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

Bristol-Myers Squibb27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Cancer, Various, NOS

Interventions

BMS-833923DRUG

Capsule, Oral, Once daily, 6 months

LenalidomideDRUG

Capsule, Oral, Once daily, 6 months

DexamethasoneDRUG

Capsule, Oral, Once a week, 6 months

Bortezomib

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

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

Outcomes

Primary Outcomes

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

Time frame: 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

Secondary Outcomes

To evaluate the safety and tolerability of BMS-833923 as a single agent or in combination with two dose levels of lenalidomide plus a fixed low-dose of dexamethasone or in combination with two dose levels of bortezomib

Time frame: 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

To evaluate the Pharmacokinetics of BMS-833923

Time frame: 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

To evaluate the Pharmacodynamics effects of BMS-833923

Time frame: 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

Data from ClinicalTrials.gov

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