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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Bortezomib

Criteria

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