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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00185653
First Posted: September 16, 2005
Last Update Posted: February 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Stanford University
  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
Intervention Model: Single Group Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Robert Lowsky, Principal Investigator, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00185653     History of Changes
Other Study ID Numbers: BMT126
73506
First Submitted: September 12, 2005
First Posted: September 16, 2005
Last Update Posted: February 14, 2011
Last Verified: February 2011

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


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