The purpose of this study is to determine if adding Elotuzumab to Pomalidomide and low-dose dexamethasone is a more effective treatment of relapsed and refractory multiple myeloma compared to pomalidomide and low-dose dexamethasone by itself.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
117
Progression Free Survival (PFS)
PFS is defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Progressive disease response criteria were defined as an increase of 25% from lowest response value in any one or more of the following: 1\. Serum M-component and/or 2. Urine M-component and/or 3. Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels 4. Bone marrow plasma cell percentage; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder
Time frame: From randomization to date of progression or death (up to approximately 21 months)
Objective Response Rate (ORR)
ORR is defined as the percentage of participants who achieved a best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) using the modified International Myeloma Working Group (IMWG) criteria described as follows, as per investigator's assessment * CR: Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and \< 5% plasma cells in bone marrow * sCR: CR, as defined above, plus the following: Normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence * VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>= 90% reduction in serum M-protein level plus urine M-protein level \< 100 mg per 24 hour * PR: \>= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>= 90% or to \< 200 mg per 24 hour.
Time frame: From first dose to disease progression (up to approximately 21 months)
Overall Survival (OS)
OS is the time from randomization to the date of death from any cause. The survival time for participants who had not died was censored at the last known alive date. OS was censored at the date of randomization for subjects who were randomized but had no follow-up.
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Winship Cancer Institute
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Investigative Clinical Research Of Indiana, Llc
Indianapolis, Indiana, United States
Beth Israel Comprehensive Cancer Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute.
Boston, Massachusetts, United States
Rochester General Hospital
Rochester, New York, United States
Carolinas Healthcare System
Charlotte, North Carolina, United States
Va Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States
St Francis Hospital
Greenville, South Carolina, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, United States
...and 45 more locations
Time frame: From randomization to death (up to approximately 52 months)