NCT05317416

Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant

A RANDOMIZED, 2-ARM, PHASE 3 STUDY OF ELRANATAMAB (PF-06863135) VERSUS LENALIDOMIDE IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA AFTER UNDERGOING AUTOLOGOUS STEM-CELL TRANSPLANTATION

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 854 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years

Detailed description

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Elranatamab	BCMA-CD3 bispecific antibody
DRUG	Lenalidomide	Immunomodulatory drug
DRUG	Lenalidomide	Immunomodulatory drug
DRUG	Elranatamab	BCMA-CD3 bispecific antibody

Timeline

• Start date: 2022-03-25
• Primary completion: 2027-08-04
• Completion: 2029-10-31
• First posted: 2022-04-07
• Last updated: 2026-04-16

Locations

209 sites across 27 countries: United States, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Netherlands, Norway, Poland, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study