NCT06215118 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 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Pfizer |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 87 participants |
| Start Date | 2024-02-20 |
| Primary Completion | 2027-04-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 87 participants in total. It began in 2024-02-20 with a primary completion date of 2027-04-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT06215118 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06215118 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06215118 currently recruiting?
Yes, NCT06215118 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT06215118 trial being conducted?
This trial is being conducted at Coral Gables, United States, Deerfield Beach, United States, Doral, United States, Miami, United States and 11 additional locations.
Who is sponsoring the NCT06215118 clinical trial?
NCT06215118 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 87 participants.