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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Advanced Cancer, Various, NOS

Treatments: Drug: Lenalidomide; Drug: Bortezomib; Drug: Dexamethasone; Drug: BMS-833923

Study type: Interventional

Funder types: Industry

Identifiers

NCT00884546

CA194-003

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 3 patient groups

Arm 1

Experimental group

Description:

BMS-833923 (Starting dose is a loading dose of 60 mg for 7 days with a 30 mg daily dose thereafter)

Treatment:

Drug: BMS-833923

Arm 2

Active Comparator group

Description:

BMS-833923 (MTD or below) Lenalidomide (at or below the recommended prescribing dose) Dexamethasone (40 mg)

Treatment:

Drug: BMS-833923

Drug: Dexamethasone

Drug: Lenalidomide

Arm 3

Active Comparator group

Description:

BMS-833923 (MTD or below) Bortezomib (at or below the recommended prescribing dose)

Treatment:

Drug: BMS-833923

Drug: Bortezomib