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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

Tracking Information
First Submitted Date  ICMJE September 18, 2006
First Posted Date  ICMJE September 19, 2006
Last Update Posted Date September 19, 2006
Study Start Date  ICMJE January 1996
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2006)
Complete or near Complete Response Rate
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2006)
  • Relapse-free Survival
  • Event-free Survival
  • Overall Survival
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Autologous Transplantation for Multiple Myeloma
Official Title  ICMJE A Prospective, Randomized Study of Single Versus Double Autologous Stem Cell Transplantation for Multiple Myeloma
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE Procedure: Autologous Stem Cell Transplantation
Study Arms  ICMJE Not Provided
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

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 18, 2006)
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE November 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00378222
Other Study ID Numbers  ICMJE BO96
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Bologna
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michele Cavo, MD Institute of Hematology and Medical Oncology - University of Bologna
PRS Account University of Bologna
Verification Date September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP