Use of Thalidomide, Lenalidomide, Carfilzomib, Bortezomib and Vorinostat in the Initial Treatment of Newly Diagnosed Multiple Myeloma Patients
Summary
The purpose of this study is to compare a standard chemotherapy regimen of cyclophosphamide, dexamethasone plus thalidomide with a newer regimen of cyclophosphamide, dexamethasone plus lenalidomide with or without carfilzomib. Patients who do not have the best response to their initial treatment may then also be given a combination of cyclophosphamide, dexamethasone plus bortezomib. Patients who are relatively fit may, on their doctor's advice, go on to receive more intensive chemotherapy, supported with a transplant of their own blood cells. This is standard treatment which patients may be offered anyway even if they didn't take part in this study. After maximal response has been achieved with the treatment described above, and as long as the myeloma has not got worse, patients will be treated with either long-term lenalidomide, lenalidomide with vorinostat, or receive no further treatment, with close observation.
Timeline
- Start
- 2010-05
- Primary completion
- 2021-12
- Completion
- 2022-12
Publications
- Beer SA, Cairns DA, Pawlyn C, Holroyd A, Ferris E, Cook G, Drayson M, Boyd K, Proszek P, Davies FE, de Tute R, Jenner M, Morgan GJ, Owen R, Hubank M, Houlston R, Jackson G, Kaiser MF. Challenging the concept of functional high-risk myeloma through transcriptional and genetic profiling. Blood. 2025 Nov 27;146(22):2670-2680. doi: 10.1182/blood.2025029987.
- Agbuduwe C, Iqbal G, Cairns D, Menzies T, Dunn J, Gregory W, Kaiser M, Owen R, Pawlyn C, Child JA, Davies F, Morgan GJ, Jackson GH, Drayson MT, Basu S. Clinical characteristics and outcomes of IgD myeloma: experience across UK national trials. Blood Adv. 2022 Sep 13;6(17):5113-5123. doi: 10.1182/bloodadvances.2022007608.
- de Tute RM, Pawlyn C, Cairns DA, Davies FE, Menzies T, Rawstron A, Jones JR, Hockaday A, Henderson R, Cook G, Drayson MT, Jenner MW, Kaiser MF, Gregory WM, Morgan GJ, Jackson GH, Owen RG. Minimal Residual Disease After Autologous Stem-Cell Transplant for Patients With Myeloma: Prognostic Significance and the Impact of Lenalidomide Maintenance and Molecular Risk. J Clin Oncol. 2022 Sep 1;40(25):2889-2900. doi: 10.1200/JCO.21.02228. Epub 2022 Apr 4.
- Walker BA, Boyle EM, Wardell CP, Murison A, Begum DB, Dahir NM, Proszek PZ, Johnson DC, Kaiser MF, Melchor L, Aronson LI, Scales M, Pawlyn C, Mirabella F, Jones JR, Brioli A, Mikulasova A, Cairns DA, Gregory WM, Quartilho A, Drayson MT, Russell N, Cook G, Jackson GH, Leleu X, Davies FE, Morgan GJ. Mutational Spectrum, Copy Number Changes, and Outcome: Results of a Sequencing Study of Patients With Newly Diagnosed Myeloma. J Clin Oncol. 2015 Nov 20;33(33):3911-20. doi: 10.1200/JCO.2014.59.1503. Epub 2015 Aug 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bortezomib | Small molecule | 1.3 mg/m2 | Subcutaneous |
| Comparator | Carfilzomib | Other / unclassified | 36 mg/m2 | Intravenous |
| Comparator | Cyclophosphamide | Other / unclassified | 500 mg | Oral |
| Comparator | Dexamethasone | Small molecule | 20 mg | Oral |
| Comparator | Dexamethasone | Small molecule | 40 mg | Oral |
| Comparator | Lenalidomide | Other / unclassified | 10 mg | Oral |
| Comparator | Lenalidomide | Other / unclassified | 25 mg | Oral |
| Comparator | Thalidomide | Other / unclassified | 200 mg | Oral |
| Comparator | Vorinostat | Small molecule | 300 mg | Oral |
| Comparator | Melphalan | Small molecule | — | — |