A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in People With Relapsed Refractory Multiple Myeloma MAGNETISMM-20
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What's the purpose of this trial?

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.

This trial is currently open and accepting patients.

What will happen during the trial?

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.

You may be able to join this trial if you:

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.

Inclusion Criteria:

  • Prior diagnosis of multiple myeloma as defined by IMWG criteria.
  • Measurable disease based on IMWG criteria as defined by at least 1 of the following:
    • Serum M-protein ≥0.5 g/dL.
    • Urinary M-protein excretion ≥200 mg/24 hours.
    • Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
  • 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).
  • ECOG performance status 0-1.
  • Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
  • Not pregnant and willing to use contraception.
  • Prior therapy with carfilzomib is allowed as long as the participant had (all apply): responded to most recent therapy with carfilzomib; Carfilzomib was not discontinued due to toxicity; Did not relapse within 60 days from discontinuation of carfilzomib; Will have at least a 6-month carfilzomib treatment-free interval from last dose received until first study treatment.

Exclusion Criteria:

  • Plasma cell leukemia, Smouldering MM, Waldenströms macroglobulinemia, Amyloidosis, POEMS Syndrome, Primary refractory MM
  • Impaired cardiovascular function or clinically significant cardiovascular diseases.
  • Participants with any active, uncontrolled bacterial, fungal, or viral infection.
  • Stem cell transplant within 12 weeks prior to enrollment, or active graft versus host disease.
  • Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
  • Previous treatment with a BCMA-directed therapy.
  • Live attenuated vaccine within 4 weeks of the first dose of study intervention.
  • Administration 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.
  • Any 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.
  • Participants who are unable to tolerate carfilzomib due to suspected carfilzomib-related congestive heart failure or thrombotic microangiopathy.

Additional Trial Information

Phase 1

Enrollment: 90 patients (estimated)

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Published Results

Efficacy of Elranatamab (ELRA) in Combination with Carfilzomib (CFZ) and Dexamethasone (DEX) in the Phase 1b MagnetisMM-20 Trial in Relapsed or Refractory Multiple Myeloma (RRMM)

December 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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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arkansas

University of Arkansas for Medical Sciences (UAMS)

Little Rock, AR

Open and Accepting

California

Beverly Hills Cancer Center

Beverly Hills, CA

Open and Accepting

Florida

Sylvester Comprehensive Cancer Center University of Miami - Aventura

Aventura, FL

Open and Accepting

Sylvester Comprehensive Cancer Center University of Miami

Coral Gables, FL

Open and Accepting

Sylvester Comprehensive Cancer Center

Coral Springs, FL

Open and Accepting

Sylvester Comprehensive Cancer Center University of Miami

Deerfield Beach, FL

Open and Accepting

Sylvester Comprehensive Cancer Center at Hollywood

Hollywood, FL

Open and Accepting

Sylvester Comprehensive Cancer Center (Main) University of Miami Health System

Miami, FL

Open and Accepting

Sylvester Comprehensive Cancer Center University of Miami - Kendall

Miami, FL

Open and Accepting

University of Miami - Sylvester Comprehensive Cancer Center - Plantation

Plantation, FL

Open and Accepting

Georgia

Winship Cancer Institute Emory University

Atlanta, GA

Open and Accepting

Emory University Winship Cancer Institute - Midtown

Atlanta, GA

Open and Accepting

Iowa

Holden Comprehensive Cancer Center - University of Iowa University of Iowa Hospitals and Clinics

Iowa City, IA

Open and Accepting

Maryland

Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Medicine

Baltimore, MD

Open and Accepting

Massachusetts

Massachusetts General Hospital

Boston, MA

Open and Accepting

New Jersey

Memorial Sloan Kettering Basking Ridge

Basking Ridge, NJ

Open and Accepting

Memorial Sloan Kettering Monmouth

Middletown, NJ

Open and Accepting

Memorial Sloan Kettering Bergen

Montvale, NJ

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

Memorial Sloan Kettering Commack

Commack, NY

Open and Accepting

Memorial Sloan Kettering Nassau

Uniondale, NY

Open and Accepting

Memorial Sloan Kettering Westchester

West Harrison, NY

Open and Accepting

Tennessee

Vanderbilt-Ingram Cancer Center Henry-Joyce Cancer Clinic

Nashville, TN

Open and Accepting
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