An Open-Label, Dose-Escalation, Phase 1/2 Study of the Oral Form of MLN9708, a Second-Generation Proteasome Inhibitor, Administered in Combination With Lenalidomide and Low-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Requiring Systemic Treatment
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
To determine the safety and tolerability of MLN9708 administered weekly in combination with lenalidomide and low-dose dexamethasone
Until occurrence of progressive disease or unacceptable toxicity
Yes
Medical Monitor
Study Director
Millennium Pharmaceuticals, Inc.
United States: Food and Drug Administration
C16005
NCT01217957
November 2010
April 2013
Name | Location |
---|---|
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Cedars-Sinai Medical Center | Los Angeles, California 90048 |
Rocky Mountain Cancer Center | Denver, Colorado 80218 |
Mayo Clinic | Jacksonville, Florida 32224 |
Emory University | Atlanta, Georgia 30322 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Mount Sinai Medical Center | Miami Beach, Florida 33140 |
The Harry and Jeanette Weinberg Cancer Institute | Baltimore, Maryland 21237-3998 |
Karmanos Cancer Institute | Detroit, Michigan 48201 |
Tennessee Oncology | Nashville, Tennessee 37203 |
Cancer Center of Central Connecticut | Southington, Connecticut |
Medical College Wisconsin | Milwaukee, Wisconsin |
Mayo Clinic- Scottsdale | Scottsdale, Arizona 85259 |
Weill-Cornell Medical College | New York City, New York 10011 |
Mayo Clinic- Rochester | Rochester, Minnesota 55095 |
Mary Babb Rudolph Cancer Center | Morgantown, West Virginia 26506 |