A Study of Tanespimycin (KOS-953) in Patients With Multiple Myeloma in First Relapse

Study Overview
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Brief Summary
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This is a phase 3, open label trial for patients with multiple myeloma in first relapse. Trial will compare tanespimycin (KOS-953), in combination with a fixed dose of bortezomib versus bortezomib alone.

Detailed Description
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Phase 3 combination study comparing tanespimycin (KOS-953) plus bortezomib to bortezomib alone in patients with multiple myeloma in first relapse after failure of previous anti-cancer therapy and/or bone marrow transplantation. Primary objective is to compare the progression-free survival (PFS) associated with the use of tanespimycin (KOS-953) in combination with bortezomib versus that associated with administration of bortezomib alone.

Official Title
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Phase 3 Randomized, Open-Label Clinical Trial of Tanespimycin (KOS-953) Plus Bortezomib Compared to Bortezomib Alone in Patients With Multiple Myeloma in First Relapse

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 Documented evidence of multiple myeloma Documented progression of disease after initial response to one line of therapy Measurable disease (serum M-protein >.5g/dl or > 200 mg urinary M protein excretion) Exclusion Criteria: Prior treatment with a heat shock 90 inhibitor or an investigational proteasome inhibitor Known active infections of HAV, HBV, HCV, or HIV Administration of chemotherapy, radiation therapy, or immune therapy within 21 days prior to randomization. Acute diffuse infiltrate pulmonary disease or pericardial dise

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 |
| --- | --- |
| Active Comparator: Arm A<br>Tanespimycin + Bortezomib | Drug: Tanespimycin<br>* Solution, IV, 340mg/m2, twice weekly for 2 weeks (3 week cycle), 60 minutes infusion<br>* Other names: BMS-722782;Drug: Bortezomib<br>* Solution, IV, 1.3 mg/m2, twice weekly for 2 weeks (3 weeks cycle), 3-5 minute bolus<br>|
| Active Comparator: Arm B<br>Bortezomib | Drug: Bortezomib<br>* Solution, IV, 1.3 mg/m2, twice weekly for 2 weeks (3 weeks cycle), 3-5 minute bolus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 6-24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival in each arm of the study |  | Up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma, Heat Shock Protein 90, Hsp90, KOS-953, 17-AAG, bortezomib, first relapse, tanespimycin, TIME-1