NCT05572515

A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma

A Phase 3 Randomized Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 614 (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 with PVd/Kd in Part 1 and to further characterize safety and efficacy of an alternative dosing for teclistamab in Part 2 in participants with relapsed or refractory multiple myeloma.

Conditions

• Relapsed or Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Teclistamab	Teclistamab will be administered subcutaneously.
DRUG	Pomalidomide	Pomalidomide will be administered orally.
DRUG	Bortezomib	Bortezomib will be administered subcutaneously.
DRUG	Dexamethasone	Dexamethasone will be administered orally in PVd and intravenously or orally in Kd.
DRUG	Carfilzomib	Carfilzomib will be administered intravenously.

Timeline

• Start date: 2023-03-29
• Primary completion: 2025-10-13
• Completion: 2031-08-31
• First posted: 2022-10-07
• Last updated: 2026-04-13

Locations

211 sites across 24 countries: United States, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Greece, India, Israel, Italy, Japan, Malaysia, Netherlands, Poland, Portugal, Spain, Sweden, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study