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Hematopoietic Stem Cell Transplantation in Myeloma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by Azienda Ospedaliera San Giovanni Battista.
Recruitment status was:  Active, not recruiting
Information provided by:
Azienda Ospedaliera San Giovanni Battista Identifier:
First received: December 26, 2006
Last updated: June 19, 2008
Last verified: June 2008
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
Intervention Model: Parallel Assignment
Masking: None (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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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Please refer to this study by its identifier: NCT00415987

Ematologia Universitaria Azienda Ospedaliera San Giovanni Battista
Torino, Italy, 10126
Sponsors and Collaborators
Azienda Ospedaliera San Giovanni Battista
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 automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00415987     History of Changes
Other Study ID Numbers: 572
Study First Received: December 26, 2006
Last Updated: June 19, 2008

Keywords provided by Azienda Ospedaliera San Giovanni Battista:
Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases processed this record on August 18, 2017