Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma
- Conditions
- LymphomaMultiple Myeloma
- Interventions
- Biological: Elotuzumab (BMS-901608; HuLuc63)
- Registration Number
- NCT01239797
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 646
-
Documented progression from most recent line of therapy
-
1-3 prior lines of therapy
-
Measurable disease
-
Life expectancy ≥3 months
-
Prior treatment with Lenalidomide permitted if:
- Best response achieved was ≥Partial Response (PR)
- Patient was not refractory
- Patient did not discontinue due to a Grade ≥3 related adverse event
- Subject did not receive more than 9 cycles of Lenalidomide and had at least 9 months between the last dose of Lenalidomide and progression
- Subjects with non-secretory or oligo-secretory or serum free light-chain only myeloma
- Active plasma cell leukemia
- Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lenalidomide + Dexamethasone +Elotuzumab Dexamethasone (IV) - Lenalidomide + Dexamethasone Lenalidomide - Lenalidomide + Dexamethasone Dexamethasone - Lenalidomide + Dexamethasone +Elotuzumab Dexamethasone (Oral) - Lenalidomide + Dexamethasone +Elotuzumab Elotuzumab (BMS-901608; HuLuc63) - Lenalidomide + Dexamethasone +Elotuzumab Lenalidomide -
- Primary Outcome Measures
Name Time Method Median Progression Free Survival (PFS) From randomization up to 326 events (up to approximately 38 months) Primary definition of Progression-free survival (PFS) defined as the time from randomization to the date of first documented tumor progression or death due to any cause. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (\> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. The primary analysis of PFS was based on the primary definition using the Independent Review Committee (IRC) tumor assessment using the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Tumor assessments were made every 4 weeks (±1 week) relative to the first dose of study medication.
Objective Response Rate (ORR) From randomization up to approximately 38 months Objective response rate (ORR) defined as the percentage of participants with a best response on-study of partial response (PR) or better (stringent CR \[sCR\], complete response \[CR\], very good partial response \[VGPR\], and partial response \[PR\]) based on the Independent Review Committee (IRC) assessment of best response using the European Group for Blood and Bone Marrow Transplant (EBMT) assessment criteria. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (\> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. Assessments were made every 4 weeks.
- Secondary Outcome Measures
Name Time Method Change From Baseline of Mean Score Pain Severity (BPI-SF) From baseline up to approximately 38 months The change from baseline of the mean score of pain severity at the end of treatment using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 ("No pain", "No interference") to 10 ("Pain as bad as you can imagine", "Highest imaginable interference") numeric rating scale.
Change From Baseline of Mean Score Pain Interference (BPI-SF) From baseline up to approximately 38 months The change from baseline of the mean score of pain interference at the end of treatment using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 ("No pain", "No interference") to 10 ("Pain as bad as you can imagine", "Highest imaginable interference") numeric rating scale.
Median Overall Survival (OS) Randomization to the date of death from any cause (up to approximately 9 years) Overall survival is defined as the time from randomization to the date of death from any cause. If a subject has not died, their survival time will be censored at the date of last contact ("last known alive date"). A subject will be censored at the date of randomization if they were randomized but had no follow-up. (Based on Kaplan Meier estimates)
Trial Locations
- Locations (39)
Ucla-Division Of Hematology/Oncology
🇺🇸Los Angeles, California, United States
Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Ut Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Dana Farber Cancer Inst
🇺🇸Boston, Massachusetts, United States
Sharp Clinical Oncology Research
🇺🇸San Diego, California, United States
University Of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
University Of Texas Md Anderson Cancer Ctr
🇺🇸Houston, Texas, United States
Northwest Cancer Center
🇺🇸Houston, Texas, United States
Va Puget Sound Health Care System
🇺🇸Seattle, Washington, United States
Northwest Alabama Cancer Center, Pc
🇺🇸Muscle Shoals, Alabama, United States
Compassionate Cancer Res Grp
🇺🇸Corona, California, United States
Medical Oncology Care Associates
🇺🇸Orange, California, United States
Florida Cancer Specialists
🇺🇸West Palm Beach, Florida, United States
San Diego Pacific Oncology& Hematology Associates, Inc
🇺🇸Encinitas, California, United States
NYU Clinical Cancer Center
🇺🇸New York, New York, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
The West Clinic
🇺🇸Memphis, Tennessee, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Acrc/Arizona Clinical Research Center, Inc.
🇺🇸Tucson, Arizona, United States
Local Institution
🇬🇧Newcastle Upon Tyne, United Kingdom
Cancer Care Centers Of Florida
🇺🇸Brooksville, Florida, United States
Mount Sinai Comprehensive Cancer Center
🇺🇸Miami Beach, Florida, United States
Winship Cancer Institute.
🇺🇸Atlanta, Georgia, United States
Cancer Institute Of Florida
🇺🇸Orlando, Florida, United States
Orchard Healthcare Research Inc.
🇺🇸Skokie, Illinois, United States
Pikeville Medical Center
🇺🇸Pikeville, Kentucky, United States
Capitol Comprehensive Cancer Care Center
🇺🇸Jefferson City, Missouri, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Gaston Hematology & Oncology
🇺🇸Gastonia, North Carolina, United States
Cancer Specialists Of South Texas, Pa
🇺🇸Corpus Christi, Texas, United States
Gundersen Clinic, Ltd
🇺🇸La Crosse, Wisconsin, United States
University Of Wisconsin Hospital And Clinics
🇺🇸Madison, Wisconsin, United States
Willis Knighton Cancer Center
🇺🇸Shreveport, Louisiana, United States
Cancer Center Of Acadiana At Lafayette General
🇺🇸Lafayette, Louisiana, United States
Georgia Health Science University
🇺🇸Augusta, Georgia, United States
Washington University School Of Medicine
🇺🇸Saint Louis, Missouri, United States
Hematology-Oncology Associates Of Fredricksburg, Inc
🇺🇸Fredericksburg, Virginia, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States