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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT06099912
Eligibility Criteria:
Inclusion Criteria:
* Adult males and females aged ≥65 years who were either transplant-ineligible or had no intent for immediate transplant;
* Subject must have documented multiple myeloma as defined by the criteria below:
Monoclonal plasma cells in the bone marrow 10% or presence of a biopsy-proven plasmacytoma;
Measurable disease as defined by any of the following:
* Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or
* IgA multiple myeloma: serum M-protein level ≥0.5 g/dL or urine M-protein level ≥200 mg/24 hours; or
* Light chain multiple myeloma: Serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.
* Has not had prior systemic therapy for multiple myeloma;
* The functional reserve of the organs can withstand systemic therapy;
* Each subject (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, as referenced in the ICF.
Exclusion Criteria:
* There are active systemic viral, fungal, or bacterial infections that require systemic anti-infective treatment;
* Severe organ dysfunction (New York Heart Association class III and IV or transaminases ≥5 normal level, except those caused by cardiac and hepatic amyloidosis secondary to MM)
* Patients with prior history of hematologic or solid tumors treated with radiotherapy or chemotherapy(except ≥5 years);
* Patients who currently have hematologic tumors or solid tumors that require radiotherapy or chemotherapy;
* Non-signation of informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT06099912
Study Brief:
Protocol Section:
NCT06099912