The goal of this study is to evaluate the best dose, safety, and effectiveness of elranatamab when combined with carfilzomib and dexamethasone, and to evaluate the best dose, safety and effectiveness of PF-07901801 (maplirpacept)when combined with elranatamab in participants with relapsed/refractory multiple myeloma.
This trial is currently open and accepting patients.
This clinical trial is organized into three different parts. This trial is open-label, which means that the participants and study team will know which part they are enrolled in, and which drugs/doses they will be receiving. Participants will be enrolled in only one part of the study, and will not be allowed to participate in other parts (rollover).
In Part 1, researchers will evaluate the safety and best dose of elranatamab when combined with carfilzomib and dexamethasone. In Arm A of Part 2, researchers will evaluate the safety and best dose of PF-07901801 (maplirpacept) both by itself, and in combination with elranatamab. In Arm B of Part 2, researchers will give participants the doses of elranatamab and PF-07901801 (maplirpacept) determined to be safest and most effective by the previous groups.
The total length of this study can be 2 years or longer. You will continue to receive the study medicines until your multiple myeloma has progressed, you experience side effects that are hard to manage, or you choose to stop receiving the study medicines. You are free to stop being in the study at any time and for any reason; this will not affect your future medical care in any way.
The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.
Phase 1
Enrollment: 90 patients (estimated)
View MoreDecember 09, 2024
Results: Of the 12 treated pts in part 1, the median age was 66.0 years (range, 45.0-80.0), 8 (66.7%) were male, none had extramedullary disease, 3 (25.0%) had high-risk cytogenic abnormalities, 4 (33.3%) had ISS stage III, and 8 (66.7%) had <30% baseline bone marrow plasma cells. Eight pts (66.7%) had Revised International Staging System disease stage I or II (unknown for 2 pts [16.7%]). Pts had a median of 2 prior lines of therapy (range, 1-3), and 41.7% had triple-class refractory disease. No pts had a stem cell transplant. At the time of data cutoff (February 22, 2024), 91.7% of pts were ongoing ELRA and CFZ tx, with DEX tx ongoing in 66.7% of pts. Median tx duration was 3.15 months (range, 0.56-13.37).
Among the 10 pts evaluable for DLTs, none were reported at DL1 or DL2. In the safety analysis population (n=12), the most common adverse events (any grade [≥50%], grade 3/4 [≥10%]) were fatigue (83.3%, 8.3%), CRS (75.0%, 0%), neutropenia (58.3%, 33.3%), thrombocytopenia (58.3%, 25.0%), injection site reaction (50.0%, 0%), leukopenia (50.0%, 16.7%), anemia (41.7%, 25.0%), lymphopenia (33.3%, 25.0%), peripheral edema (33.3%, 16.7%), increased blood alkaline phosphatase (25.0%, 16.7%), and pulmonary embolism (16.7%, 16.7%). Infections were reported in 75.0% of the pts, all grade 1/2. No ICANS was reported in any pt.
At a median follow-up of 3.24 months (range, 1.51-13.47), the unconfirmed ORR by investigator was 100%. Ten pts (83.3%) had confirmed ORR by investigator with a median TTR of 1.41 months (95% CI, 0.53-3.35). Median DOR was not reached.
Conclusions: ELRA + CFZ + DEX has demonstrated clinical efficacy and predictable safety signals. The study continues enrolling and will explore the combination of ELRA + CFZ + DEX in a larger group of pts.
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Miami, FL
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