Status:
UNKNOWN
Hematopoietic Stem Cell Transplantation in Myeloma
Lead Sponsor:
Azienda Ospedaliera San Giovanni Battista
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
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 ar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00415987
End Date
September 1 2006
Last Update
June 20 2008
Active Locations (1)
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1
Ematologia Universitaria Azienda Ospedaliera San Giovanni Battista
Torino, Italy, 10126