NCT06158269

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	DVRd	The patients will receive 4 cycles of DVRd induction therapy. After achieving PR or better response, they will receive stem cell mobilization, collection and the following ASCT. Then, the patients will accept 4 cycles of DVRd consolidation and DVR maintenance therapy. Once they sustain MRD negative condition for at least 12 months, the patients will enter the maintenance stage of lenalidomide monotherapy. Otherwise, the triple drug maintenance therapy will be continued for a total of 24 cycles or until disease progression, death, intolerance, withdrawal due to other reasons, or termination/end of the study.

Timeline

• Start date: 2023-12-01
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2023-12-06
• Last updated: 2023-12-06

Locations

1 site across 1 country: China