Multiple Ascending Dose (MAD) Combination in Subjects With Multiple Myeloma
NCT ID: NCT00884546
Last Updated: 2016-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
27 participants
INTERVENTIONAL
2009-07-31
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
BMS-833923 (Starting dose is a loading dose of 60 mg for 7 days with a 30 mg daily dose thereafter)
BMS-833923
Capsule, Oral, Once daily, 6 months
Arm 2
BMS-833923 (MTD or below)
Lenalidomide (at or below the recommended prescribing dose)
Dexamethasone (40 mg)
BMS-833923
Capsule, Oral, Once daily, 6 months
Lenalidomide
Capsule, Oral, Once daily, 6 months
Dexamethasone
Capsule, Oral, Once a week, 6 months
Arm 3
BMS-833923 (MTD or below)
Bortezomib (at or below the recommended prescribing dose)
BMS-833923
Capsule, Oral, Once daily, 6 months
Bortezomib
Powder, IV, On days 1, 4, 8, 11, 6 months
Interventions
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BMS-833923
Capsule, Oral, Once daily, 6 months
Lenalidomide
Capsule, Oral, Once daily, 6 months
Dexamethasone
Capsule, Oral, Once a week, 6 months
Bortezomib
Powder, IV, On days 1, 4, 8, 11, 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Exelixis
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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City Of Hope National Medical Center
Duarte, California, United States
Moores Ucsd Cancer Center
La Jolla, California, United States
Local Institution
Los Angeles, California, United States
The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Local Institution
Detroit, Michigan, United States
John Theurer Cancer Center
Hackensack, New Jersey, United States
Oncology Consultants, Pa
Houston, Texas, United States
Cancer Therapy And Research Center
San Antonio, Texas, United States
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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CA194-003
Identifier Type: -
Identifier Source: org_study_id
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