Ixazomib, Lenalidomide, and Combination for Maintenance in NDMM Patients

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborators: Beijing Chao Yang Hospital; Beijing Jishuitan Hospital; Jilin Provincial Tumor Hospital; Peking University First Hospital; Peking University Third Hospital; Shanxi Dayi Hospital; Xuanwu Hospital, Beijing
• Treatments: Glycine; Ixazomib; Lenalidomide

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;

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. Autologous transplantation is considered as consolidation treatment;

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.