A Phase Ib Multiple Ascending Dose Study of BMS-833923 Alone or in Combination With Lenalidomide (Revlimid) Plus Dexamethasone or in Combination With Bortezomib (Velcade) in Subjects With Relapsed or Refractory Multiple Myeloma
18 Years
N/A
Both
Advanced Cancer, Various, NOS
Trial Information
A Phase Ib Multiple Ascending Dose Study of BMS-833923 Alone or in Combination With Lenalidomide (Revlimid) Plus Dexamethasone or in Combination With Bortezomib (Velcade) in Subjects With Relapsed or Refractory Multiple Myeloma
Inclusion Criteria:
- Confirmed diagnosis of Multiple Myeloma
- Men and Women at least 18 years old
- ECOG status 0-2
- Last therapeutic or diagnostic treatment at least 21 days prior
- Bone marrow transplants must have been completed at least 3 months prior
- Any toxicity from prior therapies must have resolved to Grade ≤1
Exclusion Criteria:
- Women pregnant or breastfeeding
- WOCBP unwilling/unable to use acceptable method to avoid pregnancy
- Uncontrolled medical disorder or active infection
- Current or recent (w/in 3 months) gastrointestinal disorder
- Inability to swallow oral medication
- Inability to be venipunctured
- Uncontrolled or significant cardiovascular disease
- Uncontrolled hyperlipidemia
- Intolerance of lenalidomide or bortezomib if participating in Arms B and C
- Concurrent therapy with any other investigational product
- Subjects involuntary incarcerated
- Subjects detained for treatment of psychiatric or physical illness
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To establish DLT(s), MTD, and Phase 2 dose range and schedule of BMS-833923 administered alone, in combination with two dose levels of lenalidomide plus dexamethasone, or with two dose levels of bortezomib in subjects with relapsed or refractory MM
Outcome Time Frame:
For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA194-003
NCT ID:
NCT00884546
Start Date:
July 2009
Completion Date:
March 2012
Related Keywords:
- Advanced Cancer, Various, NOS
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| City of Hope National Medical Center | Los Angeles, California 91010 |
| Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
| Cancer Therapy and Research Center | San Antonio, Texas 78229 |
| Local Institution | Corona, California |
| Local Institution | Detroit, Michigan |
| The Sidney Kimmel Comprehensive Cancer Center | Baltimore, Maryland 21231 |
| Oncology Consultants, PA | Houston, Texas 77024 |
| John Theurer Cancer Center | Hackensack, New Jersey 07601 |
