Evaluating Elranatamab for Relapsed Multiple Myeloma
A PHASE 3, OPEN-LABEL STUDY OF ELRANATAMAB MONOTHERAPY VERSUS ELOTUZUMAB, POMALIDOMIDE, DEXAMETHASONE (EPd) OR POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE (PVd) OR CARFILZOMIB, DEXAMETHASONE (Kd) IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO RECEIVED PRIOR ANTI-CD38 DIRECTED THERAPY
PHASE3 · Pfizer · NCT06152575
This study tests if a new treatment called elranatamab can help people with relapsed multiple myeloma feel better compared to standard therapies they might have already tried.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 492 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pfizer (industry) |
| Drugs / interventions | elranatamab |
| Locations | 131 sites (Mobile, Alabama and 130 other locations) |
| Trial ID | NCT06152575 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of elranatamab, a bispecific antibody targeting B-cell maturation antigen (BCMA), in patients with relapsed multiple myeloma who have previously undergone treatment. Participants will be randomly assigned to receive either elranatamab or a combination of standard therapies selected by the study doctor. The treatment will involve weekly subcutaneous injections of elranatamab, while the combination therapy will include oral medications and injections. The goal is to compare the outcomes of elranatamab against established treatment regimens.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with relapsed multiple myeloma who have received prior treatments including anti-CD38 antibodies and lenalidomide.
Not a fit: Patients with smoldering multiple myeloma or other specific exclusions such as plasma cell leukemia or amyloidosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with relapsed multiple myeloma.
How similar studies have performed: Other studies involving bispecific antibodies targeting BCMA have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Prior diagnosis of multiple myeloma as defined by International Myeloma Working Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy including prior anti-cluster of differentiation 38 (CD38) antibody and prior lenalidomide. * Documented evidence of progressive disease or failure to achieve a response to last line of therapy per IMWG criteria. * Measurable disease defined as at least 1 of the following: (a) Serum M-protein ≥0.5 g/dL; (b) Urinary M-protein excretion ≥200 mg/24 hours; (c) Serum involved immunoglobulin FLC ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\<0.26 or \>1.65). * Have clinical laboratory values within the specified range. * ECOG (Eastern Cooperative Oncology Group) performance status ≤2. * Not pregnant or breastfeeding and willing to use contraception. Exclusion Criteria: * Smoldering multiple myeloma. * Plasma cell leukemia. * Amyloidosis. * Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin abnormalities (POEMS) syndrome. * Known central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement. * Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease. * Any active, uncontrolled bacterial, fungal, or viral infection. * Any other active malignancy within 3 years prior to enrolment (exceptions include, adequately treated basal cell or squamous cell skin cancer, carcinoma in situ) * Previous treatment with a B cell maturation antigen (BCMA)-directed therapy or CD3-redirecting therapy. * Unable to receive investigator's choice therapy. * Live attenuated vaccine within 4 weeks of the first dose of study intervention. * Administration with an investigational product (e.g. drug or vaccine) within 30 days preceding the first dose of study intervention used in this study.
Where this trial is running
Mobile, Alabama and 130 other locations
- Infirmary Cancer Care — Mobile, Alabama, United States (RECRUITING)
- Western Regional Medical Center, Inc. dba. City of Hope Phoenix — Goodyear, Arizona, United States (RECRUITING)
- Beverly Hills Cancer Center — Beverly Hills, California, United States (RECRUITING)
- Clinical Research Advisors (Encino Satellite Location) — Encino, California, United States (RECRUITING)
- University of California San Francisco — Fresno, California, United States (RECRUITING)
- Community Regional Medical Center — Fresno, California, United States (RECRUITING)
- Valkyrie Clinical Trials — Los Angeles, California, United States (RECRUITING)
- Mission Community Hospital (Satellite Site) — Panorama City, California, United States (RECRUITING)
- University of California Davis (UC Davis) Comprehensive Cancer Center — Sacramento, California, United States (RECRUITING)
- UCHealth Poudre Valley Hospital — Fort Collins, Colorado, United States (RECRUITING)
- UCHealth Harmony — Fort Collins, Colorado, United States (RECRUITING)
- UCHealth Greeley Hospital — Greeley, Colorado, United States (RECRUITING)
- UCHealth Longs Peak Hospital — Longmont, Colorado, United States (RECRUITING)
- UCHealth Longs Peak Medical Center — Longmont, Colorado, United States (RECRUITING)
- University of Miami Hospital and Clinics - Griffin Cancer Research Building — Miami, Florida, United States (NOT_YET_RECRUITING)
- Sylvester Comprehensive Cancer Center- Kendall — Miami, Florida, United States (NOT_YET_RECRUITING)
- BRCR Global — Plantation, Florida, United States (RECRUITING)
- BRCR Medical Center Inc — Plantation, Florida, United States (RECRUITING)
- BRCR Global - Tamarac — Tamarac, Florida, United States (RECRUITING)
- Simmons Cancer Institute at SIU — Springfield, Illinois, United States (RECRUITING)
- Springfield Clinic Main Campus — Springfield, Illinois, United States (RECRUITING)
- Springfield Memorial Hospital — Springfield, Illinois, United States (RECRUITING)
- Midwestern Regional Medical Center, Inc. dba City of Hope Chicago — Zion, Illinois, United States (RECRUITING)
- Community Health Network, Inc. — Indianapolis, Indiana, United States (RECRUITING)
- Community Health Network, Inc. — Indianapolis, Indiana, United States (RECRUITING)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (RECRUITING)
- MIVA Medical — Independence, Missouri, United States (RECRUITING)
- Kansas City VA Medical Center — Kansas City, Missouri, United States (NOT_YET_RECRUITING)
- Bryan Medical Center — Lincoln, Nebraska, United States (RECRUITING)
- NHO Revive Research Institute, LLC — Lincoln, Nebraska, United States (RECRUITING)
- WMCHealth Advanced Physician Services — Hawthorne, New York, United States (ACTIVE_NOT_RECRUITING)
- North Shore University Hospital — Manhasset, New York, United States (RECRUITING)
- Long Island Jewish Medical Center — New Hyde Park, New York, United States (RECRUITING)
- Westchester Medical Center — Valhalla, New York, United States (ACTIVE_NOT_RECRUITING)
- Brody school of Medicine at East Carolina University — Greenville, North Carolina, United States (RECRUITING)
- ECU Health Medical Center — Greenville, North Carolina, United States (RECRUITING)
- Oncology Hematology Care Clinical Trials, LLC — Cincinnati, Ohio, United States (RECRUITING)
- TriHealth Cancer Institute-Good Samaritan Hospital — Cincinnati, Ohio, United States (RECRUITING)
- Oncology Hematology Care Clinical Trials, LLC — Cincinnati, Ohio, United States (RECRUITING)
- Oncology Hematology Care Clinical Trials, LLC — Cincinnati, Ohio, United States (RECRUITING)
- Houston Methodist Hospital Cancer Center — Houston, Texas, United States (RECRUITING)
- Houston Methodist Willowbrook Hospital — Houston, Texas, United States (RECRUITING)
- Instituto Alexander Fleming — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina (RECRUITING)
- Hospital Universitario Austral — Pilar, Buenos Aires, Argentina (RECRUITING)
- Hospital Italiano de Buenos Aires — Ciudad de Buenos Aires, Buenos Aires F.D., Argentina (RECRUITING)
- Concord Repatriation General Hospital — Concord, New South Wales, Australia (RECRUITING)
- Sunshine Coast University Hospital — Birtinya, Queensland, Australia (RECRUITING)
- Royal Brisbane and Women's Hospital — Brisbane, Queensland, Australia (RECRUITING)
- Sir Charles Gairdner Hospital, Haematology Clinical Trials — Nedlands, Western Australia, Australia (RECRUITING)
- UZ Brussel — Brussels, Bruxelles-capitale, Région de, Belgium (RECRUITING)
+81 more sites — see ClinicalTrials.gov for the full list.
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.
Conditions: Multiple Myeloma, Elranatamab, B-Cell Maturation Antigen, BCMA, Bispecific antibody, BCMA-CD3 bispecific antibody, Myeloma, Multiple myeloma