At present, there is no prospective study on the treatment of first-relapsed multiple myeloma with daratumumab plus pomalidomide and dexamethasone (Dara-Pd). A prospective, multicenter, open, non-interventional, observational clinical study to evaluate the efficacy and safety of Dara-Pd in patients with first relapse multiple myeloma.
To evaluate the impact of daratumumab, pomalidomide, and dexamethasone (Dara-PD) compared to other regimens in the same period (including Dara-KPD, VPd, KPd, IPd, Pd) on the second progression free survival time (PFS2) of first relapse of multiple myeloma. Among them, the second progression free survival time (PFS2) is defined as the time from enrollment to disease progression or death.
Study Type
OBSERVATIONAL
Enrollment
50
The First Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGthe second progression free survival time (PFS2)
daratumumab, pomalidomide, and dexamethasone (Dara-PD) compared to other regimens in the same period (including Dara-KPD, VPd, KPd, IPd, Pd) on the second progression free survival time (PFS2) of first relapse of multiple myeloma.
Time frame: through study completion, up to 2 years
Objective Response Rate (ORR)
Evaluated according to the 2016 IMWG efficacy evaluation criteria, defined as the proportion of participants who achieved the best response as strict complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).
Time frame: through study completion, up to 2 years
Deep response rate (≥ VGPR)
Evaluated according to the 2016 IMWG efficacy evaluation criteria, defined as the proportion of subjects who achieved the best response as strict complete response (sCR), complete response (CR), and very good partial response (VGPR).
Time frame: through study completion, up to 2 years
MRD negative
MRD negative is defined as bone marrow MRD negative confirmed by new generation flow cytometry (NGF) or new generation sequencing technology (NGS) (the minimum detection sensitivity is that one clonal plasma cell can be detected from 105 nucleated cells);
Time frame: through study completion, up to 2 years
continuous MRD negative rate
Persistent MRD negative: new generation flow cytometry (NGF) or new generation sequencing technology (NGS) detects bone marrow MRD negative and imaging negative, with at least one year between two tests being negative
Time frame: through study completion, up to 2 years
Overall survival (OS)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Overall survival (OS) evaluation: defined as the time from enrollment to death.
Time frame: through study completion, up to 2 years
Evaluation of duration of remission (DOR)
Evaluation of duration of remission (DOR): defined as the time from the first response to treatment to disease progression or death
Time frame: through study completion, up to 2 years
Treatment related adverse event(AE)
Toxicity and safety will be reported based on the adverse events, as graded by CTCAE V5 and determined by routine clinical assessments.
Time frame: From enrollment through follow-up (up to 24 months).