multiple Myeloma MedDRA version: 17.0 Level: LLT Classification code 10028566 Term: Myeloma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Bortezomib
Product Name: Bortezomib
Product Code: 04274001
Pharmaceutical Form: Solution for injection
INN or Proposed INN:
Sponsors
Ernesto Pérez Persona
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - The patient should , in the investigator's opinion, be able to meet all requirements of the trial. - The patient must voluntarily sign informed consent before performing any test study that is not part of routine care of patients , with the knowledge that the patient can leave the study at the time you want, without being harmed at any time their aftercare. - Age > 75 years - The patient should be diagnosed symptomatic multiple myeloma according to established criteria and may not have received any treatment for disease (see Appendix 6) . Administration is permitted steroid pulses some urgency required prior to starting treatment or induction administration of bisphosphonates . - The patient must have measurable disease , defined as follows: - For Multiple Myeloma secretory measurable disease is defined by the presence of measurable serum monoclonal component, 1g/dL or if urinary excretion of light chains is greater than or equal to 200 mg/24 hours. - For Multiple Myeloma oligosecretory or secretory , serous level chain Free light affected 10 mg / dL (100 mg / L , with a ratio of abnormal free light chain serum) - The patient must have a life expectancy greater than 3 months life. - The patient must have the following laboratory values ??prior to initiation of treatment corresponding induction : 1. Platelet count 50000/mm3 , hemoglobin 8 g / dl , absolute neutrophil count 1000/mm3 . Lower values ??are permitted if they are due to infiltration of the MO 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 75
Exclusion criteria
Exclusion criteria: -Patients who have previously received treatment for multiple myeloma, with the exception of pulse steroids for some urgency required prior to initiating induction therapy, administration of bisphosphonates or radiotherapy either analgesic or due to the presence of plasmacytomas required for some urgency. Patients with non-measurable disease or by SFLC. -Patients with known hypersensitivity to bortezomib, boron or mannitol acid. -Patients who have received any investigational agent within 30 days prior to inclusion. - Patients who are currently in another clinical trial or receiving any investigational agent. - Poorly controlled hypertension or diabetes mellitus or other serious organic disease involving excessive risk to the patient or any psychiatric disorder that interfira with understanding of informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: No; Secondary Objective: -Analyze the effectiveness in terms of response, duration of response, time to progression (TTP)) and overall survival (OS) of the proposed scheme. . - Identify the causes of mortality in patients with MM over 75 years ; Main Objective: Analyze the effectiveness in terms of progression-free survival at 18 months? Velcadito? given monthly in patients with MM again diagnosis, over 75 years. . - To evaluate the safety and tolerability of the scheme in terms of the incidence of Clinical and laboratory toxicities ; Primary end point(s): Primary efficacy endpoint: progression-free survival (PFS) with proposed scheme, meaning SLP duration in months from the date of study entry until the date of disease progression or death from any cause. Main outcomes of safety: safety and tolerability of schemes proposed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints: efficacy in terms of response rate, duration of response, TTP and SG in both treatment groups. Determining the cause of death of patients, and to determine the degree of relationship with the GM or treatment. ;Timepoint(s) of evaluation of this end point: No | — |
Countries
Spain
Contacts
Public ContactServicio de hematología
Ernesto Pérez Persona
Outcome results
None listed