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DVRd in the Treatment of Patients With Newly Diagnosed Double-hit Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:
Phase II Clinical Study of Daratumumab Combined With Bortezomib, Lenalidomide and Dexamethasone (DVRd) in the Treatment of Patients With Newly Diagnosed Double-hit Multiple Myeloma

Clinical Trial Summary

Evaluate the efficacy of DVRd in patients with newly diagnosed double-hit multiple myeloma (MM) and the feasibility of minimal residual disease (MRD) guided maintenance therapy

Clinical Trial Description

This study is a single arm phase II study treating patients with newly diagnosed double-hit MM with DVRd induction therapy. This study will enroll 40 patients with double-hit MM who are eligible for autologous stem cell transplantation (ASCT) to evaluate the efficacy of DVRd and the feasibility of MRD guided maintenance therapy. The protocol is: DVRd induction therapy for 4 cycles, followed by ASCT, then DVRd consolidation therapy for 4 cycles, and the last DVR maintenance therapy. After induction therapy, during 60 to 90 days after ASCT, after consolidation therapy, and every 4 cycles during maintenance therapy, the patients will accept MRD monitoring. Patients with MRD negative for at least 12 months will enter the maintenance phase of lenalidomide monotherapy. Otherwise, they will accept DVR maintenance therapy for a total of 24 cycles or until disease progression, death, intolerance, withdrawal due to other reasons, or termination/end of the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06158269
Study type Interventional
Source Institute of Hematology & Blood Diseases Hospital, China
Contact Lugui Qiu
Phone 0086-022-23909171
Email qiulg@ihcams.ac.cn
Status Recruiting
Phase Phase 2
Start date December 2023
Completion date December 2027
View Details
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