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
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, China
RECRUITINGMRD negative rate
MRD detected by next generation sequencing
Time frame: through study completion, an average of 3 year
Duration of negative MRD
From the first record of negative MRD to the first record of positive MRD or the end of follow-up, whichever came first, assessed up to 3 year
Time frame: through study completion, an average of 3 year
stringent complete response (sCR)
stringent complete response
Time frame: through study completion, an average of 3 year
ORR
Overall response rate (ORR): Complete response (CR) + Very good partial response (VGPR) + Partial response (PR)
Time frame: through study completion, an average of 3 year
Duration of response (DOR)
The duration from the first record of achieving at least PR to the occurrence of progressive disease (PD) or death caused by PD, whichever occurs at first
Time frame: through study completion, an average of 3 year
Mobilization success rate
Mobilization success rate, high-quality mobilization rate and poor-quality mobilization
Time frame: after all patients accepted stem cell mobilization, an average of 1.5 year
Progression-free survival (PFS)
From date of enrollment of patients until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 year
Time frame: through study completion, an average of 3 year
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Overall survival (OS)
From date of enrollment of patients until the date of death from any cause, whichever came first, assessed up to 3 year
Time frame: through study completion, an average of 3 year