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Second malignancies in the context of lenalidomide treatment: an analysis of 2732 myeloma patients enrolled to the Myeloma XI trial

Lookup NU author(s): Professor Graham Jackson



This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


We have carried out the largest randomised trial to date of newly diagnosed myeloma patients, in which lenalidomide has been used as an induction and maintenance treatment option and here report its impact on second primary malignancy (SPM) incidence and pathology. After review, 104 SPMs were confirmed in 96 of 2732 trial patients. The cumulative incidence of SPM was 0.7% (95% confidence interval (CI) 0.4-1.0%), 2.3% (95% CI 1.6-2.7%) and 3.8% (95% CI 2.9-4.6%) at 1, 2 and 3 years, respectively. Patients receiving maintenance lenalidomide had a significantly higher SPM incidence overall (P = 0.011). Age is a risk factor with the highest SPM incidence observed in transplant non-eligible patients aged >74 years receiving lenalidomide maintenance. The 3-year cumulative incidence in this group was 17.3% (95% CI 8.2-26.4%), compared with 6.5% (95% CI 0.2-12.9%) in observation only patients (P = 0.049). There was a low overall incidence of haematological SPM (0.5%). The higher SPM incidence in patients receiving lenalidomide maintenance therapy, especially in advanced age, warrants ongoing monitoring although the benefit on survival is likely to outweigh risk.

Publication metadata

Author(s): Jones JR, Cairns DA, Gregory WM, Collett C, Pawlyn C, Sigsworth R, Striha A, Henderson R, Kaiser MF, Jenner M, Cook G, Russell NH, Williams C, Pratt G, Kishore B, Lindsay J, Drayson MT, Davies FE, Boyd KD, Owen RG, Jackson GH, Morgan GJ, NCRI Haemato-Oncology CSG

Publication type: Article

Publication status: Published

Journal: Blood Cancer Journal

Year: 2016

Volume: 6

Print publication date: 01/12/2016

Acceptance date: 24/10/2016

Date deposited: 22/03/2017

ISSN (print): 2044-5385

Publisher: Nature Publishing Group


DOI: 10.1038/bcj.2016.114


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