Multiple Ascending Dose (MAD) Combination in Subjects With Multiple Myeloma
A Phase Ib Multiple Ascending Dose Study of BMS-833923 Alone or in Combination With Lenalidomide (Revlimid) Plus Dexamethasone or in Combination With Bortezomib (Velcade) in Subjects With Relapsed or Refractory Multiple Myeloma
1 other identifier
interventional
27
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2009
Typical duration for phase_1
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2009
CompletedFirst Posted
Study publicly available on registry
April 20, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedSeptember 30, 2016
July 1, 2012
2.7 years
April 16, 2009
September 28, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
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 (3)
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
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
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
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
Study Arms (3)
Arm 1
EXPERIMENTALBMS-833923 (Starting dose is a loading dose of 60 mg for 7 days with a 30 mg daily dose thereafter)
Arm 2
ACTIVE COMPARATORBMS-833923 (MTD or below) Lenalidomide (at or below the recommended prescribing dose) Dexamethasone (40 mg)
Arm 3
ACTIVE COMPARATORBMS-833923 (MTD or below) Bortezomib (at or below the recommended prescribing dose)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Exelixiscollaborator
Study Sites (8)
City Of Hope National Medical Center
Duarte, California, 91010, United States
Moores Ucsd Cancer Center
La Jolla, California, 92093, United States
Local Institution
Los Angeles, California, 90048, United States
The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231, United States
Local Institution
Detroit, Michigan, 48201, United States
John Theurer Cancer Center
Hackensack, New Jersey, 07601, United States
Oncology Consultants, Pa
Houston, Texas, 77024, United States
Cancer Therapy And Research Center
San Antonio, Texas, 78229, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2009
First Posted
April 20, 2009
Study Start
July 1, 2009
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
September 30, 2016
Record last verified: 2012-07