Status:
COMPLETED
High-Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma
Lead Sponsor:
Stanford University
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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. Sp...
Detailed Description
Analysis of 196 previously treated patients demonstrated a median event-free survival (EFS) of 36 months with a median overall survival of more than 6 years. The main toxicity of this therapy is relat...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00349778
Start Date
August 1 2006
End Date
April 1 2010
Last Update
December 12 2017
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305