multiple myeloma
Conditions
Interventions
A:Bortezomib Administered by subcutaneous injection
B:Bortezomib Administered by intraveneous injection
Sponsors
The first affiliated hospital of Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Man or woman aged 18 years and older; 2. Subjects are newly diagnosed MM patients which are scheduled by the investigators to be treated with vincristine, Adriamycin and dexamethasone standard therapy; 3. Life expectancy > 3 months; 4. Patient has measurable disease in which to capture response, defined as one or more of the following; 1) Serum M-protein level >10.0 g/L measured by serum protein electrophoresis or immunoglobulin electrophoresis; or 2) Urinary M-protein excretion > 1 g/24 hours; or 3) Bone marrow plasmacytosis of > 30% by bone marrow aspirate and/or biopsy; or 4) Serum free light chains (by the Free lite test) > 2* the upper limit of normal (ULN), in the absence of renal failure; 5. Performance status (PS) of ECOG =50*10^9 cells/L; Absolute neutrophil count (ANC) >=0.75*10^9 cells /L; 7. Patients must have adequate hepatic function defined as Alanine transaminase(ALT) 30 ml /min.; 8. Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion criteria
Exclusion criteria: 1. MGUS and smoldering myeloma; 2. Amyloidosis, HIV positive, another malignancy; 3. Peripheral neuropathy or neuropathy pain grade 2 or high as defined by NCI CTC AE Version 4.0; 4. Uncontrolled or severe cardiovascular disease, including myocardial infarction (MI ) 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; 5. History of allergy reaction attributable to compounds containing boron or mannitol; 6. Any serious, active disease or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol or the investigator’s decision; 7. Concurrent treatment with another investigational agent; 8. Female subject who is pregnant or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Response Rate;Incidence rate of Peripheral Neuropathy;Time To Response;Progression-free Survival; | — |
Countries
China
Contacts
Public ContactJie Jin
Outcome results
None listed