Hematopoietic Stem Cell Transplantation in Myeloma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Azienda Ospedaliera San Giovanni Battista.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Azienda Ospedaliera San Giovanni Battista
ClinicalTrials.gov Identifier:
NCT00415987
First received: December 26, 2006
Last updated: June 19, 2008
Last verified: June 2008
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Azienda Ospedaliera San Giovanni Battista

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00415987     History of Changes
Other Study ID Numbers: 572
Study First Received: December 26, 2006
Last Updated: June 19, 2008
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on July 22, 2014