Low-dose lenalidomide and dexamethasone therapy after melphalan-prednisolone induction in elderly patients with newly di
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ORIGINAL ARTICLE
Low-dose lenalidomide and dexamethasone therapy after melphalan-prednisolone induction in elderly patients with newly diagnosed multiple myeloma Yasushi Onishi 1 & Hisayuki Yokoyama 1,2 & Yuna Katsuoka 2 & Toshihiro Ito 2 & Tomohumi Kimura 3 & Joji Yamamoto 4 & Shinji Nakajima 5 & Osamu Sasaki 6 & Takahide Ara 7 & Koichiro Minauchi 7 & Osamu Fukuhara 8 & Naoki Kobayashi 7 & Hideyoshi Noji 9 & Shuichi Ota 7 & Hideo Harigae 1 Received: 2 August 2020 / Accepted: 26 August 2020 # Springer-Verlag GmbH Germany, part of Springer Nature 2020
Abstract Lenalidomide (Len) and dexamethasone (dex) therapy is a standard therapy in patients with multiple myeloma. Elderly or unfit patients may reduce Len or dex doses to prevent toxicities that lead to treatment discontinuation. However, there have been few studies evaluating the efficacy and safety of lower doses of Len and dex. We conducted a phase II study of 1.5-year low-dose Len and dex therapy following melphalan and prednisolone (MP), the number of which cycles was determined by a response within 9 cycles. The Len dose was 10 mg daily and the dex dose was 20 mg weekly, which were continued for 1.5 years. Twenty-one patients were enrolled. The median number of cycles of MP was 3 (range, 2–9). The overall response rate was 81% and a very good partial response or better was achieved in 33.3% of patients. The median follow-up time for survivors was 70.5 months (range, 42–83 months), the median progression-free survival (PFS) was 27 months (95% CI, 21–33 months), and the median overall survival was not reached. Grade 3 or 4 adverse events were observed in 28.6% of patients. In conclusion, the low-dose Len and dex therapy safely achieved comparable efficacies to the standard-dose regimen in elderly patients with newly diagnosed multiple myeloma. UMIN000007889. Keywords Multiple myeloma . Low-dose lenalidomide . Melphalan . Transplant-ineligible . Elderly
Introduction Lenalidomide (Len) is a key drug for the treatment of multiple myeloma. The combination of Len at a standard dose of 25 mg and low-dose dexamethasone (dex) is a recommended first-line therapy in transplant-ineligible patients with multiple myeloma [1, 2]. Elderly or unfit
* Yasushi Onishi [email protected] 1
2
Department of Hematology and Rheumatology, Tohoku University Hospital, 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-857, Japan Department of Hematology, Sendai Medical Center, National Hospital Organization, Sendai, Miyagi, Japan
3
Department of Hematology, Suihu Hospital, Ibaraki, Japan
4
Department of Hematology, Sendai City Hospital, Sendai, Miyagi, Japan
patients are susceptible to adverse events, and dose reduction of Len or dex is often required [3–5]. However, the optimal dose of Len for elderly or unfit patients has not been determined because clinical trials did not fully cover these populations and there have been few prospective studies evaluating the efficacy and safety of low-dose Len and dex (low-dose Len/dex) therapy.
5
Department of Hematology, Japanese Red C
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