Clinical trial · Interventional
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
- 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 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.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ixazomib | Drug | Ixazomib | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Lenalidomide group
- description
- lenalidomide 25mg qod d1\~21 days, rest 7 days
- interventionNames
- Drug: Lenalidomide
- type
- ACTIVE_COMPARATOR
- label
- Ixazomib group
- description
- ixazomib 4mg orally, once a week, 3 times a month
- interventionNames
- Drug: Ixazomib
- type
- EXPERIMENTAL
- label
- Combination group
- description
- ixazomib 4mg orally, once a week, 3 times a month lenalidomide 25mg qod d1\~21 days, rest 7 days use in combination
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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; transplant-ineligible or transplant eligible yet without intent for ASCT 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; 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.
References
Publications (7)
- BACKGROUNDPalumbo A, Anderson K. Multiple myeloma. N Engl J Med. 2011 Mar 17;364(11):1046-60. doi: 10.1056/NEJMra1011442. No abstract available. PMID 21410373
- BACKGROUNDJemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin. 2009 Jul-Aug;59(4):225-49. doi: 10.3322/caac.20006. Epub 2009 May 27. PMID 19474385
- BACKGROUNDAnderson KC. Progress and Paradigms in Multiple Myeloma. Clin Cancer Res. 2016 Nov 15;22(22):5419-5427. doi: 10.1158/1078-0432.CCR-16-0625. PMID 28151709
- BACKGROUNDGay F, Jackson G, Rosinol L, Holstein SA, Moreau P, Spada S, Davies F, Lahuerta JJ, Leleu X, Bringhen S, Evangelista A, Hulin C, Panzani U, Cairns DA, Di Raimondo F, Macro M, Liberati AM, Pawlyn C, Offidani M, Spencer A, Hajek R, Terpos E, Morgan GJ, Blade J, Sonneveld P, San-Miguel J, McCarthy PL, Ludwig H, Boccadoro M, Mateos MV, Attal M. Maintenance Treatment and Survival in Patients With Myeloma: A Systematic Review and Network Meta-analysis. JAMA Oncol. 2018 Oct 1;4(10):1389-1397. doi: 10.1001/jamaoncol.2018.2961. PMID 30098165
- BACKGROUNDDimopoulos MA, Gay F, Schjesvold F, Beksac M, Hajek R, Weisel KC, Goldschmidt H, Maisnar V, Moreau P, Min CK, Pluta A, Chng WJ, Kaiser M, Zweegman S, Mateos MV, Spencer A, Iida S, Morgan G, Suryanarayan K, Teng Z, Skacel T, Palumbo A, Dash AB, Gupta N, Labotka R, Rajkumar SV; TOURMALINE-MM3 study group. Oral ixazomib maintenance following autologous stem cell transplantation (TOURMALINE-MM3): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2019 Jan 19;393(10168):253-264. doi: 10.1016/S0140-6736(18)33003-4. Epub 2018 Dec 10. PMID 30545780
- BACKGROUNDChakraborty R, Muchtar E, Kumar SK, Buadi FK, Dingli D, Dispenzieri A, Hayman SR, Hogan WJ, Kapoor P, Lacy MQ, Leung N, Warsame R, Kourelis T, Gonsalves W, Gertz MA. Outcomes of maintenance therapy with lenalidomide or bortezomib in multiple myeloma in the setting of early autologous stem cell transplantation. Leukemia. 2018 Mar;32(3):712-718. doi: 10.1038/leu.2017.256. Epub 2017 Aug 14.