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Ann Hematol. 2020 Feb;99(2):309-319. doi: 10.1007/s00277-019-03904-7. Epub 2019 Dec 23.

The effectiveness and safety of lenalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma in real-world clinical practice: a study of the Korean Multiple Myeloma Working Party (KMMWP-151 study).

Author information

1
Department of Hematology and Oncology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.
2
Department of Internal Medicine, Kosin University College of Medicine, Busan, South Korea.
3
Department of Medicine, Samsung Medical Center, Sunkyunkwan University School of Medicine, Seoul, South Korea.
4
Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, Hwasun, Jeollanamdo, South Korea.
5
Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.
6
Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
7
Division of Hematology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
8
Department of Internal Medicine, National Cancer Center of Korea, Goyang, South Korea.
9
Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
10
Department of Hematology/Oncology, Kyungpook National University Hospital, Daegu, South Korea.
11
Department of Internal Medicine, Pusan National University Hospital, Busan, South Korea.
12
Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.
13
Department of Internal Medicine, Busan Paik Hospital, Busan, South Korea.
14
Department of Hemato-Oncology, Keimyung University Dongsan Medical Center, Daegu, South Korea.
15
Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, South Korea.
16
Division of Hematology-Oncology, Department of Internal Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, South Korea.
17
Department of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, South Korea.
18
Department of Internal Medicine, Dong-A Medical Center, Dong-A University College of Medicine, Busan, South Korea.
19
Department of Medicine, Yeungnam University College of Medicine, Daegu, South Korea.
20
Department of Internal Medicine, Haeundae Baek Hospital, Busan, South Korea.
21
Division of Hematology-Oncology, Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, South Korea.
22
Department of Hematology/Oncology, Soonchunhyang University Bucheon Hospital, Bucheon, South Korea.
23
Division of Hematology-Oncology, Department of Medicine, Chung-Ang University, Seoul, South Korea.
24
Department of Internal Medicine, Gachon University Gil Hospital, Incheon, South Korea.
25
Department of Biostatistics, Clinical Trial Center, Biomedical Research Institute, Pusan National University Hospital, Busan, South Korea.
26
Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 505, Banpo-dong, Seocho-gu, Seoul, 137-701, South Korea. ckmin@catholic.ac.kr.

Abstract

Although lenalidomide plus dexamethasone (RD) is a therapeutic option for relapsed/refractory multiple myeloma (RRMM), limited real-world clinical data exist. The purpose of this study was to estimate efficacy and safety of RD in RRMM patients of the clinical practice. Data from patients at 25 university hospitals in South Korea between October 2009 and December 2016 were collected retrospectively. We report the effectiveness and safety of RD in 546 RRMM patients in routine clinical practice in South Korea. Patients (median age, 65 years) typically received median 7 cycles of RD, and 184 (33.7%) patients were treated with 10 or more cycles of RD. Patients with renal impairment (CLCr < 40 mL/min; 10.4%), comorbid conditions (≥ 2; 12.0%), and poor performance status (≥ 2; 25.1%) were included. The overall response rate was 64.2%: complete response (13.1%), very good partial response (VGPR 19.9%). With median follow-up duration of 18.6 months, median PFS and OS were 11.2 months and 25.2 months, respectively. In multivariate analysis, less than 2 comorbid conditions, normal LDH, failed one chemotherapy prior to RD, and ≥ 10 cycles of RD therapy had significantly prolonged PFS (P = 0.007, P = 0.011, P = 0.007, and P < 0.001, respectively). Adverse events were acceptable. RD is effective and safe in real-life clinical practice, including patients with comorbidities. RD is an effective and safe treatment in a real clinical setting which includes patients with comorbidities. Early and continual use of RD treatment may improve RRMM survival outcomes.

KEYWORDS:

Effectiveness; Lenalidomide plus dexamethasone; Multiple myeloma; Real-world evidence; Survival

PMID:
31872360
DOI:
10.1007/s00277-019-03904-7
[Indexed for MEDLINE]

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