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

NCT00560352 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: CA180-181
• Study Type: interventional
• Target: 16
• Locations: 4 countries
• Sites: 7

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

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

  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.

  Days 1 to 21

• MTD and Recommended MTD of Bortezomib in Combination With Dasatinib and Dexamethasone

  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 dose is the maximum dose that the participants received.

  Days 1 to 21

Secondary Outcomes (4)

• 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

  Day 1 until last tumor assessment (maximum reached: 9 months)

• Duration of Response

  First occurrence of response to disease progression or death, whichever occurred first (maximum reached: 12.2 months)

• Progression-free Survival

  Day 1 to disease progression or death, whichever came first (maximum reached: 14 months)

• 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

  Continuously from Day 1 until last day of study medication + 30 days (maximum reached: 10 months)

Study Arms (1)

Dasatinib + Bortezomib + Dexamethasone

EXPERIMENTAL

Phase I dose escalation study

Drug: Dasatinib; Drug: Bortezomib; Drug: Dexamethasone

Interventions

Dasatinib DRUG

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

Also known as: Sprycel, BMS-354825

Dasatinib + Bortezomib + Dexamethasone

Bortezomib DRUG

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

Also known as: Velcade®

Dasatinib + Bortezomib + Dexamethasone

Dexamethasone DRUG

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

Dasatinib + Bortezomib + Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (7)

Orlando Health, Inc. M.D. Anderson Cancer Center Orlando

Orlando, Florida, 32806, United States

Location

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322, United States

Location

Local Institution

Nantes, Cedex 1, 44093, France

Location

Local Institution

Lille, 59037, France

Location

Local Institution

Bari, 70124, Italy

Location

Local Institution

Bologna, 40138, Italy

Location

Local Institution

Salamanca, 37007, Spain

Location

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Dasatinib; Bortezomib; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Limitations and Caveats

The study was terminated due to an unexpectedly low recruitment rate, and no participants were enrolled in a planned dose-expansion phase.

Results Point of Contact

• Title: BMS Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2007
• First Posted: November 19, 2007
• Study Start: February 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: March 13, 2017
• Results First Posted: July 9, 2012

Record last verified: 2012-07

Locations

US (2); FR (2); IT (2); ES (1)