UARK 2006-28 Human Cord Blood Transplantation in Advanced Hematological Malignancies

Multiple Myeloma Clinical Trial

Official title:

UARK 2006-28 Human Cord Blood Transplantation in Advanced Hematological Malignancies

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00578045
• Other study ID #: 67363
• Status: Withdrawn
• Phase: Phase 1
• First received: December 18, 2007
• Last updated: October 23, 2015
• Start date: July 2006
• Est. completion date: March 2011

Study information

• Verified date: October 2015
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The researchers want to find out if subjects treated on this study will achieve long term bone marrow recovery (engraftment) and if their tumors will respond to this treatment.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with advanced hematological malignancies who have failed at least two lines of therapy.

• Karnofsky performance score > 60, unless due to disease and then > 50.

• Age > 18 years.

• An expected survival of > 3 months.

• Subjects must have signed an IRB-approved consent and been informed about the investigational nature of the study.

• Cord blood must have negative serology for HIV.

• Release of cord blood.

• The nucleated cell count of the CBU shall equal or exceed 1 x 107 per kg of recipient body weight.

Exclusion Criteria:

• Liver function: total bilirubin > 2x ULN or AST/ALT > 3x ULN.

• Creatinine > 3.0 mg/dL.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Multiple Myeloma

Intervention

Procedure:
• Transfusion
Approximately 24 hours after the chemotherapy is completed you will receive the transfusion of the human cord blood

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The researchers on this study want to find out if subjects treated on this study will achieve long term bone marrow recovery (engraftment) and if their tumors will respond to this treatment.		12 months	No
Secondary	The researchers also want to find out what types of side effects, if any, subjects will experience with this treatment.		12 months	Yes