Status:
UNKNOWN
Tandem Autologous- Nonmyeloablative Allogeneic Transplant for Newly Diagnosed Multiple Myeloma (Trapianto Tandem Autologo-Allogenico Non Mieloablativo Nel Mieloma Alla Diagnosi)
Lead Sponsor:
Azienda Ospedaliera San Giovanni Battista
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
To evaluate toxicity profile and efficacy of a tandem autologous-nonmyeloablative transplant approach in newly diagnose myeloma patients younger than 65 years
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 :
July 1 1999
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00702247
Start Date
July 1 1999
Last Update
June 20 2008
Active Locations (1)
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1
Università di Torino - Azienda Ospedaliera S.Giovanni Battista
Torino, Italy, 10126