First Relapse, Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, First relapse, the second progression free survival time (PFS2)
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.
Interventions
None listed
Sponsors
FengYan Jin
Affiliated Hospital of Hebei University
Second Hospital of Shanxi Medical University
Shandong Cancer Hospital and Institute
First Affiliated Hospital of Jinan University
Sun Yat-Sen University Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects will be enrolled in this study only if they met all of the following inclusion criteria. 1. Age 18 years or older, regardless of gender. 2. Diagnosis of symptomatic multiple myeloma based on the 2014 IMWG diagnostic criteria and the presence of measurable disease 3. First relapse of multiple myeloma; 4. Receiving first-line anti-multiple myeloma therapy; 5. The first-line therapy must be based on proteasome inhibitors and immunomodulators (RVD); 6. 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; 7. 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. 8. 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.
Exclusion criteria
1. Diagnosis of inactive multiple myeloma, including primary amyloidosis, MGUS (monoclonal gammopathy of undetermined significance) or smoldering myeloma. 2. 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； 3. 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； 4. Subject has received daratumumab or pomalidomide previously； 5. 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).； 6. Subjects with uncontrollable psychiatric disorders; 7. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Overall survival (OS) | through study completion, up to 2 years | Overall survival (OS) evaluation: defined as the time from enrollment to death. |
| 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 |
| Treatment related adverse event(AE) | From enrollment through follow-up (up to 24 months). | Toxicity and safety will be reported based on the adverse events, as graded by CTCAE V5 and determined by routine clinical assessments. |
Countries
China
Outcome results
None listed