Multiple Ascending Dose (MAD) Combination in Subjects With Multiple Myeloma
Phase 1
Completed
- Conditions
- Advanced Cancer, Various, NOS
- Interventions
- Registration Number
- NCT00884546
- Lead Sponsor
- Bristol-Myers Squibb
- 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 subjects with relapsed or refractory multiple myeloma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 BMS-833923 BMS-833923 (Starting dose is a loading dose of 60 mg for 7 days with a 30 mg daily dose thereafter) Arm 2 BMS-833923 BMS-833923 (MTD or below) Lenalidomide (at or below the recommended prescribing dose) Dexamethasone (40 mg) Arm 2 Lenalidomide BMS-833923 (MTD or below) Lenalidomide (at or below the recommended prescribing dose) Dexamethasone (40 mg) Arm 2 Dexamethasone BMS-833923 (MTD or below) Lenalidomide (at or below the recommended prescribing dose) Dexamethasone (40 mg) Arm 3 BMS-833923 BMS-833923 (MTD or below) Bortezomib (at or below the recommended prescribing dose) Arm 3 Bortezomib BMS-833923 (MTD or below) Bortezomib (at or below the recommended prescribing dose)
- Primary Outcome Measures
Name Time Method 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 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
- Secondary Outcome Measures
Name Time Method To evaluate the Pharmacokinetics of BMS-833923 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 To evaluate the safety and tolerability of BMS-833923 as a single agent or in combination with two dose levels of lenalidomide plus a fixed low-dose of dexamethasone or in combination with two dose levels of bortezomib 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 To evaluate the Pharmacodynamics effects of BMS-833923 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
Trial Locations
- Locations (7)
City Of Hope National Medical Center
🇺🇸Duarte, California, United States
The Sidney Kimmel Comprehensive Cancer Center
🇺🇸Baltimore, Maryland, United States
John Theurer Cancer Center
🇺🇸Hackensack, New Jersey, United States
Local Institution
🇺🇸Detroit, Michigan, United States
Moores Ucsd Cancer Center
🇺🇸La Jolla, California, United States
Cancer Therapy And Research Center
🇺🇸San Antonio, Texas, United States
Oncology Consultants, Pa
🇺🇸Houston, Texas, United States