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 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT03312868
Eligibility Criteria:
Inclusion Criteria:
* Biopsy proven plasmacytic for the index lesion;
* Age between 18 and 85 years;
* ECOG scale performance of 0 to 2
Exclusion Criteria:
* Refuse to sign or inability to understand the term of free and informed commitment (TCLE);
* Technical limitations for treatment with SBRT among which is cited, but not limited to, weight greater than 115 Kg, inability to abduct limb to be treated in appendicular bone plasmocytomas, intolerable pain to remain in treatment position;
* Criteria for multiple myeloma at diagnosis: more than 10% of plasma cells in bone marrow biopsy, hypercalcemia greater than 11.5 mg/dL, serum creatinine greater than 2mg/dL, creatinine clearance less than 40mL/min , Hemoglobin less than 10g/dL.
* Previous cancer diagnosis and treatments;
* Previous bone events such as fractures and osteomyelitis in the bone in which the index lesion is found;
* Prior autoimmune diseases, even if controlled;
* Extra-medullary plasmacytoma requiring elective treatment of lymph node drainage;
* Current pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03312868
Study Brief:
Protocol Section:
NCT03312868