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

August 9, 2013 updated by: Washington University School of Medicine
To determine the overall response rate (CR+PR) of patients with relapsed or refractory multiple myeloma treated with clofarabine.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate (CR+PR)
Time Frame: Every 3 months
Every 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to response
Time Frame: Every 3 months
Every 3 months
Safety and tolerability of clofarabine
Time Frame: 30 days after last treatment
30 days after last treatment
Duration of response
Time Frame: Every 3 months
Every 3 months
Time to progression
Time Frame: Every 3 months
Every 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

October 17, 2005

First Submitted That Met QC Criteria

October 17, 2005

First Posted (Estimate)

October 18, 2005

Study Record Updates

Last Update Posted (Estimate)

August 13, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-0916

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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