An Open-Label, Dose-Escalation, Phase 1/2 Study of the Oral Formulation of MLN9708, Administered Twice-weekly in Combination With Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Requiring Systemic Treatment
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) and Recommended phase 2 dose of MLN9708 (phase 1)
Based on adverse events, serious adverse events, assessments of clinical laboratory values, neurotoxicity grading, and vital sign measurements
Dose Limiting Toxcities determined in Cycle 1 to define MTD; MTD and adverse events monitored throughout the study will inform the recommended phase 2 dose, approximately 1 year
Yes
Medical Monitor
Study Director
Millennium Pharmaceuticals, Inc.
United States: Food and Drug Administration
C16008
NCT01383928
July 2011
January 2014
Name | Location |
---|---|
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Stanford University | Stanford, California 94305 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Oregon Health & Science University | Portland, Oregon 97201 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
University of Chicago | Chicago, Illinois 60637 |
Moffitt Cancer Center | Tampa, Florida 33612 |
City of Hope Cancer Center | Duarte, California 91010 |
Ohio State University Comprehensive Cancer Center | Columbus, Ohio |
Mercy St. Vincent Medical Center | Toledo, Ohio 43608 |
Virginia Cancer Specialists | Fairfax, Virginia |
Mount Sinai | New York, New York 10029 |
Associates in Hematology/Oncology | Rockville, Maryland 20850 |
Sara Cannon Research Institute | Nashville, Tennessee 37203 |
Baylor Healthcare System | Dallas, Texas 75204 |