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RECRUITING
NCT06158269
PHASE2

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

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2023-12

Completion Date

2027-12

Last Updated

2023-12-06

Healthy Volunteers

No

Interventions

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.

Locations (1)

Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, China