Study of Safety of Elotuzumab Administered Over Approximately 60 Minutes in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed or Relapsed/Refractory Multiple Myeloma Patients
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT02159365
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
To explore whether Elotuzumab dose administration over approximately 60 minutes is feasible and safe.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
-
Eastern Cooperative Oncology Group (ECOG) performance status ≤2
-
Documented evidence of active multiple myeloma:
- Newly diagnosed, not candidate for transplant
- Relapsed/refractory who have received up to 3 prior lines of therapy
-
Prior Lenalidomide exposure is permitted only if the following criteria are fulfilled:
- Not refractory to prior Lenalidomide which is defined as no progression while receiving Lenalidomide or within 60 days of last dose of Lenalidomide
- Subject did not discontinue Lenalidomide due to a Grade ≥3 related adverse event (AE)
-
Target Disease Exceptions
- Plasma cell leukemia
- Monoclonal gammopathy of undetermined significance (MGUS)
- Smoldering Myeloma
-
Primary amyloidosis
-
Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Elotuzumab + Lenalidomide/Dexamethasone Lenalidomide Elotuzumab 10 mg/kg solution intravenously weekly in cycle 1 and 2, then every other week, Lenalidomide 25 mg tablet by mouth Days 1-21 of each cycle / Dexamethasone 40 mg tablet by mouth / solution intravenously weekly until progression or discontinuation of Elotuzumab Elotuzumab + Lenalidomide/Dexamethasone Dexamethasone Elotuzumab 10 mg/kg solution intravenously weekly in cycle 1 and 2, then every other week, Lenalidomide 25 mg tablet by mouth Days 1-21 of each cycle / Dexamethasone 40 mg tablet by mouth / solution intravenously weekly until progression or discontinuation of Elotuzumab Elotuzumab + Lenalidomide/Dexamethasone Elotuzumab Elotuzumab 10 mg/kg solution intravenously weekly in cycle 1 and 2, then every other week, Lenalidomide 25 mg tablet by mouth Days 1-21 of each cycle / Dexamethasone 40 mg tablet by mouth / solution intravenously weekly until progression or discontinuation of Elotuzumab
- Primary Outcome Measures
Name Time Method Number of Participants With Grade 3 or Grade 4 (G3/4) Infusion Reactions by the End of Treatment Cycle 2 From Day 1 to End of cycle 2 treatment (approximately 56 days) Infusion reaction was defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.
- Secondary Outcome Measures
Name Time Method Number of Participants With Any Grade and Grade 3 or Grade 4 (G3/4) Infusion Reactions Over the Entire Study Period Date of first dose up to 60 days post last dose (approximately 4 years) An infusion reaction in this study is defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.
Trial Locations
- Locations (29)
Baptist Health Medical Group Oncology
🇺🇸Miami, Florida, United States
Investigative Clinical Research Of Indiana, Llc
🇺🇸Indianapolis, Indiana, United States
Comprehensive Blood And Cancer Center
🇺🇸Bakersfield, California, United States
Cancer Centers of South Texas
🇺🇸San Antonio, Texas, United States
Robert A. Moss, Md Facp, Inc.
🇺🇸Fountain Valley, California, United States
Loma Linda University Cancer Center
🇺🇸Loma Linda, California, United States
Clinical Research Alliance, Inc.
🇺🇸New York, New York, United States
Pacific Cancer Care
🇺🇸Monterey, California, United States
Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Texas Oncology-McAllen South Second Street
🇺🇸Weslaco, Texas, United States
Ventura County Hematology-Oncology Specialists
🇺🇸Oxnard, California, United States
Compassionate Cancer Res Grp
🇺🇸Fountain Valley, California, United States
Rocky Mountain Cancer Centers Llp
🇺🇸Denver, Colorado, United States
California Cancer Associates for Research and Excellence
🇺🇸Encinitas, California, United States
Horizon Oncology Research, Inc
🇺🇸Lafayette, Indiana, United States
Oncology Specialists,S.C
🇺🇸Park Ridge, Illinois, United States
Local Institution
🇺🇸Houston, Texas, United States
Blue Ridge Cancer Care
🇺🇸Blacksburg, Virginia, United States
Texas Oncology
🇺🇸Dallas, Texas, United States
Greenville Health System
🇺🇸Greenville, South Carolina, United States
Vista Oncology Inc., PS
🇺🇸Olympia, Washington, United States
Wellness Oncology & Hematology
🇺🇸West Hills, California, United States
Acrc/Arizona Clinical Research Center, Inc.
🇺🇸Tucson, Arizona, United States
Highland Oncology Group
🇺🇸Fayetteville, Arkansas, United States
Cancer Specialists Of North Florida
🇺🇸Jacksonville, Florida, United States
Center For Cancer Care & Research
🇺🇸Lakeland, Florida, United States
Blood & Cancer Center of East Texas
🇺🇸Tyler, Texas, United States
James R. Berenson, MD, Inc.
🇺🇸West Hollywood, California, United States
St Francis Hospital
🇺🇸Greenville, South Carolina, United States