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Dasatinib in Combination With Revlimid (and Dexamethasone)

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma

Intervention: Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mg (Drug); Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg (Drug); Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg (Drug); Dasatinib, 100 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg (Drug); Dasatinib, 140 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

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

Clinical Details

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

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

Primary outcome:

Recommended Phase II Dose (RP2D) of the Combination (Dasatinib + Lenalidomide + Dexamethasone)

Number of Participants With Dose-limiting Toxicity (DLT)

Number of Participants in the Dose Escalation Phase Who Reached Maximum Tolerated Dose (MTD) of Dasatinib With Lenalidomide and Dexamethasone

Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation

Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia

Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC)

Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus

Secondary outcome:

Number of Participants With Complete Response and Very Good Partial Response

Number of Participants With Partial Response

Number of Participants With Minimal Response

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Able to provide written informed consent

- Men and women age ≥ 18 years

- Confirmed diagnosis of multiple myeloma (MM) with measurable disease assessed within

1 month prior to treatment initiation

- Evidence of relapsed or refractory disease and at least one prior therapy for MM

- Eastern Cooperative Oncology Group Scale (ECOG) Performance Status of 0 - 2

- Last MM treatment at least 21 days prior to treatment initiation• Bone marrow

transplant (BMT) at least 3 months prior to treatment initiation

- Required baseline hematology and chemistry parameters

- Resolution of acute toxicity due to prior therapy to Grade <2 per National Cancer

Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3. 0 Exclusion Criteria:

- Women who are pregnant or breastfeeding

- Men whose sexual partners are women of child bearing potential (WOCBP) or WOCBP who

are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least one month (4 weeks) before and for at least one month (4 weeks) after the last dose of study medication.

- Clinically significant cardiac disease (New York Heart Association [NYHA] Class III

or IV)

- Abnormal corrected QT interval using Fridericia's formula (QTcF) interval prolonged

(> 450 msec)

- Medications that are generally considered to have a risk of causing "Torsades de

Pointes"

- Malabsorption syndrome or uncontrolled gastrointestinal toxicities

- Clinically significant pleural effusion in the previous 12 months or current ascites

- Clinically-significant coagulation or platelet function disorder

- Dementia, chronic medical or psychiatric condition, or laboratory abnormality

- Other severe, acute, or chronic medical or psychiatric condition or laboratory

abnormality, serious uncontrolled medical disorder or active infection

- Intolerance to dasatinib and/or lenalidomide

- Subjects with a history of severe rash, hypersensitivity reaction or anaphylaxis

related to prior thalidomide treatment

Locations and Contacts

Local Institution, Toulouse Cedex 03 31059, France

Local Institution, Vandoeuvre Les Nancy 54511, France

Mayo Clinic Arizona, Scottsdale, Arizona 85259, United States

Local Institution, Prahran, Victoria 3181, Australia

Additional Information

BMS Clinical Trial Information

BMS clinical trial educational resource

Investigator Inquiry form

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

Starting date: May 2008
Last updated: November 14, 2013

Page last updated: August 23, 2015

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