Multiple Myeloma Clinical Trial

Dasatinib in Combination With Revlimid (and Dexamethasone)

Summary

The purpose of this study was to determine the safety and tolerability of dasatinib when given in combination with lenalidomide and a low dose dexamethasone for the treatment of relapsed or refractory multiple myeloma.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Able to provide written informed consent
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:

Women who are pregnant or breastfeeding
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

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

35

Study ID:

NCT00560391

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 4 Locations for this study

See Locations Near You

Mayo Clinic Arizona
Scottsdale Arizona, 85259, United States
Local Institution
Prahran Victoria, 3181, Australia
Local Institution
Toulouse Cedex 03 , 31059, France
Local Institution
Vandoeuvre Les Nancy , 54511, France

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

35

Study ID:

NCT00560391

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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