A Study of Tanespimycin (KOS-953) in Patients With Relapsed-refractory Multiple Myeloma (TIME-2)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: tanespimycin; Drug: Bortezomib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00514371

KAG-302

CA200-003

Details and patient eligibility

About

This is a phase 2/3, open label trial for patients with relapsed-refractory multiple myeloma. Study agent is tanespimycin (KOS-953), at three different dose levels in combination with a fixed dose of bortezomib.

Full description

Phase 2/3 combination study comparing bortezomib plus one of three doses of tanespimycin in patients with relapsed-refractory multiple myeloma after failure of at least three prior anti-cancer therapy regimens. Prior therapy must include bortezomib and lenalidomide. Primary objective is to assess the dose-response relationship of objective response rate (ORR) using EBMT/IBMTR criteria of any three dose levels of tanespimycin (KOS-953) in combination with bortezomib after four treatment cycles.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Good performance status
• Histologic evidence of multiple myeloma
• Have had at least three prior treatment regimens for multiple myeloma that included both bortezomib and lenalidomide
• No prior treatment with a heat shock 90 inhibitor or an investigational proteasome inhibitor
• No known infections of HAV, HBV, HCV, or HIV
• No chemotherapy, radiation therapy, or immune therapy for three weeks prior to enrollment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 3 patient groups

tanespimycin and bortezomib

Experimental group

Description:

A patient will receive a standard dose of bortezomib followed by a high dose of tanespimycin.

Treatment:

Drug: Bortezomib

Drug: tanespimycin

bortezomib and tanespimycin

Experimental group

Description:

A patient will receive a standard dose of bortezomib followed by a mid dose of tanespimycin.

Treatment:

Drug: Bortezomib

Drug: tanespimycin

bortezomib tanespimycin

Experimental group

Description:

A patient will receive a standard dose of bortezomib followed by a low dose of tanespimycin.

Treatment:

Drug: Bortezomib

Drug: tanespimycin