Multiple MyelomaPhase 2/3TIME-2NCT00514371
A Study of Tanespimycin (KOS-953) in Patients With Relapsed-refractory Multiple Myeloma
A Phase 2/3 study testing tanespimycin and Bortezomib in people with Multiple Myeloma, run by Bristol-Myers Squibb at 11 sites in United States.
Trial 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. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 11 sitesUnited States
- Study dates
- Aug 2007to Feb 2009
- Phase
- Phase 2/3
- 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
- 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.
Who cannot join
None listed.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Local Institution
Augusta, Georgia, 30912
Local Institution
Baltimore, Maryland, 21201
Local Institution
Berkeley, California, 94704
Local Institution
Boston, Massachusetts, 02215
Local Institution
Columbia, South Carolina, 29210
Local Institution
New York, New York, 10011
Local Institution
New York, New York, 10021
Local Institution
Omaha, Nebraska, 68114
Local Institution
Pittsburgh, Pennsylvania, 15224
Local Institution
San Francisco, California, 94143
Local Institution
Winston-Salem, North Carolina, 27157
About this study
Official title: Phase 2/3 Randomized, Open-Label Clinical Trial of Tanespimycin (KOS-953) Plus Bortezomib Comparing Three Doses of Tanespimycin in Patients With Relapsed-Refractory Multiple Myeloma
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.
Read the detailed description
Phase 2/3 combination study comparing bortezomib plus one of three doses of tanespimycin in patients with relapsed-refractory multiple myeloma after failure of at least three prior anti-cancer therapy regimens. Prior therapy must include bortezomib and lenalidomide. Primary objective is to assess the dose-response relationship of objective response rate (ORR) using EBMT/IBMTR criteria of any three dose levels of tanespimycin (KOS-953) in combination with bortezomib after four treatment cycles.
- Conditions
- Multiple Myeloma
- Being tested
- tanespimycin, Bortezomib
- Keywords
- Multiple Myeloma, Heat Shock Protein 90, Hsp90, KOS-953, 17-AAG, bortezomib, relapsed-refractory, tanespimycin
- 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
High dose
BortezomibDrug
Mid dose, and low dose
| Study group | Role | What they receive |
|---|---|---|
| tanespimycin and bortezomib | Experimental | A patient will receive a standard dose of bortezomib followed by a high dose of tanespimycin. Receives: Drug: tanespimycin; Drug: Bortezomib |
| bortezomib and tanespimycin | Experimental | A patient will receive a standard dose of bortezomib followed by a mid dose of tanespimycin. Receives: Drug: tanespimycin; Drug: Bortezomib |
| bortezomib tanespimycin | Experimental | A patient will receive a standard dose of bortezomib followed by a low dose of tanespimycin. Receives: Drug: tanespimycin; Drug: Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Measured: approximately 3 months
Secondary outcomes (1)
Response rate between treatment arms and time-to-event endpoints.
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 posted9 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionFeb 2009
- Study completionFeb 2009
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514371
- Sponsor's protocol ID
- CA200-003
- Other IDs
- KAG-302
- Acronym
- TIME-2
- Status last verified
- Nov 2015
- First submitted
- 8 Aug 2007
- Last updated
- 7 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2/3 Randomized, Open-Label Clinical Trial of Tanespimycin (KOS-953) Plus Bortezomib Comparing Three Doses of Tanespimycin in Patients With Relapsed-Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00514371
- Acronym / sponsor ID
- TIME-2 / CA200-003
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Heat Shock Protein 90, Hsp90, KOS-953, 17-AAG, bortezomib, relapsed-refractory, tanespimycin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 9 Aug 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 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.
Detailed description
Phase 2/3 combination study comparing bortezomib plus one of three doses of tanespimycin in patients with relapsed-refractory multiple myeloma after failure of at least three prior anti-cancer therapy regimens. Prior therapy must include bortezomib and lenalidomide. Primary objective is to assess the dose-response relationship of objective response rate (ORR) using EBMT/IBMTR criteria of any three dose levels of tanespimycin (KOS-953) in combination with bortezomib after four treatment cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tanespimycin and bortezomib | Experimental | Drug: tanespimycin, Drug: BortezomibA patient will receive a standard dose of bortezomib followed by a high dose of tanespimycin. |
| bortezomib and tanespimycin | Experimental | Drug: tanespimycin, Drug: BortezomibA patient will receive a standard dose of bortezomib followed by a mid dose of tanespimycin. |
| bortezomib tanespimycin | Experimental | Drug: tanespimycin, Drug: BortezomibA patient will receive a standard dose of bortezomib followed by a low dose of tanespimycin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
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-722782High dose | Drug | bortezomib and tanespimycin, bortezomib tanespimycin, tanespimycin and bortezomib |
| BortezomibMid dose, and low dose | Drug | bortezomib and tanespimycin, bortezomib tanespimycin, tanespimycin and bortezomib |
Primary outcome
Objective Response Rate
Time frame: approximately 3 months
1 secondary outcome
Response rate between treatment arms and time-to-event endpoints.
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 7 Dec 2015.
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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
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing tanespimycin and Bortezomib in people with Multiple Myeloma, run by Bristol-Myers Squibb at 11 sites in United States.
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 6 inclusion and 0 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 7 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Objective Response Rate (time frame: approximately 3 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 7 Dec 2015.