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A non-interventional, observational registry of adult patients with multiple myeloma treated with Revlimid (lenalidomide) in China: interim analysis
Abstracts PO-376 A Non-interventional Observational Registry of Patients (Pts) With Relapsed/ Refractory Multiple Myeloma (RRMM) Treated With Lenalidomide (LEN) and Dexamethasone (DEX) in Taiwan S.Y. Huang,1 Y.B. Yu,2 S.P. Yeh,3 T.Y. Chen,4 W.Y. Kao,5 C.C. Chen,6 M.C. Wang,7 H.Y. Lin,8 S.F. Lin,9 T.H. Lin,10 Y. Hua,11 M. Puccio-Pick,11 D. DeMarco,11 C. Jacques,11 P. Dunn12
observed. LEN was active in this heavily pretreated population. A practice of reducing starting LEN dose based on body-mass index was noted among treating physicians which may have impacted outcomes; however results in pts with 1-3 prior Tx was similar to previous studies. These data support the use of LEN + DEX for the Tx of non-Caucasian pts with RRMM. Figure
Abstract Title: A Non-interventional Observational Registry of Patients (Pts) With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With Lenalidomide (LEN) and Dexamethasone (DEX) in Taiwan
1
Division of Hematology, Department of Internal Medicine, National
Taiwan University Hospital, Taipei, Taiwan; 2Taipei Veterans General Hospital, Taiwan; 3China Medical University Hospital, Taiwan; 4National Cheng Kung University Hospital, Taiwan; 5Tri Service General Hospital, Taiwan; 6Chang Gung Memorial Hospital, Chiayi, Taiwan; 7
Chang Gung Memorial Hospital, Kaohsiung, Taiwan; 8Changhua
Christian Hospital, Changhua, Taiwan; 9Kaohsiung Medical University Hospital, Taiwan; 11
10
Taichung Veterans General Hospital, Taiwan;
Celgene Corporation, Summit, New Jersey;
12
Chang Gung Me-
morial Hospital and Chang Gung University, Linkou, Taiwan
Introduction: Over the past decades the incidence of multiple myeloma (MM) has risen in Asia. However, the use of novel agents for MM treatment (Tx) in Asia is low. The IMiDsÒ immunomodulatory agent LEN, in combination with DEX, has recently been approved for the Tx of RRMM after 1 prior therapy in Taiwan. This prospective, observational, non-interventional, multicenter registry (T-CC-MM-009) assessed the first 100 pts with RRMM prescribed LEN+DEX in Taiwan. Patients and Methods: Pts were prescribed LEN, and had 1 prior Tx. The recommended starting dose of LEN was 25 mg on days 1-21 and DEX was 40 mg on days 1-4, 9-12, and 17-20 for the first 4 28-day cycles. DEX was given on days 1-4 in cycles 5+. Dose modifications were according to the package insert. The primary objective was safety including assessment of LEN-related AEs. Efficacy was a secondary objective. Results: Most pts were 65 years (68.4%), male (63.3%), with stage III disease (61.2%). Pts were heavily pretreated: 74.4% received 4 prior antimyeloma Tx. The median duration of Tx was 34.6 weeks. The majority of pts (75.5%) completed 3 Tx cycles. Starting LEN dose was modified for 33.7% of pts. Most pts (82.7%) had 1 LEN-related adverse event (AE; all grades). AEs resulted in LEN dose modifications and/or interruptions in 59.2% of pts. The most common grade 3/4 hematologic AEs were neutropenia (20.4%), thrombocytopenia (9.2%), and anemia (7.1%). Infections (9.2) and fatigue (5.1%) were the most common grade 3/ 4 nonhematologic AEs. Three (3.1%) thromboembolic events were observed. There were 3 second primary malignancies reported; 2 occurred within 1 year suggesting that they may have been unrelated to LEN Tx on the registry. The overall response rate (partial response) was 34.7% for all pts and 58.3% for pts who had 1-3 prior Tx. Time to disease progression was 20.7 mos (95% CI, 11.0 mos-not evaluable [NE]) overall and NE (95% CI, 21.6 mos-NE) with 1-3 prior Tx. Conclusion: Results show LEN+DEX had a generally consistent safety profile to previous studies in Western populations, except a lower rate of thromboembolic events was
PO-377 A non-interventional, observational registry of adult patients with multiple myeloma treated with Revlimid (lenalidomide) in China: interim analysis J. Lu,1 X. Huang,1 W. Chen,2 Z. Liu,3 X. Wang,4 W. Li,5 Y. Zhong,6 Z. Fu,7 X. Li,8 Y. Hu,9 H. Liu,10 X. Zhang,11 J. Zhou,12 F. Meng13 1
Department of Hematology, People’s Hospital, Peking University Institute of Hematology, Beijing, China; 2Department of Hematology, Chaoyang Hospital affiliated with Capital Medical University, Beijing, China; 3Department of Hematology, Shengjing Hospital affiliated with China Medical University, Beijing, China; 4Department of Hematology, The Xinjiang Uygur Autonomous Region People’s Hospital, Xinjiang, China; 5Department of Hematology, No.1 Hospital of Jilin University, Changchun, China; 6Department of Hematology, Chaoyang Hospital affiliated with Capital Medical University Hospital in West Region, Beijing, China; 7Department of Hematology, First Hospital affiliated with Suzhou University, Jiangsu Province, China; 8Department of Hematology, Xiangya Hospital of Central South University, Changsha, China; 9Department of Hematology, Union Hospital affiliated with Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; 10Department of Hematology, Beijing Hospital of Ministry of Health, Beijing, China;
11
Department of Hematology,
15th International Myeloma Workshop, September 23-26, 2015
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Abstracts Second Affiliated Hospital, Third Military Medical University, Chongqing, China;
12
Department of Hematology, Tongji Hospital,
Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China;
13
Department of Hematology, Nanfang
Hospital, Southern Medical University, Guangzhou, China
1
Amyloidosis and Myeloma Unit, Department of Hematology, Hospital
Clínic de Barcelona, IDIBAPS, Barcelona; 2Department of Hematology. Hospital de la Santa Creu i Sant Pau, Barcelona; 3Department of Hematology. Hospital Mútua de Terrassa, Terrassa; 4Department of Hematology. Hospital de Vall d’Hebron, Barcelona; 5Department of Hematology. Hospital Arnau de Vilanova, Lleida; 6Department of
Introduction: Multiple myeloma (MM), the second most frequent hematologic malignancy, is characterized by hypercalcemia, renal impairment, anemia, and bone lesion. Lenalidomide (Revlimid) is thought to improve treatment outcomes for MM by various mechanisms, such as immune regulation and anti-microangiogenesis. We performed this registry study to evaluate the efficacy and safety of lenalidomide in real-world clinical practice in Chinese patients with MM who have received 1 prior therapy. Patients and Methods: This is a prospective, multi-center, observational study. The inclusion criteria required a diagnosis of MM, 1 prior therapy, and lenalidomide as part of standard care for patients’ treatment. The registry will capture data from z300 patients being prescribed lenalidomide in specified hospitals, and all patients will be followed in the registry for 1 year after enrollment of the last patient. The study was launched in Nov 2013 and is planned to end in Dec 2016. An interim analysis was scheduled when 100 patients were enrolled. The primary endpoint was progression-free survival (PFS), defined as the time from administration of the first dose of lenalidomide to time of treatment failure, including relapse, refractory disease, death, or censored at last follow-up. Response rate ( partial response [PR]) was assessed using International Myeloma Working Group Uniform Response Criteria. Results: At the interim analysis in Oct 2014, 97 patients were enrolled, with a median follow-up of 5.4 months. The median age of patients was 63 years, with more patients being male (62.9% vs. 37.1%). The median duration of MM since first diagnosis was 12.04 months. 54 patients were evaluable for response, while the remaining 43 patients were not followed long enough. 12 CR + sCR (12.4%), 9 VGPR (9.3%), and 18 PR (18.6%) were observed. The median time to response was 2.8months. 10 disease progression events (10.3%) and 4 deaths (4.1%) were observed. The median PFS was not reached, with a 12-month PFS rate of 61.9% (range, 42.1%76.7%). In total, 46 adverse events were documented, most of which were hematologic toxicities (n ¼ 17; 17.5%) and infections (n ¼ 17; 17.5%). Grade 3/4 toxicities occurred in 12 patients (11.3%), and 2 patients died. Conclusion: Lenalidomide was effective in previously treated patients with MM in a Chinese population, with acceptable toxicities. Longer follow-up and further accrual of patients are warranted.
PO-378 PACE as salvage therapy for relapsed or refractory multiple myeloma I. Isola,1 M. Granell,2 J.M. Martí,3 M. Gironella,4 A. García-Guiñón,5 J. López-Pardo,2 A. Muntañola,3 E. Abella,6 C. Motlló,7 L. Escoda,8 J. Sierra,2 J. Bladé,1 L. Rosiñol,1 C. Fernández de Larrea1, on behalf of the Catalan Group for Multiple Myeloma and Amyloidosis
e300
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15th International Myeloma Workshop, September 23-26, 2015
Hematology. Hospital del Mar, Barcelona; 7Department of Hematology. Hospital Germans Trias i Pujol, Badalona; 8Department of Hematology. Hospital Joan XXIII, Tarragona
Introduction: Treatment of patients with relapsed or refractory multiple myeloma (MM) is challenging. Limited evidence suggests that PACE, a combination chemotherapy regimen, could be useful as a salvage therapy for patients with aggressive disease. The focus of this report was to analyze the efficacy, tolerability and durability of response of PACE regimen in a series of patients with relapsed or refractory MM. Patients and Methods: Medical records of all patients with relapsed or refractory MM who received PACE from January 2010 to January 2015 at seven hospitals in Catalonia were reviewed. Treatment with PACE consisted of a 4-day continuous infusion of cisplatin (10 mg/m2/d), etoposide (40 mg/m2/d), doxorubicin (10 mg/m2/d) and cyclophosphamide (400 mg/m2/d) administered every 4 weeks depending on tolerance and efficacy. Results: Forty patients received PACE, with a median of 19.5 months from diagnosis. Patient characteristics are summarized in Table 1. Patients underwent a median of 2 cycles of PACE (range 16). The overall response (minimal response or better) was 55%: 3 (7%) complete remission (CR), 6 (15%) very good partial response, 11 (28%) partial response (PR) and 2 (5%) minimal response. Of the 20 patients in which extramedullary disease response was evaluated, 6 (30%) achieved CR, 8 (40%) PR and 6 (30%) progressed or had stable disease. Median follow-up for all patients was 8.4 months. For the entire cohort, median progression free survival (PFS) was 4.8 months (95% CI 2.8-6.9) and median overall survival (OS) was 9.5 months (95% CI 4.7-14.4). The 22 patients who responded had a median PFS and OS from PACE of 6.6 months (95% CI 3.7-9.6) and 13 months (95% CI 10.4-15.7), respectively. Six of these patients proceeded to allogeneic and 4 to autologous stem-cell transplantation. Two variables were found to have a significant effect on OS: any autologous stem-cell transplantation prior to PACE vs. none (13.3 vs. 6.9 months, p¼0.027) and extramedullary involvement at PACE (7.9 vs. 21.2 months, p¼0.016). Grade 4 neutropenia and thrombocytopenia occurred in 33 (83%) and 25 patients (63%). Febrile neutropenia occurred in 13 patients, and two patients died due to treatment toxicity within two months of PACE. Conclusion: Treatment with PACE resulted in an overall response rate of 55%; however the PFS was short. In this group of patients with advanced disease, this therapeutic regimen could help to reduce disease burden prior to transplantation.
observed. LEN was active in this heavily pretreated population. A practice of reducing starting LEN dose based on body-mass index was noted among treating physicians which may have impacted outcomes; however results in pts with 1-3 prior Tx was similar to previous studies. These data support the use of LEN + DEX for the Tx of non-Caucasian pts with RRMM. Figure
Abstract Title: A Non-interventional Observational Registry of Patients (Pts) With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With Lenalidomide (LEN) and Dexamethasone (DEX) in Taiwan
1
Division of Hematology, Department of Internal Medicine, National
Taiwan University Hospital, Taipei, Taiwan; 2Taipei Veterans General Hospital, Taiwan; 3China Medical University Hospital, Taiwan; 4National Cheng Kung University Hospital, Taiwan; 5Tri Service General Hospital, Taiwan; 6Chang Gung Memorial Hospital, Chiayi, Taiwan; 7
Chang Gung Memorial Hospital, Kaohsiung, Taiwan; 8Changhua
Christian Hospital, Changhua, Taiwan; 9Kaohsiung Medical University Hospital, Taiwan; 11
10
Taichung Veterans General Hospital, Taiwan;
Celgene Corporation, Summit, New Jersey;
12
Chang Gung Me-
morial Hospital and Chang Gung University, Linkou, Taiwan
Introduction: Over the past decades the incidence of multiple myeloma (MM) has risen in Asia. However, the use of novel agents for MM treatment (Tx) in Asia is low. The IMiDsÒ immunomodulatory agent LEN, in combination with DEX, has recently been approved for the Tx of RRMM after 1 prior therapy in Taiwan. This prospective, observational, non-interventional, multicenter registry (T-CC-MM-009) assessed the first 100 pts with RRMM prescribed LEN+DEX in Taiwan. Patients and Methods: Pts were prescribed LEN, and had 1 prior Tx. The recommended starting dose of LEN was 25 mg on days 1-21 and DEX was 40 mg on days 1-4, 9-12, and 17-20 for the first 4 28-day cycles. DEX was given on days 1-4 in cycles 5+. Dose modifications were according to the package insert. The primary objective was safety including assessment of LEN-related AEs. Efficacy was a secondary objective. Results: Most pts were 65 years (68.4%), male (63.3%), with stage III disease (61.2%). Pts were heavily pretreated: 74.4% received 4 prior antimyeloma Tx. The median duration of Tx was 34.6 weeks. The majority of pts (75.5%) completed 3 Tx cycles. Starting LEN dose was modified for 33.7% of pts. Most pts (82.7%) had 1 LEN-related adverse event (AE; all grades). AEs resulted in LEN dose modifications and/or interruptions in 59.2% of pts. The most common grade 3/4 hematologic AEs were neutropenia (20.4%), thrombocytopenia (9.2%), and anemia (7.1%). Infections (9.2) and fatigue (5.1%) were the most common grade 3/ 4 nonhematologic AEs. Three (3.1%) thromboembolic events were observed. There were 3 second primary malignancies reported; 2 occurred within 1 year suggesting that they may have been unrelated to LEN Tx on the registry. The overall response rate (partial response) was 34.7% for all pts and 58.3% for pts who had 1-3 prior Tx. Time to disease progression was 20.7 mos (95% CI, 11.0 mos-not evaluable [NE]) overall and NE (95% CI, 21.6 mos-NE) with 1-3 prior Tx. Conclusion: Results show LEN+DEX had a generally consistent safety profile to previous studies in Western populations, except a lower rate of thromboembolic events was
PO-377 A non-interventional, observational registry of adult patients with multiple myeloma treated with Revlimid (lenalidomide) in China: interim analysis J. Lu,1 X. Huang,1 W. Chen,2 Z. Liu,3 X. Wang,4 W. Li,5 Y. Zhong,6 Z. Fu,7 X. Li,8 Y. Hu,9 H. Liu,10 X. Zhang,11 J. Zhou,12 F. Meng13 1
Department of Hematology, People’s Hospital, Peking University Institute of Hematology, Beijing, China; 2Department of Hematology, Chaoyang Hospital affiliated with Capital Medical University, Beijing, China; 3Department of Hematology, Shengjing Hospital affiliated with China Medical University, Beijing, China; 4Department of Hematology, The Xinjiang Uygur Autonomous Region People’s Hospital, Xinjiang, China; 5Department of Hematology, No.1 Hospital of Jilin University, Changchun, China; 6Department of Hematology, Chaoyang Hospital affiliated with Capital Medical University Hospital in West Region, Beijing, China; 7Department of Hematology, First Hospital affiliated with Suzhou University, Jiangsu Province, China; 8Department of Hematology, Xiangya Hospital of Central South University, Changsha, China; 9Department of Hematology, Union Hospital affiliated with Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; 10Department of Hematology, Beijing Hospital of Ministry of Health, Beijing, China;
11
Department of Hematology,
15th International Myeloma Workshop, September 23-26, 2015
- e299
Abstracts Second Affiliated Hospital, Third Military Medical University, Chongqing, China;
12
Department of Hematology, Tongji Hospital,
Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China;
13
Department of Hematology, Nanfang
Hospital, Southern Medical University, Guangzhou, China
1
Amyloidosis and Myeloma Unit, Department of Hematology, Hospital
Clínic de Barcelona, IDIBAPS, Barcelona; 2Department of Hematology. Hospital de la Santa Creu i Sant Pau, Barcelona; 3Department of Hematology. Hospital Mútua de Terrassa, Terrassa; 4Department of Hematology. Hospital de Vall d’Hebron, Barcelona; 5Department of Hematology. Hospital Arnau de Vilanova, Lleida; 6Department of
Introduction: Multiple myeloma (MM), the second most frequent hematologic malignancy, is characterized by hypercalcemia, renal impairment, anemia, and bone lesion. Lenalidomide (Revlimid) is thought to improve treatment outcomes for MM by various mechanisms, such as immune regulation and anti-microangiogenesis. We performed this registry study to evaluate the efficacy and safety of lenalidomide in real-world clinical practice in Chinese patients with MM who have received 1 prior therapy. Patients and Methods: This is a prospective, multi-center, observational study. The inclusion criteria required a diagnosis of MM, 1 prior therapy, and lenalidomide as part of standard care for patients’ treatment. The registry will capture data from z300 patients being prescribed lenalidomide in specified hospitals, and all patients will be followed in the registry for 1 year after enrollment of the last patient. The study was launched in Nov 2013 and is planned to end in Dec 2016. An interim analysis was scheduled when 100 patients were enrolled. The primary endpoint was progression-free survival (PFS), defined as the time from administration of the first dose of lenalidomide to time of treatment failure, including relapse, refractory disease, death, or censored at last follow-up. Response rate ( partial response [PR]) was assessed using International Myeloma Working Group Uniform Response Criteria. Results: At the interim analysis in Oct 2014, 97 patients were enrolled, with a median follow-up of 5.4 months. The median age of patients was 63 years, with more patients being male (62.9% vs. 37.1%). The median duration of MM since first diagnosis was 12.04 months. 54 patients were evaluable for response, while the remaining 43 patients were not followed long enough. 12 CR + sCR (12.4%), 9 VGPR (9.3%), and 18 PR (18.6%) were observed. The median time to response was 2.8months. 10 disease progression events (10.3%) and 4 deaths (4.1%) were observed. The median PFS was not reached, with a 12-month PFS rate of 61.9% (range, 42.1%76.7%). In total, 46 adverse events were documented, most of which were hematologic toxicities (n ¼ 17; 17.5%) and infections (n ¼ 17; 17.5%). Grade 3/4 toxicities occurred in 12 patients (11.3%), and 2 patients died. Conclusion: Lenalidomide was effective in previously treated patients with MM in a Chinese population, with acceptable toxicities. Longer follow-up and further accrual of patients are warranted.
PO-378 PACE as salvage therapy for relapsed or refractory multiple myeloma I. Isola,1 M. Granell,2 J.M. Martí,3 M. Gironella,4 A. García-Guiñón,5 J. López-Pardo,2 A. Muntañola,3 E. Abella,6 C. Motlló,7 L. Escoda,8 J. Sierra,2 J. Bladé,1 L. Rosiñol,1 C. Fernández de Larrea1, on behalf of the Catalan Group for Multiple Myeloma and Amyloidosis
e300
-
15th International Myeloma Workshop, September 23-26, 2015
Hematology. Hospital del Mar, Barcelona; 7Department of Hematology. Hospital Germans Trias i Pujol, Badalona; 8Department of Hematology. Hospital Joan XXIII, Tarragona
Introduction: Treatment of patients with relapsed or refractory multiple myeloma (MM) is challenging. Limited evidence suggests that PACE, a combination chemotherapy regimen, could be useful as a salvage therapy for patients with aggressive disease. The focus of this report was to analyze the efficacy, tolerability and durability of response of PACE regimen in a series of patients with relapsed or refractory MM. Patients and Methods: Medical records of all patients with relapsed or refractory MM who received PACE from January 2010 to January 2015 at seven hospitals in Catalonia were reviewed. Treatment with PACE consisted of a 4-day continuous infusion of cisplatin (10 mg/m2/d), etoposide (40 mg/m2/d), doxorubicin (10 mg/m2/d) and cyclophosphamide (400 mg/m2/d) administered every 4 weeks depending on tolerance and efficacy. Results: Forty patients received PACE, with a median of 19.5 months from diagnosis. Patient characteristics are summarized in Table 1. Patients underwent a median of 2 cycles of PACE (range 16). The overall response (minimal response or better) was 55%: 3 (7%) complete remission (CR), 6 (15%) very good partial response, 11 (28%) partial response (PR) and 2 (5%) minimal response. Of the 20 patients in which extramedullary disease response was evaluated, 6 (30%) achieved CR, 8 (40%) PR and 6 (30%) progressed or had stable disease. Median follow-up for all patients was 8.4 months. For the entire cohort, median progression free survival (PFS) was 4.8 months (95% CI 2.8-6.9) and median overall survival (OS) was 9.5 months (95% CI 4.7-14.4). The 22 patients who responded had a median PFS and OS from PACE of 6.6 months (95% CI 3.7-9.6) and 13 months (95% CI 10.4-15.7), respectively. Six of these patients proceeded to allogeneic and 4 to autologous stem-cell transplantation. Two variables were found to have a significant effect on OS: any autologous stem-cell transplantation prior to PACE vs. none (13.3 vs. 6.9 months, p¼0.027) and extramedullary involvement at PACE (7.9 vs. 21.2 months, p¼0.016). Grade 4 neutropenia and thrombocytopenia occurred in 33 (83%) and 25 patients (63%). Febrile neutropenia occurred in 13 patients, and two patients died due to treatment toxicity within two months of PACE. Conclusion: Treatment with PACE resulted in an overall response rate of 55%; however the PFS was short. In this group of patients with advanced disease, this therapeutic regimen could help to reduce disease burden prior to transplantation.