Brief Summary
The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplanta procedure that involves replacing unhealthy blood-forming cells (stem cells) with healthy stem cells. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years.
Intervention / Treatment
- Drug: Elranatamab
- Drug: Lenalidomide
- Drug: Lenalidomide
- Drug: Elranatamab
Inclusion Criteria:
- Diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of MM as defined according to IMWG criteria (Rajkumar, 2014) with measurable disease at diagnosis
- Part 1 patients must be MRD positive, Part 2 patients can be MRD negative or MRD positive
- History of induction therapy for newly diagnosed MM, followed by high dosethe amount of medication taken therapy and autologous stem cell transplant. Randomization must occur within 120 days from the stem cell transplant. For participants who receive consolidation therapy after ASCT, randomization must occur within 60 days of consolidation and within 7 months from ASCT.
- Partial Response or better according to IMWG criteria at the time of randomization
- Must have an archival bone marrowsoft, spongy tissue found in bones that makes blood cells aspirateto draw out fluid or tissue from the body, often with a syringe sample(s) to identify the dominant malignantcancerous, may grow and spread to other areas of the body (index) clone by central laboratory NGS test (ClonoSEQ assay) that is used to track MRD status. This sample should preferably be collected before induction treatment (eg, at diagnosis) or before transplant.
- ECOG performance status ≤1
- Resolved acutenew, recent, comes with an urgent or significant sense, is sudden, sharp effects of any prior therapy to baseline severity or CTCAE Gradea description of how abnormal cancer cells and tissue look under a microscope when compared to healthy cells ≤ 1
- Not pregnant and willing to use contraception.