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

Bristol-Myers Squibb31 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Myeloma

Interventions

TanespimycinDRUG

Solution, IV, 340mg/m2, twice weekly for 2 weeks (3 week cycle), 60 minutes infusion

BortezomibDRUG

Solution, IV, 1.3 mg/m2, twice weekly for 2 weeks (3 weeks cycle), 3-5 minute bolus

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (19)

Comprehensive Blood And Cancer Center

Bakersfield, California, United States

Moores Ucsd Cancer Center

Outcomes

Primary Outcomes

Progression-free survival

Time frame: 6-24 months

Secondary Outcomes

Overall survival in each arm of the study

Time frame: Up to 24 months

Data from ClinicalTrials.gov

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