Back to resultsHigh Dose Sequential Therapy and Autologous Stem Cell Rescue for Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
high dose chemotherapy then autologous hematopoietic cell transplant
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:- received cytoreduction prior to transplant adequate organ function Exclusion Criteria:- previous transplant smoldering MM or benign monoclonal gammopathy
Sites / Locations
- Stanford University School of Medicine
Outcomes
Primary Outcome Measures
Toxicity and efficacy of sequentially administered high dose chemotherapy and autologous hematopoietic cell transplantation
Secondary Outcome Measures
Full Information
NCT ID
NCT00186238
First Posted
September 13, 2005
Last Updated
September 10, 2010
Sponsor
Stanford University
1. Study Identification
Unique Protocol Identification Number
NCT00186238
Brief Title
High Dose Sequential Therapy and Autologous Stem Cell Rescue for Multiple Myeloma
Official Title
High Dose Sequential Therapy and Autologous Stem Cell Rescue for Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
September 1994 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Stanford University
4. Oversight
5. Study Description
Brief Summary
To assess the role of autologous hematopoietic cell rescue in the treatment of multiple myeloma.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
high dose chemotherapy then autologous hematopoietic cell transplant
Primary Outcome Measure Information:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:- received cytoreduction prior to transplant
adequate organ function Exclusion Criteria:- previous transplant
smoldering MM or benign monoclonal gammopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sally Arai
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
High Dose Sequential Therapy and Autologous Stem Cell Rescue for Multiple Myeloma
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