Dara-PD in the Treatment of Patients With First Relapse of Multiple Myeloma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFengYan Jin
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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；
Trial population
the first relapse of multiple myeloma
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 2 trial groupsGroup A: daratumumab, pomalidomide, and dexamethasone (Dara-PD)
Group B: other regimens in the same period (including Dara-KPD, VPd, KPd, IPd, Pd)
Trial outcomes
Primary outcomes
1
the 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 yearsSecondary outcomes
1
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 years2
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 years3
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 years4
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
FengYan Jin
Lead sponsor
The First Hospital of Jilin University
Sponsor institution
Affiliated Hospital of Hebei University
Collaborator
Second Hospital of Shanxi Medical University
Collaborator
Shandong Cancer Hospital and Institute
Collaborator
First Affiliated Hospital of Jinan University
Collaborator
Sun Yat-Sen University Cancer Center
Collaborator
Source ClinicalTrials.gov