A Study of Tanespimycin (KOS-953) in Patients With Relapsed-refractory Multiple Myeloma

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: tanespimycin
* Drug: Bortezomib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tanespimycin and bortezomib<br>A patient will receive a standard dose of bortezomib followed by a high dose of tanespimycin. | Drug: tanespimycin<br>* High dose<br>* Other names: BMS-722782;Drug: Bortezomib<br>* Mid dose, and low dose<br>|
| Experimental: bortezomib and tanespimycin<br>A patient will receive a standard dose of bortezomib followed by a mid dose of tanespimycin. | Drug: tanespimycin<br>* High dose<br>* Other names: BMS-722782;Drug: Bortezomib<br>* Mid dose, and low dose<br>|
| Experimental: bortezomib tanespimycin<br>A patient will receive a standard dose of bortezomib followed by a low dose of tanespimycin. | Drug: tanespimycin<br>* High dose<br>* Other names: BMS-722782;Drug: Bortezomib<br>* Mid dose, and low dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate |  | approximately 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate between treatment arms and time-to-event endpoints. |  | Up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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KOS-953, 17-AAG, Multiple Myeloma, Heat Shock Protein 90, Hsp90, bortezomib, relapsed-refractory, tanespimycin