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Hematopoietic Stem Cell Transplantation in Myeloma

Sponsor
Azienda Ospedaliera San Giovanni Battista (Other)
Overall Status
Unknown status
CT.gov ID
NCT00415987
Collaborator
(none)
1
Location

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Hematopoietic Stem Cell Transplantation
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Completion Date :
Sep 1, 2006

Outcome Measures

Primary Outcome Measures

  1. Survival Outcomes []

Secondary Outcome Measures

  1. Response Rate []

  2. Toxicity []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00415987
Other Study ID Numbers:
  • 572
First Posted:
Dec 27, 2006
Last Update Posted:
Jun 20, 2008
Last Verified:
Jun 1, 2008
Keywords provided by , ,
Multiple Myeloma
Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell

Study Results

No Results Posted as of Jun 20, 2008