This phase II trial studies how well daratumumab, pomalidomide, and dexamethasone work in treating patients with multiple myeloma that has come back (relapsed). Immunotherapy with daratumumab may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as pomalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving daratumumab with dexamethasone and pomalidomide may work bettering in treating patient compared to dexamethasone and pomalidomide alone.
PRIMARY OBJECTIVE: 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. SECONDARY OBJECTIVES: 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). OUTLINE: 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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
Best overall response rate to the therapy
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.
Time frame: Up to 3 years
Overall survival time
The distribution of survival time will be estimated using the method of Kaplan-Meier.
Time frame: From registration to death due to any cause, assessed up to 3 years
Progression-free survival
The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
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
Incidence of adverse events
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.
Time frame: Up to 3 years
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McLeod Regional Medical Center
Florence, South Carolina, United States