NCT06189833

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

Phase 2 Study Applying Innovative Minimal Residual Disease (MRD) Techniques for Participants With Previously Untreated Multiple Myeloma Treated With D-VRd Prior To and After High-dose Therapy Followed by Autologous Stem Cell Transplantation (ASCT) - TAURUS

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Stichting European Myeloma Network · Network
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Daratumumab	Daratumumab will be administered via a subcutaneous injection (SC)
DRUG	Bortezomib	Bortezomib will be administered via a subcutaneous injection (SC)
DRUG	Lenalidomide	Lenalidomide will be administered orally
DRUG	Dexamethasone	Dexamethasone will be administered orally

Timeline

• Start date: 2023-11-23
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2024-01-05
• Last updated: 2024-04-23

Locations

31 sites across 5 countries: Austria, Germany, Greece, Italy, Netherlands

Regulatory

• FDA-regulated drug study