Study of Pomalidomide, Oral Dexamethasone and Ixazomib in Patients With Relapsed MM Who Have Received Lenalidomide

• Status: Recruiting
• Trial end date: 2024-07-26
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of ixazomib, oral dexamethasone and in patients with relapsed multiple myeloma who have received lenalidomide.

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

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborators: Beijing Chao Yang Hospital; Beijing Hospital; Beijing Jishuitan Hospital; First Hospital of China Medical University; Peking University Third Hospital; Second Hospital of Shanxi Medical University; The First Affiliated Hospital of Anhui Medical University; The First Affiliated Hospital of Dalian Medical University; The First Affiliated Hospital of Zhengzhou University; The Second Affiliated Hospital of Harbin Medical University; Tianjin Medical University Cancer Institute and Hospital; Tianjin Medical University General Hospital
• Treatments: Dexamethasone; Ixazomib; Pomalidomide

Criteria

Inclusion Criteria:

1. Male or female patients 18 years of age or older;

2. Newly diagnosed MM patients who fulfill the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma (Revised in 2020) Standards;

3. Patients with relapsed MM who have received 1 to 3 prior therapies (including lenalidomide);

4. There must be a washout period of two weeks (14 days) from the last treatment (excluding dexamethasone treatment);

5. Previously untreated subjects with ixazomib or pomalidomide;

6. Subjects of childbearing age should take effective contraceptive measures and must agree to comply with all contraceptive requirements; Contraceptive requirements: women with fertility must decide to adopt two reliable contraceptive methods at the same time (a highly effective method of contraception-fallopian tube ligation, intrauterine contraceptive device, hormones (contraceptive pills, needles, patches, vaginal rings or implants) ) Or partner's vas deferens ligation, another effective contraceptive program-male rubber or synthetic condoms, diaphragm or cervical cap); unless the cause of hysterectomy, or a history of infertility in time, effective contraception is also required. Men must agree to use a latex condom during sexual contact with a Females of childbearing potential even if they have had a successful vasectomy;

7. Patients must have measurable disease defined by at least 1 of the following 3 measurements: Serum M-protein≥5 g/ L, Urine M-protein≥200 mg/24 hours, Serum free light chain assay: involved free light chain level≥100 mg/L, provided that the serum free light chain ratio is abnormal;

8. Hematology satisfies the following conditions: when myeloma cells are less than 50%, ANC≥1.0×109/L (including with the support of G-CSF) and PLT≥75×109/L; when myeloma cells are ≥50% , Any ANC and PLT≥50×109/L;

9. Must be able to take antithrombotic drugs, such as low molecular weight heparin sodium or aspirin;

10. Physical performance status (ECOG) score ≤ 2; Expected lifetime More than 3 months.

11. 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, pomalidomide or dexamethasone;

2. Patients who have used ixazomib or pomalidomide;

3. Patients who are resistant to bortezomib;

4. Patients with severe cardiopulmonary insufficiency;

5. Patients with severe liver and kidney dysfunction, ALT or AST or bilirubin exceeds 3 times the upper limit of normal range, and the creatinine clearance rate is less than 30 ml/min;

6. patients with other malignancies (except for carcinoma in situ);

7. patients with serious bacterial or viral infections, such as HIV or HBV, HCV, etc.;

8. Patients with active new thrombosis or unwilling to receive anti-thrombotic therapy;

9. Patients with extramedullary disease;

10. Patients with peripheral neuropathy ≥ Grade 3;

11. Pregnant or lactating women;

12. Can't strictly contraception;

13. Psychiatric patients and patients with other serious mental illness that potentially impact signing informed consent and disease consultation and follow-up;

14. Patients who have participated in other clinical trials within one month.