Phase II trial evaluating fotemustine (Muphoran) treatment in patients with refractory or relapsing multiple myeloma - ND
- Conditions
- multiple myelomaMedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myeloma
- Registration Number
- EUCTR2008-001175-29-IT
- Lead Sponsor
- OSPEDALE POLICLINICO S. MATTEO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
patients with refractory or relapsing multiple myeloma treated with at least 3 therapeutic lines (bortezomib, thalidomide and/or lenalidomide) age > 18 years, performance status score > 60%, measurable disease, ...
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
pregnancy, lactation, concomitant immunotherapy, biologic therapy or sperimental drug, ...
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to evaluate fotemustine toxicity in association with high dose dexametasone in patients with refractory or relapsing multiple myeloma;Secondary Objective: time to progression progression free survival overall survival response rate time to response response duration;Primary end point(s): haematological and extrahaematological toxicity
- Secondary Outcome Measures
Name Time Method