Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma (MM)
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma
Both
Multiple Myeloma
Trial Information
Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma (MM)
Inclusion Criteria:
- 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:
1. Best response achieved was ≥ Partial Response (PR)
2. Patient was not refractory
3. Patient did not discontinue due to a Grade ≥ 3 related adverse event
4. Subject did not receive more than 9 cycles of Lenalidomide and had at least 9
months between the last dose of Lenalidomide and progression
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival (PFS) - Time from randomization to date of first tumor progression or death due to any cause, provided death is not more than 10 weeks after the last tumor assessment
Outcome Time Frame:
Tumor assessments every 4 weeks (±1 week) relative to the first dose of study medication (median length of time for tumor assessments should be approximately 13 months)
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
Australia: Department of Health and Ageing Therapeutic Goods Administration
Study ID:
CA204-004
NCT ID:
NCT01239797
Start Date:
June 2011
Completion Date:
October 2017
Related Keywords:
- Multiple Myeloma
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Capitol Comprehensive Cancer Care Clinic | Jefferson City, Missouri 65109 |
| Mount Sinai Comprehensive Cancer Center | Miami Beach, Florida 33140 |
| Alta Bates Summit Comprehensive Cancer Center | Berkeley, California 94704 |
| Mid Dakota Clinic, PC | Bismarck, North Dakota 58501 |
| Palm Beach Cancer Institute | West Palm Beach, Florida 33401 |
| Tennessee Cancer Specialists | Knoxville, Tennessee 37920 |
| Medical Oncology Care Associates | Orange, California 92668 |
| Henry Ford Health System | Detroit, Michigan 48202 |
| Local Institution | Bronx, New York |
| Local Institution | Vancouver, Washington |
| Local Institution | Green Bay, Wisconsin |
| ACRC/Arizona Clinical Research Center, Inc. | Tucson, Arizona 85712 |
| Local Institution | Birmingham, Alabama |
| Local Institution | Springfield, Massachusetts |
| Local Institution | Oklahoma City, Oklahoma |
| Local Institution | North Charleston, South Carolina |
| Local Institution | Austin, Texas |
| Cancer Specialists of South Texas, PA | Corpus Christi, Texas 78412 |
| Sharp Clinical Oncology Research | San Diego, California 92123 |
| St. Luke's-Roosevelt Hospital Center | New York, New York |
| Local Institution | Louisville, Kentucky |
| Winship Cancer Institute, Emory University | Atlanta, Georgia 30322 |
| Local Institution | Detroit, Michigan |
| Investigative Clinical Research of Indiana, LLC | Indianapolis, Indiana 46254 |
| Northwest Alabama Cancer Center, PC | Florence, Alabama 35630 |
| NYU Clinical Cancer Center | New York, New York 10016 |
| Pasco Hernando Oncology Associates, PA | New Port Richey, Florida 34642 |
| Northwest Cancer Center | Houston, Texas 77042 |
| Weill Cornell Medical College | New York, New York 10021 |
| Mecklenburg Medical Group | Charlotte, North Carolina |
| University of Texas Southwestern | Dallas, Texas 75390 |
| Charleston Hematology Oncology Associates, PA | Charleston, South Carolina 29403 |
| Gaston Hematology & Oncology | Gastonia, North Carolina 28054 |
| Compassionate Cancer Care Medical Group Inc | Fountain Valley, California 92708 |
| Cancer Institute Of Florida | Orlando, Florida 32804 |
| St Johns Medical Research Institute, Inc. | Springfield, Missouri 65807 |
| San Diego Pacific Oncology& Hematology Associates, Inc | Encinitas, California 92024 |
| Marin Cancer Care, Inc | Greenbrae, California 94904 |
| Space Coastal Medical Assoc. | Titusville, Florida 32796 |
| Cancer Center Of Acadiana At Lafayette General | Lafayette, Louisiana 70503 |
| Willis Knighton Cancer Center | Shreveport, Louisiana 71103 |
| Univ Of Oklahoma Health Science Center | Oklahoma City, Oklahoma 73104 |
| Hematology-Oncology Associates Of Fredricksburg, Inc | Fredricksburg, Virginia 22408 |
