NCT04217967CompletedPhase 4
Ixazomib, Lenalidomide, and Combination for Maintenance in NDMM Patients
A Multicenter, Open-label, Prospective Study of Ixazomib, Lenalidomide, and Ixazomib in Combination With Lenalidomide for Maintenance Therapy in Patients With Newly Diagnosed Multiple Myeloma
Source: ClinicalTrials.gov · Last updated 1 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 211 (actual)
- First submitted
- 1 Jan 2020
- Start date
- 24 Sept 2019
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- Peking Union Medical College Hospital
- Diseases
- Multiple myeloma
- NCT number
- NCT04217967
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 211
- From 24 Sept 2019 to the primary completion date, 30 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients who are allergic or intolerant to ixazomib or lenalidomide;
- patients with other malignancies (except for carcinoma in situ);
- patients with serious bacterial or viral infections, such as HIV or HBV, HCV, etc.;
- Psychiatric patients and patients with other serious mental illness that potentially impact signing informed consent and disease consultation and follow-up.
Lab values
- patients with severe hepatic insufficiency, ALT or bilirubin more than 2 times the upper limits of normal range;
Other
- patients with severe cardiopulmonary dysfunction;
- pregnant or lactating women;
- can not be strictly contraceptive;
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| PekingUMCH Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.