PHASE II STUDY ON TREATMENT WITH VELCADE, DEXAMETHASONE AND FOTEMUSTINE IN PATIENTS AFFECTED BY RELAPSED/REFRACTORY MULTIPLE MYELOMA - B-MUD
- Conditions
- Relapsed/refractory Multiple MyelomaMedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myeloma
- Registration Number
- EUCTR2009-011838-10-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
Documented relapsed or progressive disease after al least one previous therapy; age > 18; Performance status score > 60%; MM documented in serum or urine; absence of severe disease or concomitant neoplasia; Negative HIV test; Negative pregnancy test; Laboratory values within the protocol limits.
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
Pregnancy or breast-feeding; neuropathy >= grade 2 NCI; concomitant biological therapy, immunotherapy or other experimental drugs in the previous 21 days; plasmapheresis in the previous 30 days; Major surgery in the previous 30 days.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluation of toxicity of the treatment with Fotemustine associated with Bortezomib and high-dose Dexamethasone in patients affected by relapsed/refractory multiple myeloma after at least one previous therapy.;Secondary Objective: Time to progression(TTP); Time to next treatment (TTNT); Progression free Survival (PFS); Overall Survival (OS); Complete + Partial Response (CR+PR); Time to Response; Response Duration.;Primary end point(s): Number of patients with toxicity at maximum dose
- Secondary Outcome Measures
Name Time Method