Autologous Transplantation for Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Autologous Stem Cell Transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Myeloma previously untreated, Single autologous transplantation, Double autologous transplantation, Complete response
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Complete or near Complete Response Rate
Secondary Outcome Measures
Relapse-free Survival
Event-free Survival
Overall Survival
Full Information
NCT ID
NCT00378222
First Posted
September 18, 2006
Last Updated
September 18, 2006
Sponsor
University of Bologna
1. Study Identification
Unique Protocol Identification Number
NCT00378222
Brief Title
Autologous Transplantation for Multiple Myeloma
Official Title
A Prospective, Randomized Study of Single Versus Double Autologous Stem Cell Transplantation for Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
January 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Bologna
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
Following demonstration that single autologous transplantation for the treatment of younger patients with newly diagnosed multiple myeloma prolonged overall survival in comparison with conventional chemotherapy, double autologous transplantation was tested, initially in refractory myeloma and subsequently to include also patients with newly diagnosed disease. To explore the role of double autologous stem-cell transplantation as part of up-front therapy for multiple myeloma, in 1996 we launched a prospective, randomized trial comparing a single course of stem-cell-supported melphalan with the same regimen followed, after three to six months, by a second autologous transplantation in support of melphalan and busulfan. The study was designed to detect a 15 percent increase in complete or near complete response rate with double transplants compared to a single transplantation. With a 2-sided significance level α = 0.05 and a power 1-β = 0.80, 162 patients were required in each treatment arm of the study to detect a statistically significant increase in complete or near complete response rate from 30% in the single-transplant arm to 45% in the double-transplant arm. Primary study endpoint was the complete or near complete response rate. Secondary study endpoints were relapse-free survival, event-free survival and overall survival. The recruitment target was 324 patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Myeloma previously untreated, Single autologous transplantation, Double autologous transplantation, Complete response
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
324 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Autologous Stem Cell Transplantation
Primary Outcome Measure Information:
Title
Complete or near Complete Response Rate
Secondary Outcome Measure Information:
Title
Relapse-free Survival
Title
Event-free Survival
Title
Overall Survival
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Cavo, MD
Organizational Affiliation
Institute of Hematology and Medical Oncology - University of Bologna
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
Citation
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
Results Reference
result
Learn more about this trial
Autologous Transplantation for Multiple Myeloma
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