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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)

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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.

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Abbreviations

RD:

lenalidomide plus dexamethasone

RRMM:

relapsed/refractory multiple myeloma

ORR:

overall response rate

TTP:

the time to disease progression

ASCT:

autologous stem cell transplantation

CR:

complete response

VGPR:

very good partial response

PR:

partial response

MR:

minimal response

SD:

stable disease

PD:

progressive disease

PFS:

progression-free survival

OS:

overall survival

ISS:

International Staging System

MM:

multiple myeloma

AE:

adverse event

ECOG:

performance status

VMP:

bortezomib, melphalan, and prednisolone

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Acknowledgments

The authors would like to thank all the researchers and research nurses who worked on data collection. This manuscript was edited by native English-speaking experts from eWorldEditing, Eugene, OR, USA.

Funding

The study was supported by Celgene Corporation.

Author information

Author notes

  1. Jae-Cheol Jo and Ho Sup Lee contributed equally to this work.

Authors and Affiliations

  1. Department of Hematology and Oncology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea

    Jae-Cheol Jo & Yoojin Lee

  2. Department of Internal Medicine, Kosin University College of Medicine, Busan, South Korea

    Ho Sup Lee

  3. Department of Medicine, Samsung Medical Center, Sunkyunkwan University School of Medicine, Seoul, South Korea

    Kihyun Kim

  4. Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, Hwasun, Jeollanamdo, South Korea

    Je-Jung Lee

  5. Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea

    Sung-Soo Yoon

  6. Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea

    Soo-Mee Bang

  7. Division of Hematology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea

    Jin Seok Kim

  8. Department of Internal Medicine, National Cancer Center of Korea, Goyang, South Korea

    Hyeon-Seok Eom

  9. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea

    Dok Hyun Yoon

  10. Department of Hematology/Oncology, Kyungpook National University Hospital, Daegu, South Korea

    Yoojin Lee

  11. Department of Internal Medicine, Pusan National University Hospital, Busan, South Korea

    Ho-Jin Shin

  12. Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea

    Yong Park

  13. Department of Internal Medicine, Busan Paik Hospital, Busan, South Korea

    Won Sik Lee

  14. Department of Hemato-Oncology, Keimyung University Dongsan Medical Center, Daegu, South Korea

    Young Rok Do

  15. Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, South Korea

    Yeung-Chul Mun

  16. Division of Hematology-Oncology, Department of Internal Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, South Korea

    Mark Hong Lee

  17. Department of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, South Korea

    Hyo Jung Kim

  18. Department of Internal Medicine, Dong-A Medical Center, Dong-A University College of Medicine, Busan, South Korea

    Sung-Hyun Kim

  19. Department of Medicine, Yeungnam University College of Medicine, Daegu, South Korea

    Min Kyoung Kim

  20. Department of Internal Medicine, Haeundae Baek Hospital, Busan, South Korea

    Sung-Nam Lim

  21. Division of Hematology-Oncology, Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, South Korea

    Su-Hee Cho

  22. Department of Hematology/Oncology, Soonchunhyang University Bucheon Hospital, Bucheon, South Korea

    Seong Kyu Park

  23. Division of Hematology-Oncology, Department of Medicine, Chung-Ang University, Seoul, South Korea

    Jun Ho Yi

  24. Department of Internal Medicine, Gachon University Gil Hospital, Incheon, South Korea

    Jae Hoon Lee

  25. Department of Biostatistics, Clinical Trial Center, Biomedical Research Institute, Pusan National University Hospital, Busan, South Korea

    Jinmi Kim

  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

    Chang-Ki Min

Authors
  1. Jae-Cheol Jo
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  2. Ho Sup Lee
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  3. Kihyun Kim
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  15. Yeung-Chul Mun
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  26. Chang-Ki Min
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Consortia

the Korean Multiple Myeloma Working Party (KMMWP)

Contributions

All authors had access to primary clinical trial data. This study was planned and led by Chang-Ki Min, written by Jae-Cheol Jo and Ho Sup Lee, and analyzed statistically by Jinmi Kim. Patient information was provided by the many investigators of the KMMWP. All authors were involved in manuscript preparation, which was led by Jae-Cheol Jo, Ho Sup Lee, and Chang-Ki Min, and approval of the final version of the manuscript.

Corresponding author

Correspondence to Chang-Ki Min.

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Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

The study was approved by the institutional review board (IRB approval number 2015-08-011) of Kosin University Gospel Hospital and conducted in full compliance with good clinical practice as defined under Ministry of Food and Drug Safety regulations and the International Conference on Harmonization (ICH) guidelines. This study was a retrospective study using only patient hospital information and, as such, it was granted IRB approval for exemption with regard to informed consent. For this type of study, formal consent is not required.

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Jo, JC., Lee, H.S., Kim, K. et al. 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). Ann Hematol 99, 309–319 (2020). https://doi.org/10.1007/s00277-019-03904-7

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