Clinical trial NCT00241371: A Phase II Study of Clofarabine in Patients With Relapsed or Refractory Multiple Myeloma
Official title: A Phase II Study of Clofarabine in Patients With Relapsed or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2005-10-18
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall response rate (CR+PR)
timeFrame: Every 3 months
Secondary outcomes:
measure: Time to response
timeFrame: Every 3 months
measure: Safety and tolerability of clofarabine
timeFrame: 30 days after last treatment
measure: Duration of response
timeFrame: Every 3 months
measure: Time to progression
timeFrame: Every 3 months
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ravi Vij, M.D.
role: PRINCIPAL_INVESTIGATOR
References: