Multiple ascending dose (MAD) combination in subjects with multiple myeloma (clinicaltrials.gov) - Jul 12, 2012 - P1, N=66 -> 27; Recruiting -> Completed; Completion date: Jun 2013 -> Mar 2012
Enrollment change • Trial completion • Trial completion date • Multiple Myeloma
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This study has been completed.
First Received on April 16, 2009. Last Updated on July 12, 2012 History of Changes
Sponsor: Bristol-Myers Squibb
Collaborator: Exelixis
Information provided by (Responsible Party): Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00884546
Purpose
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.
Condition
Advanced Cancer, Various, NOS
Intervention
Drug: BMS-833923
Drug: Lenalidomide
Drug: Dexamethasone
Drug: Bortezomib
Phase
Phase 1
Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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
Resource links provided by NLM:
Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Multiple Myeloma
Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Bortezomib Lenalidomide
U.S. FDA Resources
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Enrollment: 27
Study Start Date: July 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
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