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:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT04217967
Eligibility Criteria:
Inclusion Criteria:
1. Age older than 18 years;
2. Newly diagnosed MM patients who fulfill the diagnostic criteria of International Myeloma Working Group (IMWG) 2014 standard; transplant-ineligible or transplant eligible yet without intent for ASCT
3. Maintenance treatment will start after first-line treatment or second-line treatment;
4. The total courses of front-line regimens are between 4-9;
5. The clinical efficacy before the enrollment is partial response (PR) or better;
6. Physical performance status (ECOG) score ≤ 2;
7. Patients participate in the study based on his/her own will and voluntarily sign the informed consent form
Exclusion Criteria:
1. Patients who are allergic or intolerant to ixazomib or lenalidomide;
2. patients with severe cardiopulmonary dysfunction;
3. patients with severe hepatic insufficiency, ALT or bilirubin more than 2 times the upper limits of normal range;
4. patients with other malignancies (except for carcinoma in situ);
5. patients with serious bacterial or viral infections, such as HIV or HBV, HCV, etc.;
6. pregnant or lactating women;
7. can not be strictly contraceptive;
8. Psychiatric patients and patients with other serious mental illness that potentially impact signing informed consent and disease consultation and follow-up.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04217967
Study Brief:
Protocol Section:
NCT04217967