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
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Elotuzumab Type: Drug
Name: Lenalidomide Type: Drug
Name: Dexamethasone Type: Drug
Overall Status
Recruiting
Summary
To explore whether Elotuzumab dose administration over approximately 60 minutes is feasible and safe.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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
Locations
Acrc/Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States
Status: Recruiting
Contact: Manuel R Modiano, Site 0019 - 520-290-2510
Highland Oncology Group
Fayetteville, Arkansas, United States
Status: Recruiting
Contact: Patrick Travis, Site 0012
Comprehensive Blood And Cancer Center
Bakersfield, California, United States
Status: Recruiting
Contact: Alan Cartmell, Site 0002 - 661-322-2206
California Cancer Associates For Research And Excellence
Encinitas, California, United States
Status: Recruiting
Contact: Alberto Bessudo, Site 0008 - 760-452-3909
Compassionate Cancer Care Medical Group Inc
Fountain Valley, California, United States
Status: Recruiting
Contact: Haresh Jhangiani, Site 0006 - 951-276-2760
Robert A. Moss, Md Facp, Inc.
Fountain Valley, California, United States
Status: Recruiting
Contact: Robert A Moss, Site 0029 - 714-641-0210
Loma Linda University Cancer Center
Loma Linda, California, United States
Status: Recruiting
Contact: Chien-Shing Chen, Site 0005 - 909-558-4050
Ventura County Hematology-Oncology Specialists
Oxnard, California, United States
Status: Recruiting
Contact: Todd Yates, Site 0028 - 805-485-8709
Pacific Cancer Care
Salinas, California, United States
Status: Recruiting
Contact: Laura Stampleman, Site 0031 - 831-755-1701
Wellness Oncology & Hematology
West Hills, California, United States
Status: Recruiting
Contact: Ashkan Lashkari, Site 0004 - 818-346-1773
James R. Berenson, Md, Inc.
West Hollywood, California, United States
Status: Recruiting
Contact: James Berenson, Site 0001 - 310-623-1200
Rocky Mountain Cancer Centers Llp
Denver, Colorado, United States
Status: Recruiting
Contact: Robert Rifkin, Site 0013 - 303-388-4876
Cancer Specialists Of North Florida
Jacksonville, Florida, United States
Status: Recruiting
Contact: Suprith Badarinath, Site 0020 - 904-388-2619
Center For Cancer Care & Research
Lakeland, Florida, United States
Status: Recruiting
Contact: Shalini Mulaparthi, Site 0030 - 863-603-4737
Advanced Medical Specialties
Miami, Florida, United States
Status: Recruiting
Contact: Lisa Reale, Site 0015 - 305-728-1860
Oncology Specialists,S.C
Park Ridge, Illinois, United States
Status: Recruiting
Contact: Jacob Bitran, Site 0007 - 847-268-8200
Investigative Clinical Research Of Indiana, Llc
Indianapolis, Indiana, United States
Status: Recruiting
Contact: Robert Manges, Site 0003 - 317-297-2208
Horizon Oncology Research, Inc
Lafayette, Indiana, United States
Status: Recruiting
Contact: Wael Harb, Site 0016 - 765-446-5111
Local Institution
Grand Island, Nebraska, United States
Status: Not yet recruiting
Contact: Site 0018
Clinical Research Alliance, Inc.
New York, New York, United States
Status: Recruiting
Contact: Morton Coleman, Site 0022 - 516-488-2918
Greenville Health System
Greenville, South Carolina, United States
Status: Recruiting
Contact: Suzanne Fanning, Site 0017 - 864-241-6251
St Francis Hospital
Greenville, South Carolina, United States
Status: Recruiting
Contact: Fahd Quddus, Site 0025 - 864-546-3699
Texas Oncology
Arlington, Texas, United States
Status: Recruiting
Contact: Scott Fleischauer, Site 0014 - 817-467-6092
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Status: Recruiting
Contact: Joseph Fay, Site 0024 - 214-818-8427
Texas Oncology
Dallas, Texas, United States
Status: Recruiting
Contact: Kristi J Mcintyre, Site 0009 - 214-739-4175
Local Institution
Houston, Texas, United States
Status: Not yet recruiting
Contact: Site 0026
Cancer Care Centers Of South Texas
San Antonio, Texas, United States
Status: Recruiting
Contact: Roger M Lyons, Site 0010 - 210-595-5300
Blood & Cancer Center Of East Texas
Tyler, Texas, United States
Status: Recruiting
Contact: Gary Gross, Site 0027 - 903-597-2273
Texas Oncology
Weslaco, Texas, United States
Status: Recruiting
Contact: Daniel Farray-Berges, Site 0011 - 956-969-0021
Blue Ridge Cancer Care
Blacksburg, Virginia, United States
Status: Recruiting
Contact: Heather Brooks, Site 0023 - 540-381-5291
Vista Oncology Inc., Ps
Olympia, Washington, United States
Status: Recruiting
Contact: Joseph Ye, Site 0032 - 360-352-2900
Start Date
June 2014
Completion Date
August 2018
Sponsors
Bristol-Myers Squibb
Source
Bristol-Myers Squibb
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page