A phase 3, prospective, randomized clinical study with Velcade-Thalidomide- Dexamethasone versus Thalidomide-Dexamethasone for previously untreated patients with symptomatic multiple myeloma who are candidates to receive double autologous transplantation. 26866138-MMY-3006
Phase 1
- Conditions
- terapia del mieloma nultuplo in pazienti con danno d' organo e assenza di precedente terapia per MMMedDRA version: 9.1Level: HLTClassification code 10028229Term: Multiple myelomas
- Registration Number
- EUCTR2005-003723-39-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the probability of answer to VELCADE-thalidomide-dexamethasone (the group of A treatment) or thalidomide-dexamethasone (group of B treatment) like primary therapy of induction of the answer.;Secondary Objective: 1) comparare la probabilita' di risposta a VELCADE-Talidomide-Desametasone (gruppo di trattamento A) o a Talidomide-Desametasone (gruppo di trattamento B) come terapia di consolidamento dopo trapianto autologo; 2) comparare il tempo alla progressione nei 2 gruppi di trattamento; 3) comparare la sopravvivenza globale e libera da eventi nei 2 gruppi di pazienti; 4) comparare la tossicita' di VELCADE-Talidomide-Desametasone e Talidomide-Desametasone; 5) comparare l efficienza della raccolta di PBSC nei 2 gruppi di pazienti. <br>;Primary end point(s):
- Secondary Outcome Measures
Name Time Method