Teclistamab in Combination With Daratumumab for High-Risk Smoldering Myeloma: A Clinical and Correlative Phase 2 Immuno-Oncology Study (the REVIVE Study)
NCT06100237 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-02-23
Summary
The purpose of this study is to see whether combination treatment of Teclistamab and Daratumumab (Tel-Dara) or combination Talquetamab and Daratumumab (Tal-Dara) will delay the onset of multiple myeloma.
Conditions
Interventions
- DRUG
-
Teclistamab will be administered by subcutaneous (SC) injection per discretion of treating physician. Participants will receive the recommended dosage.
- DRUG
-
Talquetamab will be administered per discretion of treating physician. Participants will receive the recommended dosage.
- DRUG
-
Daratumumab SC
Daratumumab SC will be administered by subcutaneous (SC) injection per discretion of treating physician. Participants will receive the recommended dosage.
Sponsors & Collaborators
-
Janssen Scientific Affairs, LLC
collaborator INDUSTRY -
Carl Ola Landgren, MD, PhD
lead OTHER
Principal Investigators
-
Carl O Landgren, MD, PhD · University of Miami
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-04
- Primary Completion
- 2028-12-31
- Completion
- 2029-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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