A Study of Tanespimycin (KOS-953) in Patients With Multiple Myeloma in First Relapse (BMS TIME-1)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Multiple Myeloma

Treatments: Drug: Tanespimycin; Drug: Bortezomib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00546780

KAG-301

CA200-004

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Arm A

Active Comparator group

Description:

Tanespimycin + Bortezomib

Treatment:

Drug: Tanespimycin

Drug: Bortezomib

Arm B

Active Comparator group

Description:

Bortezomib

Treatment:

Drug: Bortezomib