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A Phase II Study of Clofarabine in Patients With Relapsed or Refractory Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00241371
Recruitment Status : Terminated (No response seen in patients)
First Posted : October 18, 2005
Last Update Posted : August 13, 2013
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
To determine the overall response rate (CR+PR) of patients with relapsed or refractory multiple myeloma treated with clofarabine.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Clofarabine Phase 2

Detailed Description:

To determine the time to response, duration of response, and time to progression of patients treated with clofarabine.

To determine the safety and tolerability of clofarabine in these patients.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Clofarabine in Patients With Relapsed or Refractory Multiple Myeloma
Study Start Date : March 2005
Primary Completion Date : November 2005
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Clofarabine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Clofarabine
4 mg/m2 IV over 1 hour on days 1-5 of each 28 day cycle.
Drug: Clofarabine

Primary Outcome Measures :
  1. Overall response rate (CR+PR) [ Time Frame: Every 3 months ]

Secondary Outcome Measures :
  1. Time to response [ Time Frame: Every 3 months ]
  2. Safety and tolerability of clofarabine [ Time Frame: 30 days after last treatment ]
  3. Duration of response [ Time Frame: Every 3 months ]
  4. Time to progression [ Time Frame: Every 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Multiple myeloma diagnosed by standard 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:

  1. Receiving any other investigational agents.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00241371

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Principal Investigator: Ravi Vij, M.D. Washington University School of Medicine

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00241371     History of Changes
Other Study ID Numbers: 04-0916
First Posted: October 18, 2005    Key Record Dates
Last Update Posted: August 13, 2013
Last Verified: August 2013

Keywords provided by Washington University School of Medicine:
Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents