Advanced Cancer, Various, NOSPhase 1NCT00884546
Multiple Ascending Dose (MAD) Combination in Subjects With Multiple Myeloma
A Phase 1 study testing BMS-833923, Lenalidomide and Dexamethasone in people with Advanced Cancer, Various, NOS, run by Bristol-Myers Squibb at 8 sites in United States.
Trial summary
To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-833923 administered alone, in combination with lenalidomide plus dexamethasone, or in combination with bortezomib in subjects with relapsed or refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Various, NOS
- What is being tested?
- BMS-833923, Lenalidomide and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 8 sitesUnited States
- Study dates
- Jul 2009to Mar 2012
- Phase
- Phase 1
- 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
- Confirmed diagnosis of Multiple Myeloma
- Men and Women at least 18 years old
- ECOG status 0-2
- Last therapeutic or diagnostic treatment at least 21 days prior
- Bone marrow transplants must have been completed at least 3 months prior
- Any toxicity from prior therapies must have resolved to Grade ≤1
Who cannot join
- Women pregnant or breastfeeding
- WOCBP unwilling/unable to use acceptable method to avoid pregnancy
- Uncontrolled medical disorder or active infection
- Current or recent (w/in 3 months) gastrointestinal disorder
- Inability to swallow oral medication
- Inability to be venipunctured
Show all 12Show fewer
- Uncontrolled or significant cardiovascular disease
- Uncontrolled hyperlipidemia
- Intolerance of lenalidomide or bortezomib if participating in Arms B and C
- Concurrent therapy with any other investigational product
- Subjects involuntary incarcerated
- Subjects detained for treatment of psychiatric or physical illness
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
Local Institution
Detroit, Michigan, 48201
City Of Hope National Medical Center
Duarte, California, 91010
John Theurer Cancer Center
Hackensack, New Jersey, 07601
Oncology Consultants, Pa
Houston, Texas, 77024
Moores Ucsd Cancer Center
La Jolla, California, 92093
Local Institution
Los Angeles, California, 90048
Cancer Therapy And Research Center
San Antonio, Texas, 78229
About this study
Official title: A Phase Ib Multiple Ascending Dose Study of BMS-833923 Alone or in Combination With Lenalidomide (Revlimid) Plus Dexamethasone or in Combination With Bortezomib (Velcade) in Subjects With Relapsed or Refractory Multiple Myeloma
To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-833923 administered alone, in combination with lenalidomide plus dexamethasone, or in combination with bortezomib in subjects with relapsed or refractory multiple myeloma.
- Conditions
- Advanced Cancer, Various, NOS
- Being tested
- BMS-833923, Lenalidomide, Dexamethasone, Bortezomib
- Medical subject headings
- Pyloric Stenosis, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-833923Drug
Capsule, Oral, Once daily, 6 months
LenalidomideDrug
Also called Revlimid
Capsule, Oral, Once daily, 6 months
DexamethasoneDrug
Capsule, Oral, Once a week, 6 months
BortezomibDrug
Also called Velcade
Powder, IV, On days 1, 4, 8, 11, 6 months
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | BMS-833923 (Starting dose is a loading dose of 60 mg for 7 days with a 30 mg daily dose thereafter) Receives: Drug: BMS-833923 |
| Arm 2 | Active comparator | BMS-833923 (MTD or below)
Lenalidomide (at or below the recommended prescribing dose)
Dexamethasone (40 mg) Receives: Drug: BMS-833923; Drug: Lenalidomide; Drug: Dexamethasone |
| Arm 3 | Active comparator | BMS-833923 (MTD or below)
Bortezomib (at or below the recommended prescribing dose) Receives: Drug: BMS-833923; Drug: Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish DLT(s), MTD, and Phase 2 dose range and schedule of BMS-833923 administered alone, in combination with two dose levels of lenalidomide plus dexamethasone, or with two dose levels of bortezomib in subjects with relapsed or refractory MM
Measured: For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles
Secondary outcomes (3)
To evaluate the safety and tolerability of BMS-833923 as a single agent or in combination with two dose levels of lenalidomide plus a fixed low-dose of dexamethasone or in combination with two dose levels of bortezomib
Measured: For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles
To evaluate the Pharmacokinetics of BMS-833923
Measured: For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles
To evaluate the Pharmacodynamics effects of BMS-833923
Measured: For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startJul 2009
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Cancer, Various, NOSStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Exelixis
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884546
- Sponsor's protocol ID
- CA194-003
- Status last verified
- Jul 2012
- First submitted
- 16 Apr 2009
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Multiple Ascending Dose Study of BMS-833923 Alone or in Combination With Lenalidomide (Revlimid) Plus Dexamethasone or in Combination With Bortezomib (Velcade) in Subjects With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00884546
- Acronym / sponsor ID
- CA194-003
- Conditions
- Advanced Cancer, Various, NOS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Exelixis
- Study start
- Jul 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 20 Apr 2009 (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.
To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-833923 administered alone, in combination with lenalidomide plus dexamethasone, or in combination with bortezomib in subjects with relapsed or refractory multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: BMS-833923BMS-833923 (Starting dose is a loading dose of 60 mg for 7 days with a 30 mg daily dose thereafter) |
| Arm 2 | Active comparator | Drug: BMS-833923, Drug: Lenalidomide, Drug: DexamethasoneBMS-833923 (MTD or below) Lenalidomide (at or below the recommended prescribing dose) Dexamethasone (40 mg) |
| Arm 3 | Active comparator | Drug: BMS-833923, Drug: BortezomibBMS-833923 (MTD or below) Bortezomib (at or below the recommended prescribing dose) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed diagnosis of Multiple Myeloma
- Men and Women at least 18 years old
- ECOG status 0-2
- Last therapeutic or diagnostic treatment at least 21 days prior
- Bone marrow transplants must have been completed at least 3 months prior
Key exclusion criteria (12 listed)
- Women pregnant or breastfeeding
- WOCBP unwilling/unable to use acceptable method to avoid pregnancy
- Uncontrolled medical disorder or active infection
- Current or recent (w/in 3 months) gastrointestinal disorder
- Inability to swallow oral medication
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 |
|---|---|---|
| BMS-833923Capsule, Oral, Once daily, 6 months | Drug | Arm 1, Arm 2, Arm 3 |
| LenalidomideAlso: RevlimidCapsule, Oral, Once daily, 6 months | Drug | Arm 2 |
| DexamethasoneCapsule, Oral, Once a week, 6 months | Drug | Arm 2 |
| BortezomibAlso: VelcadePowder, IV, On days 1, 4, 8, 11, 6 months | Drug | Arm 3 |
Primary outcome
To establish DLT(s), MTD, and Phase 2 dose range and schedule of BMS-833923 administered alone, in combination with two dose levels of lenalidomide plus dexamethasone, or with two dose levels of bortezomib in subjects with relapsed or refractory MM
Time frame: For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles
3 secondary outcomes
To evaluate the safety and tolerability of BMS-833923 as a single agent or in combination with two dose levels of lenalidomide plus a fixed low-dose of dexamethasone or in combination with two dose levels of bortezomib
Time frame: For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles
To evaluate the Pharmacokinetics of BMS-833923
Time frame: For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles
To evaluate the Pharmacodynamics effects of BMS-833923
Time frame: For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles
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 30 Sep 2016.
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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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-833923, Lenalidomide and Dexamethasone in people with Advanced Cancer, Various, NOS, run by Bristol-Myers Squibb at 8 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 12 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 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To establish DLT(s), MTD, and Phase 2 dose range and schedule of BMS-833923 administered alone, in combination with two dose levels of lenalidomide plus dexamethasone, or with two dose levels of bortezomib in subjects with relapsed or refractory MM (time frame: For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles). 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 30 Sep 2016.