NCT00378222

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P50-P75 for phase_3 multiple-myeloma

Timeline
Completed

Started Jan 1996

Longer than P75 for phase_3 multiple-myeloma

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1996

Completed
9.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2006

Completed
Last Updated

September 19, 2006

Status Verified

September 1, 2006

First QC Date

September 18, 2006

Last Update Submit

September 18, 2006

Conditions

Multiple Myeloma

Keywords

Myeloma previously untreatedSingle autologous transplantationDouble autologous transplantationComplete response

Outcome Measures

Primary Outcomes (1)

  • Complete or near Complete Response Rate

Secondary Outcomes (3)

  • Relapse-free Survival

  • Event-free Survival

  • Overall Survival

Interventions

Autologous Stem Cell TransplantationPROCEDURE

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Previously untreated
  • Younger than 61 years
  • Symptomatic myeloma
  • Measurable disease
  • Fit to receive high-dose chemotherapy

You may not qualify if:

  • M-GUS
  • Solitary plasmacytoma
  • Plasma cell leukemia
  • AL Amyloidosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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

    RESULT

MeSH Terms

Conditions

Multiple MyelomaPathologic Complete Response

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesDisease ProgressionDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michele Cavo, MD

    Institute of Hematology and Medical Oncology - University of Bologna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 18, 2006

First Posted

September 19, 2006

Study Start

January 1, 1996

Study Completion

November 1, 2005

Last Updated

September 19, 2006

Record last verified: 2006-09