Testing new combinations of medicines for relapsed refractory multiple myeloma
A PHASE 1B, OPEN-LABEL STUDY OF ELRANATAMAB IN COMBINATION WITH CARFILZOMIB PLUS DEXAMETHASONE AND ELRANATAMAB IN COMBINATION WITH PF-07901801 IN PARTICIPANTS WITH RELAPSED REFRACTORY MULTIPLE MYELOMA
This study is testing new combinations of medicines to see if they can help people with relapsed refractory multiple myeloma who haven't had success with other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Drugs / interventions | CAR-T, elranatamab |
| Locations | 31 sites (Little Rock, Arkansas and 30 other locations) |
| Trial ID | NCT05675449 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and tolerability of elranatamab combined with either carfilzomib and dexamethasone or maplirpacept in patients with relapsed refractory multiple myeloma. The study is divided into two parts: the first part assesses the combination of elranatamab with carfilzomib and dexamethasone, while the second part explores the combination of elranatamab with maplirpacept and aims to determine the optimal dosing. All medications are administered over 4-week cycles, with elranatamab given as a subcutaneous injection and the other drugs delivered via intravenous infusion. This trial seeks to provide new treatment options for patients who have not responded to previous therapies.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with multiple myeloma who have received multiple lines of prior therapy and meet specific eligibility criteria.
Not a fit: Patients with plasma cell leukemia or those who have not received the required prior therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could offer new effective treatment combinations for patients with relapsed refractory multiple myeloma.
How similar studies have performed: Other studies have shown promise with similar combinations of 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. * Urinary M-protein excretion ≥200 mg/24 hours. * Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\<0.26 or \>1.65). * Part 1: Received at least 1 but not more than 3 prior lines of therapy for multiple myeloma (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 line of therapy). * Part 2: Received at least 3 prior lines of therapy for multiple myeloma who are refractory to at least one IMiD, one PI and one anti-CD38 antibody. * ECOG performance status 0-1. * Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1. * Not pregnant or breastfeeding and willing to use contraception. Exclusion Criteria: * Plasma cell leukemia, Smouldering MM, Waldenströms macroglobulinemia, Amyloidosis, POEMS Syndrome, Primary refractory MM * Impaired cardiovascular function or clinically significant cardiovascular diseases. * Participants with any active, uncontrolled bacterial, fungal, or viral infection. * Stem cell transplant within 12 weeks prior to enrollment, or active graft versus host disease. * 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. * Part 1: Previous treatment with a BCMA-directed therapy. * Part 2: Previous treatment with any anti-BCMA directed therapy, with the exception of CAR-T. Previous treatment with a CD47-SIRP alpha-directed therapy. * Part 1: Prior treatment with carfilzomib * Live attenuated vaccine within 4 weeks of the first dose of study intervention. * Administration with an investigational product (e.g. drug or vaccine) concurrent with study intervention or within 30 days preceding the first dose of study intervention used in this study. * Any of the following within 3 months of enrollment: erosive esophagitis, treatment resistant peptic ulcer, infectious or inflammatory bowel disease, pulmonary embolism or uncontrolled thromboembolic event. * Intolerance to or participants who have had a severe (Grade ≥3) allergic or anaphylactic reaction to antibodies or therapeutic proteins
Where this trial is running
Little Rock, Arkansas and 30 other locations
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (Recruiting)
- Beverly Hills Cancer Center — Beverly Hills, California, United States (Recruiting)
- Clinical Research Advisors (Encino Satellite Location) — Encino, California, United States (Recruiting)
- Clinical Research Advisors (Korea Town Satellite Location) — Los Angeles, California, United States (Recruiting)
- Clinical Research Advisors (West Hollywood Satellite Location) — Los Angeles, California, United States (Recruiting)
- Sylvester Comprehensive Cancer Center - Aventura — Aventura, Florida, United States (Recruiting)
- Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center — Coral Gables, Florida, United States (Recruiting)
- Sylvester Comprehensive Cancer Center - Coral Springs — Coral Springs, Florida, United States (Recruiting)
- University of Miami Hospital and Clinics - Deerfield Beach — Deerfield Beach, Florida, United States (Recruiting)
- Sylvester Comprehensive Cancer Center - Hollywood — Hollywood, Florida, United States (Recruiting)
- Sylvester Comprehensive Cancer Center — Miami, Florida, United States (Recruiting)
- University of Miami Hospital And Clinics — Miami, Florida, United States (Recruiting)
- Sylvester Comprehensive Cancer Center - Kendall — Miami, Florida, United States (Recruiting)
- Sylvester Comprehensive Cancer Center - Plantation — Plantation, Florida, United States (Recruiting)
- Emory University Hospital Midtown — Atlanta, Georgia, United States (Recruiting)
- Emory University Hospital — Atlanta, Georgia, United States (Recruiting)
- Winship Cancer Institute — Atlanta, Georgia, United States (Recruiting)
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States (Recruiting)
- Oncology Investigational Drug Service,Department of Pharmacy Services — Baltimore, Maryland, United States (Recruiting)
- The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- MSK Monmouth — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street). — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center - Main Campus — New York, New York, United States (Recruiting)
- Henry-Joyce Cancer Clinic — Nashville, Tennessee, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- Rambam Health Care Campus — Haifa, Israel (Recruiting)
- Division of Hematology Hadassah Medical Center - Ein Kerem — Jerusalem, Israel (Recruiting)
- Hematology Division Davidoff Center, Rabin Medical Center, Beilinson Hospital — Petah Tikva, Israel (Recruiting)
- The Chaim Sheba Medical Center — Ramat-Gan, Israel (Recruiting)
- Tel-Aviv Sourasky Medical Center — Tel Aviv, Israel (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.