A Phase 1B, Open-Label Study of Elranatamab in Combination with Iberdomide in Participants with Relapsed Refractory Multiple Myeloma MAGNETISMM-30

What's the purpose of this trial?

The main purpose of the study is to understand how safe and tolerable is elranatamab when given along with iberdomide. There are 2 parts to this study. Part 1 will look at how safe and tolerable is elranatamab when given with iberdomide. Part 2 will look at the correct amount of this combination that can be given to patients with relapsed or refractory multiple myeloma. Myeloma is a type of cancer that begins in plasma cells (white blood cells that produce antibodies). Refractory means a disease or condition that does not respond to treatment. Relapsed means the return of a disease after a period of improvement. All study medicines are given in cycles that last 28 days. Everyone taking part in this study will receive elranatamab as a shot under the skin. Iberdomide will be taken by mouth once a day for 21 days over a 28-day cycle. Participants will receive study medicine until: * their disease progresses or, * they experience unacceptable side effects or, * they choose to no longer take part in the study. The study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and can be used for multiple myeloma treatment.

This trial is currently open and accepting patients.

What will happen during the trial?

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 by SPEP
* Urinary M-protein excretion ≥200 mg/24 hour by UPEP
* Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FL ratio (\<0.26 or \>1.65)
* Part 1: Received 2-4 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor.
* Part 2: Received 1-3 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor.
* ECOG performance status 0-1
* Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1

Exclusion Criteria:

* Plasma cell leukemia, Smoldering multiple myeloma, Waldenström's macroglobulinemia, Amyloidosis, POEMS Syndrome
* Impaired cardiovascular function or clinically significant cardiovascular diseases
* Stem cell transplant within 12 weeks prior to enrollment or active graft vs host disease
* Participants with any active, uncontrolled bacterial, fungal, or viral infection
* 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:
* BCMA-directed or CD3 redirecting therapy
* Iberdomide (CC-220) or Mezigdomide
* Administration of strong inhibitor or inducer of CYP3A4/5 within 2 weeks prior to dosing and during the study
* Administration with an investigational product within 30 days preceding the first dose of study intervention
* Participant is unable or unwilling to undergo protocol required thromboembolism prophylaxis

Additional Trial Information

Phase 1

Enrollment: 87 patients (estimated)

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Published Results

Safety and efficacy of elranatamab in combination with iberdomide in patients with relapsed or refractory multiple myeloma: Results from the phase 1b MagnetisMM-30 trial

December 09, 2025

Of the 22 pts in Part 1 (DL1: 13, DL−1: 9), the median age was 68 y (range, 46-83), 10 (45.5%) were male, 4 (18.2%) had extramedullary disease, 9 (40.9%) had high-risk cytogenetics, defined as t(4;14), t(14;16), or del(17p), 1 (4.5%) had R-ISS stage III, and 2 (9.1%) had ≥50% baseline bone marrow plasma cells. Pts had a median of 2.5 prior LOT (range, 2-4), and 11 (50%) had triple-class refractory disease.

At data cutoff (June 23, 2025), the median (range) ELRA treatment duration was 3.1 mo (0.5-7.2) overall and 6.1 mo (0.5-7.2) for DL1 and 1.9 mo (1.5-3.3) for DL−1. IBER treatment duration was 2.6 mo (0.1-6.7) overall and 5.7 mo (0.1-6.7) for DL1 and 1.6 mo (0.7-3.0) for DL−1. ELRA + IBER was ongoing in 77.3% (DL1: 8, DL−1: 9) of pts.

Four pts had DLTs; 2 in DL1 (1 grade [G]3 anorexia; 1 G4 neutropenia) and 2 in DL−1 (1 G3 febrile neutropenia; 1 G4 neutropenia). Treatment-emergent adverse events (TEAEs) were reported in 100% (G3/4 68.2%) of pts. The most frequent TEAEs (any G ≥45% or G3/4 ≥10%) were cytokine release syndrome (68.2%, all ≤G2), fatigue (63.6%, all ≤G2), neutropenia (59.1%, G3/4 59.1%), diarrhea (45.5%, all ≤G2), anemia (31.8%, G3/4 13.6%), and thrombocytopenia (27.3%, G3/4 13.6%). Infections were reported in 40.9% (G3/4 4.5%) of pts and immune effector cell–associated neurotoxicity syndrome events were reported in 2 pts (9.1%, 1 G1 and 1 G2).

At a median follow-up of 6.1 mo (95% CI, 2.8-7.1), estimated by reverse Kaplan-Meier, the unconfirmed ORR was 90.9% (95% CI, 70.8-98.9) in 20/22 pts; 45.5% (10/22) had CR or better and 68.2% (15/22) had very good partial response or better. The confirmed ORR was 77.3% (17/22) with a median time to response of 1.1 mo (range, 0.5-2.4).

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Trial Locations

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Georgia

Winship Cancer Institute Emory University

Atlanta, GA

Open and Accepting

Emory University Winship Cancer Institute - Midtown

Atlanta, GA

Open and Accepting

Indiana

Simon Cancer Center Indiana University

Indianapolis, IN

Open and Accepting

Maryland

University of Maryland Medical Center Marlene and Stewart Greenebaum Comprehensive Cancer Center

Baltimore, MD

Open and Accepting

Massachusetts

Brigham and Women's Hospital

Boston, MA

Open and Accepting

Dana-Farber Cancer Institute

Boston, MA

Open and Accepting

University of Massachusetts Medical School

Worcester, MA

Open and Accepting

New Hampshire

Dartmouth-Hitchcock Medical Center Norris Cotton Cancer Center

Lebanon, NH

Open and Accepting

New Jersey

Memorial Sloan Kettering Basking Ridge

Basking Ridge, NJ

Recruitment on Hold
Show Arm Statuses
  • Dose Escalation: Active, Not Recruiting

Memorial Sloan Kettering Monmouth

Middletown, NJ

Recruitment on Hold
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  • Dose Escalation: Active, Not Recruiting

Memorial Sloan Kettering Bergen

Montvale, NJ

Recruitment on Hold
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  • Dose Escalation: Active, Not Recruiting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Recruitment on Hold
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  • Dose Escalation: Active, Not Recruiting

Memorial Sloan Kettering Commack

Commack, NY

Recruitment on Hold
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  • Dose Escalation: Active, Not Recruiting

Memorial Sloan Kettering Nassau

Uniondale, NY

Recruitment on Hold
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  • Dose Escalation: Active, Not Recruiting

Memorial Sloan Kettering Westchester

West Harrison, NY

Recruitment on Hold
Show Arm Statuses
  • Dose Escalation: Active, Not Recruiting

Wisconsin

Medical College of Wisconsin Froedtert Hospital

Milwaukee, WI

Not Yet Accepting
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