Dasatinib in Combination With Revlimid (and Dexamethasone)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Multiple Myeloma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00560391

CA180-180

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 5 patient groups

Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mg

Experimental group

Description:

Participants received a combination of dasatinib, 70 mg QD, lenalidomide, 15 mg QD, and dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22, in 28-day cycles.

Treatment:

Drug: Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mg

Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg

Experimental group

Description:

Participants received a combination of dasatinib, 70 mg QD, lenalidomide, 20 mg QD, and dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22, in 28-day cycles.

Treatment:

Drug: Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg

Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg

Experimental group

Description:

Participants received a combination of dasatinib, 100 mg QD, lenalidomide, 20 mg QD, and dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22, in 28-day cycles.

Treatment:

Drug: Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg

Dasatinib, 100 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg

Experimental group

Description:

Participants received a combination of dasatinib, 100 mg QD, lenalidomide, 25 mg QD, and dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22, in 28-day cycles.

Treatment:

Drug: Dasatinib, 100 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg

Dasatinib, 140 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg

Experimental group

Description:

Participants received a combination of dasatinib, lenalidomide, and dexamethasone in varying doses in 28-day cycles.

Treatment:

Drug: Dasatinib, 140 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg