Tandem Autologous- Nonmyeloablative Allogeneic Transplant for Newly Diagnosed Multiple Myeloma (Trapianto Tandem Autologo-Allogenico Non Mieloablativo Nel Mieloma Alla Diagnosi)
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ClinicalTrials.gov Identifier: NCT00702247
Verified June 2008 by Azienda Ospedaliera San Giovanni Battista. Recruitment status was: Recruiting
Allogeneic Stem Cell Transplantation for Multiple Myeloma: a Two Step Approach to Reduce Toxicity Involving High-Dose Melphalan and Autologous Stem Cell Transplant Followed by PBSC Allografting After Low-Dose TBI
Study Start Date
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Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
Age > 65 years
Previously treated myeloma
Absence of a sibling (genetic randomisation cannot be applied)
Karnofsky performance status score < 60%
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.