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

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00186238
First received: September 13, 2005
Last updated: September 10, 2010
Last verified: September 2010
  Purpose

To assess the role of autologous hematopoietic cell rescue in the treatment of multiple myeloma.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High Dose Sequential Therapy and Autologous Stem Cell Rescue for Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: September 1994
Study Completion Date: April 2010
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Sally Arai, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00186238     History of Changes
Other Study ID Numbers: BMT27, 73217, BMT27
Study First Received: September 13, 2005
Last Updated: September 10, 2010
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 August 18, 2014