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


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate (CR+PR)

Outcome Time Frame:

Every 3 months until progressive disease

Safety Issue:

No

Principal Investigator

Ravi Vij, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

04-0916

NCT ID:

NCT00241371

Start Date:

March 2005

Completion Date:

December 2007

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110