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NCT05565391 · ClinicalTrials.gov registry record
A Study to Learn About the Medicine (Called Elranatamab) in People With Relapsed Refractory Multiple Myeloma
A clinical trial, sponsored by Pfizer.
- Completed
- Registry status
- 508
- Enrollment target
NCT05565391: Completed study, sponsored by Pfizer.
NCT05565391 is a clinical trial that has completed, run by Pfizer. The registered enrollment target is 508 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05565391 has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- 508 participants
- Enrollment target
Study Summary
This study is to understand how well elranatamab (PF-06863135) may be used for relapsed refractory multiple myeloma (RRMM). Sometimes MM might improve at first, but then gets resistant to the treatment and starts growing again (known as relapsed refractory). This study medicine will be compared with standard-of-care (SOC) therapies used in real-world clinical practice. For people receiving elranatamab, we will use data from the phase 2 clinical trial (MagnetisMM-3). We will also use data from two real-world databases, representing the SOC in clinical practice. This study does not seek any participants for enrollment. We will compare the experiences of people receiving elranatamab to people receiving SOC therapies. This way, it will help us to know how well elranatamab can be used for RRMM treatment.
Primary Outcome
ORR was the percentage of participants with objective response (OR) per IMWG criteria. For the analysis set of participants from Study C1071003 and COTA, OR was partial response (PR) or better (stringent complete response \[sCR\]+complete response \[CR\]+very good partial response \[VGPR\]+PR). For Study C1071003 and Flatiron Health, OR was PR or better (at least VGPR+PR). sCR: CR \& normal serum free light chain (sFLC) ratio \& absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR
Interventions
- DRUG Elranatamab
- DRUG Standard of care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 508 participants |
| Start Date | 2022-10-03 |
| Est. Completion | 2022-11-04 |
What the finished NCT05565391 record still lists
NCT05565391 is an observational study that tracks outcomes without assigning an intervention. The registered 508 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Elranatamab is the first listed.
NCT05565391 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05565391 about?
NCT05565391 is a clinical study titled "A Study to Learn About the Medicine (Called Elranatamab) in People With Relapsed Refractory Multiple Myeloma". This study is to understand how well elranatamab (PF-06863135) may be used for relapsed refractory multiple myeloma (RRMM). Sometimes MM might improve at first, but then gets resistant to the treatment and starts growing again (known as relapsed refractory). This study medicine will be compared with...
What is the current status of trial NCT05565391?
This trial is currently completed. The enrollment target is 508 participants. The study started on 2022-10-03. Estimated completion is 2022-11-04.
What interventions are being tested in trial NCT05565391?
The interventions under investigation include: Elranatamab (DRUG), Standard of care (DRUG).
Who is sponsoring clinical trial NCT05565391?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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