minimal Residual Disease (MRD) Negative CR Rate, Phase 3: Progression-Free Survival (PFS)
Secondary: Phase 2: Area Under the Serum Concentration-Time Curve (AUC), Phase 2: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability, Phase 2: MRD Negative CR Rate, Phase 2: Maximum Observed Serum Concentration (Cmax), Phase 2: Overall Survival (OS), Phase 2: PFS, Phase 2: Time to Cmax (Time to Maximum Observed Concentration, Tmax), Phase 3: Change from Baseline and Time to Deterioration in the Remaining Scales and Items of EORTC QLQ-C30
Oncology