Tandem Autologous- Nonmyeloablative Allogeneic Transplant for Newly Diagnosed Multiple Myeloma (Trapianto Tandem Autologo-Allogenico Non Mieloablativo Nel Mieloma Alla Diagnosi)

Allogeneic Stem Cell Transplantation for Multiple Myeloma: a Two Step Approach to Reduce Toxicity Involving High-Dose Melphalan and Autologous Stem Cell Transplant Followed by PBSC Allografting After Low-Dose TBI

To evaluate toxicity profile and efficacy of a tandem autologous-nonmyeloablative transplant approach in newly diagnose myeloma patients younger than 65 years

Study Overview

Status

Unknown

Conditions

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Torino, Italy, 10126
        • Recruiting
        • Università di Torino - Azienda Ospedaliera S.Giovanni Battista
        • Contact:
        • Contact:
        • Principal Investigator:
          • Benedetto Bruno, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Durie-Salmon stage IIA-IIIB multiple myeloma
  • Age > 18 and ≤ 65 years
  • Previously untreated myeloma
  • Presence of a sibling (potential donor)
  • Bilirubins < twice normal;ALAT and ASAT < four times normal
  • Left ventricular ejection fraction > 40%
  • Creatinine clearances > 40 mL/min
  • Pulmonary dysfunction with diffusing capacity for carbon monoxide (DLCO) > 40% and/or need for continuous oxygen supplementation
  • Karnofsky performance status > 60%
  • Patients must give written informed consent

Exclusion Criteria:

  • Age > 65 years
  • Previously treated myeloma
  • Absence of a sibling (genetic randomisation cannot be applied)
  • Karnofsky performance status score < 60%
  • HIV-infection
  • Pregnancy
  • Refusal to use contraceptive techniques during and for 12 months following treatment
  • Patients unable to give written informed consent
  • PS. Informed consent is obtained from each patient according to the Institutional Review Boards of the participating centers. The study is conducted according to the Declaration of Helsinki.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: yearly
yearly

Secondary Outcome Measures

Outcome Measure
Time Frame
event free survival
Time Frame: yearly
yearly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Bruno Benedetto, MD, PhD, University of Torino - Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1999

Study Registration Dates

First Submitted

June 19, 2008

First Submitted That Met QC Criteria

June 19, 2008

First Posted (Estimate)

June 20, 2008

Study Record Updates

Last Update Posted (Estimate)

June 20, 2008

Last Update Submitted That Met QC Criteria

June 19, 2008

Last Verified

June 1, 2008

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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