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TerminatedNCT00241371Updated Aug 13, 2013

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

A Phase 2 interventional study of Clofarabine in Multiple Myeloma, sponsored by Washington University School of Medicine. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-13.

Sponsored by Washington University School of Medicine · Phase 2, Interventional, and Treatment

Why this study was terminated
No response seen in patients
Phase
Phase 2
Study type
Interventional
Enrollment
8
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Multiple Myeloma

Keywords

  • Multiple Myeloma
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 8 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Clofarabine

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

    Drug: Clofarabine

Interventions

  • DrugClofarabine
06

What researchers measure

Primary outcomes

  1. Overall response rate (CR+PR)

    Time frame: Every 3 months

Secondary outcomes

  1. Time to response

    Time frame: Every 3 months

  2. Safety and tolerability of clofarabine

    Time frame: 30 days after last treatment

  3. Duration of response

    Time frame: Every 3 months

  4. Time to progression

    Time frame: Every 3 months

07

Study locations

1 site
  • Washington University School of Medicine
    St. Louis, Missouri 63110, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00241371
Lead sponsor
Washington University School of Medicine
Responsible party
Sponsor
First posted
Oct 18, 2005
Start date
Mar 2005
Primary completion
Nov 2005
Completion
Dec 2007
Last update
Aug 13, 2013

Study contacts

Ravi Vij, M.D.
principal investigator · Washington University School of Medicine
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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