Multiple myeloma. Level: HLT Classification code 10028229
Conditions
Interventions
Trade Name: VELCADE*1FL 3,5MG
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Bortezomib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
OSPEDALE POLICLINICO S. MATTEO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must satisfy the following criteria to be enrolled in the study: Diagnosis of multiple myeloma II/III clinical stage (Durie and Salmon [see attachment 1]), or I stage in progression previously untreated Age /= 60% Agree to use as acceptable barrier methods for contraception for the duration of the induction phase (for male subject). If female subjects are still having menstrual periods and are not surgically sterile, they must be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study and have negative serum beta-HCG pregnancy at screening. Have pre-treatment clinical laboratory values meeting the following criteria within 14 days before enrollment: Platelet count >/= 100x109/L Haemoglobin >/= 8 g/dL (prior RBC transfusion or recombinant human erythropoietin use is allowed) Absolute neutrophil count (ANC) >/=1.0 x109/L Aspartate aminotransferase (AST) =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Potential subjects who meet any of the following criteria will be excluded from participating in the study: Diagnosis of smoldering myeloma or MGUS or Waldenstroms disease or other conditions in which IgM M-protein is presenting the absence of a clonal plasma cell infiltration with lytic bone lesions. Prior or current systemic therapy for multiple myeloma including steroids (with the exception of emergency use of a short course [maximum 4 days] of steroids before randomisation Radiotherapy within 30 days before entry Plasmapheresis within 30 days before entry Major surgery within 30 days before entry Has known or suspected hypersensitivity or intolerance to boron, mannitol, or heparin, if an indwelling catheter is used History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis History of hypotension or has decreased blood pressure Pregnant or breastfeeding Neuropathy Grade 2 Receipt of extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy before enrollment Serious medical or psychiatric illness likely to interfere with participation in this clinical study Have received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study Other malignancy within the past 5 years. Exceptions for the following if treated and not active: basal cell or non metastatic squamous cell carcinome of the skin, cervical carcinoma in situ or International Federation of Gynaecology and Obstetrics stage 1 carcinoma of the cervix.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of Bortezomib in increasing the rate of complete remission before mobilization therapy.;Secondary Objective: The secondary objectives of this study are to determine whether the addition of the combination Velcade+Dexamethasone in the induction phase of a high-dose program in subjects with previously untreated multiple myeloma who are candidates to high-dose therapy improves the following: time to progression (TTP) progression free survival (PFS), overall survival (OS), response rate (CR+PR), time to response, and duration of response. Feasibility and toxicity of the protocol will be also assessed.;Primary end point(s): The primary end point is the percentage of CR. | — |
Countries
Italy
Outcome results
None listed