AN OPEN-LABEL, 2-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) + DARATUMUMAB + LENALIDOMIDE VERSUS DARATUMUMAB + BORTEZOMIB + LENALIDOMIDE + DEXAMETHASONE IN TRANSPLANT-INELIGIBLE PARTICIPANTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
Summary
Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity. The main purpose of the study is to evaluate if the combination of Elranatamab, Daratumumab and Lenalidomide offers superior clinical benefit compared with the combination of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in people with newly diagnosed multiple myeloma. There are 2 parts to this study. Part 1 will characterize the safety and tolerability of elranatamab in combination with daratumumab and lenalidomide or in combination with lenalidomide and will identify the optimal dose(s) of the combination regimen. Part 2 of the study will evaluate the rate of minimal residual disease (MRD) negative CR and the progression free survival (PFS) of the combination of elranatamab, daratumumab, and lenalidomide compared with the combination of daratumumab, bortezomib, lenalidomide, and dexamethasone in participants with newly diagnosed multiple myeloma.
Arms & interventions
- DrugElranatamab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
- DrugDaratumumab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
- DrugLenalidomide
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
- DrugDexamethasone
Randomized
- DrugBortezomib
Randomized
Outcome measures
Primary
Part 1 Dose Limiting Toxicity
Time frame: From the first dose of elranatamab/first full dose in combination with EDR until 28 days (+/- visit window) from the first administration of elranatamab with daratumumab and lenalidomide
Part 2: Progression free survival per IMWG
Time frame: From randomization up to 97 months.
Part 2: Minimal Residual Disease negative CR rate
Time frame: At 12 months after randomization
Secondary
Overall Survival
Time frame: From date of randomization up to 97 months
Overall minimal residual disease negative CR rate
Time frame: From date of randomization up to 97 months
Sustained MRD negative CR rate (Part 2)
Time frame: From date of randomization up to 97 months
Duration of minimal residual disease negative CR (Part 2)
Time frame: From date of minimal residual disease negative CR status up to 97 months
PFS by investigator
Time frame: From date of randomization up to 97 months
PFS2 by investigator (Part 2)
Time frame: From the date of randomization up to 97 months
Objective Response Rate
Time frame: From the date of randomization up to 97 months
Complete Response Rate
Time frame: From the date of randomization up to 97 months
Time to Response
Time frame: From the date of randomization to date of confirmed objective response up to 97 months
Duration of Response
Time frame: From the date of confirmed objective response up to 97 months
Duration of Complete Response
Time frame: From the date of confirmed complete response up to 97 months
Frequency of treatment-emergent adverse events
Time frame: From the date of first dose of study intervention up to 97 months
Frequency of abnormal laboratory results
Time frame: From the date of first dose of study intervention up to 97 months
Pharmacokinetics of elranatamab when used in the elranatamab + daratumumab + lenalidomide or elranatamab + lenalidomide combinations
Time frame: From date of first dose of study intervention up to 97 months
Incidence of Anti-Drug Antibody against elranatamab
Time frame: From date of first dose of study intervention up to 97 months
Pharmacokinetics of daratumumab and lenalidomide when used in the elranatamab+daratumumab+lenalidomide or elranatamab+lenalidomide combinations (Part 1)
Time frame: From date of first dose of study intervention up to 97 months
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (Part 2)
Time frame: From date the informed consent is signed up to 97 months
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Myeloma 20 (Part 2)
Time frame: From date the informed consent is signed up to 97 months
Eligibility criteria
Study locations (10)
MSK Basking Ridge
Basking Ridge, New Jersey, 07920
MSK Monmouth
Middletown, New Jersey, 07748
MSK Bergen
Montvale, New Jersey, 07645
MSK Commack
Commack, New York, 11725
MSK Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York, New York, 10021
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, 10065
Memorial Sloan Kettering Cancer Center-Main Campus
New York, New York, 10065
MSK Nassau
Uniondale, New York, 11553
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030