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Non-Myeloablative Allogeneic Transplantation From Unrelated Donors in Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Transplantation
Hematopoietic cell transplantation
Sponsored by
Azienda Ospedaliera San Giovanni Battista
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Divisione Universitaria Ematologia Azienda Ospedaliera S G BattistaRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 16, 2006
Last Updated
December 27, 2006
Sponsor
Azienda Ospedaliera San Giovanni Battista
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1. Study Identification

Unique Protocol Identification Number
NCT00327314
Brief Title
Non-Myeloablative Allogeneic Transplantation From Unrelated Donors in Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Unknown status
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Azienda Ospedaliera San Giovanni Battista

4. Oversight

5. Study Description

Brief Summary
The protocol aims at reducing transplant toxicity and mortality in patients with multiple myeloma.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Transplantation
Intervention Type
Procedure
Intervention Name(s)
Hematopoietic cell transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benedetto Bruno, MD, PhD
Phone
+39-011-6334419
Email
benedetto.bruno@unito.it
First Name & Middle Initial & Last Name or Official Title & Degree
Luisa Giaccone, MD
Phone
+39-011-6334419
Email
luisa.giaccone@unito.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benedetto Bruno, MD, PhD
Organizational Affiliation
Divisione di Ematologia _ Azienda Ospedaliera S G Battista di Torino
Official's Role
Principal Investigator
Facility Information:
Facility Name
Divisione Universitaria Ematologia Azienda Ospedaliera S G Battista
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benedetto Bruno, MD, PhD
First Name & Middle Initial & Last Name & Degree
Luisa Giaccone, MD

12. IPD Sharing Statement

Learn more about this trial

Non-Myeloablative Allogeneic Transplantation From Unrelated Donors in Multiple Myeloma

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