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NCT Number: NCT00546780

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tanespimycin

Drug

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

Other names: BMS-722782

bortezomib

Drug

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

Primary outcomes

  1. Progression-free survival

    Time frame: 6-24 months

Secondary outcomes

  1. Overall survival in each arm of the study

    Time frame: Up to 24 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Acronym: BMS TIME-1

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 19, 2007
Registry last updated
Jun 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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