Advanced Cancer, Various, NOS Clinical Trial
Official title:
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
| Verified date | July 2012 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 27 |
| Est. completion date | March 2012 |
| Est. primary completion date | March 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | The Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland |
| United States | Local Institution | Detroit | Michigan |
| United States | City Of Hope National Medical Center | Duarte | California |
| United States | John Theurer Cancer Center | Hackensack | New Jersey |
| United States | Oncology Consultants, Pa | Houston | Texas |
| United States | Moores Ucsd Cancer Center | La Jolla | California |
| United States | Local Institution | Los Angeles | California |
| United States | Cancer Therapy And Research Center | San Antonio | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb | Exelixis |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes | |
| Secondary | 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 | Yes | |
| Secondary | 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 | No | |
| Secondary | 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 | No |