A PHASE II MULTICENTER STUDY OF BORTEZOMIB, THALIDOMIDE, PEGHILATED LIPOSOMAL DOXORUBICIN, DEXAMETHASONE (ThaDD-V)IN PATIENTS AFFECTED BY RELAPSED-REFRACTORY MULTIPLE MYELOMA - ND
- Conditions
- Relapsed-refractory MMMedDRA version: 6.1Level: PTClassification code 10028228
- Registration Number
- EUCTR2006-002564-25-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-Realapsed-refractory multiple myeloma (MM)
2-Less or equal 2 previuos chemotherapy regimens
3-Age <= 80 years
4-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 or treated with > 2 chemotherapy regimens MM
2-Pregnant or lactated women
3-Refuse of contracceptive methods
4-Neuropathy > grade 2
5-Inadequate cardiac, hepatic, bone marrow and cerebral functions
6-Other active or in remission from <5 years neoplasia
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