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

Primary Purpose

Multiple Myeloma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Clofarabine
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Clofarabine

Arm Description

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

Outcomes

Primary Outcome Measures

Overall response rate (CR+PR)

Secondary Outcome Measures

Time to response
Safety and tolerability of clofarabine
Duration of response
Time to progression

Full Information

First Posted
October 17, 2005
Last Updated
August 9, 2013
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00241371
Brief Title
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

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Why Stopped
No response seen in patients
Study Start Date
March 2005 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clofarabine
Arm Type
Experimental
Arm Description
4 mg/m2 IV over 1 hour on days 1-5 of each 28 day cycle.
Intervention Type
Drug
Intervention Name(s)
Clofarabine
Primary Outcome Measure Information:
Title
Overall response rate (CR+PR)
Time Frame
Every 3 months
Secondary Outcome Measure Information:
Title
Time to response
Time Frame
Every 3 months
Title
Safety and tolerability of clofarabine
Time Frame
30 days after last treatment
Title
Duration of response
Time Frame
Every 3 months
Title
Time to progression
Time Frame
Every 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ravi Vij, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

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

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