Multiple Myeloma Clinical Trial
Official title:
A Prospective, Randomized Study of Single Versus Double Autologous Stem Cell Transplantation for Multiple Myeloma
Verified date | September 2006 |
Source | University of Bologna |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ministry of Health |
Study type | Interventional |
The present study was designed in an attempt to prospectively evaluate in a randomized fashion whether further cytotoxic dose intensification, as delivered with two sequential autologous stem-cell transplantations, improved the outcome of younger patients with newly diagnosed multiple myeloma in comparison with a single autologous transplantation.
Status | Completed |
Enrollment | 324 |
Est. completion date | November 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Previously untreated - Younger than 61 years - Symptomatic myeloma - Measurable disease - Fit to receive high-dose chemotherapy Exclusion Criteria: - M-GUS - Solitary plasmacytoma - Plasma cell leukemia - AL Amyloidosis |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Bologna |
Cavo M et al. Superiority of Double over Single Autologous Stem Cell Transplantation as First-Line Therapy for Multiple Myeloma. Blood (ASH Annual Meeting Abstracts) 2004 104: Abstract 536
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete or near Complete Response Rate | |||
Secondary | Relapse-free Survival | |||
Secondary | Event-free Survival | |||
Secondary | Overall Survival |
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