A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135) and Iberdomide in Patients With Relapsed or Refractory Multiple Myeloma (MagnetisMM-30)

Recruiting now · Phase 1

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT06215118

Run by

Pfizer

People needed

87

Starts

2024-02-20

Expected to finish

2028-03-09

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center — Coral Gables, Florida, United States (enrolling)
• University of Miami Hospital and Clinics Deerfield Beach — Deerfield Beach, Florida, United States (enrolling)
• Sylvester Comprehensive Cancer Center- Doral — Doral, Florida, United States (enrolling)
• Sylvester Comprehensive Cancer Center — Miami, Florida, United States (enrolling)
• University of Miami Hospital and Clinics — Miami, Florida, United States (enrolling)
• Sylvester Comprehensive Cancer Center Kendall — Miami, Florida, United States (enrolling)
• Sylvester Comprehensive Cancer Center Plantation — Plantation, Florida, United States (enrolling)
• Emory University Hospital Midtown — Atlanta, Georgia, United States (enrolling)
• Emory University Hospital — Atlanta, Georgia, United States (enrolling)
• Winship Cancer Institute — Atlanta, Georgia, United States (enrolling)
• Indiana CTSI Clinical Research Center (ICRC) — Indianapolis, Indiana, United States (enrolling)
• Indiana University Health University Hospital — Indianapolis, Indiana, United States (enrolling)
• Indiana University Melvin and Bren Simon Comprehensive Cancer Center (IUSCCC) — Indianapolis, Indiana, United States (enrolling)
• University of Maryland — Baltimore, Maryland, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Dana-Farber Cancer Institute - Chestnut Hill — Newton, Massachusetts, United States (enrolling)
• University of Massachusetts Chan Medical School — Worcester, Massachusetts, United States (enrolling)
• Methodist Hospital — Omaha, Nebraska, United States (enrolling)
• Oncology Hematology West P.C. dba Nebraska Cancer - Methodist — Omaha, Nebraska, United States (enrolling)
• Oncology Hematology West P.C. dba Nebraska Cancer Specialists — Omaha, Nebraska, United States (enrolling)
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
• MSK Basking Ridge — Basking Ridge, New Jersey, United States (enrolling)
• MSK Monmouth — Middletown, New Jersey, United States (enrolling)
• MSK Bergen — Montvale, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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