Status:
COMPLETED
Multiple Ascending Dose (MAD) Combination in Subjects With Multiple Myeloma
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Exelixis
Conditions:
Advanced Cancer, Various, NOS
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-833923 administered alone, in combination with lenalidomide plus dexamethasone, or in combination with bortezomib in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00884546
Start Date
July 1 2009
End Date
March 1 2012
Last Update
September 30 2016
Active Locations (8)
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1
City Of Hope National Medical Center
Duarte, California, United States, 91010
2
Moores Ucsd Cancer Center
La Jolla, California, United States, 92093
3
Local Institution
Los Angeles, California, United States, 90048
4
The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231