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: - Diagnosis of MM as defined according to IMWG criteria (Rajkumar, 2014) - with measurable disease at diagnosis as defined by serum M protein =0.5 g/dL (5 g/L), by urine M protein =200 mg/24 hours, or by serum FLC assay with involved FLC level =10 mg/dL, provided serum FLC ratio is abnormal. -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 7 months from ASCT. Screening tests should be performed after the last dose of consolidation. - Partial Response or better according to IMWG criteria at the time of randomization - Identification of the dominant malignant (index) clone as assessed by central laboratory NGS test (Adaptive Biotechnologies clonoSEQ® assay or as described in Appendix 10.9.6). - 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. - A bone marrow aspirate sample collected at screening is required to determine MRD status. - 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 380 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 380
Exclusion criteria
Exclusion criteria: - Plasma cell leukemia - Amyloidosis, Waldenström’s macroglobulinemia, or 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 enrolment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ or Stage 0/1 with minimal risk of recurrence per the investigator. - Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, and known HIV or AIDS-related illness. Active Infection must be resolved at least 21 days prior to enrollment. Patients treated with systemic anti-infectious agents within 28 days prior to enrollment are not eligible. Prophylactic use of systemic agents is permitted. - 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 versus lenalidomide;Secondary Objective: Secondary Objectives: • To compare the efficacy of elranatamab versus lenalidomide • 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): • PFS by BICR per IMWG;Timepoint(s) of evaluation of this end point: PFS - Assessed approximately every 28 days and for approximately 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •OS •MRD negativity rate at 12 months after randomization per IMWG as assessed via NGS PFS by investigator per IMWG • Sustained MRD negativity rate at 24 months after randomization as assessed via NGS • 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 • PFS2 by Investigator per IMWG • 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: •OS-For approx. 5 years•MRD negativity rate-12 months after randomization per IMWG as assessed via NGS• MRD negativity rate(Overall, Duration and Sustained)Assessed every 6 months and for approx. 5 years •PFS&PFS2:Assessed approx. every 28 days and for approx. 5 years •CRR&DOCR-Assessed approximately every 28 days and 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 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, Spain, Sweden, Taiwan, Turkey, United States
Contacts
Public ContactClinicalTrials.gov Call Center
Pfizer Inc.
Outcome results
None listed