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

Sponsor:	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

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

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

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

U.S. FDA Resources

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:	July 2012
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 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 Other Names: Sprycel® BMS-354825 Revlimid®

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
Subjects with a history of severe rash, hypersensitivity reaction or anaphylaxis related to prior thalidomide treatment

Contacts and Locations

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

Locations

United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
Australia, New South Wales
Local Institution
Waratah, New South Wales, Australia, 2298
Australia, Victoria
Local Institution
Prahran, Victoria, Australia, 3181
France
Local Institution
Lille Cedex, France, 59037
Local Institution
Vandoeuvre Les Nancy, France, 54511
Netherlands
Local Institution
Rotterdam, Netherlands, 3015 CE

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

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

Investigator Inquiry form 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

No publications provided

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00560391 History of Changes
Other Study ID Numbers:	CA180-180
Study First Received:	November 16, 2007
Last Updated:	February 2, 2012
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

Additional relevant MeSH terms:

Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate

Dexamethasone
Dexamethasone 21-phosphate
Lenalidomide
BB 1101
Dasatinib
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on February 09, 2012