Dasatinib in Combination With Revlimid (and Dexamethasone)
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mg; Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg; Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg; Dasatinib, 100 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg; Dasatinib, 140 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg
Intervention description: Participants received dasatinib, 70 mg once daily (QD), for 28 days plus lenalidomide, 15 mg QD, for 21 days plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22.; Participants received dasatinib, 70 mg QD, for 28 days plus lenalidomide, 20 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22.; Participants received dasatinib, 100 mg QD, for 28 days, plus lenalidomide, 20 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22.; Participants received dasatinib, 100 mg QD, for 28 days, plus lenalidomide, 25 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22.; Participants received dasatinib, 140 mg QD, for 28 days, plus lenalidomide, 25 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22. Cohort includes 4 participants who received treatment during the dose-finding phase and 13 participants who received treatment in the dose-expansion phase.
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Lenalidomide; Dasatinib; BB 1101
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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