Autologous Transplantation for Multiple Myeloma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-01-31

Study Completion Date

2005-11-30

Brief Summary

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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

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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.

Conditions

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Multiple Myeloma

Keywords

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Myeloma previously untreated Single autologous transplantation Double autologous transplantation Complete response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Autologous Stem Cell Transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Michele Cavo, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Hematology and Medical Oncology - University of Bologna

References

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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

Reference Type RESULT

Other Identifiers

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BO96

Identifier Type: -

Identifier Source: org_study_id