NCT05083169

A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma

A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 587 (actual)
• 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 daratumumab (Tec-Dara) with daratumumab subcutaneously (SC) in combination with pomalidomide and dexamethasone (DPd) or daratumumab SC in combination with bortezomib and dexamethasone (DVd).

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Daratumumab	Daratumumab will be administered SC injection.
DRUG	Pomalidomide	Pomalidomide will be administered orally.
DRUG	Dexamethasone	Dexamethasone will be administered orally or intravenously.
DRUG	Bortezomib	Bortezomib will be administered SC injection.
DRUG	Teclistamab	Teclistamab will be administered SC injection.

Timeline

• Start date: 2021-10-14
• Primary completion: 2028-12-08
• Completion: 2028-12-08
• First posted: 2021-10-19
• Last updated: 2026-04-13

Locations

176 sites across 21 countries: United States, Argentina, Belgium, Brazil, Canada, China, Denmark, France, Germany, Greece, Italy, Japan, Netherlands, Poland, Russia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study