Autologous Transplantation for Multiple Myeloma

Phase 3

Completed

• Conditions: Multiple Myeloma

• Registration Number: NCT00378222
• Lead Sponsor: 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.

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 Timeline

• Study Start: 1996-01
• Study Completion: 2005-11
• Status Verified: 2006-09
• Study First Submitted: 2006-09-18
• Study First Submitted QC: 2006-09-18
• Last Update Submitted: 2006-09-18
• Study First Posted: 2006-09-19
• Last Update Posted: 2006-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 324

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Complete or near Complete Response Rate

Secondary Outcome Measures

Name	Time	Method
Relapse-free Survival
Event-free Survival
Overall Survival