MULTIPLE MYELOMA MedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria - Diagnosis of MM as defined according to IMWG criteria (Rajkumar, 2014) History of induction 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 6 months from ASCT. - Partial Response or better according to IMWG criteria at the time of randomization - MRD positive (=10^-5) at screening by central laboratory NGS test (ClonoSEQ assay) Must have an archival bone marrow aspirate sample(s) that identified the dominant malignant (index) clone 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 183 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 183
Exclusion criteria
Exclusion criteria: Medical Conditions: 1. Plasma cell leukemia 2. POEMS syndrome 3. Systemic amyloid light chain amyloidosis 4. Impaired cardiovascular function or clinically significant cardiovascular diseases, defined as any of the following within 6 months prior to enrollment: • Acute myocardial infarction or acute coronary syndromes (eg, unstable angina, coronary artery bypass graft, coronary angioplasty or stenting, symptomatic pericardial effusion); • Clinically significant cardiac arrhythmias (eg, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia); • Thromboembolic or cerebrovascular events (eg, transient ischemic attack, cerebrovascular accident, deep vein thrombosis [unless associated with a central venous access complication] or pulmonary embolism); • Prolonged QT syndrome or QTcF =470 msec at screening. 5. Ongoing Grade = 3 peripheral sensory or motor neuropathy 6. History of GBS or GBS variants, or history of any Grade =3 peripheral motor polyneuropathy 7. Live attenuated vaccine within 4 weeks of the first dose. 8. Known or suspected hypersensitivity to the study interventions or any of its excipients. 9. 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. 10. Other surgical (including major surgery within 14 days prior to enrollment), medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study. Prior/Concomitant Therapy: 11. Previous MM maintenance treatment 12. Prior treatment with BCMA targeted therapy Prior/Concurrent Clinical Study Experience: 13. 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). Diagnostic Assessments: 14. Serum pregnancy test (for females of childbearing potential) positive at screening. 15. Participants with active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, and known HIV or AIDS-related illness.. Other Exclusions: 16. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members. Exclusion Criteria - Plasma cell leukemia - POEMS syndrome - Systematic amyloid light chain amyloidosis - Previous MM maintenance treatment - Prior treatment with BCMA targeted therapy - 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 - 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 |
|---|---|
| Main Objective: To compare the efficacy of elranatamab (Arm A) versus lenalidomide (Arm B);Secondary Objective: Secondary Objectives: • To compare the efficacy of Arm A vs Arm B • To determine the safety and tolerability of elranatamab • To evaluate the PK of elranatamab • To evaluate the immunogenicity of elranatamab • To evaluate the impact of study intervention on participant health-related quality of life (HRQoL);Primary end point(s): • MRD negativity rate per IMWG as assessed via NGS • PFS by BICR per IMWG;Timepoint(s) of evaluation of this end point: MRD negativity rate - 12 months after randomization per IMWG as assessed via NGS PFS - Assessed approximately every 28 days and for approximately 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • PFS by investigator per IMWG • Overall MRD negativity rate per IMWG • Duration of MRD negativity per IMWG • Sustained MRD negativity per IMWG • CRR by BICR and investigator per IMWG • DOCR by BICR and investigator per IMWG • OS • AEs and laboratory abnormalities as graded by NCI CTCAE v5.0. • Severity of CRS and ICANS assessed according to ASTCT criteria (Lee et al, 2019). • Pre- and postdose concentrations of elranatamab • ADAs and NAbs against elranatamab • EORTC QLQ-C30+MY20;Timepoint(s) of evaluation of this end point: • PFS - Assessed approx. every 28 days and for approx. 5 years • MRD negativity rate (Overall, Duration and Sustained) - Assessed every 6 months and for approx. 5 years • CRR & DOCR - Assessed approximately every 28 days and for approx. 5 years • OS - Assessed For approx. 5 years • AEs and laboratory abnormalities - Up to 90 days after last dose for AE frequency and at every cycle (each cycle ~ 28 days) for lab abnormalities • Severity of CRS and ICANS - Assessed at every cycle • Pre- and post-dose concentrations of elranatamab - Assessed approx. every 1 - 3 cycles • ADAs and NAbs against elranatamab - Assessed approx. every 1 to 6 cycles • EORTC QLQ-C30+MY20 - Assessed every cycle for year 1, every 3 cycles for year 2 and then once every 6 cycles | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, Czechia, Czech Republic, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Netherlands, Norway, Poland, Russian Federation, Spain, Sweden, Taiwan, Turkey, United States
Contacts
Public ContactClinicalTrials.gov Call Center
Pfizer Inc.
Outcome results
None listed