Multiple Myeloma Clinical Trial

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

Summary

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

View Full Description

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Multiple myeloma diagnosed by standard criteria.
Measurable levels of monoclonal protein in serum (>= 0.5 g/dL) or urine (>= 0.2 g/24 hr).
At least 1 prior therapies for multiple myeloma with documented evidence of progression on the most recent treatment.
Age 18 years or older.
ECOG performance status <= 2.

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
Women of child bearing potential must agree to use adequate contraception prior to study entry and for the duration of study.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Receiving any other investigational agents.
Receiving concurrent steroids with a dose equivalent of prednisone of >= 150 mg/month.
Pregnant or nursing.
Active systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.
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.
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 is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

8

Study ID:

NCT00241371

Recruitment Status:

Terminated

Sponsor:

Washington University School of Medicine

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

8

Study ID:

NCT00241371

Recruitment Status:

Terminated

Sponsor:


Washington University School of Medicine

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider