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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Exelixis
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Thalidomide

Criteria

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