Transplantation and Hematopoietic cell transplantation in Multiple Myeloma - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Multiple Myeloma

Intervention / Treatment

Detailed Description

Primary end points are engraftment and non-relapse mortality. Secondary end points are disease response, overall survival, progression and event free survivals. Patient eligibility criteria.

Inclusion criteria included:

Diagnosis of Durie-Salmon stage IIA-IIIB multiple myeloma
Age > 18 and ≤ 65 years at the start of the donor search
Presence of concurrent co-morbidities precluding myeloablative conditioning or refusal to undergo a conventional allogeneic transplant
Capacity to give informed consent

Exclusion criteria included:

Age > 65 years
Karnofsky performance status score < 60%
Progressive disease or stable disease for less than three months
Central nervous system (CNS) involvement
Left ventricular ejection fraction < 35% or symptomatic heart failure
Poorly controlled hypertension
Pulmonary dysfunction with diffusing capacity for carbon monoxide (DLCO) < 40% and/or need for continuous oxygen supplementation
Abnormal liver disease with a serum bilirubin greater than twice normal or SGOT and/or SGPT greater than four times the upper limits of normal
HIV positive patients
Pregnancy
Refusal to use contraceptive techniques during and for 12 months following treatment

Informed consent is obtained during study registration from each patient according to the Institutional Review Boards of the participating centers. The study is conducted according to the Declaration of Helsinki.

Study Type

Interventional

Enrollment

100

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 Locations

Italy
- - Torino, Italy, 10126
    - Recruiting
    - Divisione Universitaria Ematologia Azienda Ospedaliera S G Battista
    - Principal Investigator:
      
      Benedetto Bruno, MD, PhD
    - Sub-Investigator:
      
      Luisa Giaccone, MD

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:

Diagnosis of Durie-Salmon stage IIA-IIIB multiple myeloma
Age > 18 and ≤ 65 years at the start of the donor search
Presence of concurrent co-morbidities precluding myeloablative conditioning or refusal to undergo a conventional allogeneic transplant
Capacity to give informed consent

Exclusion Criteria:

Age > 65 years
Karnofsky performance status score < 60%
Progressive disease or stable disease for less than three months
Central nervous system involvement
Left ventricular ejection fraction < 35% or symptomatic heart failure
Poorly controlled hypertension
Pulmonary dysfunction with diffusing capacity for carbon monoxide (DLCO) < 40% and/or need for continuous oxygen supplementation
Abnormal liver disease with a serum bilirubin greater than twice normal or SGOT and/or SGPT greater than four times the upper limits of normal
HIV positive patients
Pregnancy
Refusal to use contraceptive techniques during and for 12 months following treatment

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: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

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 di Ematologia _ Azienda Ospedaliera S G Battista di Torino

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

December 1, 2002

Study Completion

October 1, 2006

Study Registration Dates

First Submitted

May 16, 2006

First Submitted That Met QC Criteria