Combining Elranatamab with Other Cancer Treatments for Multiple Myeloma
A PHASE 1B/2, OPEN LABEL UMBRELLA STUDY OF ELRANATAMAB (PF-06863135), A B-CELL MATURATION ANTIGEN (BCMA) CD3 BISPECIFIC ANTIBODY, IN COMBINATION WITH OTHER ANTI-CANCER TREATMENTS IN PARTICIPANTS WITH MULTIPLE MYELOMA
This study is testing if combining a new cancer drug called elranatamab with other treatments can help people with tough-to-treat multiple myeloma feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Drugs / interventions | elranatamab |
| Locations | 29 sites (Gilbert, Arizona and 28 other locations) |
| Trial ID | NCT05090566 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness and determine the recommended dose of elranatamab when used alongside other anti-cancer therapies in patients with multiple myeloma. Participants must have relapsed or refractory multiple myeloma and have undergone at least three prior lines of therapy. The study will assess clinical benefits and safety profiles of the combination treatments, which include elranatamab with nirogacestat and elranatamab with lenalidomide and dexamethasone.
Who should consider this trial
Good fit: Ideal candidates are adults with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy.
Not a fit: Patients with active plasma cell leukemia, amyloidosis, or those who have had a stem cell transplant within the last 12 weeks may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients with difficult-to-treat multiple myeloma.
How similar studies have performed: Other studies have shown promise with similar combination therapies in multiple myeloma, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Relapsed/refractory multiple myeloma with at least 3 prior lines of therapy * Refractory to at least one IMiD, one proteasome inhibitor, and one anti-CD38 antibody * Measurable disease defined by at least one of the following: 1. Serum M-protein \>/= 0.5 g/dL by SPEP 2. Urinary M-protein excretion \>/= 200 mg/24 hours by UPEP 3. Serum immunoglobulin FLC \>/= 10 mg/dL (\>/= 100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio * ECOG performance status 0 -1 * Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade \</= 1 Exclusion Criteria: * Active plasma cell leukemia * Amyloidosis * Stem cell transplant with 12 weeks prior to enrollment, or active GVHD * POEMS syndrome * Any active uncontrolled bacterial, fungal, or viral infection * Impaired cardiovascular function or clinically significant cardiovascular diseases within 6 months prior to enrollment * Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study treatment (whichever is longer) * Sub-Study A Only: Previous treatment with BCMA bispecific antibody * Sub-Study B Only: Previous treatment with BCMA directed therapy
Where this trial is running
Gilbert, Arizona and 28 other locations
- Banner Gateway Medical Center — Gilbert, Arizona, United States (Recruiting)
- Banner Gateway Medical Pavilion — Gilbert, Arizona, United States (Recruiting)
- Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (Recruiting)
- University of Arkansas for Medical Sciences - Winthrop P. Rockefeller Cancer Institute — Little Rock, Arkansas, United States (Recruiting)
- Beverly Hills Cancer Center — Beverly Hills, California, United States (Recruiting)
- Clinical Research Advisors — Encino, California, United States (Recruiting)
- Clinical Research Advisors — Los Angeles, California, United States (Recruiting)
- Cedars Sinai Medical Center Oncology IDS Pharmacy Attn:Suwicha Limvorasak ,PharmaD — Los Angeles, California, United States (Recruiting)
- Cedars Sinai Medical Center — Los Angeles, California, United States (Recruiting)
- Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute (SOCCI) — Los Angeles, California, United States (Recruiting)
- Clinical Research Advisors — Los Angeles, California, United States (Recruiting)
- Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center — Coral Gables, Florida, United States (Recruiting)
- Sylvester Comprehensive Cancer Center- Deerfield Beach — Deerfield Beach, Florida, United States (Recruiting)
- Sylvester Comprehensive Cancer Center — Miami, Florida, United States (Recruiting)
- UHealth Tower — Miami, Florida, United States (Recruiting)
- UChicago Medicine - River East — Chicago, Illinois, United States (Recruiting)
- University of Chicago Medical Center — Chicago, Illinois, United States (Recruiting)
- UChicago Medicine at Ingalls - Flossmoor — Flossmoor, Illinois, United States (Recruiting)
- UChicago Medicine Ingalls Memorial — Harvey, Illinois, United States (Recruiting)
- University of Chicago Comprehensive Cancer Center at Silver Cross Hospital — New Lenox, Illinois, United States (Recruiting)
- The University of Chicago Medicine Center for Advanced Care Orland Park — Orland Park, Illinois, United States (Recruiting)
- UChicago Medicine at Ingalls - Tinley Park — Tinley Park, Illinois, United States (Recruiting)
- OIDS, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States (Recruiting)
- The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Also Imaging Facility) — Baltimore, Maryland, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
- Arthur J.E. Child Comprehensive Cancer Centre — Calgary, Alberta, Canada (Recruiting)
- The Ottawa Hospital - General Campus — Ottawa, Ontario, Canada (Recruiting)
- Princess Margaret Cancer Centre — Toronto, Ontario, 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.