NCT05623020

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,116 (estimated)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Elranatamab	Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
DRUG	Daratumumab	Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
DRUG	Lenalidomide	Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
DRUG	Dexamethasone	Randomized
DRUG	Bortezomib	Randomized

Timeline

• Start date: 2022-11-10
• Primary completion: 2030-10-18
• Completion: 2033-10-03
• First posted: 2022-11-21
• Last updated: 2026-04-15

Locations

89 sites across 16 countries: Australia, Canada, China, Czechia, France, Germany, Greece, Israel, Italy, Japan, Netherlands, Poland, South Korea, Spain, Switzerland, Taiwan

Regulatory

• FDA-regulated drug study