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Autologous Transplantation for Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00378222
Recruitment Status : Completed
First Posted : September 19, 2006
Last Update Posted : September 19, 2006
Information provided by:
University of Bologna

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Procedure: Autologous Stem Cell Transplantation Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Study of Single Versus Double Autologous Stem Cell Transplantation for Multiple Myeloma
Study Start Date : January 1996
Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Primary Outcome Measures :
  1. Complete or near Complete Response Rate

Secondary Outcome Measures :
  1. Relapse-free Survival
  2. Event-free Survival
  3. Overall Survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00378222

Sponsors and Collaborators
University of Bologna
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Principal Investigator: Michele Cavo, MD Institute of Hematology and Medical Oncology - University of Bologna
Publications of Results:
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

Layout table for additonal information Identifier: NCT00378222    
Other Study ID Numbers: BO96
First Posted: September 19, 2006    Key Record Dates
Last Update Posted: September 19, 2006
Last Verified: September 2006
Keywords provided by University of Bologna:
Myeloma previously untreated
Single autologous transplantation
Double autologous transplantation
Complete response
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases