POST-AUTHORIZATION SAFETY OF LENALIDOMIDE + DEXAMETHASONE IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA: EARLY SAFETY REPORT OF TURKISH PASS STUDY
(Abstract release date: 05/21/15)
EHA Library. Tuglular T. 06/12/15; 102730; PB1859
Disclosure(s): Marmara University Medical Faculty Pendik Training and Research HospitalDepartment of Internal Medicine Division of Hematology
Tulin Tuglular
Contributions
Contributions
Abstract
Abstract: PB1859
Type: Publication Only
Background
Prognosis of patients with multiple myeloma (MM) has improved with the use of novel agents in the past decade. The data on real-world safety of these agents is limited. Following its regulatory approval in 2010, lenalidomide is now commonly used in the relapsed/refractory multiple myeloma (RRMM) setting in Turkey.
Aims
This post-authorization observational study is designed to define the safety profile of lenalidomide + dexamethasone therapy under routine real-world clinical practice by characterizing and identifying the incidence of adverse events (AE) of special interest in RRMM patients in Turkey.
Methods
Patients aged ≥18 years with RRMM and started on lenalidomide + dexamethasone treatment were included in the study. Patients who had previously received lenalidomide and discontinued or who had a treatment interruption for ≥4 weeks were excluded from the study. Thromboprophylaxis was allowed but not required. AEs were graded according to NCI-CTCAE (version 4.03) grading.
Results
As of January 30, 2015, 119 patients across 24 institutions in Turkey were enrolled. Of those, results of 111 patients with available data are going to be presented in this early safety report. Median follow-up was 19.9 weeks (range, 1.4–56.4). Median age was 62 years (range, 29–85) and 56.8% were male. Among 98 of the patients whose ECOG status were recorded at entry, 81 (82.7%) had good performance status (ECOG score 0–1) and 17 (17.3%) had an ECOG score of 2–4. Median number of prior therapies was two (29.7% had one prior therapy, 53.2% had two prior therapies and 17.1% had ≥3 prior therapies). Fifty-four (48.6%) patients had received autologous stem cell transplantation. The overall incidence of peripheral neuropathy at the baseline was 30.6%. Starting dose of lenalidomide was 25 mg in 85 (76.6%) patients, while 15 mg, 10 mg, and 5 mg were the initial dose in 10 (9.0%), 11 (9.9%), and 5 (4.5%) patients, respectively. Dose modifications were required in 13 (11.7%) patients. Prophylaxis for thromboembolism was performed in total of 37 (33.3%) patients with aspirin (n=21), heparin (n=15) and warfarin (n=1). Overall, 46 Grade 3-4 AEs were observed in 41 (%36.9) patients and 70 (63.1%) patients were free of Grade 3-4 AEs. Grade 3–4 neutropenia, pneumonia, anemia, and thrombocytopenia developed in 8.1%, 5.4%, 3.6%, and 1.8% of patients, respectively. VTE was reported only in one patient (Grade 2). Among 111 patients, 69 (62.2%) are still receiving lenalidomide + dexamethasone while 42 (37.8%) patients discontinued treatment (AEs : 12 [10.8%], death: 10 [9.0%], progression: 6 [5.4%], and other reasons: 14 [%12.6]). No second primary malignancy was reported.
Summary
Early safety data confirmed known AEs of lenalidomide plus dexamethasone therapy in RRMM patients in Turkey. Longer-term follow-up of AEs in this study will provide better characterization of AEs.
Keyword(s): Multiple myeloma, Refractory, Relapse, Safety
Session topic: Publication Only
Type: Publication Only
Background
Prognosis of patients with multiple myeloma (MM) has improved with the use of novel agents in the past decade. The data on real-world safety of these agents is limited. Following its regulatory approval in 2010, lenalidomide is now commonly used in the relapsed/refractory multiple myeloma (RRMM) setting in Turkey.
Aims
This post-authorization observational study is designed to define the safety profile of lenalidomide + dexamethasone therapy under routine real-world clinical practice by characterizing and identifying the incidence of adverse events (AE) of special interest in RRMM patients in Turkey.
Methods
Patients aged ≥18 years with RRMM and started on lenalidomide + dexamethasone treatment were included in the study. Patients who had previously received lenalidomide and discontinued or who had a treatment interruption for ≥4 weeks were excluded from the study. Thromboprophylaxis was allowed but not required. AEs were graded according to NCI-CTCAE (version 4.03) grading.
Results
As of January 30, 2015, 119 patients across 24 institutions in Turkey were enrolled. Of those, results of 111 patients with available data are going to be presented in this early safety report. Median follow-up was 19.9 weeks (range, 1.4–56.4). Median age was 62 years (range, 29–85) and 56.8% were male. Among 98 of the patients whose ECOG status were recorded at entry, 81 (82.7%) had good performance status (ECOG score 0–1) and 17 (17.3%) had an ECOG score of 2–4. Median number of prior therapies was two (29.7% had one prior therapy, 53.2% had two prior therapies and 17.1% had ≥3 prior therapies). Fifty-four (48.6%) patients had received autologous stem cell transplantation. The overall incidence of peripheral neuropathy at the baseline was 30.6%. Starting dose of lenalidomide was 25 mg in 85 (76.6%) patients, while 15 mg, 10 mg, and 5 mg were the initial dose in 10 (9.0%), 11 (9.9%), and 5 (4.5%) patients, respectively. Dose modifications were required in 13 (11.7%) patients. Prophylaxis for thromboembolism was performed in total of 37 (33.3%) patients with aspirin (n=21), heparin (n=15) and warfarin (n=1). Overall, 46 Grade 3-4 AEs were observed in 41 (%36.9) patients and 70 (63.1%) patients were free of Grade 3-4 AEs. Grade 3–4 neutropenia, pneumonia, anemia, and thrombocytopenia developed in 8.1%, 5.4%, 3.6%, and 1.8% of patients, respectively. VTE was reported only in one patient (Grade 2). Among 111 patients, 69 (62.2%) are still receiving lenalidomide + dexamethasone while 42 (37.8%) patients discontinued treatment (AEs : 12 [10.8%], death: 10 [9.0%], progression: 6 [5.4%], and other reasons: 14 [%12.6]). No second primary malignancy was reported.
Summary
Early safety data confirmed known AEs of lenalidomide plus dexamethasone therapy in RRMM patients in Turkey. Longer-term follow-up of AEs in this study will provide better characterization of AEs.
Keyword(s): Multiple myeloma, Refractory, Relapse, Safety
Session topic: Publication Only
Abstract: PB1859
Type: Publication Only
Background
Prognosis of patients with multiple myeloma (MM) has improved with the use of novel agents in the past decade. The data on real-world safety of these agents is limited. Following its regulatory approval in 2010, lenalidomide is now commonly used in the relapsed/refractory multiple myeloma (RRMM) setting in Turkey.
Aims
This post-authorization observational study is designed to define the safety profile of lenalidomide + dexamethasone therapy under routine real-world clinical practice by characterizing and identifying the incidence of adverse events (AE) of special interest in RRMM patients in Turkey.
Methods
Patients aged ≥18 years with RRMM and started on lenalidomide + dexamethasone treatment were included in the study. Patients who had previously received lenalidomide and discontinued or who had a treatment interruption for ≥4 weeks were excluded from the study. Thromboprophylaxis was allowed but not required. AEs were graded according to NCI-CTCAE (version 4.03) grading.
Results
As of January 30, 2015, 119 patients across 24 institutions in Turkey were enrolled. Of those, results of 111 patients with available data are going to be presented in this early safety report. Median follow-up was 19.9 weeks (range, 1.4–56.4). Median age was 62 years (range, 29–85) and 56.8% were male. Among 98 of the patients whose ECOG status were recorded at entry, 81 (82.7%) had good performance status (ECOG score 0–1) and 17 (17.3%) had an ECOG score of 2–4. Median number of prior therapies was two (29.7% had one prior therapy, 53.2% had two prior therapies and 17.1% had ≥3 prior therapies). Fifty-four (48.6%) patients had received autologous stem cell transplantation. The overall incidence of peripheral neuropathy at the baseline was 30.6%. Starting dose of lenalidomide was 25 mg in 85 (76.6%) patients, while 15 mg, 10 mg, and 5 mg were the initial dose in 10 (9.0%), 11 (9.9%), and 5 (4.5%) patients, respectively. Dose modifications were required in 13 (11.7%) patients. Prophylaxis for thromboembolism was performed in total of 37 (33.3%) patients with aspirin (n=21), heparin (n=15) and warfarin (n=1). Overall, 46 Grade 3-4 AEs were observed in 41 (%36.9) patients and 70 (63.1%) patients were free of Grade 3-4 AEs. Grade 3–4 neutropenia, pneumonia, anemia, and thrombocytopenia developed in 8.1%, 5.4%, 3.6%, and 1.8% of patients, respectively. VTE was reported only in one patient (Grade 2). Among 111 patients, 69 (62.2%) are still receiving lenalidomide + dexamethasone while 42 (37.8%) patients discontinued treatment (AEs : 12 [10.8%], death: 10 [9.0%], progression: 6 [5.4%], and other reasons: 14 [%12.6]). No second primary malignancy was reported.
Summary
Early safety data confirmed known AEs of lenalidomide plus dexamethasone therapy in RRMM patients in Turkey. Longer-term follow-up of AEs in this study will provide better characterization of AEs.
Keyword(s): Multiple myeloma, Refractory, Relapse, Safety
Session topic: Publication Only
Type: Publication Only
Background
Prognosis of patients with multiple myeloma (MM) has improved with the use of novel agents in the past decade. The data on real-world safety of these agents is limited. Following its regulatory approval in 2010, lenalidomide is now commonly used in the relapsed/refractory multiple myeloma (RRMM) setting in Turkey.
Aims
This post-authorization observational study is designed to define the safety profile of lenalidomide + dexamethasone therapy under routine real-world clinical practice by characterizing and identifying the incidence of adverse events (AE) of special interest in RRMM patients in Turkey.
Methods
Patients aged ≥18 years with RRMM and started on lenalidomide + dexamethasone treatment were included in the study. Patients who had previously received lenalidomide and discontinued or who had a treatment interruption for ≥4 weeks were excluded from the study. Thromboprophylaxis was allowed but not required. AEs were graded according to NCI-CTCAE (version 4.03) grading.
Results
As of January 30, 2015, 119 patients across 24 institutions in Turkey were enrolled. Of those, results of 111 patients with available data are going to be presented in this early safety report. Median follow-up was 19.9 weeks (range, 1.4–56.4). Median age was 62 years (range, 29–85) and 56.8% were male. Among 98 of the patients whose ECOG status were recorded at entry, 81 (82.7%) had good performance status (ECOG score 0–1) and 17 (17.3%) had an ECOG score of 2–4. Median number of prior therapies was two (29.7% had one prior therapy, 53.2% had two prior therapies and 17.1% had ≥3 prior therapies). Fifty-four (48.6%) patients had received autologous stem cell transplantation. The overall incidence of peripheral neuropathy at the baseline was 30.6%. Starting dose of lenalidomide was 25 mg in 85 (76.6%) patients, while 15 mg, 10 mg, and 5 mg were the initial dose in 10 (9.0%), 11 (9.9%), and 5 (4.5%) patients, respectively. Dose modifications were required in 13 (11.7%) patients. Prophylaxis for thromboembolism was performed in total of 37 (33.3%) patients with aspirin (n=21), heparin (n=15) and warfarin (n=1). Overall, 46 Grade 3-4 AEs were observed in 41 (%36.9) patients and 70 (63.1%) patients were free of Grade 3-4 AEs. Grade 3–4 neutropenia, pneumonia, anemia, and thrombocytopenia developed in 8.1%, 5.4%, 3.6%, and 1.8% of patients, respectively. VTE was reported only in one patient (Grade 2). Among 111 patients, 69 (62.2%) are still receiving lenalidomide + dexamethasone while 42 (37.8%) patients discontinued treatment (AEs : 12 [10.8%], death: 10 [9.0%], progression: 6 [5.4%], and other reasons: 14 [%12.6]). No second primary malignancy was reported.
Summary
Early safety data confirmed known AEs of lenalidomide plus dexamethasone therapy in RRMM patients in Turkey. Longer-term follow-up of AEs in this study will provide better characterization of AEs.
Keyword(s): Multiple myeloma, Refractory, Relapse, Safety
Session topic: Publication Only
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