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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00241371
• Other study ID #: 04-0916
• Status: Terminated
• Phase: Phase 2
• First received: October 17, 2005
• Last updated: August 9, 2013
• Start date: March 2005
• Est. completion date: December 2007

Study information

• Verified date: August 2013
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 2007
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Clofarabine

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (CR+PR)		Every 3 months	No
Secondary	Time to response		Every 3 months	No
Secondary	Safety and tolerability of clofarabine		30 days after last treatment	Yes
Secondary	Duration of response		Every 3 months	No
Secondary	Time to progression		Every 3 months	No

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine