NCT00546780

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for phase_3 multiple-myeloma

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_3 multiple-myeloma

Geographic Reach
2 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2007

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

June 28, 2011

Status Verified

June 1, 2011

Enrollment Period

2.1 years

First QC Date

October 17, 2007

Last Update Submit

June 21, 2011

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaHeat Shock Protein 90Hsp90KOS-95317-AAGbortezomibfirst relapsetanespimycinTIME-1

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    6-24 months

Secondary Outcomes (1)

  • Overall survival in each arm of the study

    Up to 24 months

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Tanespimycin + Bortezomib

Drug: TanespimycinDrug: Bortezomib

Arm B

ACTIVE COMPARATOR

Bortezomib

Drug: Bortezomib

Interventions

TanespimycinDRUG

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

Also known as: BMS-722782
Arm A
BortezomibDRUG

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

Arm AArm B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Comprehensive Blood And Cancer Center

Bakersfield, California, 93309, United States

Location

Moores Ucsd Cancer Center

La Jolla, California, 92093, United States

Location

University Of California Medical Center

San Francisco, California, 94143, United States

Location

Rocky Mountain Cancer Centers

Denver, Colorado, 80218, United States

Location

University Of Iowa Hospitals And Clinics

Iowa City, Iowa, 52242, United States

Location

University Of Kansas Medical Center

Westwood, Kansas, 66205, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Henry Ford Health System Irb

Detroit, Michigan, 48202, United States

Location

Capitol Comprehensive Cancer Care Center

Jefferson City, Missouri, 65109, United States

Location

Columbia University Medical Center (Cumc)

New York, New York, 10032, United States

Location

Wake Forest Univ Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Kaiser Permanente Oncology/Hematology

Portland, Oregon, 97227, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Tennessee Cancer Specialists

Knoxville, Tennessee, 37920, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

University Of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Medical College Of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Local Institution

Edmonton, Alberta, T6G 1Z2, Canada

Location

Related Links

MeSH Terms

Conditions

Multiple Myeloma

Interventions

tanespimycinBortezomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 17, 2007

First Posted

October 19, 2007

Study Start

February 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

June 28, 2011

Record last verified: 2011-06

Locations

US(18)CA(1)