Clinical trial NCT06252792: Dara-PD in the Treatment of Patients With First Relapse of Multiple Myeloma
Official title: Prospective, Multicenter, Open and Non-interference Observational Clinical Study of Daratumumab, Pomalidomide and Dexamethasone (Dara-PD) in the Treatment of Patients With First Relapse of Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Multiple Myeloma
First Relapse
Keywords: Multiple Myeloma
First relapse
the second progression free survival time (PFS2)
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
Collaborators: name: Affiliated Hospital of Hebei University
name: Second Hospital of Shanxi Medical University
name: Shandong Cancer Hospital and Institute
name: First Affiliated Hospital of Jinan University
name: Sun Yat-sen University
First posted: 2024-02-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the first relapse of multiple myeloma

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the second progression free survival time (PFS2)
timeFrame: through study completion, up to 2 years
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: through study completion, up to 2 years
measure: Deep response rate (≥ VGPR)
timeFrame: through study completion, up to 2 years
measure: MRD negative
timeFrame: through study completion, up to 2 years
measure: continuous MRD negative rate
timeFrame: through study completion, up to 2 years
measure: Overall survival (OS)
timeFrame: through study completion, up to 2 years
measure: Evaluation of duration of remission (DOR)
timeFrame: through study completion, up to 2 years
Other outcomes:
Locations:
Study officials:
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