High Dose Sequential Therapy and Autologous Stem Cell Rescue for Multiple Myeloma
This study has been completed.
Sponsor:
Stanford University
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00186238
First received: September 13, 2005
Last updated: September 10, 2010
Last verified: September 2010
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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) |
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
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 May 19, 2013