A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma
Both
Multiple Myeloma
Trial Information
A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma
Inclusion Criteria:
- Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:
- have not received any prior systemic anti-myeloma therapy AND
- have measurable disease AND
- are not candidates for high-dose therapy plus stem-cell transplantation (SCT)
because of age (≥ 65 years) or coexisting conditions. Refusal to undergo high
dose therapy with SCT is NOT sufficient for entry onto CA204006 for a subject <
65 years old. There must be a comorbidity that prevents SCT for a subject < 65
years old
Exclusion Criteria:
- Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
- Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
- Monoclonal Gammopathy of Undetermined Significance (MGUS)
- 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:
Every 4 weeks (-1/+3 days) relative to the first dose of study medication.
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:
CA204-006
NCT ID:
NCT01335399
Start Date:
August 2011
Completion Date:
November 2018
Related Keywords:
- Multiple Myeloma
- Newly Diagnosed
- Previously Untreated
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| University of Michigan | Ann Arbor, Michigan 48109-0624 |
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| 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 |
| Washington Cancer Institute at Washington Hospital Center | Washington, District of Columbia 20010 |
| Columbia Comprehensive Cancer Care Clinic | Columbia, Missouri 65201 |
| Florida Cancer Specialists | Fort Myers, Florida 33901 |
| Alta Bates Summit Comprehensive Cancer Center | Berkeley, California 94704 |
| Palm Beach Cancer Institute | West Palm Beach, Florida 33401 |
| Greater Baltimore Medical Center | Baltimore, Maryland 21204 |
| Integrated Community Oncology Network | Jacksonville Beach, Florida 32250 |
| Tennessee Cancer Specialists | Knoxville, Tennessee 37920 |
| Medical Oncology Care Associates | Orange, California 92668 |
| Cancer Care Associates | Tulsa, Oklahoma 74136 |
| Henry Ford Health System | Detroit, Michigan 48202 |
| Cleveland Clinic | Cleveland, Ohio 44195 |
| Local Institution | Chicago, Illinois |
| Local Institution | Bronx, New York |
| Local Institution | Cincinnati, Ohio |
| Local Institution | Vancouver, Washington |
| Local Institution | Green Bay, Wisconsin |
| ACRC/Arizona Clinical Research Center, Inc. | Tucson, Arizona 85712 |
| Local Institution | Corona, California |
| Local Institution | Springfield, Massachusetts |
| Local Institution | Duncansville, Pennsylvania |
| Local Institution | North Charleston, South Carolina |
| Local Institution | Rome, Georgia |
| Local Institution | New Orleans, Louisiana |
| Cancer Specialists of South Texas, PA | Corpus Christi, Texas 78412 |
| Virginia Commonwealth University | Richmond, Virginia |
| Yale University School Of Medicine | New Haven, Connecticut 06520 |
| Sharp Clinical Oncology Research | San Diego, California 92123 |
| The University of Chicago | Chicago, Illinois 60637 |
| St. Luke's-Roosevelt Hospital Center | New York, New York |
| Edwards Comprehensive Cancer Center | Huntington, West Virginia 25701 |
| Local Institution | Louisville, Kentucky |
| Tennessee Oncology, PLLC | Clarksville, Tennessee 37043 |
| The University of Texas MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| Local Institution | Detroit, Michigan |
| Investigative Clinical Research of Indiana, LLC | Indianapolis, Indiana 46254 |
| Stony Brook University Medical Center | Stony Brook, New York 11794 |
| Northwest Cancer Center | Houston, Texas 77042 |
| St. Luke's Roosevelt Hospital Center | New York, New York 10019 |
| Mecklenburg Medical Group | Charlotte, North Carolina |
| Charleston Hematology Oncology Associates, PA | Charleston, South Carolina 29403 |
| Michiana Hematology Oncology, P.C. | South Bend, Indiana 46601 |
| Birmingham Hematology & Oncology Associates Llc | Birmingham, Alabama 35205 |
| Compassionate Cancer Care Medical Group Inc | Fountain Valley, California 92708 |
| Piedmont Hematology Oncology Associates, PA | Winston Salem, North Carolina 27103 |
| Marin Cancer Care, Inc | Greenbrae, California 94904 |
| Cancer Center Of Acadiana At Lafayette General | Lafayette, Louisiana 70503 |
| Hematology-Oncology Associates Of Fredricksburg, Inc | Fredricksburg, Virginia 22408 |
| Cancer Care Centers Of Florida | Brooksville, Florida 34613 |
| Harry & Jeanette Weinberg Cancer Institute | Baltimore, Maryland 21237 |
| Mercy Medical Research Institute | Springfield, Missouri 65807 |
| Benson, Md, Don | Columbus, Ohio 43210 |
| Gundersen Clinic, Ltd | La Crosse, Wisconsin 54601 |
| Dean Clinic-Hematology And Oncology | Madison, Wisconsin 53717 |
