Safety Study of Dasatinib With Bortezomib (Velcade®) and Dexamethasone for Multiple Myeloma

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2011-02-28

Brief Summary

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The purpose of this study is to determine the safety and tolerability of dasatinib with bortezomib in the treatment of relapsed or refractory multiple myeloma.

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Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dasatinib + Bortezomib + Dexamethasone

Phase I dose escalation study

Group Type EXPERIMENTAL

Dasatinib

Intervention Type DRUG

Tablets; oral; approximately 2 years on study, depending on response; 50 mg once daily (QD), 100 mg QD, 140 mg QD

Bortezomib

Intervention Type DRUG

Powder; intravenous; approximately 2 years on study, depending on response; 1.0 mg/m\^2 QD, 1.3 mg/m\^2 QD

Dexamethasone

Intervention Type DRUG

Tablets; oral; approximately 2 years on study, depending on response; 20 mg QD

Interventions

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Dasatinib

Tablets; oral; approximately 2 years on study, depending on response; 50 mg once daily (QD), 100 mg QD, 140 mg QD

Intervention Type DRUG

Bortezomib

Powder; intravenous; approximately 2 years on study, depending on response; 1.0 mg/m\^2 QD, 1.3 mg/m\^2 QD

Intervention Type DRUG

Dexamethasone

Tablets; oral; approximately 2 years on study, depending on response; 20 mg QD

Intervention Type DRUG

Other Intervention Names

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Sprycel BMS-354825 Velcade®

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of multiple myeloma with measurable disease
* Evidence of relapsed or refractory disease and at least 2 prior therapies for multiple myeloma
* Eastern Cooperative Oncology Group Performance Status of 0 - 2
* Last treatment for multiple myeloma not within 21 days prior to study treatment initiation
* Bone marrow transplant not within 3 months prior to study treatment initiation
* Required baseline hematology and chemistry parameters.

Exclusion Criteria

* Clinically significant cardiac disease (New York Heart Association Class III or IV)
* Abnormal QT interval corrected for heart rate using Fridericia's formula prolonged (\>450 msec) after electrolytes have been corrected on baseline electrocardiogram
* Malabsorption syndrome or uncontrolled gastrointestinal toxicities
* Dementia, chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation
* Clinically significant pleural effusion in the previous 12 months or current ascites
* Clinically significant coagulation or platelet function disorder
* Intolerance to dasatinib and/or bortezomib
* Acute diffuse infiltrative pulmonary disease
* Prior or concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer currently in complete remission, cervical carcinoma in situ, or any other cancer from which the participant has been disease-free for 3 years.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No