Phase 2 Study Applying MRD Techniques for Participants With Previously Untreated Multiple Myeloma Treated With D-VRd Prior To and After High-dose Therapy Followed by ASCT - TAURUS
NCT06189833 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2024-04-23
Summary
This is a multicenter, single arm, open-label, Phase 2 study in mutiple myeloma with newly diagnosed and treatment-naïve participants for whom high-dose therapy and autologous stem cell transplantation is part of the intended treatment plan. The study is evaluating a technique called Mass Spectrometry Minimal Residual Disease (MS-MRD) using blood samples and compares it with the minimal residual disease (MRD) technique using bone marrow samples.
Conditions
Interventions
- DRUG
-
Daratumumab will be administered via a subcutaneous injection (SC)
- DRUG
-
Bortezomib will be administered via a subcutaneous injection (SC)
- DRUG
-
Lenalidomide will be administered orally
- DRUG
-
Dexamethasone will be administered orally
Sponsors & Collaborators
-
Janssen Pharmaceutica
collaborator INDUSTRY -
Stichting European Myeloma Network
lead NETWORK
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-23
- Primary Completion
- 2024-12-31
- Completion
- 2025-12-31
- FDA Drug
- Yes
Countries
- Austria
- Germany
- Greece
- Italy
- Netherlands
Study Locations
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