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
- 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
- Primary Outcome Measures
Name Time Method overall survival yearly
- Secondary Outcome Measures
Name Time Method event free survival yearly
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the efficacy of tandem autologous-nonmyeloablative allogeneic transplantation in multiple myeloma?
How does the tandem autologous-nonmyeloablative approach compare to standard high-dose therapy with autologous stem cell transplantation for multiple myeloma in terms of efficacy and toxicity?
Which biomarkers are associated with improved outcomes following PBSC allografting after low-dose TBI in multiple myeloma patients?
What are the most common adverse events associated with tandem autologous-nonmyeloablative allogeneic transplantation for multiple myeloma and how are they managed?
Are there any combination therapies or alternative approaches that show comparable efficacy to tandem autologous-nonmyeloablative allogeneic transplantation in multiple myeloma?
Trial Locations
- Locations (1)
Università di Torino - Azienda Ospedaliera S.Giovanni Battista
🇮🇹Torino, Italy
Università di Torino - Azienda Ospedaliera S.Giovanni Battista🇮🇹Torino, ItalyBenedetto Bruno, MD, PhDPrincipal InvestigatorMario BoccadoroContact+39-011-6336728mario.boccadoro@unito.it