Dasatinib in Combination With Revlimid (and Dexamethasone) - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00560391

Purpose

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

Condition	Intervention	Phase
Multiple Myeloma	Drug: Dasatinib + Lenalidomide + Dexamethasone	Phase I

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Lenalidomide CC 5013 Dasatinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
Official Title:	A Phase I Single Arm Dose Escalation Study of the Combination of Dasatinib (Sprycel®) With Lenalidomide (Revlimid®) and Dexamethasone in Subjects With Relapsed and/ or Refractory Multiple Myeloma

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Determination of Maximum Tolerated Dose through dose escalation [ Time Frame: at cohort intervals of 28 day cycles ] [ Designated as safety issue: Yes ]
Safety and Tolerability [ Time Frame: Adverse events assessed continuously throughout study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Tolerability of the combination [ Time Frame: assessed continuously throughout the study ] [ Designated as safety issue: Yes ]
Recommended dose of the combination for future Phase II studies [ Time Frame: at end of study ] [ Designated as safety issue: Yes ]
Observation of presence/absence of any antitumor activity [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	45
Study Start Date:	May 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Active Comparator	Drug: Dasatinib + Lenalidomide + Dexamethasone Dasatinib - tablets, Oral, 20mg and 50mg, once daily, up to 96 weeks Lenalidomide - capsules, Oral, 10mg and 15 mg, once daily, up to 96 weeks Dexamethasone - tablets, Oral, 2mg, once daily, up to 96 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Able to provide written informed consent
Men and women age ≥ 18 years
Confirmed diagnosis of MM with measurable disease
Evidence of relapsed or refractory disease and at least one prior therapy for MM
ECOG Performance Status 0 - 2
Last MM treatment not within 21 days prior to study treatment initiation
BMT not within 3 months prior to study treatment initiation
Required baseline hematology and chemistry parameters

Exclusion Criteria:

Clinically significant cardiac disease (NYHA Class III or IV)
Abnormal QTcF interval prolonged (> 450 msec)
Malabsorption syndrome or uncontrolled gastrointestinal toxicities
Clinically significant pleural effusion in the previous 12 months or current ascitis
Clinically-significant coagulation or platelet function disorder
Intolerance to dasatinib and/or lenalidomide

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560391

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations

United States, Arizona
Mayo Clinic Arizona	Recruiting
Scottsdale, Arizona, United States, 85259
Contact: A. Keith Stewart, Site 001
Australia, New South Wales
Local Institution	Recruiting
Waratah, New South Wales, Australia, 2298
Contact: Site 011
Australia, Victoria
Local Institution	Not yet recruiting
Prahran, Victoria, Australia, 3181
Contact: Site 008
France
Local Institution	Recruiting
Lille Cedex, France, 59037
Contact: Site 006
Local Institution	Not yet recruiting
Vandoeuvre Les Nancy, France, 54511
Contact: Site 009
Local Institution	Not yet recruiting
Toulouse Cedex 03, France, 31059
Contact: Site 010
Netherlands
Local Institution	Recruiting
Rotterdam, Netherlands, 3015 CE
Contact: Site 005

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA180-180
Study First Received:	November 16, 2007
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00560391
Health Authority:	United States: Food and Drug Administration; France: Ministry of Health; Netherlands: Medicines Evaluation Board (MEB); Australia: Department of Health and Ageing Therapeutic Goods Administration

Study placed in the following topic categories:

Dexamethasone
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Lenalidomide
Vascular Diseases
Paraproteinemias

Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Dasatinib
Lymphoproliferative Disorders
Dexamethasone acetate
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Antiemetics
Enzyme Inhibitors

Protein Kinase Inhibitors
Hormones
Glucocorticoids
Pharmacologic Actions
Neoplasms
Autonomic Agents
Therapeutic Uses
Cardiovascular Diseases
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009