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A PHASE 1B, OPEN-LABEL STUDY OF ELRANATAMAB IN COMBINATION WITH CARFILZOMIB PLUS DEXAMETHASONE AND ELRANATAMAB IN COMBINATION WITH PF-07901801 IN PARTICIPANTS WITH RELAPSED REFRACTORY MULTIPLE MYELOMA
The main purpose of the study is to evaluate the safety and tolerability of the combination of elranatamab and carfilzomib and dexamethasone or elranatamab and maplirpacept. There are 2 parts to this study. Part 1 will evaluate the safety and tolerability of elranatamab when given in combination with carfilzomib plus dexamethasone. Part 2 has 2 arms. The first will evaluate the safety and tolerability of elranatamab when given in combination with maplirpacept. The second will identify the optimal dose(s) of elranatamab plus maplirpacept. All study medicines are given over 4-week cycles. Everyone taking part in this study will receive elranatamab as a shot under the skin. Participants in Part 1 will also receive weekly carfilzomib as an IV infusion (given directly into a vein) and dexamethasone either by mouth (as a pill) or by IV infusion. Participants in Part 2 will receive elranatamab in combination with maplirpacept as an IV infusion (given directly into a vein) The investigators will examine the experiences of people receiving the study medicines. This will help determine if the study medicines are safe and can be used for multiple myeloma treatment. Participants will take part in this study for about 2 years after the first dose.
Eligibility Criteria
Inclusion Criteria
- 1Prior diagnosis of multiple myeloma as defined by IMWG criteria.
- 2Measurable disease based on IMWG criteria as defined by at least 1 of the following:
- 3Serum M-protein ≥0.5 g/dL.
- 4Urinary M-protein excretion ≥200 mg/24 hours.
- 5Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\<0.26 or \>1.65).
- 6Part 1: Received at least 1 but not more than 3 prior lines of therapy for multiple myeloma (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 line of therapy).
- 7Part 2: Received at least 3 prior lines of therapy for multiple myeloma who are refractory to at least one IMiD, one PI and one anti-CD38 antibody.
- 8ECOG performance status 0-1.
- 9Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
- 10Not pregnant or breastfeeding and willing to use contraception.
Exclusion Criteria
- 1Plasma cell leukemia, Smouldering MM, Waldenströms macroglobulinemia, Amyloidosis, POEMS Syndrome, Primary refractory MM
- 2Impaired cardiovascular function or clinically significant cardiovascular diseases.
- 3Participants with any active, uncontrolled bacterial, fungal, or viral infection.
- 4Stem cell transplant within 12 weeks prior to enrollment, or active graft versus host disease.
- 5Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
- 6Part 1: Previous treatment with a BCMA-directed therapy.
- 7Part 2: Previous treatment with any anti-BCMA directed therapy, with the exception of CAR-T. Previous treatment with a CD47-SIRP alpha-directed therapy.
- 8Part 1: Prior treatment with carfilzomib
- 9Live attenuated vaccine within 4 weeks of the first dose of study intervention.
- 10Administration with an investigational product (e.g. drug or vaccine) concurrent with study intervention or within 30 days preceding the first dose of study intervention used in this study.
- 11Any of the following within 3 months of enrollment: erosive esophagitis, treatment resistant peptic ulcer, infectious or inflammatory bowel disease, pulmonary embolism or uncontrolled thromboembolic event.
- 12Intolerance to or participants who have had a severe (Grade ≥3) allergic or anaphylactic reaction to antibodies or therapeutic proteins
Locations
40 sites participating in this study
Emory University Hospital Midtown
Atlanta, Georgia 30308
Emory University Administration Office
Atlanta, Georgia 30322
Emory University Hospital
Atlanta, Georgia 30322