NCT05552222

A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma

A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab SC and Lenalidomide (Tal-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,590 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab and lenalidomide (Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Teclistamab	Teclistamab will be administered as SC injection.
DRUG	Daratumumab	Daratumumab will be administered as SC injection.
DRUG	Lenalidomide	Lenalidomide will be administered orally.
DRUG	Dexamethasone	Dexamethasone will be administered either orally or intravenously (IV).
DRUG	Talquetamab	Talquetamab will be administered as SC injection.

Timeline

• Start date: 2022-10-25
• Primary completion: 2031-04-30
• Completion: 2033-10-28
• First posted: 2022-09-23
• Last updated: 2026-04-13

Locations

263 sites across 25 countries: United States, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Greece, Israel, Italy, Japan, Netherlands, Norway, Poland, Portugal, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study