Multiple MyelomaPhase 3BMS TIME-1NCT00546780
A Study of Tanespimycin (KOS-953) in Patients With Multiple Myeloma in First Relapse
A Phase 3 study testing Tanespimycin and Bortezomib in people with Multiple Myeloma, run by Bristol-Myers Squibb at 19 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Tanespimycin and Bortezomib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Feb 2008to Mar 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States18 sites
Comprehensive Blood And Cancer Center
Bakersfield, California, 93309
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
University Of Virginia Health System
Charlottesville, Virginia, 22908
Baylor University Medical Center
Dallas, Texas, 75246
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Henry Ford Health System Irb
Detroit, Michigan, 48202
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, 52242
Capitol Comprehensive Cancer Care Center
Jefferson City, Missouri, 65109
Tennessee Cancer Specialists
Knoxville, Tennessee, 37920
Moores Ucsd Cancer Center
La Jolla, California, 92093
Medical College Of Wisconsin
Milwaukee, Wisconsin, 53226
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Columbia University Medical Center (Cumc)
New York, New York, 10032
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Kaiser Permanente Oncology/Hematology
Portland, Oregon, 97227
University Of California Medical Center
San Francisco, California, 94143
University Of Kansas Medical Center
Westwood, Kansas, 66205
Wake Forest Univ Health Sciences
Winston-Salem, North Carolina, 27157
About this study
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
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- Tanespimycin, Bortezomib
- Keywords
- Multiple Myeloma, Heat Shock Protein 90, Hsp90, KOS-953, 17-AAG, bortezomib, first relapse, tanespimycin, TIME-1
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TanespimycinDrug
Also called BMS-722782
Solution, IV, 340mg/m2, twice weekly for 2 weeks (3 week cycle), 60 minutes infusion
BortezomibDrug
Solution, IV, 1.3 mg/m2, twice weekly for 2 weeks (3 weeks cycle), 3-5 minute bolus
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Tanespimycin + Bortezomib Receives: Drug: Tanespimycin; Drug: Bortezomib |
| Arm B | Active comparator | Bortezomib Receives: Drug: Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 6-24 months
Secondary outcomes (1)
Overall survival in each arm of the study
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2007 (estimated)
- Study startFeb 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546780
- Sponsor's protocol ID
- CA200-004
- Other IDs
- KAG-301
- Acronym
- BMS TIME-1
- Status last verified
- Jun 2011
- First submitted
- 17 Oct 2007
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00546780
- Acronym / sponsor ID
- BMS TIME-1 / CA200-004
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Heat Shock Protein 90, Hsp90, KOS-953, 17-AAG, bortezomib, first relapse, tanespimycin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 19 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: Tanespimycin, Drug: BortezomibTanespimycin + Bortezomib |
| Arm B | Active comparator | Drug: BortezomibBortezomib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TanespimycinAlso: BMS-722782Solution, IV, 340mg/m2, twice weekly for 2 weeks (3 week cycle), 60 minutes infusion | Drug | Arm A |
| BortezomibSolution, IV, 1.3 mg/m2, twice weekly for 2 weeks (3 weeks cycle), 3-5 minute bolus | Drug | Arm A, Arm B |
Primary outcome
Progression-free survival
Time frame: 6-24 months
1 secondary outcome
Overall survival in each arm of the study
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tanespimycin and Bortezomib in people with Multiple Myeloma, run by Bristol-Myers Squibb at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 6-24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2011.