NCT00514371

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for phase_2 multiple-myeloma

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_2 multiple-myeloma

Geographic Reach
1 country

11 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

Study Start

First participant enrolled

August 1, 2007

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

December 7, 2015

Status Verified

November 1, 2015

Enrollment Period

1.5 years

First QC Date

August 8, 2007

Last Update Submit

November 6, 2015

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaHeat Shock Protein 90Hsp90KOS-95317-AAGbortezomibrelapsed-refractorytanespimycin

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate

    approximately 3 months

Secondary Outcomes (1)

  • Response rate between treatment arms and time-to-event endpoints.

    Up to 24 months

Study Arms (3)

tanespimycin and bortezomib

EXPERIMENTAL

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

Drug: tanespimycinDrug: Bortezomib

bortezomib and tanespimycin

EXPERIMENTAL

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

Drug: tanespimycinDrug: Bortezomib

bortezomib tanespimycin

EXPERIMENTAL

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

Drug: tanespimycinDrug: Bortezomib

Interventions

tanespimycinDRUG

High dose

Also known as: BMS-722782
bortezomib and tanespimycinbortezomib tanespimycintanespimycin and bortezomib
BortezomibDRUG

Mid dose, and low dose

bortezomib and tanespimycinbortezomib tanespimycintanespimycin and bortezomib

Eligibility Criteria

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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Local Institution

Berkeley, California, 94704, United States

Location

Local Institution

San Francisco, California, 94143, United States

Location

Local Institution

Augusta, Georgia, 30912, United States

Location

Local Institution

Baltimore, Maryland, 21201, United States

Location

Local Institution

Boston, Massachusetts, 02215, United States

Location

Local Institution

Omaha, Nebraska, 68114, United States

Location

Local Institution

New York, New York, 10011, United States

Location

Local Institution

New York, New York, 10021, United States

Location

Local Institution

Winston-Salem, North Carolina, 27157, United States

Location

Local Institution

Pittsburgh, Pennsylvania, 15224, United States

Location

Local Institution

Columbia, South Carolina, 29210, United States

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 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2007

First Posted

August 9, 2007

Study Start

August 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

December 7, 2015

Record last verified: 2015-11

Locations

US(11)