Multiple Ascending Dose (MAD) Combination in Subjects With Multiple Myeloma

Completed · Phase 1

Conditions studied: Advanced Cancer, Various, NOS

In brief

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.

Key facts

Study ID

NCT00884546

Run by

Bristol-Myers Squibb

People needed

27

Starts

2009-07-01

Expected to finish

2012-03-01

Last updated by the study team

2016-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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