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

The Washington University

Status and phase: Terminated; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: Clofarabine

Study type: Interventional

Funder types: Other

Identifiers

NCT00241371

04-0916

Details and patient eligibility

About

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

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Clofarabine

Experimental group

Description:

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

Treatment:

Drug: Clofarabine