Multiple Myeloma
Conditions
Interventions
Part 1 Dose Level 1:Elranatamab, Daratumumab, Lenalidomide
Part 1 Multiple Dose Levels :Elranatamab, Daratumumab, Lenalidomide
Part 2 Randomized Arm A:Elranatamab, Daratumumab,Lenalidomide
Part 2 Ran
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: *Diagnosis of multiple myeloma (MM) as defined by IMWG criteria (Rajkumar et al., 2014) *Measurable disease based on IMWG criteria as defined by at least 1 of the following: *Serum M-protein >=0.5 g/dL (Part 1) and >=1 g/dL (Part 2); *Urinary M-protein excretion >=200 mg/24 hours; *Involved FLC >-10 mg/dL (>=100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (1.65). *Part 1: Participants with relapsed/refractory multiple myeloma (RRMM) who have received 1-2 prior lines of therapy including at least one immunomodulatory drug and one proteasome inhibitor: or participants with newly-diagnosed multiple myeloma (NDMM) that are transplant-ineligible as defined by age >=65 years or transplant-ineligible as defined by age <65 years with comorbidities impacting the possibility of transplant. *Part 2: participants with newly-diagnosed multiple myeloma that are transplant-ineligible defined as: *Participants not considered candidates for high-dose chemotherapy and ASCT due to age or *Participants with important comorbidities likely to have a negative impact on tolerability of high dose chemotherapy and ASCT. *ECOG performance status <=2. *Not pregnant and willing to use contraception *For participants with RRMM: Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade <=1.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: *Smoldering Multiple Myeloma. *Monoclonal gammopathy of undetermined significance. *Waldenstroms Macroglobulinemia *Plasma cell leukemia. *Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) COVID-19/SARS-CoV-2, HBV, HCV, and known HIV or AIDS-related illness. *Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or Stage 0/1 with minimal risk of recurrence per investigator. *For participants with RRMM: Previous treatment with a BCMA-directed therapy or anti-CD38-directed therapy within 6 months preceding the first dose of study intervention in this study. Stem cell transplant =20 mg of dexamethasone during screening. *Live attenuated vaccine administered within 4 weeks of the first dose of study intervention. *Administration of investigational product (eg, drug or vaccine) concurrent with study intervention or within 30 days (or as determined by the local requirement) preceding the first dose of study intervention used in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome Measures : *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
| Measure | Time frame |
|---|---|
| Secondary Outcome Measures : *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] *Predose and post dose concentrations of elranatamab *Incidence of Anti-Drug Antibody against elranatamab [Time Frame: From date of first dose of study intervention up to 97 months] *Immunogenicity of elranatamab *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 inte | — |
Countries
Australia, Canada, China, Czechia, France, Germany, Greece, Israel, Italy, Japan, Korea, Republic of, Netherlands, Poland, Spain, Switzerland, Taiwan
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed