A Study of Tanespimycin (KOS-953) in Patients With Relapsed-refractory Multiple Myeloma
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer, Hematology, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2007 |
| End Date: | February 2009 |
Phase 2/3 Randomized, Open-Label Clinical Trial of Tanespimycin (KOS-953) Plus Bortezomib Comparing Three Doses of Tanespimycin in Patients With Relapsed-Refractory Multiple Myeloma
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.
myeloma. Study agent is tanespimycin (KOS-953), at three different dose levels in
combination with a fixed dose of bortezomib.
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.
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.
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.
We found this trial at
10
sites
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