High Dose Sequential Therapy and Autologous Stem Cell Rescue for Multiple Myeloma

September 10, 2010 updated by: Stanford University
To assess the role of autologous hematopoietic cell rescue in the treatment of multiple myeloma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To assess the toxicity and efficacy of sequentially administered high dose cyclophosphamide and VP-16 followed by total body irradiation or BCNU and high dose mephalan and autologous stem cell rescue in the treatment of multiple myeloma.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:- received cytoreduction prior to transplant

  • adequate organ function Exclusion Criteria:- previous transplant
  • smoldering MM or benign monoclonal gammopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Toxicity and efficacy of sequentially administered high dose chemotherapy and autologous hematopoietic cell transplantation
Time Frame: Patients will have a daily CBC with platelet count, and chemistries until engraftment, then as indicated clinically. Chest x-rays will be done weekly until engraftment, then as indicated clinically. Patients will be restaged for abnormal proteins (SPIE)
Patients will have a daily CBC with platelet count, and chemistries until engraftment, then as indicated clinically. Chest x-rays will be done weekly until engraftment, then as indicated clinically. Patients will be restaged for abnormal proteins (SPIE)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Sally Arai, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1994

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

September 14, 2010

Last Update Submitted That Met QC Criteria

September 10, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMT27
  • 73217
  • NCT00186238

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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