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
Sally Arai

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Robert Lowsky
Robert Lowsky

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Laura Johnston
Laura Johnston

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Robert Negrin
Robert Negrin

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Judith Shizuru
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

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