Hematopoietic Stem Cell Transplantation in Myeloma

This study is ongoing, but not recruiting participants.

Sponsored by:	Azienda Ospedaliera San Giovanni Battista
Information provided by:	Azienda Ospedaliera San Giovanni Battista
ClinicalTrials.gov Identifier:	NCT00415987

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma	Procedure: Hematopoietic Stem Cell Transplantation	Phase II Phase III

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Azienda Ospedaliera San Giovanni Battista:

Primary Outcome Measures:

Survival Outcomes

Secondary Outcome Measures:

Response Rate
Toxicity

Estimated Study Completion Date:

September 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415987

Locations

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

Sponsors and Collaborators

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

More Information

Publications indexed to this study:

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.

Study ID Numbers:	572
Study First Received:	December 26, 2006
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00415987
Health Authority:	Italy: Ethics Committee

Keywords provided by Azienda Ospedaliera San Giovanni Battista:

Multiple Myeloma

Study placed in the following topic categories:

Immunoproliferative Disorders
Hemorrhagic Disorders
Multiple myeloma
Hematologic Diseases
Blood Protein Disorders
Blood Coagulation Disorders

Vascular Diseases
Paraproteinemias
Lymphoproliferative Disorders
Hemostatic Disorders
Neoplasms, Plasma Cell
Multiple Myeloma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009