Clinical trial · Interventional
Study of Pomalidomide, Oral Dexamethasone and Ixazomib in Patients With Relapsed MM Who Have Received Lenalidomide
A Multi-center, Open-label, Single-arm Clinical Study of Ixazomib/Pomalidomide/Dexamethasone (IxaPD) in the Treatment of Patients With Relapsed Multiple Myeloma
NCT04989140CI-TRIAL-00053384unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drug: Ixazomib Drug:pomalidomide Drug:dexamethasone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IxaPD
- description
- Ixazomib 4 mg, capsules, orally, once on Days 1, 8 and 15 of every 28-day cycle , pomalidomide 25mg qd day 1\~21 of every 28-day cycle, Dexamethasone 40 mg (20 mg for patients \>75 years of age) was given on days 1, 8, 15, and 22 of every 28-day cycle.
- interventionNames
- Drug: Drug: Ixazomib Drug:pomalidomide Drug:dexamethasone
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- Time Frame: From date of enrollment until the date of first documented progression, assessed up to 24 months
- description
- From enrollment to first disease progression
Secondary outcomes (4)
- measure
- Adverse events assessment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.