Back to resultsUARK 2006-28 Human Cord Blood Transplantation in Advanced Hematological Malignancies
Primary Purpose
Multiple Myeloma
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Transfusion
Sponsored by
About this trial
This is an interventional prevention trial for Multiple Myeloma
Eligibility Criteria
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.
Sites / Locations
- University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Approximately 24 hours after the chemotherapy is completed you will receive the transfusion of the human cord blood
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The researchers also want to find out what types of side effects, if any, subjects will experience with this treatment.
Full Information
NCT ID
NCT00578045
First Posted
December 18, 2007
Last Updated
October 23, 2015
Sponsor
University of Arkansas
1. Study Identification
Unique Protocol Identification Number
NCT00578045
Brief Title
UARK 2006-28 Human Cord Blood Transplantation in Advanced Hematological Malignancies
Official Title
UARK 2006-28 Human Cord Blood Transplantation in Advanced Hematological Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Withdrawn
Why Stopped
no accrual
Study Start Date
July 2006 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Arkansas
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Approximately 24 hours after the chemotherapy is completed you will receive the transfusion of the human cord blood
Intervention Type
Procedure
Intervention Name(s)
Transfusion
Intervention Description
Approximately 24 hours after the chemotherapy is completed you will receive the transfusion of the human cord blood
Primary Outcome Measure Information:
Title
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The researchers also want to find out what types of side effects, if any, subjects will experience with this treatment.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frits van Rhee, MD, PhD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
UARK 2006-28 Human Cord Blood Transplantation in Advanced Hematological Malignancies
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