Ixazomib, Lenalidomide, and Combination for Maintenance in NDMM Patients (NCT04217967) | Clinical Trial Compass
CompletedPhase 4
Ixazomib, Lenalidomide, and Combination for Maintenance in NDMM Patients
China211 participantsStarted 2019-09-24
Plain-language summary
The purpose of this study is to evaluate the real-world efficacy and safety of ixazomib, lenalidomide, or ixazomib in combination with lenalidomide as maintenance therapy in patients with newly diagnosed multiple myeloma in China.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age older than 18 years;
. 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
. Maintenance treatment will start after first-line treatment or second-line treatment;
. The total courses of front-line regimens are between 4-9;
. The clinical efficacy before the enrollment is partial response (PR) or better;
. Physical performance status (ECOG) score ≤ 2;
. Patients participate in the study based on his/her own will and voluntarily sign the informed consent form
Exclusion criteria
. Patients who are allergic or intolerant to ixazomib or lenalidomide;
. patients with severe cardiopulmonary dysfunction;
. patients with severe hepatic insufficiency, ALT or bilirubin more than 2 times the upper limits of normal range;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
progression-free survival
Timeframe: From date of enrollment until the date of first documented progression, assessed up to 20 months
2
overall survival
Timeframe: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
. patients with other malignancies (except for carcinoma in situ);
. patients with serious bacterial or viral infections, such as HIV or HBV, HCV, etc.;
. pregnant or lactating women;
. can not be strictly contraceptive;
. Psychiatric patients and patients with other serious mental illness that potentially impact signing informed consent and disease consultation and follow-up.