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

NCT ID: NCT00185653

Last Updated: 2011-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-31

Study Completion Date

2008-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Autologous followed by non-myeloablative allogeneic transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Stanford University School of Medicine

Principal Investigators

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Robert Lowsky

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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73506

Identifier Type: -

Identifier Source: secondary_id

BMT126

Identifier Type: -

Identifier Source: secondary_id

NCT00185653

Identifier Type: -

Identifier Source: secondary_id

BMT126

Identifier Type: -

Identifier Source: org_study_id

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