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NCT05317416 · ClinicalTrials.gov registry record · Phase 3
Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant
A Phase 3 study of Multiple Myeloma, sponsored by Pfizer.
- Active
- Registry status
- Phase 3
- Development phase
- 811
- Enrollment target
- 20
- Study locations
NCT05317416: Active Phase 3 study of Multiple Myeloma, sponsored by Pfizer.
NCT05317416 is a Phase 3 study of Multiple Myeloma that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 811 participants, above the 545-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (49% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05317416, a Phase 3 study of Multiple Myeloma, is active but no longer recruiting, sponsored by Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 811 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years
Primary Outcome
Progression Free Survival assessed by Blinded Independent Central review per IMWG response criteria
Conditions Studied
Interventions
- DRUG Lenalidomide
- DRUG Elranatamab
Study Locations (20)
California
- Ronald Reagan UCLA Medical Center - Los Angeles
- UCLA Department of Medicine - Hematology/Oncology - Los Angeles
- UCLA Hematology/Oncology - Los Angeles
- UCLA Hematology/Oncology - Santa Monica - Los Angeles
- Santa Monica UCLA Medical Center & Orthopaedic Hospital - Santa Monica
Arizona
- Banner Gateway Medical Center - Gilbert
- Banner Gateway Medical Pavilion - Gilbert
- Banner MD Anderson Cancer Center - Gilbert
New York
- WMCHealth Advanced Physician Services - Hawthorne
- Westchester Medical Center - Valhalla
Ohio
- Cleveland Clinic - Cleveland
- OhioHealth Arthur G.H. Bing, MD, Cancer Center - Columbus
District of Columbia
- Georgetown University Medical Center - Washington D.C.
Florida
- Miami Cancer Institute at Baptist Health, Inc. - Miami
Georgia
- Winship Cancer Institute, Emory University - Atlanta
Illinois
- Loyola University Chicago - Maywood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 811 participants |
| Start Date | 2022-03-25 |
| Est. Completion | 2029-10-31 |
| Phase | Phase 3 |
What the registry record for NCT05317416 still lists
NCT05317416 is an interventional study that assigns participants to a tested intervention. The registered 811 participants enrollment target is mid-sized for trials with a published cap, above the 545-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (49% higher).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 2 interventions - of which Lenalidomide is the first listed.
NCT05317416 names 20 study sites across 12 states, led by California, Arizona, New York.
Frequently Asked Questions
What is clinical trial NCT05317416 about?
NCT05317416 is a clinical study titled "Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant". The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants...
What is the current status of trial NCT05317416?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 811 participants. The study started on 2022-03-25. Estimated completion is 2029-10-31.
What conditions does trial NCT05317416 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT05317416?
The interventions under investigation include: Lenalidomide (DRUG), Elranatamab (DRUG).
Who is sponsoring clinical trial NCT05317416?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05317416 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05317416's enrollment target sits among peer trials
811 27th of 438 higher than 412 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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