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High-Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma
Not Recruiting
Trial ID: NCT00349778
Purpose
This study uses a sequence of high-dose chemotherapy drugs and a stem cell transplant to
treat multiple myeloma. The study is being performed to evaluate the efficacy and side
effects of treatment. Specifically, the study is designed to reduce the risk of interstitial
pneumonitis.
Official Title
High-Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma
Stanford Investigator(s)
Sally Arai
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Robert Lowsky
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Laura Johnston
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Robert Negrin
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Judith Shizuru
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and of Pediatrics (Stem Cell Transplantation)
Eligibility
INCLUSION CRITERIA
- Stage II to III multiple myeloma, or progression after initial treatment of Stage I
disease; early or relapsed
- Age 18 to 75 years.
- Pathology reviewed and the diagnosis confirmed at Stanford University Medical Center.
- Patients with amyloidosis may be eligible for this trial, with approval by the
Principle Investigator.
- Patients must have a Karnofsky performance status > 70%.
- Aspartate aminotransferase (AST) must be < 2 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) must be < 2 x ULN
- Total bilirubin < 2 mg/dL.
- Serum creatinine < 2.0 or 24-hour creatinine clearance ≥ 60 mL/min.
- Patients must be HIV-negative.
- Patients must provide signed, informed consent.
EXCLUSION CRITERIA
- Severe psychological or medical illness
- Prior autologous hematopoietic cell transplantation
- Pregnant
- Lactating women
- Smoldering multiple myeloma,
- Monoclonal gammopathy of unknown significance or primary amyloidosis will be excluded
from this study
Intervention(s):
drug: cyclophosphamide
drug: etoposide
drug: Melphalan
drug: Carmustine
drug: Filgrastim
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
BMT Referrals
6507230822