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NCT05623020 · ClinicalTrials.gov registry record · Phase 3
A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant
A Phase 3 study, sponsored by Pfizer.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,116
- Enrollment target
NCT05623020 is a Phase 3 study that is actively recruiting participants, run by Pfizer. The registered enrollment target is 1,116 participants.
The verdict
NCT05623020, a Phase 3 study, is actively recruiting participants, sponsored by Pfizer.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,116 participants
- Enrollment target
Study Summary
Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity. The main purpose of the study is to evaluate if the combination of Elranatamab, Daratumumab and Lenalidomide offers superior clinical benefit compared with the combination of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in people with newly diagnosed multiple myeloma. There are 2 parts to this study. Part 1 will characterize the safety and tolerability of elranatamab in combination with daratumumab and lenalidomide or in combination with lenalidomide and will identify the optimal dose(s) of the combination regimen. Part 2 of the study will evaluate the rate of minimal residual disease (MRD) negative CR and the progression free survival (PFS) of the combination of elranatamab, daratumumab, and lenalidomide compared with the combination of daratumumab, bortezomib, lenalidomide, and dexamethasone in participants with newly diagnosed multiple myeloma.
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Elranatamab
- DRUG Daratumumab
- DRUG Bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,116 participants |
| Start Date | 2022-11-10 |
| Est. Completion | 2033-10-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05623020
The ClinicalTrials.gov registry entry for NCT05623020 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 1,116 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Dexamethasone is the first listed.
NCT05623020 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05623020 about?
NCT05623020 is a clinical study titled "A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant". Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity. The main purpose of the study is to evaluate if the combination of Elranatamab, Daratumumab and Lenalidomide offers superior...
What is the current status of trial NCT05623020?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,116 participants. The study started on 2022-11-10. Estimated completion is 2033-10-03.
What interventions are being tested in trial NCT05623020?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Elranatamab (DRUG), Daratumumab (DRUG), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT05623020?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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