Dasatinib for Modulating Immune System After Autologous Stem Cell Transplants for Multiple Myeloma, Non-Hodgkin, or Hodgkin Lymphoma

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 8

Inclusion Criteria

Recipients of first ASCT for the treatment of hematologic malignancies (multiple myeloma, Hodgkin's and non Hodgkin's lymphoma)
Patients must be between 100 to 180 days after ASCT
Dasatinib use prior to ASCT is allowed
Performance status >= 60%
Presence of LGL clone prior to enrollment will not be an exclusion criterion if the LGL clone is < 25% of T cell population
Total bilirubin < 2.0 times the institutional upper limit of normal (ULN)
Hepatic enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT]) =< 2.5 times the institutional ULN
Serum creatinine < 1.5 times the institutional ULN
Hemoglobin >= 8 g/dL
Absolute neutrophil counts >= 1,500 cells per uL
Platelets >= 100,000 per uL
Patient should be able to provide signed written informed consent; before any study procedures are performed, subjects will have the details of the study described to them, and they will be given a written informed consent document to read; then, if subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnel; written consent will include a Health Insurance Portability and Accountability Act (HIPAA) form according to institutional guidelines
Patient should be able to take oral medication (dasatinib must be swallowed whole)

Exclusion Criteria

Patients who have evidence of disease progression before day 100 after ASCT
Sex and reproductive status:
- Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after the last dose of study drug
- Women who are pregnant or breastfeeding
- Women with a positive pregnancy test
- Sexually active fertile men not using effective birth control if their partners are WOCBP
Medical history and concurrent diseases:
No malignancy (other than the one treated in this study) which required radiotherapy or systemic treatment within the past 5 years
Concurrent medical condition which may increase the risk of toxicity, including:
- Pleural or pericardial effusion of any grade at the time of screening for study
- Cardiac symptoms; any of the following should be considered for exclusion:
  - Uncontrolled angina, congestive heart failure or myocardial infarction (MI) (within 6 months)
  - Diagnosed congenital long QT syndrome
  - Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
  - Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (> 450 msec)
History of significant bleeding disorder unrelated to cancer, including:
- Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)* Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
- Ongoing or recent (=< 3 months) significant gastrointestinal bleeding
Any previous history of >= grade 3 toxicity to dasatinib
Prohibited treatments and or therapies
Category I drugs that are generally accepted to have a risk of causing torsades de pointes including: (patients must discontinue drug 7 days prior to starting dasatinib):
- Quinidine, procainamide, disopyramide
- Amiodarone, sotalol, ibutilide, dofetilide
- Erythromycin, clarithromycin
- Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide
- Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
Patient agrees to discontinue St. Johns Wort while receiving dasatinib therapy (discontinue St. Johns Wort at least 5 days before starting dasatinib)
Patient agrees that intravenous (IV) bisphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia
Other exclusion criteria:
Prisoners or subjects who are involuntarily incarcerated
Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dasatinib	Dasatinib	This is a phase 1 dose escalation study, using a standard 3+3 design. Dasatinib is administered orally once daily in the outpatient setting. The starting dose of dasatinib is 20 mg daily. The increment of dose escalation is 20 mg per dose level. Thus, there will be 5 dose levels (20 mg, 40 mg, 60 mg, 80 mg and 100 mg, respectively) with 3 patients in each cohort. Patients will continue on dasatinib for 6 months

Primary Outcome Measures

Name	Time	Method
Dose limiting toxicity (DLT) graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4	2 months
Maximum tolerated dose (MTD)graded according to the NCI CTCAE version 4	2 months	Defined as highest dose at which no more than one of dose limiting toxicity (DLT) is observed (among the first 6 patients treated and evaluable for toxicity for the purpose of cohort dose escalation decisions).

Secondary Outcome Measures

Name	Time	Method
Incidence of large granular lymphocytes (LGL) lymphocytosis	6 months	95% confidence intervals estimated.

Dasatinib for Modulating Immune System After Autologous Stem Cell Transplants for Multiple Myeloma, Non-Hodgkin, or Hodgkin Lymphoma

Recruitment & Eligibility

Study & Design

Trial Locations

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