BMS TIME-1: A Study of Tanespimycin (KOS-953) in Patients With Multiple Myeloma in First Relapse

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT00546780

Collaborator

(none)

Enrollment

Locations

Arms

24.9

Duration (Months)

1.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: Tanespimycin Drug: Bortezomib	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm A Tanespimycin + Bortezomib	Drug: Tanespimycin Solution, IV, 340mg/m2, twice weekly for 2 weeks (3 week cycle), 60 minutes infusion Other Names: BMS-722782 Drug: Bortezomib Solution, IV, 1.3 mg/m2, twice weekly for 2 weeks (3 weeks cycle), 3-5 minute bolus
Active Comparator: Arm B Bortezomib	Drug: Bortezomib Solution, IV, 1.3 mg/m2, twice weekly for 2 weeks (3 weeks cycle), 3-5 minute bolus

Arm

Intervention/Treatment

Active Comparator: Arm A

Tanespimycin + Bortezomib

Drug: Tanespimycin

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

Other Names:

BMS-722782

Drug: Bortezomib

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

Active Comparator: Arm B

Bortezomib

Drug: Bortezomib

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

Outcome Measures

Primary Outcome Measures

Progression-free survival [6-24 months]

Secondary Outcome Measures

Overall survival in each arm of the study [Up to 24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Comprehensive Blood And Cancer Center	Bakersfield	California	United States	93309
2	Moores Ucsd Cancer Center	La Jolla	California	United States	92093
3	University Of California Medical Center	San Francisco	California	United States	94143
4	Rocky Mountain Cancer Centers	Denver	Colorado	United States	80218
5	University Of Iowa Hospitals And Clinics	Iowa City	Iowa	United States	52242
6	University Of Kansas Medical Center	Westwood	Kansas	United States	66205
7	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
8	Henry Ford Health System Irb	Detroit	Michigan	United States	48202
9	Capitol Comprehensive Cancer Care Center	Jefferson City	Missouri	United States	65109
10	Columbia University Medical Center (Cumc)	New York	New York	United States	10032
11	Wake Forest Univ Health Sciences	Winston-Salem	North Carolina	United States	27157
12	Kaiser Permanente Oncology/Hematology	Portland	Oregon	United States	97227
13	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
14	Tennessee Cancer Specialists	Knoxville	Tennessee	United States	37920
15	Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203
16	Baylor University Medical Center	Dallas	Texas	United States	75246
17	University Of Virginia Health System	Charlottesville	Virginia	United States	22908
18	Medical College Of Wisconsin	Milwaukee	Wisconsin	United States	53226
19	Local Institution	Edmonton	Alberta	Canada	T6G 1Z2