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
Public ClinicalTrials.gov record NCT05623020. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
AN OPEN-LABEL, 2-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) + DARATUMUMAB + LENALIDOMIDE VERSUS DARATUMUMAB + BORTEZOMIB + LENALIDOMIDE + DEXAMETHASONE IN TRANSPLANT-INELIGIBLE PARTICIPANTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05623020
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,116 participants
Conditions and interventions
Conditions
Interventions
- Elranatamab Drug
- Daratumumab Drug
- Lenalidomide Drug
- Dexamethasone Drug
- Bortezomib Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 9, 2022
- Primary completion
- Oct 17, 2030
- Completion
- Oct 2, 2033
- Last update posted
- Aug 23, 2026
2022 – 2033
United States locations
- U.S. sites
- 10
- U.S. states
- 4
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Jupiter Medical Center/Anderson Family Cancer Institute | Jupiter | Florida | 33458 | Recruiting |
| MSK Basking Ridge | Basking Ridge | New Jersey | 07920 | Recruiting |
| MSK Monmouth | Middletown | New Jersey | 07748 | Recruiting |
| MSK Bergen | Montvale | New Jersey | 07645 | Recruiting |
| MSK Commack | Commack | New York | 11725 | Recruiting |
| MSK Westchester | Harrison | New York | 10604 | Recruiting |
| Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street). | New York | New York | 10021 | Recruiting |
| Memorial Sloan Kettering Cancer Center-Main Campus | New York | New York | 10065 | Recruiting |
| MSK Nassau | Uniondale | New York | 11553 | Recruiting |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 129 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05623020, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 23, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05623020 live on ClinicalTrials.gov.