Hematopoietic Stem Cell Transplantation in Myeloma

June 19, 2008 updated by: Azienda Ospedaliera San Giovanni Battista
The treatment assignment is based on the presence or absence of an HLA-identical sibling donor (Genetic Randomisation, NOT formal Randomisation). Patients with suitable HLA-identical sibling donors are offered a tandem transplant approach consisting of standard autografting nonmyeloablative radiotherapy and allografting. Patients without HLA-identical siblings are treated with standard double autologous transplantation as per Institutional guidelines or enrolled in other treatment programs approved by local IRBs.This is a multi-center study. The Division of Hematology of University of Torino at the S.G.B. Hospital, Torino, Italy, is the co-ordinating Center.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

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

Study Locations

  • Italy
      • Torino, Italy, 10126
        • Ematologia Universitaria Azienda Ospedaliera San Giovanni Battista

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Survival Outcomes

Secondary Outcome Measures

Outcome Measure
Toxicity
Response Rate

Collaborators and Investigators

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

Sponsor

Azienda Ospedaliera San Giovanni Battista

Investigators

  • Principal Investigator: Benedetto Bruno, MD, PhD, Divisione Ematologia, Università di Torino, Azienda Ospedaliera San Giovanni Battista, Torino, Italy
  • Study Director: Mario Boccadoro, MD, Divisione Ematologia, Università di Torino, Azienda Ospedaliera San Giovanni Battista, 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.

General Publications

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 Completion

September 1, 2006

Study Registration Dates

First Submitted

December 26, 2006

First Submitted That Met QC Criteria

December 26, 2006

First Posted (Estimate)

December 27, 2006

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

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 572

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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