Dara-PD in the Treatment of Patients With First Relapse of Multiple Myeloma
- Conditions
- First RelapseMultiple Myeloma
- Registration Number
- NCT06252792
- Lead Sponsor
- FengYan Jin
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
Subjects will be enrolled in this study only if they met all of the following inclusion criteria.
- Age 18 years or older, regardless of gender.
- Diagnosis of symptomatic multiple myeloma based on the 2014 IMWG diagnostic criteria and the presence of measurable disease
- First relapse of multiple myeloma;
- Receiving first-line anti-multiple myeloma therapy;
- The first-line therapy must be based on proteasome inhibitors and immunomodulators (RVD);
- Subject must have achieved a response (partial response [PR] or better based on investigator's determination of response by the IMWG criteria) to at one prior regimen;
- Each subject (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.
- Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously. Contraception must begin 4 weeks prior to dosing and continue until at least 3 months after receiving the last dose of the study drug. A woman of childbearing potential must have a negative serum or urine pregnancy tests at screening within 14 days prior to randomization.
- Diagnosis of inactive multiple myeloma, including primary amyloidosis, MGUS (monoclonal gammopathy of undetermined significance) or smoldering myeloma.
- Relapsed and refractory myeloma：Relapsed and refractory myeloma is defined as disease that is nonresponsive while on salvage therapy, or progresses within 60 days of last therapy in patients who have achieved minimal response (MR) or better at some point previously before then progressing in their disease course；
- Primary refractory myeloma：Primary refractory myeloma is defined as disease that is nonresponsive in patients who have never achieved a minimal response or better with any therapy；
- Subject has received daratumumab or pomalidomide previously；
- Subject has a history of malignancy (other than multiple myeloma) within 3 years before the date of randomization (exceptions is malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years).；
- Subjects with uncontrollable psychiatric disorders;
- Subject is known or suspected of not being able to comply with the study protocol.Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the second progression free survival time (PFS2) through study completion, up to 2 years 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.
- Secondary Outcome Measures
Name Time Method Overall survival (OS) through study completion, up to 2 years Overall survival (OS) evaluation: defined as the time from enrollment to death.
Objective Response Rate (ORR) through study completion, up to 2 years 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).
Deep response rate (≥ VGPR) through study completion, up to 2 years 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).
MRD negative through study completion, up to 2 years 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);
continuous MRD negative rate through study completion, up to 2 years 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
Evaluation of duration of remission (DOR) through study completion, up to 2 years Evaluation of duration of remission (DOR): defined as the time from the first response to treatment to disease progression or death