NCT00702247
Unknown
Phase 2
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
Azienda Ospedaliera San Giovanni Battista1 site in 1 countryJuly 1999
ConditionsMultiple Myeloma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Multiple Myeloma
- Sponsor
- Azienda Ospedaliera San Giovanni Battista
- Locations
- 1
- Primary Endpoint
- overall survival
- Last Updated
- 17 years ago
Overview
Brief Summary
To evaluate toxicity profile and efficacy of a tandem autologous-nonmyeloablative transplant approach in newly diagnose myeloma patients younger than 65 years
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
overall survival
Time Frame: yearly
Secondary Outcomes
- event free survival(yearly)
Study Sites (1)
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