Back to resultsHematopoietic Stem Cell Transplantation in Myeloma
Primary Purpose
Multiple Myeloma
Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Hematopoietic Stem Cell Transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma
Eligibility Criteria
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.
Sites / Locations
- Ematologia Universitaria Azienda Ospedaliera San Giovanni Battista
Outcomes
Primary Outcome Measures
Survival Outcomes
Secondary Outcome Measures
Response Rate
Toxicity
Full Information
NCT ID
NCT00415987
First Posted
December 26, 2006
Last Updated
June 19, 2008
Sponsor
Azienda Ospedaliera San Giovanni Battista
1. Study Identification
Unique Protocol Identification Number
NCT00415987
Brief Title
Hematopoietic Stem Cell Transplantation in Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Azienda Ospedaliera San Giovanni Battista
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Hematopoietic Stem Cell Transplantation
Primary Outcome Measure Information:
Title
Survival Outcomes
Secondary Outcome Measure Information:
Title
Response Rate
Title
Toxicity
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benedetto Bruno, MD, PhD
Organizational Affiliation
Divisione Ematologia, Università di Torino, Azienda Ospedaliera San Giovanni Battista, Torino, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mario Boccadoro, MD
Organizational Affiliation
Divisione Ematologia, Università di Torino, Azienda Ospedaliera San Giovanni Battista, Torino, Italy
Official's Role
Study Director
Facility Information:
Facility Name
Ematologia Universitaria Azienda Ospedaliera San Giovanni Battista
City
Torino
ZIP/Postal Code
10126
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
17360989
Citation
Bruno B, Rotta M, Patriarca F, Mordini N, Allione B, Carnevale-Schianca F, Giaccone L, Sorasio R, Omede P, Baldi I, Bringhen S, Massaia M, Aglietta M, Levis A, Gallamini A, Fanin R, Palumbo A, Storb R, Ciccone G, Boccadoro M. A comparison of allografting with autografting for newly diagnosed myeloma. N Engl J Med. 2007 Mar 15;356(11):1110-20. doi: 10.1056/NEJMoa065464.
Results Reference
derived
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Hematopoietic Stem Cell Transplantation in Myeloma
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