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Lenalidomide is effective and safe for the treatment of patients with relapsed multiple myeloma and very severe renal impairment

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Abstract

Patients with multiple myeloma (MM) and severe renal impairment (SRI) have shorter survival than MM patients without renal failure. Although lenalidomide is a highly active drug, this immunomodulatory agent is frequently neglected in this context due to its predominant renal clearance and, consequently, an increased risk of toxicity. This risk might be overcome with the proper lenalidomide dose adjustment to renal function. This study evaluates the outcomes of 23 relapsed MM patients with SRI (baseline creatinine clearance (CrCl) <30 mL/min) treated with lenalidomide-dexamethasone (LenDex), including 56 % (13 patients) under hemodialysis. The median CrCl at start of LenDex was 19 mL/min; an overall response rate (partial response or better) of 56 % was obtained, with a median follow-up from start of LenDex of 52 months (8–79). The median time until maximal response was 4 months, and in 58 % (7/12), the response was longer than 2 years. Nine percent had renal improvement, but all the 13 patients on hemodialysis remained under treatment. LenDex was interrupted in three cases because of adverse events (infections and cutaneous events); 78 % of the patients were on thromboprophylaxis with aspirin. It is important to notice that, after initial dose adjustment of therapy, there should be a continuous process of dose adjustment, taking into account variations in renal function. Furthermore, lenalidomide dose adjustment should be made according to the individual tolerance, even with stable renal function. LenDex dose adjustment, according to these principles, does not negatively impact response and improves treatment tolerance. It has a clear potential to treat this group of patients and to induce long duration of responses [event-free survival (EFS) 20.5 m and overall survival (OS) 42.6 m].

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Authors and Affiliations

  1. Hemato-Oncology Unit, Champalimaud Centre for the Unknown, Lisboa, Portugal

    Cristina João & Paulo Lúcio

  2. Medical School, Faculdade de Ciências Médicas, Universidade NOVA de Lisboa, Lisbon, Portugal

    José Freitas

  3. Oncology Department, Hospital Fernando Fonseca, EPE, Amadora, Portugal

    Fernando Gomes

  4. Hematology Department, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal

    Catarina Geraldes

  5. Hematology Department, Instituto Português de Oncologia de Lisboa, Lisbon, Portugal

    Inês Coelho

  6. Hematology Department, Centro Hospitalar de Lisboa Norte, Lisbon, Portugal

    Manuel Neves & Graça V. Esteves

  7. Statistics and Clinical Research Unit, Instituto Português de Oncologia de Lisboa, Lisbon, Portugal

    Susana Esteves

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  1. Cristina João
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Correspondence to Cristina João.

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Conflict of interest

C.J. has received honoraria from Janssen, Celgene, Amgen, Gilead, and BMS and has served on the advisory boards of Celgene, Janssen, Roche, Amgen, and BMS. I.C. has received honoraria from Janssen and Gilead. M.N. has received honoraria from Janssen and Celgene and serves on the advisory board of Celgene. P.L. has received honoraria from and serves on the advisory boards of Janssen, Celgene, Amgen, and BMS. C.G. has received honoraria from and serves on the advisory boards of Janssen, Celgene, Amgen, and BMS. F.G. has received honoraria from Celgene. S.E. and J.F. declare no conflict of interests. G.E. has received honoraria from and serves on the advisory boards of Janssen, Celgene, Amgen, and BMS.

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João, C., Freitas, J., Gomes, F. et al. Lenalidomide is effective and safe for the treatment of patients with relapsed multiple myeloma and very severe renal impairment. Ann Hematol 95, 931–936 (2016). https://doi.org/10.1007/s00277-016-2662-6

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  • DOI: https://doi.org/10.1007/s00277-016-2662-6

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