Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, Heat Shock Protein 90, Hsp90, KOS-953, 17-AAG, bortezomib, relapsed-refractory, tanespimycin
Brief summary
This is a phase 2/3, open label trial for patients with relapsed-refractory multiple myeloma. Study agent is tanespimycin (KOS-953), at three different dose levels in combination with a fixed dose of bortezomib.
Detailed description
Phase 2/3 combination study comparing bortezomib plus one of three doses of tanespimycin in patients with relapsed-refractory multiple myeloma after failure of at least three prior anti-cancer therapy regimens. Prior therapy must include bortezomib and lenalidomide. Primary objective is to assess the dose-response relationship of objective response rate (ORR) using EBMT/IBMTR criteria of any three dose levels of tanespimycin (KOS-953) in combination with bortezomib after four treatment cycles.
Interventions
DRUGtanespimycin
High dose
DRUGBortezomib
Mid dose, and low dose
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Good performance status * Histologic evidence of multiple myeloma * Have had at least three prior treatment regimens for multiple myeloma that included both bortezomib and lenalidomide * No prior treatment with a heat shock 90 inhibitor or an investigational proteasome inhibitor * No known infections of HAV, HBV, HCV, or HIV * No chemotherapy, radiation therapy, or immune therapy for three weeks prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate | approximately 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Response rate between treatment arms and time-to-event endpoints. | Up to 24 months |
Countries
United States
Outcome results
None listed