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
Sponsor study identifier
interventional
27
1 country
8
Study Start
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2012
Actual (reported)Study Completion
March 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 16, 2009
Actual (reported)April 20, 2009
Actual (reported)July 2009
Date type not reportedThis date has not been verified as actual or estimated.
March 2012
Actual (reported)March 2012
Actual (reported)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
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
BMS-833923 (Starting dose is a loading dose of 60 mg for 7 days with a 30 mg daily dose thereafter)
BMS-833923 (MTD or below) Lenalidomide (at or below the recommended prescribing dose) Dexamethasone (40 mg)
Capsule, Oral, Once daily, 6 months
Capsule, Oral, Once daily, 6 months
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
Bristol-Myers Squibb
Bristol-Myers Squibb
27 participants (actual enrollment reported by the registry).
First Submitted
April 16, 2009
First Posted
April 20, 2009
Study Start
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
BMS-833923 (MTD or below) Bortezomib (at or below the recommended prescribing dose)
Capsule, Oral, Once a week, 6 months
Powder, IV, On days 1, 4, 8, 11, 6 months
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Cancer Therapy And Research Center
San Antonio, Texas, 78229, United States
Primary Completion
March 2012
Actual (reported)Study Completion
March 2012
Actual (reported)Last Updated
September 30, 2016
Record last verified: 2012-07
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Source: ClinicalTrials.gov.
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