Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant

Inclusion Criteria:

• Diagnosis of MM as defined according to IMWG criteria (Rajkumar, 2014) withmeasurable disease at diagnosis

• Part 1 patients must be MRD positive, Part 2 patients can be MRD negative or MRDpositive

• History of induction therapy for newly diagnosed MM, followed by high dose therapyand autologous stem cell transplant. Randomization must occur within 120 days fromthe stem cell transplant. For participants who receive consolidation therapy afterASCT, randomization must occur within 60 days of consolidation and within 7 monthsfrom ASCT.

• Partial Response or better according to IMWG criteria at the time of randomization

• Must have an archival bone marrow aspirate sample(s) to identify the dominantmalignant (index) clone by central laboratory NGS test (ClonoSEQ assay) that is usedto track MRD status. This sample should preferably be collected before inductiontreatment (eg, at diagnosis) or before transplant.

• ECOG performance status ≤1

• Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1

• Not pregnant and willing to use contraception

Exclusion Criteria:

• Plasma cell leukemia

• Amyloidosis, Waldenström's macroglobulinemia

• POEMS syndrome

• Known active CNS involvement or clinical signs of myelomatous meningeal involvement

• Previous MM maintenance treatment

• Prior treatment with BCMA targeted therapy

• Any other active malignancy within 3 years prior to enrollment, except foradequately treated basal cell or squamous cell skin cancer, or carcinoma in situ

• Active, uncontrolled bacterial, fungal, or viral infection, including (but notlimited to) HBV, HCV, and known HIV or AIDS-related illness

• Previous administration with an investigational drug or vaccine within 30 days (oras determined by the local requirement) or 5 half-lives preceding the first dose ofstudy intervention used in this study (whichever is longer)