Bispecific T-cell Redirectors as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients
NCT06505369 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2024-07-17
Summary
This is Phase 2, open-label, multicentre, non-randomised study evaluating participants with newly diagnosed MM eligible for high-dose therapy. The goal of the study is to determine if consolidation with T-cell redirectors - Talquetamab and Teclistamab in sequence will improve the response depth: increase MRD negative CR rate.
Conditions
Interventions
- DRUG
-
Daratumumab will be administered by SC injection
- DRUG
-
Bortezomib will be administered by SC injection
- DRUG
-
Lenalidomide will be administered by oral route
- DRUG
-
Dexamethasone will be administered by oral route
- DRUG
-
Talquetamab will be administered by SC injection
- DRUG
-
Teclistamab will be administered by SC injection
Sponsors & Collaborators
-
Janssen Pharmaceutica
collaborator INDUSTRY -
North Estonia Medical Centre
lead OTHER
Principal Investigators
-
Diana Loigom, MD · North Estonia Medical Centre
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-19
- Primary Completion
- 2026-11-30
- Completion
- 2028-10-31
Countries
- Denmark
- Estonia
- Norway
Study Locations
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