A phase II, multicenter study of etoposide, aracytin, dexamethasone and bortezomib in patients affected by relapsed/refractory multiple myeloma previously treated with thalidomide - ND
- Conditions
- relapsed/refractory multiple myeloma patientsMedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myeloma
- Registration Number
- EUCTR2006-002588-22-IT
- Lead Sponsor
- AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
1-MM relapsed/refractory after thalidomide treatment
2-age < 80 years
3-written informed consent
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) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1-De novo MM
2-Pregnancy or lactating women
3-contracceptive methods refusal
4-inadequate hepatic, cardiac, renal and cerebral function
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method