Health Condition 1: C900- Multiple myeloma
Conditions
Interventions
Intervention1: Arm A: Elranatamab: The elranatamab dosing regimen that will be evaluated in this study is 76 mg QW administered as a SC injection following the 2 step-up priming doses of 12 mg on C1D1
Sponsors
Pfizer Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of MM as defined according to IMWG criteria (Rajkumar et al, 2014) 2. History of 3 to 8 cycles of induction therapy for NDMM, followed by high-dose therapy and autologous stem cell transplantation. 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 6 months from ASCT. 3. PR or better according to IMWG criteria at the time of randomization 4. Identification of the dominant malignant (index) clone as assessed by central laboratory NGS test (Adaptive Biotechnologies clonoSEQ® assay). (a) Must have an archived bone marrow aspirate sample(s) that identifies the dominant malignant (index) clone that is used to track MRD status by central laboratory assessment (Adaptive Biotechnologies clonoSEQ® assay). This sample should preferably be collected before induction treatment (eg, at diagnosis) or before transplant 5. Adequate post-ASCT recovery of BM function characterized by ANC =1.0 × 109/L, Platelets =75 × 109/L, Hemoglobin =8 g/dL 6.ECOG performance status 7. LVEF = 40% as determined by a MUGA scan or ECHO 8. Adequate hepatic, renal and bone marrow function (limitations on use of G-CSF and transfusion to reach eligibility levels 9. Corrected serum calcium = 14 mg/dL (= 3.5 mmol/L) 10. Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade = 1
Exclusion criteria
Exclusion criteria: 1. Smoldering MM, Plasma cell leukemia, Systemic amyloid light chain amyloidosis 2. POEMS syndrome 3. Stem cell transplant within 12 weeks prior to enrollment, or active graft versus host disease 4. Ongoing Grade = 3 peripheral sensory or motor neuropathy 5. History of Guillain-Barré Syndrome (GBS), GBS variants, or Grade >3 peripheral motor polyneuropathy 6. Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection 7. Prior therapy (a) Previous BCMA-directed therapy (b) Previous Multiple Myeloma Maintenance Treatment 8. Any other active malignancy within 3 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ 9. Investigational product within 30 days or 5 half-lives (whichever is longer) prior to dosing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS by BICR per IMWGTimepoint: the date of randomization to date of confirmed PD per IMWG criteria or death due to any cause, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survivalTimepoint: Assessed for up to approximately 5 years (rogression Free Survival by investigator per IMWG response criteria);Overall minimal residual disease negativity rateTimepoint: Assessed approximately every 6 months and for approximately 5 years (Minimal residual disease negativity rate per IMWG criteria);Duration of minimal residual disease negativity rateTimepoint: Assessed approximately every 6 months and for approximately 5 years (Minimal residual disease negativity per IMWG criteria);Sustained minimal residual disease negativity rateTimepoint: Assessed for approximately 5 years (Minimal residual disease negativity per IMWG criteria that has lasted a minimum of 12 months);Complete response rateTimepoint: Assessed approximately every 28 days and for approximately 5 years (Complete response rate by blinded independent central review and by investigator per IMWG criteria);Duration of complete responseTimepoint: Assessed approximately every 28 days and for approximately 5 years (Duration of complete response by blinded independent central review and by investigator per IMWG criteria);Overall survivalTimepoint: For approximately 5 years (time from randomization until death due to any cause);Frequency of adverse eventsTimepoint: Up to 90 days after last dose;Frequency of laboratory abnormalitiesTimepoint: Assessed for up to approximately 5 years;Pre and post dose concentrations of elranatamabTimepoint: Assessed approximately every 1 to 3 cycles (each cycle approximately 28 days) - total Assessed for up to approximately 5 years;Progression Free Survival 2Timepoint: Assessed for up to approximately 5 year (Progression Free Survival to the date of second objective disease progression by investigator per IMWG response criteria) | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Netherlands, Norway, Poland, Republic of Korea, Spain, Sweden, Taiwan, Turkey, United States of America
Contacts
Public ContactDr Seema Pai
Pfizer Limited
Outcome results
None listed