Primary end points are engraftment and non-relapse mortality. Secondary end points are
disease response, overall survival, progression and event free survivals. Patient
eligibility criteria.
Inclusion criteria included:
- Diagnosis of Durie-Salmon stage IIA-IIIB multiple myeloma
- Age > 18 and ≤ 65 years at the start of the donor search
- Presence of concurrent co-morbidities precluding myeloablative conditioning or refusal
to undergo a conventional allogeneic transplant
- Capacity to give informed consent
Exclusion criteria included:
- Age > 65 years
- Karnofsky performance status score < 60%
- Progressive disease or stable disease for less than three months
- Central nervous system (CNS) involvement
- Left ventricular ejection fraction < 35% or symptomatic heart failure
- Poorly controlled hypertension
- Pulmonary dysfunction with diffusing capacity for carbon monoxide (DLCO) < 40% and/or
need for continuous oxygen supplementation
- Abnormal liver disease with a serum bilirubin greater than twice normal or SGOT and/or
SGPT greater than four times the upper limits of normal
- HIV positive patients
- Pregnancy
- Refusal to use contraceptive techniques during and for 12 months following treatment
Informed consent is obtained during study registration from each patient according to the
Institutional Review Boards of the participating centers. The study is conducted according
to the Declaration of Helsinki.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Benedetto Bruno, MD, PhD
Principal Investigator
Divisione di Ematologia _ Azienda Ospedaliera S G Battista di Torino
Italy: Ministry of Health
MM 1641
NCT00327314
December 2002
October 2006
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