A noninterventional observational registry of patients with multiple myeloma treated with lenalidomide in Taiwan

Shang Yi Huang, Yuan Bin Yu, Su Peng Yeh, Tsai Yun Chen, Woei Yau Kao, Chih Cheng Chen, Ming Chung Wang, Hsuan Yu Lin, Sheng Fung Lin, Tseng Hsi Lin, Ye Hua, Marie Puccio-Pick, Dena DeMarco, Christian Jacques, Po Dunn

Research output: Contribution to journalArticle

Abstract

Background/Purpose The incidence of multiple myeloma in Asia has risen in the past 30 years. Lenalidomide, an IMiD immunomodulatory agent, has improved the overall survival in patients with relapsed/refractory multiple myeloma (RRMM) when used with dexamethasone versus dexamethasone alone. This observational registry (T-CC-MM-009; NCT01752075) assessed the safety and efficacy of lenalidomide plus dexamethasone in a large Chinese population of patients with RRMM. Methods This registry followed the first 100 patients treated with lenalidomide plus dexamethasone in Taiwan. Patients were ≥18 years old and had ≥1 prior treatment. The recommended starting dose for the first four 28-day cycles was 25 mg lenalidomide on days 1–21 and 40 mg dexamethasone on days 1–4, 9–12, and 17–20. Thereafter, dexamethasone was given on days 1–4 only. The primary objective was safety; secondary objectives were efficacy, lenalidomide dosage, and reasons for discontinuation. Results The median duration of treatment was 34.6 weeks, and 75.5% completed ≥3 cycles. Most patients (82.7%) experienced ≥1 treatment-related adverse event; the most commonly reported were neutropenia (23.5%), thrombocytopenia (19.4%), anemia (16.3%), fatigue (16.3%), and hypoesthesia (15.3%). Bleeding events (25.5% of patients) were mostly grade 1/2 (80%). Three patients (3%) had venous thromboembolic events. Two invasive second primary malignancies were reported; however, time to onset was <1 year, suggesting they may not be related to lenalidomide. The overall response rate was 34.7%; median time to disease progression was 20.5 months. Conclusion These data confirm the safety and efficacy of lenalidomide plus dexamethasone for patients with RRMM in Taiwan.

Original languageEnglish
Pages (from-to)705-710
Number of pages6
JournalJournal of the Formosan Medical Association
Volume116
Issue number9
DOIs
Publication statusPublished - 2017 Sep

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Multiple Myeloma
Taiwan
Registries
Dexamethasone
Safety
Second Primary Neoplasms
Hypesthesia
lenalidomide
Neutropenia
Thrombocytopenia
Fatigue
Disease Progression
Anemia
Therapeutics
Hemorrhage
Survival
Incidence
Population

All Science Journal Classification (ASJC) codes

  • Medicine(all)

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Huang, Shang Yi ; Yu, Yuan Bin ; Yeh, Su Peng ; Chen, Tsai Yun ; Kao, Woei Yau ; Chen, Chih Cheng ; Wang, Ming Chung ; Lin, Hsuan Yu ; Lin, Sheng Fung ; Lin, Tseng Hsi ; Hua, Ye ; Puccio-Pick, Marie ; DeMarco, Dena ; Jacques, Christian ; Dunn, Po. / A noninterventional observational registry of patients with multiple myeloma treated with lenalidomide in Taiwan. In: Journal of the Formosan Medical Association. 2017 ; Vol. 116, No. 9. pp. 705-710.
@article{8497193d82e1416296fe73bc093f926c,
title = "A noninterventional observational registry of patients with multiple myeloma treated with lenalidomide in Taiwan",
abstract = "Background/Purpose The incidence of multiple myeloma in Asia has risen in the past 30 years. Lenalidomide, an IMiD immunomodulatory agent, has improved the overall survival in patients with relapsed/refractory multiple myeloma (RRMM) when used with dexamethasone versus dexamethasone alone. This observational registry (T-CC-MM-009; NCT01752075) assessed the safety and efficacy of lenalidomide plus dexamethasone in a large Chinese population of patients with RRMM. Methods This registry followed the first 100 patients treated with lenalidomide plus dexamethasone in Taiwan. Patients were ≥18 years old and had ≥1 prior treatment. The recommended starting dose for the first four 28-day cycles was 25 mg lenalidomide on days 1–21 and 40 mg dexamethasone on days 1–4, 9–12, and 17–20. Thereafter, dexamethasone was given on days 1–4 only. The primary objective was safety; secondary objectives were efficacy, lenalidomide dosage, and reasons for discontinuation. Results The median duration of treatment was 34.6 weeks, and 75.5{\%} completed ≥3 cycles. Most patients (82.7{\%}) experienced ≥1 treatment-related adverse event; the most commonly reported were neutropenia (23.5{\%}), thrombocytopenia (19.4{\%}), anemia (16.3{\%}), fatigue (16.3{\%}), and hypoesthesia (15.3{\%}). Bleeding events (25.5{\%} of patients) were mostly grade 1/2 (80{\%}). Three patients (3{\%}) had venous thromboembolic events. Two invasive second primary malignancies were reported; however, time to onset was <1 year, suggesting they may not be related to lenalidomide. The overall response rate was 34.7{\%}; median time to disease progression was 20.5 months. Conclusion These data confirm the safety and efficacy of lenalidomide plus dexamethasone for patients with RRMM in Taiwan.",
author = "Huang, {Shang Yi} and Yu, {Yuan Bin} and Yeh, {Su Peng} and Chen, {Tsai Yun} and Kao, {Woei Yau} and Chen, {Chih Cheng} and Wang, {Ming Chung} and Lin, {Hsuan Yu} and Lin, {Sheng Fung} and Lin, {Tseng Hsi} and Ye Hua and Marie Puccio-Pick and Dena DeMarco and Christian Jacques and Po Dunn",
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Huang, SY, Yu, YB, Yeh, SP, Chen, TY, Kao, WY, Chen, CC, Wang, MC, Lin, HY, Lin, SF, Lin, TH, Hua, Y, Puccio-Pick, M, DeMarco, D, Jacques, C & Dunn, P 2017, 'A noninterventional observational registry of patients with multiple myeloma treated with lenalidomide in Taiwan', Journal of the Formosan Medical Association, vol. 116, no. 9, pp. 705-710. https://doi.org/10.1016/j.jfma.2016.11.005

A noninterventional observational registry of patients with multiple myeloma treated with lenalidomide in Taiwan. / Huang, Shang Yi; Yu, Yuan Bin; Yeh, Su Peng; Chen, Tsai Yun; Kao, Woei Yau; Chen, Chih Cheng; Wang, Ming Chung; Lin, Hsuan Yu; Lin, Sheng Fung; Lin, Tseng Hsi; Hua, Ye; Puccio-Pick, Marie; DeMarco, Dena; Jacques, Christian; Dunn, Po.

In: Journal of the Formosan Medical Association, Vol. 116, No. 9, 09.2017, p. 705-710.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A noninterventional observational registry of patients with multiple myeloma treated with lenalidomide in Taiwan

AU - Huang, Shang Yi

AU - Yu, Yuan Bin

AU - Yeh, Su Peng

AU - Chen, Tsai Yun

AU - Kao, Woei Yau

AU - Chen, Chih Cheng

AU - Wang, Ming Chung

AU - Lin, Hsuan Yu

AU - Lin, Sheng Fung

AU - Lin, Tseng Hsi

AU - Hua, Ye

AU - Puccio-Pick, Marie

AU - DeMarco, Dena

AU - Jacques, Christian

AU - Dunn, Po

PY - 2017/9

Y1 - 2017/9

N2 - Background/Purpose The incidence of multiple myeloma in Asia has risen in the past 30 years. Lenalidomide, an IMiD immunomodulatory agent, has improved the overall survival in patients with relapsed/refractory multiple myeloma (RRMM) when used with dexamethasone versus dexamethasone alone. This observational registry (T-CC-MM-009; NCT01752075) assessed the safety and efficacy of lenalidomide plus dexamethasone in a large Chinese population of patients with RRMM. Methods This registry followed the first 100 patients treated with lenalidomide plus dexamethasone in Taiwan. Patients were ≥18 years old and had ≥1 prior treatment. The recommended starting dose for the first four 28-day cycles was 25 mg lenalidomide on days 1–21 and 40 mg dexamethasone on days 1–4, 9–12, and 17–20. Thereafter, dexamethasone was given on days 1–4 only. The primary objective was safety; secondary objectives were efficacy, lenalidomide dosage, and reasons for discontinuation. Results The median duration of treatment was 34.6 weeks, and 75.5% completed ≥3 cycles. Most patients (82.7%) experienced ≥1 treatment-related adverse event; the most commonly reported were neutropenia (23.5%), thrombocytopenia (19.4%), anemia (16.3%), fatigue (16.3%), and hypoesthesia (15.3%). Bleeding events (25.5% of patients) were mostly grade 1/2 (80%). Three patients (3%) had venous thromboembolic events. Two invasive second primary malignancies were reported; however, time to onset was <1 year, suggesting they may not be related to lenalidomide. The overall response rate was 34.7%; median time to disease progression was 20.5 months. Conclusion These data confirm the safety and efficacy of lenalidomide plus dexamethasone for patients with RRMM in Taiwan.

AB - Background/Purpose The incidence of multiple myeloma in Asia has risen in the past 30 years. Lenalidomide, an IMiD immunomodulatory agent, has improved the overall survival in patients with relapsed/refractory multiple myeloma (RRMM) when used with dexamethasone versus dexamethasone alone. This observational registry (T-CC-MM-009; NCT01752075) assessed the safety and efficacy of lenalidomide plus dexamethasone in a large Chinese population of patients with RRMM. Methods This registry followed the first 100 patients treated with lenalidomide plus dexamethasone in Taiwan. Patients were ≥18 years old and had ≥1 prior treatment. The recommended starting dose for the first four 28-day cycles was 25 mg lenalidomide on days 1–21 and 40 mg dexamethasone on days 1–4, 9–12, and 17–20. Thereafter, dexamethasone was given on days 1–4 only. The primary objective was safety; secondary objectives were efficacy, lenalidomide dosage, and reasons for discontinuation. Results The median duration of treatment was 34.6 weeks, and 75.5% completed ≥3 cycles. Most patients (82.7%) experienced ≥1 treatment-related adverse event; the most commonly reported were neutropenia (23.5%), thrombocytopenia (19.4%), anemia (16.3%), fatigue (16.3%), and hypoesthesia (15.3%). Bleeding events (25.5% of patients) were mostly grade 1/2 (80%). Three patients (3%) had venous thromboembolic events. Two invasive second primary malignancies were reported; however, time to onset was <1 year, suggesting they may not be related to lenalidomide. The overall response rate was 34.7%; median time to disease progression was 20.5 months. Conclusion These data confirm the safety and efficacy of lenalidomide plus dexamethasone for patients with RRMM in Taiwan.

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