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
NCT05552222 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1590
Last updated 2026-05-08
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
Interventions
- DRUG
-
Teclistamab will be administered as SC injection.
- DRUG
-
Daratumumab will be administered as SC injection.
- DRUG
-
Lenalidomide will be administered orally.
- DRUG
-
Dexamethasone will be administered either orally or intravenously (IV).
- DRUG
-
Talquetamab will be administered as SC injection.
Sponsors & Collaborators
-
Janssen Research & Development, LLC
lead INDUSTRY
Principal Investigators
-
Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-25
- Primary Completion
- 2031-04-30
- Completion
- 2033-10-28
- FDA Drug
- Yes
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
Study Locations
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