Effects of Elranatamab and Iberdomide in Patients with Multiple Myeloma
A PHASE 1B, OPEN-LABEL STUDY OF ELRANATAMAB IN COMBINATION WITH IBERDOMIDE IN PARTICIPANTS WITH RELAPSED REFRACTORY MULTIPLE MYELOMA
This study is testing a new combination of two medications, elranatamab and iberdomide, to see if they are safe and effective for people with multiple myeloma who have not responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 87 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Drugs / interventions | elranatamab |
| Locations | 21 sites (Deerfield Beach, Florida and 20 other locations) |
| Trial ID | NCT06215118 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and tolerability of elranatamab when combined with iberdomide in patients with relapsed or refractory multiple myeloma. It consists of two parts: the first part assesses the safety and tolerability of the combination, while the second part determines the optimal dosage for patients. Participants will receive elranatamab via subcutaneous injection and iberdomide orally over 28-day cycles until disease progression, unacceptable side effects, or withdrawal from the study. The study focuses on patients who have previously undergone multiple lines of therapy for their condition.
Who should consider this trial
Good fit: Ideal candidates are adults with a prior diagnosis of multiple myeloma who have received multiple lines of therapy and have measurable disease.
Not a fit: Patients with plasma cell leukemia, smoldering multiple myeloma, or other specified conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this combination therapy could provide a new treatment option for patients with relapsed or refractory multiple myeloma.
How similar studies have performed: Other studies have shown promise with similar combination therapies in treating multiple myeloma, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Deerfield Beach, Florida and 20 other locations
- University of Miami Hospital and Clinics Deerfield Beach — Deerfield Beach, Florida, United States (Not_yet_recruiting)
- University of Miami Hospital and Clinics — Miami, Florida, United States (Not_yet_recruiting)
- Indiana University Health University Hospital — Indianapolis, Indiana, United States (Recruiting)
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center (IUSCCC) — Indianapolis, Indiana, United States (Recruiting)
- University of Maryland — Baltimore, Maryland, United States (Recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Dana-Farber Cancer Institute - Chestnut Hill — Newton, Massachusetts, United States (Recruiting)
- University of Massachusetts Chan Medical School — Worcester, Massachusetts, United States (Not_yet_recruiting)
- Oncology Hematology West P.C. dba Nebraska Cancer - Methodist — Omaha, Nebraska, United States (Recruiting)
- Oncology Hematology West P.C. dba Nebraska Cancer Specialists — Omaha, Nebraska, United States (Recruiting)
- MSK Basking Ridge — Basking Ridge, New Jersey, United States (Recruiting)
- MSK Commack — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy — Long Island City, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street). — New York, New York, United States (Recruiting)
- Liverpool Hospital — Liverpool, New South Wales, Australia (Recruiting)
- Townsville University Hospital — Douglas, Queensland, Australia (Recruiting)
- Epworth Hospital — Richmond, Victoria, Australia (Recruiting)
- Slade Pharmacy — Richmond, Victoria, Australia (Recruiting)
- CIUSSS de l'Est-de-l'Île-de-Montréal — Montreal, Quebec, Canada (Recruiting)
- Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer — Sherbrooke, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.