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)
NCT ID: NCT06215118
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
87 participants
INTERVENTIONAL
2024-02-20
2028-03-09
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1 Dose Escalation
Non-randomized elranatamab plus iberdomide
Elranatamab
BCMA-CD3 bispecific antibody
Iberdomide
cereblon-modulating agent
Part 2 Dose Randomization
Randomized elranatamab plus iberdomide
Elranatamab
BCMA-CD3 bispecific antibody
Iberdomide
cereblon-modulating agent
Interventions
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Elranatamab
BCMA-CD3 bispecific antibody
Iberdomide
cereblon-modulating agent
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Winship Cancer Institute
Atlanta, Georgia, United States
Indiana CTSI Clinical Research Center (ICRC)
Indianapolis, Indiana, United States
Indiana University Health University Hospital
Indianapolis, Indiana, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center (IUSCCC)
Indianapolis, Indiana, United States
University of Maryland
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Dana-Farber Cancer Institute - Chestnut Hill
Newton, Massachusetts, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
Methodist Hospital
Omaha, Nebraska, United States
Oncology Hematology West P.C. dba Nebraska Cancer - Methodist
Omaha, Nebraska, United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
MSK Basking Ridge
Basking Ridge, New Jersey, United States
MSK Monmouth
Middletown, New Jersey, United States
MSK Bergen
Montvale, New Jersey, United States
MSK Commack
Commack, New York, United States
MSK Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
Long Island City, New York, United States
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York, New York, United States
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, United States
MSK Nassau
Uniondale, New York, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
University of Washington
Seattle, Washington, United States
Liverpool Hospital
Liverpool, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Townsville University Hospital
Douglas, Queensland, Australia
Epworth Freemasons
East Melbourne, Victoria, Australia
Epworth Hospital
Richmond, Victoria, Australia
Slade Pharmacy
Richmond, Victoria, Australia
Dr. Everett Chalmers Regional Hospital
Fredericton, New Brunswick, Canada
CIUSSS de l'Est-de-l'Île-de-Montréal
Montreal, Quebec, Canada
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer
Sherbrooke, Quebec, Canada
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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MagnetisMM-30
Identifier Type: OTHER
Identifier Source: secondary_id
C1071030
Identifier Type: -
Identifier Source: org_study_id