Newly diagnosed elderly multiple myeloma patients MedDRA version: 9.1 Level: LLT Classification code 10028228
Conditions
Interventions
Trade Name: BORTEZOMIB
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Bortezomib
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentratio
Sponsors
Dutch-Belgian Cooperative Trial Group for Hematology Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age = 75 years old or age 200 mg/24 hours; Non-secretory myeloma: > 30% plasma cells in the bone marrow and at least one plasmacytoma > 2 cm as determined by clinical examination or applicable radiographs (i.e., MRI or CT scan). Patient has a Karnofsky performance status > 50%. Patient has a life-expectancy >3 months Pretreatment clinical laboratory values within 14 days of enrolment: platelet count = 80x109/L hemoglobin = 8 g/dL absolute neutrophil count (ANC) = 1.0x109/L AST = 2.5 times the upper limit of normal ALT = 2.5 times the upper limit of normal total bilirubin = 1.5 times the upper limit of normal cleareance creatinine = 20 ml/min Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: Any serious medical condition, laboratory abnormality or psychiatric illness that prevented the subject from signing the informed consent form or placed the subjects at unacceptable risk. ?Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid; < to the equivalent of dexamethasone 40 mg/day for 4 days). Pregnant or lactating females Known positive for HIV or active infectious hepatitis type A, B or C Peripheral neuropathy or neuropatic pain grade 2 or higher, as defined by National Cancer Institute Common Toxicity Criteria (NCI CTC) 3.0 Infiltrative pulmonary disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Determine wheter VMP and VCP and VP induce a significant Very Good partial response`` rate in patients wwith newly diagnosed MM 2. determine the Complete Response (CR) rate 3. Determine the Partial response rate;Secondary Objective: 1. Determine Safety 2. determine the Progression Free Survival (PFS) 3. Duration of time to progression;Primary end point(s): 1. Very Good Partial response 2. Complete response 3. Partial response | — |
Countries
Italy
Outcome results
None listed