Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-24 @ 5:10 PM
NCT ID:
NCT02773550
Eligibility 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:
* 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.
Exclusion Criteria:
* Patients who have previously received treatment for multiple myeloma, with the exception of steroid pulses for some urgency required prior to initiating induction therapy, administration of bisphosphonates or radiotherapy either analgesic or due to the presence of plasmacytomas require it 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 enrollment.
* Patients who are currently in another clinical trial or receiving any investigational agent.
* Hypertension or poorly controlled diabetes mellitus or other serious organic disease involving excessive risk to the patient or any psychiatric disorder that interfere with the understanding of informed consent.
* Acute diffuse infiltrative pulmonary disease and pericardial disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
75 Years
Study:
NCT02773550
Study Brief:
Protocol Section:
NCT02773550