Daratumumab, Pomalidomide, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT03841565|
Recruitment Status : Not yet recruiting
First Posted : February 15, 2019
Last Update Posted : October 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Plasma Cell Myeloma||Biological: Daratumumab Drug: Dexamethasone Drug: Pomalidomide||Phase 2|
I. To determine the overall response rate (partial response [PR], very good partial response [VGPR], complete response [CR], or stringent complete response [sCR]) of daratumumab retreatment in combination with pomalidomide and dexamethasone (DPd) in patients with relapsed refractory multiple myeloma.
I. To assess progression free survival and overall survival associated with retreatment with daratumumab in combination with pomalidomide and dexamethasone (DPd) in patients with relapsed and refractory multiple myeloma.
II. To determine the toxicities associated with retreatment with daratumumab in combination with pomalidomide and dexamethasone (DPd) .
Patients receive pomalidomide orally (PO) once daily (QD) on days 1-21 and daratumumab intravenously (IV) on days 1, 8, 15, and 22 of cycles 1-2, days 1-15 of cycles 3-6, and day 1 of subsequent cycles. Patients also receive dexamethasone PO on days 1, 8, 15, and 22 of cycles 1-12. Cycles every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for every 3 months until subsequent treatment or progressive disease, then every 6 months for up to 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Daratumumab Retreatment in Patients With Relapsed Multiple Myeloma|
|Estimated Study Start Date :||March 31, 2020|
|Estimated Primary Completion Date :||March 31, 2024|
|Estimated Study Completion Date :||March 31, 2025|
Experimental: Treatment (pomalidomide, daratumumab, dexamethasone)
Patients receive pomalidomide PO QD on days 1-21 and daratumumab IV on days 1, 8, 15, and 22 of cycles 1-2, days 1-15 of cycles 3-6, and day 1 of subsequent cycles. Patients also receive dexamethasone PO on days 1, 8, 15, and 22 of cycles 1-12. Cycles every 28 days in the absence of disease progression or unacceptable toxicity.
- Best overall response rate to the therapy [ Time Frame: Up to 3 years ]A success will be defined as a partial response or better noted as the objective status on two consecutive evaluations. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
- Overall survival time [ Time Frame: From registration to death due to any cause, assessed up to 3 years ]The distribution of survival time will be estimated using the method of Kaplan-Meier.
- Progression-free survival [ Time Frame: From registration to the earliest date of documentation of disease progression on initial therapy or death due to any cause, assessed up to 3 years ]The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
- Incidence of adverse events [ Time Frame: Up to 3 years ]Will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.
- Proportion of minimal residual disease (MRD) negativity [ Time Frame: Up to 3 years ]MRD will be assessed on bone marrow aspirate in all patients achieving complete response (CR) or stringent CR (sCR). The proportion of patients who achieve MRD negative status will be estimated by the number of patients who are MRD negative divided by the total number of evaluable patients who achieve CR or sCR. Exact binomial 95% confidence intervals for the true MRD negative rate will be calculated.
- Changes in clonal population and CD38 expression [ Time Frame: Baseline up to 3 years ]Will be summarized descriptively by median, min, max, and interquartile range at each time point. Changes from baseline to after treatment will be assess using paired analyses, including Wilcoxon signed rank tests.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841565
|United States, Illinois|
|Illinois CancerCare-Peoria||Not yet recruiting|
|Peoria, Illinois, United States, 61615|
|Contact: Jennifer A. Anderson 309-243-3605 email@example.com|
|Principal Investigator: Gregory J. Gerstner|
|United States, Michigan|
|Michigan Cancer Research Consortium NCORP||Not yet recruiting|
|Ann Arbor, Michigan, United States, 48106|
|Contact: Lauren Swafford 734-712-4329 Lauren.Swafford@stjoeshealth.org|
|Principal Investigator: Christopher M. Reynolds|
|United States, Minnesota|
|Mayo Clinic||Not yet recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Shaji K. Kumar 507-284-2511|
|Principal Investigator: Shaji K. Kumar|
|United States, Wisconsin|
|Saint Vincent Hospital Cancer Center Green Bay||Not yet recruiting|
|Green Bay, Wisconsin, United States, 54301|
|Contact: Amy J. Koffarnus 920-433-8261 Amy.Koffarnus@hshs.org|
|Principal Investigator: Anthony J. Jaslowski|
|Aurora Cancer Care-Milwaukee West||Not yet recruiting|
|Wauwatosa, Wisconsin, United States, 53226|
|Contact: Jennifer Mathieu 414-302-2312 firstname.lastname@example.org|
|Principal Investigator: Michael A. Thompson|
|Principal Investigator:||Shaji K Kumar||Academic and Community Cancer Research United|