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Hematopoietic Stem Cell Transplantation in Myeloma

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ClinicalTrials.gov Identifier: NCT00415987
Recruitment Status : Unknown
Verified June 2008 by Azienda Ospedaliera San Giovanni Battista.
Recruitment status was:  Active, not recruiting
First Posted : December 27, 2006
Last Update Posted : June 20, 2008
Sponsor:
Information provided by:
Azienda Ospedaliera San Giovanni Battista

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Procedure: Hematopoietic Stem Cell Transplantation Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources




Primary Outcome Measures :
  1. Survival Outcomes

Secondary Outcome Measures :
  1. Response Rate
  2. Toxicity


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00415987     History of Changes
Other Study ID Numbers: 572
First Posted: December 27, 2006    Key Record Dates
Last Update Posted: June 20, 2008
Last Verified: June 2008

Keywords provided by Azienda Ospedaliera San Giovanni Battista:
Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases