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

NCT00241371 | Terminated Phase 2

• 1 other identifier: 04-0916
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Overall response rate (CR+PR)

  Every 3 months

Secondary Outcomes (4)

• Time to response

  Every 3 months

• Safety and tolerability of clofarabine

  30 days after last treatment

• Duration of response

  Every 3 months

• Time to progression

  Every 3 months

Study Arms (1)

Clofarabine

EXPERIMENTAL

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

Drug: Clofarabine

Interventions

Clofarabine DRUG

Clofarabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Clofarabine

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Nucleotides; Ribonucleotides

Study Officials

• Ravi Vij, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2005
• First Posted: October 18, 2005
• Study Start: March 1, 2005
• Primary Completion: November 1, 2005
• Study Completion: December 1, 2007
• Last Updated: August 13, 2013

Record last verified: 2013-08

Locations

US (1)