Tandem Autologous- Nonmyeloablative Allogeneic Transplant for Newly Diagnosed Multiple Myeloma (Trapianto Tandem Autologo-Allogenico Non Mieloablativo Nel Mieloma Alla Diagnosi)
Phase 2
- Conditions
- Multiple Myeloma
- Interventions
- Procedure: Hematopoietic Stem Cell Transplantation
- Registration Number
- NCT00702247
- Lead Sponsor
- Azienda Ospedaliera San Giovanni Battista
- Brief Summary
To evaluate toxicity profile and efficacy of a tandem autologous-nonmyeloablative transplant approach in newly diagnose myeloma patients younger than 65 years
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Hematopoietic Stem Cell Transplantation -
- Primary Outcome Measures
Name Time Method overall survival yearly
- Secondary Outcome Measures
Name Time Method event free survival yearly
Trial Locations
- Locations (1)
Università di Torino - Azienda Ospedaliera S.Giovanni Battista
🇮🇹Torino, Italy