A Phase II Study of Clofarabine in Patients With Relapsed or Refractory Multiple Myeloma
NCT ID: NCT00241371
Last Updated: 2013-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
8 participants
INTERVENTIONAL
2005-03-31
2007-12-31
Brief Summary
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Detailed Description
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To determine the safety and tolerability of clofarabine in these patients.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Clofarabine
4 mg/m2 IV over 1 hour on days 1-5 of each 28 day cycle.
Clofarabine
Interventions
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Clofarabine
Eligibility Criteria
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Inclusion Criteria
2. Measurable levels of monoclonal protein in serum (\>= 0.5 g/dL) or urine (\>= 0.2 g/24 hr).
3. At least 1 prior therapies for multiple myeloma with documented evidence of progression on the most recent treatment.
4. Age 18 years or older.
5. ECOG performance status \<= 2.
6. Acceptable organ and marrow function as defined below:
* Hemoglobin \>= 8 gm/dL
* Absolute neutrophil count \>= 1,000/mm3
* Platelets \>= 50,000/mm3
* Total bilirubin \<= 2.5 X institutional upper limit of normal
* AST, ALT \<= 2.5 X institutional upper limit of normal
* Creatinine 1.5 x institutional upper limit of normal
* Normal cardiac function as determined by standard institutional methods
7. Women of child bearing potential must agree to use adequate contraception prior to study entry and for the duration of study.
8. Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
2. Receiving concurrent steroids with a dose equivalent of prednisone of \>= 150 mg/month.
3. Pregnant or nursing.
4. Active systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.
5. Severe concurrent disease, including severe insulin-dependent diabetes, uncontrolled hypertension, transient ischemic attacks, uncontrolled symptomatic coronary artery disease, or symptomatic CNS involvement or psychiatric illness/social situations that would limit compliance with study requirements.
6. History of other malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast unless the subject has been off treatment and free from disease for \>= 3 years.
18 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Ravi Vij, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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04-0916
Identifier Type: -
Identifier Source: org_study_id