Dasatinib in Combination With Revlimid (and Dexamethasone)
NCT ID: NCT00560391
Last Updated: 2016-08-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
35 participants
INTERVENTIONAL
2008-05-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mg
Participants received a combination of dasatinib, 70 mg QD, lenalidomide, 15 mg QD, and dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22, in 28-day cycles.
Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mg
Participants received dasatinib, 70 mg once daily (QD), for 28 days plus lenalidomide, 15 mg QD, for 21 days plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22.
Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg
Participants received a combination of dasatinib, 70 mg QD, lenalidomide, 20 mg QD, and dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22, in 28-day cycles.
Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg
Participants received dasatinib, 70 mg QD, for 28 days plus lenalidomide, 20 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22.
Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg
Participants received a combination of dasatinib, 100 mg QD, lenalidomide, 20 mg QD, and dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22, in 28-day cycles.
Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg
Participants received dasatinib, 100 mg QD, for 28 days, plus lenalidomide, 20 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22.
Dasatinib, 100 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg
Participants received a combination of dasatinib, 100 mg QD, lenalidomide, 25 mg QD, and dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22, in 28-day cycles.
Dasatinib, 100 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg
Participants received dasatinib, 100 mg QD, for 28 days, plus lenalidomide, 25 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22.
Dasatinib, 140 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg
Participants received a combination of dasatinib, lenalidomide, and dexamethasone in varying doses in 28-day cycles.
Dasatinib, 140 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg
Participants received dasatinib, 140 mg QD, for 28 days, plus lenalidomide, 25 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22. Cohort includes 4 participants who received treatment during the dose-finding phase and 13 participants who received treatment in the dose-expansion phase.
Interventions
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Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mg
Participants received dasatinib, 70 mg once daily (QD), for 28 days plus lenalidomide, 15 mg QD, for 21 days plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22.
Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg
Participants received dasatinib, 70 mg QD, for 28 days plus lenalidomide, 20 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22.
Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg
Participants received dasatinib, 100 mg QD, for 28 days, plus lenalidomide, 20 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22.
Dasatinib, 100 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg
Participants received dasatinib, 100 mg QD, for 28 days, plus lenalidomide, 25 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22.
Dasatinib, 140 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg
Participants received dasatinib, 140 mg QD, for 28 days, plus lenalidomide, 25 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22. Cohort includes 4 participants who received treatment during the dose-finding phase and 13 participants who received treatment in the dose-expansion phase.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Men and women age ≥ 18 years
* Confirmed diagnosis of multiple myeloma (MM) with measurable disease assessed within 1 month prior to treatment initiation
* Evidence of relapsed or refractory disease and at least one prior therapy for MM
* Eastern Cooperative Oncology Group Scale (ECOG) Performance Status of 0 - 2
* Last MM treatment at least 21 days prior to treatment initiation• Bone marrow transplant (BMT) at least 3 months prior to treatment initiation
* Required baseline hematology and chemistry parameters
* Resolution of acute toxicity due to prior therapy to Grade \<2 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Exclusion Criteria
* Men whose sexual partners are women of child bearing potential (WOCBP) or WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least one month (4 weeks) before and for at least one month (4 weeks) after the last dose of study medication.
* Clinically significant cardiac disease (New York Heart Association \[NYHA\] Class III or IV)
* Abnormal corrected QT interval using Fridericia's formula (QTcF) interval prolonged (\> 450 msec)
* Medications that are generally considered to have a risk of causing "Torsades de Pointes"
* Malabsorption syndrome or uncontrolled gastrointestinal toxicities
* Clinically significant pleural effusion in the previous 12 months or current ascites
* Clinically-significant coagulation or platelet function disorder
* Dementia, chronic medical or psychiatric condition, or laboratory abnormality
* Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality, serious uncontrolled medical disorder or active infection
* Intolerance to dasatinib and/or lenalidomide
* Subjects with a history of severe rash, hypersensitivity reaction or anaphylaxis related to prior thalidomide treatment
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Mayo Clinic Arizona
Scottsdale, Arizona, United States
Local Institution
Prahran, Victoria, Australia
Local Institution
Toulouse, , France
Local Institution
Vandœuvre-lès-Nancy, , France
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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CA180-180
Identifier Type: -
Identifier Source: org_study_id
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