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

Phase 3 Randomized, Open-Label Clinical Trial of Tanespimycin (KOS-953) Plus Bortezomib Compared to Bortezomib Alone in Patients With Multiple Myeloma in First Relapse

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00546780

Acronym

BMS TIME-1

Enrollment

Registered

2007-10-19

Start date

2008-02-29

Completion date

2010-03-31

Last updated

2011-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma, Heat Shock Protein 90, Hsp90, KOS-953, 17-AAG, bortezomib, first relapse, tanespimycin, TIME-1

Brief 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.

Detailed 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.

Interventions

DRUGTanespimycin

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

DRUGBortezomib

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Progression-free survival	6-24 months

Secondary

Measure	Time frame
Overall survival in each arm of the study	Up to 24 months

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026