multiple myeloma MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Interventions
Product Name: Fotemustine
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Fotemustine
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Sponsors
OSPEDALE POLICLINICO S. MATTEO
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: pregnancy, lactation, concomitant immunotherapy, biologic therapy or sperimental drug, ...
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed