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

This study has been terminated.
(No response seen in patients)
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00241371
First received: October 17, 2005
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Multiple Myeloma
Drug: Clofarabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Clofarabine in Patients With Relapsed or Refractory Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Overall response rate (CR+PR) [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to response [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
  • Safety and tolerability of clofarabine [ Time Frame: 30 days after last treatment ] [ Designated as safety issue: Yes ]
  • Duration of response [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: March 2005
Study Completion Date: December 2007
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clofarabine
4 mg/m2 IV over 1 hour on days 1-5 of each 28 day cycle.
Drug: Clofarabine

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00241371

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

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00241371     History of Changes
Other Study ID Numbers: 04-0916
Study First Received: October 17, 2005
Last Updated: August 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Clofarabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014