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A Phase I Study of Dasatinib With Bortezomib (VelcadeĀ®) and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Phase 1
18 Years
Not Enrolling
Multiple Myeloma

Thank you

Trial Information

A Phase I Study of Dasatinib With Bortezomib (VelcadeĀ®) and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma


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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) and Recommended MTD of Dasatinib in Combination With Bortezomib and Dexamethasone

Outcome Description:

MTD is defined as the dose level combination below the dose level that produces a dose-limiting toxicity in at least 2 out of 6 or fewer participants in that cohort. If MTD is not reached, the recommended MTD is the maximum dose that the participants received.

Outcome Time Frame:

Days 1 to 21

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

February 2008

Completion Date:

February 2011

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Winship Cancer Institute, Emory University Atlanta, Georgia  30322
Orlando Health, Inc. M.D. Anderson Cancer Center Orlando Orlando, Florida  32806