Dara-PD in the Treatment of Patients With First Relapse of Multiple Myeloma

Study Purpose

The investigators designed the present study with the aim of observing the efficacy and survival of D-Pd regimen compared with other regimens (including D-KPD,VPd, KPd, IPd, Pd) in the same period for the first relapse of MM patients receiving RVD regimen, so as to provide a safe and effective treatment strategy for the first relapse of MM patients.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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. Achieve ≥PR to initial therapy. 7. Each subject (or their legally acceptable representative) must sign an informed consent form indicating that he or she is willing to participate in the study; 8. Women of childbearing potential must have a negative pregnancy test prior to enrollment and agree to use contraception during the study and for 3 months after the last treatment;

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. Exposure history of first-line daratumumab and pomalidomide； 5. Subject has a history of malignancy within 3 years before the date of screening (except for cured malignancies with minimal risk of recurrence within 3 years)； 6. Subjects with uncontrollable psychiatric disorders; 7. Subjects who, in the opinion of the investigator, are not suitable for participation in this study.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06252792
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	FengYan Jin
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Myeloma, First Relapse

Additional Details

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.

Arms & Interventions

Arms

: daratumumab, pomalidomide, and dexamethasone (Dara-PD)

the first relapse of patients who received daratumumab, pomalidomide, and dexamethasone (Dara-PD) treatment

: other regimens in the same period (including Dara-KPD, VPd, KPd, IPd, Pd)

the first relapse of patients who received other regimens in the same period (including Dara-KPD, VPd, KPd, IPd, Pd) treatment

Interventions

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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