A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral MLN9708 Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Progression free survival (PFS)
To determine whether the addition of oral MLN9708 to the background therapy of lenalidomide and dexamethasone improves PFS in patients with relapsed and/or refractory multiple myeloma
Change from the time of screening; Day 1 of each cycle; at EOT and thereafter every 4 weeks until disease progression
No
Medical Monitor
Study Director
Millennium Pharmaceuticals, Inc.
United States: Food and Drug Administration
C16010
NCT01564537
June 2012
May 2019
Name | Location |
---|---|
University of Michigan | Ann Arbor, Michigan 48109-0624 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Mayo Clinic | Rochester, Minnesota 55905 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Weill Medical College of Cornell University | New York, New York 10021 |
Alta Bates Comprehensive Cancer Center | Berkeley, California 94704 |
Vanderbilt University Medical Center | Nashville, Tennessee 37232-2516 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
Arizona Oncology Associates | Tucson, Arizona 85712-2254 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
Kentucky Cancer Clinic | Pikeville, Kentucky 41501 |
University of Arkansas Medical Sciences | Little Rock, Arkansas 72205 |
Clearview Cancer Institute | Huntsville, Alabama 35805 |
Jones Clinic | Germantown, Tennessee 38138 |
Portsmouth Regional Hospital | Portsmouth, New Hampshire 03802 |
Columbia University Medical Center | New York, New York 10032 |
Scranton Hematology Oncology | Scranton, Pennsylvania 18510 |
West Virginia University | Morgantown, West Virginia 26506 |
Cancer and Blood Disease Center | Lecanto, Florida 34461 |
MUSC Hollings Cancer Center | Charleston, South Carolina 29425 |
Cancer Care of North Florida | Lake City, Florida 32055 |
Northwest Georgia Oncology Center | Marietta, Georgia 30060 |
Blood and Cancer Clinic | Fayetteville, North Carolina 28304 |
Pacific Cancer Medical Center Incorporated | Anaheim, California 92801 |
Shands Hospital at University of Florida | Gainesville, Florida 32610 |
John H. Stroger Jr. Hospital of Cook County | Chicago, Illinois 60612 |
Fred Hutchinson Cancer Research | Seattle, Washington 98109 |