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

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ClinicalTrials.gov Identifier: NCT00186238
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : September 14, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
To assess the role of autologous hematopoietic cell rescue in the treatment of multiple myeloma.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Procedure: high dose chemotherapy then autologous hematopoietic cell transplant Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Dose Sequential Therapy and Autologous Stem Cell Rescue for Multiple Myeloma
Study Start Date : September 1994
Primary Completion Date : September 2006
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 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) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:- received cytoreduction prior to transplant

- adequate organ function

Exclusion Criteria:- previous transplant

- smoldering MM or benign monoclonal gammopathy

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): NCT00186238


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

Responsible Party: Sally Arai, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00186238     History of Changes
Other Study ID Numbers: BMT27
73217
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: September 14, 2010
Last Verified: September 2010

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