Evaluation of the safety and efficacy of bortezomib combined with cyclophosphamide and dexametasone for induction and maintenance in bortezomib naive refractory on relapsed MM, stage II - III.
Conditions
Interventions
Trade Name: Velcade
Product Name: Velcade
Pharmaceutical Form: Solution for injection
INN or Proposed INN: bortezomib
Concentration unit: g/ml gram(s)/millilitre
Concentration type: equal
Sponsors
University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age = 18 years Stage II-III Multiple Myeloma Relapse or primary refractory disease after initial chemotherapy WHO performance status 0 – 2 Life expectancy of at least 6 weeks ANC (absolute neutrophil count) = 1.0x109/l (or = 0.5x109/l, if due to bone marrow infiltration by malignancy) Platelet count = 75x109/l (or = 50x109/l, if due to bone marrow infiltration by malignancy) Written informed consent (present in patient’s file) Patient is able and willing to use adequate contraception during therapy and for at least 1 month after study Patient has the ability to understand the requirements of the study 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: Previous treatment with bortezomib Urine production < 1.5 l/24h Pre-existent polyneuropathy (grade 2 or higher, according to CTCAE 3.0) Pregnancy or positive pregnancy tests during study and for 1 month after final dose of thalidomide History of active malignancy during the past 5 years (with the exception of basal carcinoma of the skin) Active uncontrolled infections Additional uncontrolled serious medical or psychiatric illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the safety and efficacy of bortezomib combined with cyclophosphamide and dexamethasone for induction and maintenance therapy. ;Secondary Objective: N.A.;Primary end point(s): Response during re-induction and maintenance therapy (Non, minor, PR, VGPR and CR). Toxicity related to induction and maintenance scheme. | — |
Countries
Netherlands
Outcome results
None listed