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Trial Title:
Dara-PD in the Treatment of Patients With First Relapse of Multiple Myeloma
NCT ID:
NCT06252792
Condition:
Multiple Myeloma
First Relapse
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Recurrence
Conditions: Keywords:
Multiple Myeloma
First relapse
the second progression free survival time (PFS2)
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
the first relapse of multiple myeloma
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
June 15, 2024
Completion date:
June 15, 2026
Lead sponsor:
Agency:
FengYan Jin
Agency class:
Other
Collaborator:
Agency:
Affiliated Hospital of Hebei University
Agency class:
Other
Collaborator:
Agency:
Second Hospital of Shanxi Medical University
Agency class:
Other
Collaborator:
Agency:
Shandong Cancer Hospital and Institute
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Jinan University
Agency class:
Other
Collaborator:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
The First Hospital of Jilin University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06252792
