Autologous Transplantation for Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by:
University of Bologna
ClinicalTrials.gov Identifier:
NCT00378222
First received: September 18, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
  Purpose

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 Intervention Phase
Multiple Myeloma
Procedure: Autologous Stem Cell Transplantation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Study of Single Versus Double Autologous Stem Cell Transplantation for Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by University of Bologna:

Primary Outcome Measures:
  • Complete or near Complete Response Rate

Secondary Outcome Measures:
  • Relapse-free Survival
  • Event-free Survival
  • Overall Survival

Estimated Enrollment: 324
Study Start Date: January 1996
Estimated Study Completion Date: November 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378222

Sponsors and Collaborators
University of Bologna
Investigators
Principal Investigator: Michele Cavo, MD Institute of Hematology and Medical Oncology - University of Bologna
  More Information

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

ClinicalTrials.gov Identifier: NCT00378222     History of Changes
Other Study ID Numbers: BO96
Study First Received: September 18, 2006
Last Updated: September 18, 2006
Health Authority: Italy: Ministry of Health

Keywords provided by University of Bologna:
Myeloma previously untreated
Single autologous transplantation
Double autologous transplantation
Complete response

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014