CompletedPhase 1

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

United States27 participantsStarted 2009-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 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 details

NCT IDNCT00884546

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-03

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