Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 18 and over Pharmaceutical / Industry CA200-004 KAG-301, NCT00546780

Trial Description

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.

Further Study Information

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.

Eligibility Criteria

Inclusion Criteria:

• Good performance status

• Histologic evidence of multiple myeloma

Exclusion Criteria:

• Prior treatment with a heat shock 90 inhibitor or an investigational proteasome inhibitor

• Known infections of HAV, HBV, HCV, or HIV

• Chemotherapy, radiation therapy, or immune therapy for three weeks prior to enrollment.

Trial Contact Information

Trial Lead Organizations/Sponsors

Bristol-Myers Squibb Company - New York

Bristol-Myers Squibb

Study Director

For participation information at a USA site use a phone number below. For site information outside the USA please email:
		Email: Clinical.Trials@bms.com

First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

U.S.A.
Massachusetts
	Boston
	Local Institution
		Site 012

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00546780
Information obtained from ClinicalTrials.gov on October 14, 2008