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

Phase 2

Terminated

• Conditions: Multiple Myeloma
• Interventions: Drug: Clofarabine

• Registration Number: NCT00241371
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-10-17
• Study First Submitted QC: 2005-10-17
• Study First Posted: 2005-10-18
• Primary Completion: 2005-11
• Study Completion: 2007-12
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-09
• Last Update Posted: 2013-08-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clofarabine	Clofarabine	4 mg/m2 IV over 1 hour on days 1-5 of each 28 day cycle.

Primary Outcome Measures

Name	Time	Method
Overall response rate (CR+PR)	Every 3 months

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of clofarabine	30 days after last treatment
Duration of response	Every 3 months
Time to response	Every 3 months
Time to progression	Every 3 months

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States