Status:
UNKNOWN
Non-Myeloablative Allogeneic Transplantation From Unrelated Donors in Multiple Myeloma
Lead Sponsor:
Azienda Ospedaliera San Giovanni Battista
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The protocol aims at reducing transplant toxicity and mortality in patients with multiple myeloma.
Detailed Description
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. Inclusio...
Eligibility Criteria
Inclusion
- 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
- Age \> 65 years
- Karnofsky performance status score \< 60%
- Progressive disease or stable disease for less than three months
- Central nervous system 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
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00327314
Start Date
December 1 2002
End Date
October 1 2006
Last Update
December 28 2006
Active Locations (1)
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1
Divisione Universitaria Ematologia Azienda Ospedaliera S G Battista
Torino, Italy, 10126