High-Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma

Completed · Phase 2

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT00349778

Run by

Stanford University

People needed

102

Starts

2006-08-01

Expected to finish

2010-04-01

Last updated by the study team

2017-12-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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