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


Phase 1
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Frits van Rhee, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas

Authority:

United States: Institutional Review Board

Study ID:

2006-28

NCT ID:

NCT00578045

Start Date:

July 2006

Completion Date:

March 2011

Related Keywords:

  • Multiple Myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Hematologic Neoplasms

Name

Location
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205