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NCT01364363 Clinical Trial

Unrelated Donor Stem Cell Transplantation

Multiple Myeloma Clinical Trial

Official title:
Allogeneic Hematopoietic Progenitor Cell Transplantation From Unrelated Donors

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01364363
Other study ID # SIRB#13-6190
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2005
Est. completion date July 2015

Study information
Verified date November 2022
Source Scripps Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to provide an opportunity for patients with malignancies or bone marrow failure states who lack a suitable sibling donor to undergo allogeneic hematopoietic progenitor cell transplantation using cells from unrelated individuals or cord blood registries.

Description:

same

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 69 Years
Eligibility Inclusion Criteria: - > 18 years of Age - < 70 years - ECOG performance status 0, 1 or 2 - Left Ventricular Ejection Fraction > 30% - Creatinine clearance > 40ml/min - Transaminases < 2X normal - Total bilirubin < 2X normal - HIV seronegativity - Weight < 70kg for cord blood transplantation - Ability to cover the cost of the transplant, necessary medications, and transportation/housing. - Caregiver must be available while outpatient Exclusion Criteria: - Greater than one antigen mismatch at HLA-A, B, C or DR plus one allele mismatch at HLA-A, B, C or DR

Study Design

Related Conditions & MeSH terms

  • Acute Lymphoblastic Leukemia
  • Acute Myelogenous Leukemia
  • Anemia, Aplastic
  • Chronic Lymphocytic Leukemia
  • Chronic Myelogenous Leukemia
  • Hemoglobinuria
  • Hemoglobinuria, Paroxysmal
  • Hodgkin's Lymphoma
  • Large Granulocytic Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Acute
  • Lymphoma
  • Multiple Myeloma
  • Myelodysplastic Syndromes
  • Myeloproliferative Syndromes
  • Non-Hodgkin's Lymphoma
  • Paroxysmal Nocturnal Hemoglobinuria
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Severe Aplastic Anemia
  • Small Lymphocytic Lymphoma
  • Syndrome

Intervention

Procedure:
• Allogeneic transplantation
Allogeneic transplantation with matched unrelated donors

Locations
Country Name City State
United States Scripps Green Hospital La Jolla California

Sponsors (1)
Lead Sponsor Collaborator
Scripps Health

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bone Marrow and Peripheral Blood Chimerism Percent of donor and host cells in peripheral blood and bone marrow will be measured by short tandem repeat (STR) testing and/or standard cytogenetic testing. 30 days post-transplant
Primary Bone Marrow and Peripheral Blood Chimerism Percent of donor and host cells in peripheral blood and bone marrow will be measured by short tandem repeat (STR) testing and/or standard cytogenetic testing. 100 days post-transplant
Primary Bone Marrow and Peripheral Blood Chimerism Percent of donor and host cells in peripheral blood and bone marrow will be measured by short tandem repeat (STR) testing and/or standard cytogenetic testing. 365 days post-transplant
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