Access to Elranatamab for Multiple Myeloma Patients
ELRANATAMAB POST TRIAL ACCESS: AN OPEN-LABEL, SINGLE-ARM STUDY FOR PARTICIPANTS WITH MULTIPLE MYELOMA CONTINUING FROM PFIZER-SPONSORED ELRANATAMAB CLINICAL STUDIES
PHASE4 · Pfizer · NCT06057402
This study is providing continued access to the treatment elranatamab for people with Multiple Myeloma who have already seen benefits from it in earlier trials.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pfizer (industry) |
| Drugs / interventions | elranatamab |
| Locations | 15 sites (Fort Collins, Colorado and 14 other locations) |
| Trial ID | NCT06057402 on ClinicalTrials.gov |
What this trial studies
This is an open-label, single-arm study providing post-trial access to elranatamab for participants with Multiple Myeloma who have previously benefited from this treatment in earlier studies. Participants will continue receiving elranatamab until their disease progresses, they experience unacceptable side effects, withdraw consent, or the drug becomes commercially available in their country. The study aims to ensure ongoing treatment for those who have shown clinical benefit from elranatamab.
Who should consider this trial
Good fit: Ideal candidates are patients who have completed a qualifying Parent Study and are still deriving clinical benefit from elranatamab.
Not a fit: Patients who have not previously participated in a Parent Study or who have discontinued treatment are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide continued access to an effective treatment for patients with Multiple Myeloma.
How similar studies have performed: Other studies involving elranatamab have shown promise, indicating that this approach may build on existing positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must agree to follow the reproductive criteria as outlined in the protocol * Participants have completed a qualifying Parent Study, were still receiving elranatamab when the Parent Study terminated or completed, and are deriving clinical benefit from elranatamab (as determined by the investigator). Exclusion Criteria: * Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. * Participants not previously enrolled or who have discontinued study treatment in a Parent Study are ineligible for participation in this study.
Where this trial is running
Fort Collins, Colorado and 14 other locations
- 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)
- Longs Peak Hospital — Longmont, Colorado, United States (RECRUITING)
- UCHealth Longs Peak Medical Center — Longmont, Colorado, United States (RECRUITING)
- UCHealth - Medical Center of the Rockies — Loveland, Colorado, United States (RECRUITING)
- University of Miami Hospital and Clinics Deerfield Beach — Deerfield Beach, Florida, United States (RECRUITING)
- University of Miami Hospital and Clinics - Griffin Cancer Research Building — Miami, Florida, United States (RECRUITING)
- St. David's South Austin Medical Center — Austin, Texas, United States (RECRUITING)
- Slade Pharmacy — Richmond, Victoria, Australia (NOT_YET_RECRUITING)
- Cross Cancer Institute — Edmonton, Alberta, Canada (RECRUITING)
- Peking University Third Hospital — Beijing, Beijing Municipality, China (ACTIVE_NOT_RECRUITING)
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (ACTIVE_NOT_RECRUITING)
- Shandong Provincial Hospital — Jinan, Shandong, China (RECRUITING)
- National Taiwan University Hospital — Taipei, Taiwan (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.
Conditions: Multiple Myeloma, Elranatamab, Post Trial Access, Roll-over Study, Extension Study, MM-15, MagnetisMM15, BCMA