A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma
NCT05572515 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 614
Last updated 2026-04-13
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
Interventions
- DRUG
-
Teclistamab will be administered subcutaneously.
- DRUG
-
Pomalidomide will be administered orally.
- DRUG
-
Bortezomib will be administered subcutaneously.
- DRUG
-
Dexamethasone will be administered orally in PVd and intravenously or orally in Kd.
- DRUG
-
Carfilzomib will be administered intravenously.
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
- 2023-03-29
- Primary Completion
- 2025-10-13
- Completion
- 2031-08-31
- FDA Drug
- Yes
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
Study Locations
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