Autologous Transplantation for Multiple Myeloma
September 18, 2006 updated by: University of Bologna
A Prospective, Randomized Study of Single Versus Double Autologous Stem Cell Transplantation for Multiple Myeloma
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
324
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
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Complete or near Complete Response Rate
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Secondary Outcome Measures
Outcome Measure |
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Overall Survival
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Relapse-free Survival
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Event-free Survival
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michele Cavo, MD, Institute of Hematology and Medical Oncology - University of Bologna
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1996
Study Completion
November 1, 2005
Study Registration Dates
First Submitted
September 18, 2006
First Submitted That Met QC Criteria
September 18, 2006
First Posted (ESTIMATE)
September 19, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
September 19, 2006
Last Update Submitted That Met QC Criteria
September 18, 2006
Last Verified
September 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
Other Study ID Numbers
- BO96
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.