Newly Diagnosed Multiple Myeloma After Transplant
Conditions
Interventions
Drug: Elranatamab
BCMA-CD3 bispecific antibody
Drug: Lenalidomide
Immunomodulatory drug
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: *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 contraception
Exclusion criteria
Exclusion criteria: Exclusion Criteria: *Plasma cell leukemia *Amyloidosis, Waldenstrom'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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome Measures: Progression Free Survival [ Time Frame: Assessed for up to approximately 5 years ] Progression Free Survival assessed by Blinded Independent Central review per IMWG response criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome Measures: *Minimal residual disease Negative rate [Time Frame: 12 months after randomization] per IMWG as assessed via next generation sequencing (NGS) *Progression Free Survival by BICR per IMWG in IMWG 2025 high-risk participants [Time Frame: Assessed up to approximately 5 years] Progression Free Survival by BICR per IMWG in IMWG 2025 high-risk participants *PFS by BICR per IMWG in IMWG 2025 standard-risk participant [Time Frame: Assessed up to approximately 5 years] PFS by BICR per IMWG in IMWG 2025 standard-risk participant *Overall Survival [Time Frame: Assessed for up to approximately 5 years] Defined as the time from randomization until death due to any cause *MRD-negative rate per IMWG 2025 [Time Frame: 12 months after randomization] Assessed via NGS in IMWG 2025 subgroups *Sustained MRD negative rate [Time Frame: 24 months after randomization] Sustained Minimal Residual Disease negative rate per IMWG criteria as assessed via Next Generation Sequencing *Progression Free Survival [Time Frame: Assessed for up to approximately 5 years] Progression Free Survival by investigator per IMWG response criteria *Overall minimal residual disease negative rate [Time Frame: Assessed for up to approximately 5 years] Minimal residual disease negative rate per IMWG criteria *Duration of minimal residual disease negativity [Time Frame: Assessed for up to approximately 5 years] Minimal residual disease negativity per IMWG criteria *Sustained minimal residual disease negativity rate [Time Frame: Assessed for up to approximately 5 years] Minimal residual disease negativity per IMWG criteria that has lasted a minimum of 12 months *Complete response rate [Time Frame: Assessed for up to approximately 5 years] Complete response rate by blinded independent central review and by investigator per IMWG criteria *Duration of complete response [Time Frame: Assessed for up to approximately 5 years] Duration of complete response by blinded independent central review and by | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed