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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: Recruiting Phase 3 study, sponsored by Pfizer.

NCT05623020 is a Phase 3 study that is actively recruiting participants, run by Pfizer. The registered enrollment target is 1,116 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% higher). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 1,116 participants
Start Date 2022-11-10
Est. Completion 2033-10-03
Phase Phase 3
Pfizer

1,845 total trials

What NCT05623020 shows while recruiting

NCT05623020 is an interventional study that assigns participants to a tested intervention. Its 1,116 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% higher).

The record links to 0 conditions, and to 5 interventions - of which Dexamethasone is the first listed.

NCT05623020 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT05623020's enrollment target sits among peer trials

1,116 251st of 2000 higher than 1,750 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05623020, the US trial registry maintained by the National Library of Medicine. NCT05623020 (large enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.