A Phase II Study of Dasatinib in the Treatment of Relapsed or Plateau Phase Multiple Myeloma

Completed · Phase 2

Conditions studied: Relapsed, Refractory or Plateau Phase Multiple Myeloma

In brief

To evaluate the response rate (Complete Response \[CR\] and Partial Response \[PR\]) to dasatinib in patients with relapsed, refractory or plateau phase multiple myeloma whose serum paraprotein levels are \>0.5g/dL or urine paraprotein levels are \>1.0g/24 hours.

Key facts

Study ID

NCT00429949

Run by

Washington University School of Medicine

People needed

21

Starts

2007-01-01

Expected to finish

2008-01-01

Last updated by the study team

2014-08-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Multiple myeloma diagnosed by standard criteria with either relapsed or plateau-phase disease.
• Relapsed: At least 1 prior therapy for multiple myeloma with documented evidence of progression on the most recent treatment.
• Plateau-phase: subjects with myeloma who had a response to their most recent multiple myeloma therapy (including autologous transplantation or other investigational agents) and have residual detectable monoclonal protein in their serum or urine that has been stable for greater than or equal to 3 months (+/- 25% change in M-protein).
• Measurable levels of monoclonal protein in serum (greater than or equal to 0.5 g/dL) or urine (greater than or equal to 1.0 g/24 hr).
• Age 18 years or older.
• ECOG performance status of less than or equal to 2.
• Acceptable organ and marrow function as defined below:
• Hemoglobin of greater than or equal to 8 gm/dL
• Absolute neutrophil count of greater than or equal to 500/mm3
• Platelets of greater than or equal to 50,000/mm3
• PT and PTT of less than or equal to 1.5 times the institutional Upper Limit of Normal (ULN)
• Total bilirubin of less than or equal to 2.0 times the institutional ULN institutional ULN
• Hepatic enzymes (AST, ALT ) equal to 2.5 times the institutional ULN
• Serum Na, K+, Mg2+, Phosphate and Ca2+ greater than or equal to Lower Limit of Normal (LLN)
• Serum Creatinine of less than or equal to 1.5 times the institutional ULN
• Ability to understand and the willingness to sign a written informed consent document.
• Ability to take oral medication (dasatinib must be swallowed whole)
• Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (sensitivity of less than or equal to 25IU HCG/L) within 72 hours prior to the start of study drug administration
• Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped.
• Signed written informed consent including HIPAA according to institutional guidelines.

You may not qualify if…

• Receiving any of the following therapies or medications:
• Any investigational agents within 30 days.
• Drugs that are generally accepted to have a risk of causing Torsade de Pointes including:
• 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
• Subjects who have discontinued any of these medications must have a wash-out period of at least 7 days prior to the first dose of dasatinib.
• Medications known to be potent CYP3A4 inhibitors (See Appendix D).
• The concomitant use of H2 blockers or proton pump inhibitors with dasatinib is not recommended. The use of antacids should be considered in place of H2 blockers or proton pump inhibitors in patients receiving dasatinib therapy (See section 5.5.2.3 for important cautions regarding use of antacids.)
• Patient agrees to discontinue St. Johns Wort while receiving dasatinib therapy.
• Patient agrees that IV bisphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia.
• Prior therapy with dasatinib
• Biopsy proven amyloidosis.
• History of other malignancy (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) 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
• Clinically-significant coagulation or platelet function disorder (e.g. known von Willebrand's disease)
• Cardiac Symptoms or Cardiovascular Disease, including:
• Myocardial infarction within 6 months
• Uncontrolled angina within 6 months
• Congestive heart failure within 6 months
• Diagnosed or suspected congenital long QT syndrome

Where it is running

• Washington Universtiy in St. Louis — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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