Clinical trial NCT00560352: Safety Study of Dasatinib With Bortezomib (Velcade®) and Dexamethasone for Multiple Myeloma
Official title: A Phase I Study of Dasatinib With Bortezomib (Velcade®) and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Multiple Myeloma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2007-11-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Key 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.

Key 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.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) and Recommended MTD of Dasatinib in Combination With Bortezomib and Dexamethasone
timeFrame: Days 1 to 21
measure: MTD and Recommended MTD of Bortezomib in Combination With Dasatinib and Dexamethasone
timeFrame: Days 1 to 21
Secondary outcomes:
measure: Best Overall Tumor Response Rate (RR) As Assessed Using International Uniform Response Criteria for Multiple Myeloma and Criteria of the European Bone Marrow Transplant Registry
timeFrame: Day 1 until last tumor assessment (maximum reached: 9 months)
measure: Duration of Response
timeFrame: First occurrence of response to disease progression or death, whichever occurred first (maximum reached: 12.2 months)
measure: Progression-free Survival
timeFrame: Day 1 to disease progression or death, whichever came first (maximum reached: 14 months)
measure: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs) Leading to Discontinuation, AEs Leading to Discontinuation, AEs, and Drug-related AEs by Grade
timeFrame: Continuously from Day 1 until last day of study medication + 30 days (maximum reached: 10 months)
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Health, Inc. M.D. Anderson Cancer Center Orlando
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: Nantes
country: France
facility: Local Institution
state: Cedex 1
city: Lille Cedex
country: France
facility: Local Institution
city: Bari
country: Italy
facility: Local Institution
city: Bologna
country: Italy
facility: Local Institution
city: Salamanca
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: