The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
748
Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug
Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug
Tablets, Oral, 28 mg, once daily, on Days 1, 8, 15, 22 (cycles 1\&2) ; Days 1 \&15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the date of the first documented tumor progression (as determined by the Independent Review Committee (IRC)) or death due to any cause. The IRC conducted a blinded, independent review of the tumor assessments based on the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Censoring rules applied: * Participants receiving subsequent systemic anti-myeloma therapy prior to documented progression were censored at the date of the last adequate tumor assessment prior to new therapy. * Participants who had an event (progression or death) \> 10 weeks after their last tumor assessment were censored at their last adequate tumor assessment prior to the event. * Participants without progression or death (and not receiving subsequent therapy prior to progression) were censored at their last adequate tumor assessment. * Participants without any post-baseline tumor assessments were censored on the date of randomization
Time frame: From randomization to date of first documented tumor progression or death due to any cause (up to 8 years)
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with objective response among all randomized subjects. Participants with an objective response are those participants experiencing a partial response (PR) or better, based on Independent Review Committee (IRC) assessment, as per EBMT criteria.
Time frame: From randomization to primary completion date (approximately 8 years)
Overall Survival (OS)
Survival is defined as the time from randomization to the date of death. A participant who did not die had his or her survival duration censored at the date of last contact ('last known date alive").
Time frame: From randomization to the date of death (up to 8 years)
Mean Change From Baseline of Pain Severity Score and Pain Interference Score
Pain severity (sensory dimension) and pain interference (reactive dimension, assessing the degree to which pain interferes with function) are measured using the Brief Pain Inventory- Short Form (BPI-SF). BPI-SF numeric rating scale goes from 0 (No pain) to 10 (Pain as bad as you can imagine).
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Tablets, Oral, 40 mg, once daily, on Days 8 \& 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Solution, Intravenous (IV), 8 mg, Once daily, on Days 1, 8, 15, 22 (cycles 1\&2) ; Days 1 \&15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Local Institution - 1628
Birmingham, Alabama, United States
Local Institution - 7619
Mobile, Alabama, United States
Local Institution - 7618
Mobile, Alabama, United States
Local Institution - 7617
Chandler, Arizona, United States
Local Institution - 1644
Tucson, Arizona, United States
Local Institution - 1618
Bakersfield, California, United States
Local Institution - 1602
Berkeley, California, United States
Local Institution - 1636
Corona, California, United States
Local Institution - 1668
Corona, California, United States
Local Institution - 1616
Greenbrae, California, United States
...and 225 more locations
Time frame: From Baseline to End of Treatment (approximately 8 years)
Progression Free Survival (PFS) Rate at Specific Time-points
PFS rate is defined as the percentage of participants experiencing PFS at the defined time-points.
Time frame: From randomization to the specified time-point (up to 5 years)