drugset / Trial / NCT04217967
Ixazomib, Lenalidomide, and Combination for Maintenance in NDMM Patients
Phase 4
Completed
211 enrolled
Peking Union Medical College Hospital
Beijing Chao Yang Hospital · collabBeijing Hospital · collabBeijing Jishuitan Hospital · collabJilin Provincial Tumor Hospital · collabPeking University First Hospital · collabPeking University Third Hospital · collabSecond Hospital of Shanxi Medical University · collabShanxi Bethune Hospital · collabThe First Affiliated Hospital of Anhui Medical University · collabThe First Affiliated Hospital of Shanxi Medical University · collabTianjin Medical University General Hospital · collabXuanwu Hospital, Beijing · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2019-09-24
- Primary completion
- 2024-06-30
- Completion
- 2024-06-30
Publications
- Background Palumbo A, Anderson K. Multiple myeloma. N Engl J Med. 2011 Mar 17;364(11):1046-60. doi: 10.1056/NEJMra1011442. No abstract available.
- Background Jemal 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.
- Background Anderson 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.
- Background Gay 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.
- Background Dimopoulos 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.
- Background Chakraborty 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.
- Background Kumar SK, Berdeja JG, Niesvizky R, Lonial S, Laubach JP, Hamadani M, Stewart AK, Hari P, Roy V, Vescio R, Kaufman JL, Berg D, Liao E, Rajkumar SV, Richardson PG. Ixazomib, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma: long-term follow-up including ixazomib maintenance. Leukemia. 2019 Jul;33(7):1736-1746. doi: 10.1038/s41375-019-0384-1. Epub 2019 Jan 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ixazomib | Unknown | 4 mg | Oral |
| Subject | Lenalidomide | Other / unclassified | 25 mg | Oral |