Multiple Myeloma Clinical Trial
Official title:
High-Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma
Verified date | November 2017 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 102 |
Est. completion date | April 2010 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Stanford University School of Medicine | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
Chen AI, Negrin RS, McMillan A, Shizuru JA, Johnston LJ, Lowsky R, Miklos DB, Arai S, Weng WK, Laport GG, Stockerl-Goldstein K. Tandem chemo-mobilization followed by high-dose melphalan and carmustine with single autologous hematopoietic cell transplantat — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Pulmonary Toxicity | Pulmonary toxicity was assessed as the incidence of interstitial pneumonitis. | 2 years | |
Secondary | Overall Participant Survival (OS) | Survival status was assessed 5 years after transplant. | 5 years | |
Secondary | Number of Participants That Relapse After Autologous Transplantation | Relapse was measured as the number of patients who relapse after high-dose sequential therapy then autologous transplantation | 5 years |
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