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 range

18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Advanced Cancer, Various, NOS trials