Trattamento

Experimental: Arm A – Part 1
Elranatamab:

Drug: Elranatamab
BCMA-CD3 bispecific antibody
Drug: Elranatamab
BCMA-CD3 bispecific antibody

Active Comparator: Arm B – Part 1
Lenalidomide:

Drug: Lenalidomide
Immunomodulatory drug
Drug: Lenalidomide
Immunomodulatory drug

Active Comparator: Arm B – Part 2
Lenalidomide:

Drug: Lenalidomide
Immunomodulatory drug
Drug: Lenalidomide
Immunomodulatory drug

Experimental: Arm C – Part 2
Elranatamab:

Drug: Elranatamab
BCMA-CD3 bispecific antibody
Drug: Elranatamab
BCMA-CD3 bispecific antibody

Obiettivo principale

Progression Free Survival assessed by Blinded Independent Central review per IMWG response criteria

Criteri di inclusione

• Diagnosis 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 dose 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 marrow aspirate sample(s) to identify the dominant malignant (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 acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1
• Not pregnant and willing to use contraceptionNot pregnant and willing to use contraception

Criteri di esclusione

• 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 for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
• Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, and known HIV or AIDS-related illness
• Previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)