Mixed Chimera Allogeneic Transplantation From Matched Unrelated Donors For The Treatment Of Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00185653
First received: September 12, 2005
Last updated: February 10, 2011
Last verified: February 2011
  Purpose

The purpose of the study is to determine the toxicity and feasibility of non-myeloablative allogeneic hematopoietic cell transplants for multiple myeloma from unrelated donors.


Condition Intervention
Multiple Myeloma
Procedure: Autologous followed by non-myeloablative allogeneic transplantation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mixed Chimera Allogeneic Transplantation From Matched Unrelated Donors for the Treatment of Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Feasibility and laboratory-measured efficacy of mixed chimera unrelated donor allogeneic transplants.

Estimated Enrollment: 40
Study Start Date: October 2000
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Detailed Description:

The primary objective of the protocol is to evaluate the toxicity and tolerability of this mixed chimerism matched unrelated donor allogeneic transplant approach for patients with multiple myeloma. Response, toxicity, survival and graft-versus-host disease will be evaluated.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:a) Multiple myeloma which is responsive to therapy. Eligible patients may have early or relapsed disease. Patients must have Stage II-III disease or have progression after initial treatment of Stage I disease. Patients who have relapsed following autologous transplantation may be eligible for this protocol.

b) Age <= 60 years. c) No prior therapy which would preclude the use of low-dose total body irradiation.

d) Patients must have their pathology reviewed and the diagnosis confirmed at Stanford University Medical Center. Patients with smoldering multiple myeloma, monoclonal gammopathy of unknown significance, or amyloidosis will be excluded from this study.

e) Patients must have a Karnofsky performance status > 70%. f) DLCO >= 60% predicted. g) ALT and AST must be < 2X normal. Total bilirubin less than 2 mg/dl. h) Serum creatinine < 2.0 or 24-hour creatinine clearance >= 50 ml/min. i) Patients must be HIV negative. j) Pregnant or lactating women will not be eligible to participate. k) Patients must provide signed, informed consent.

Exclusion Criteria:a) Severe psychological or medical illness b) Patients who have undergone prior allogeneic hematopoietic cell transplantation will not be eligible for this study.

c) Patients who have an HLA-identical sibling donor will be excluded

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00185653

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Robert Lowsky Stanford University
  More Information

No publications provided

Responsible Party: Robert Lowsky, Principal Investigator, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00185653     History of Changes
Other Study ID Numbers: BMT126, 73506, BMT126
Study First Received: September 12, 2005
Last Updated: February 10, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 26, 2014