A PHASE 2 MULTICENTER STUDY OF POMALIDOMIDE IN COMBINATION WITH LOW-DOSE DEXAMETHASONE IN JAPANESE PATIENTS WITH RELAPSED AND REFRACTORY MULTIPLE MYELOMA: THE MM-011 TRIAL
(Abstract release date: 05/19/16)
EHA Library. Hagiwara S. 06/09/16; 134868; PB1968
Dr. Shotaro Hagiwara
Contributions
Contributions
Abstract
Abstract: PB1968
Type: Publication Only
Background
Pomalidomide in combination with low-dose dexamethasone (POM + LoDEX) has shown efficacy in patients with relapsed and refractory multiple myeloma (RRMM). In this patient population, POM + LoDEX prolonged progression-free survival (PFS) compared with POM alone (Richardson et al, Blood, 2014) and provided a PFS and overall survival (OS) benefit compared with high-dose DEX alone (San Miguel et al, Lancet Oncol, 2013), while demonstrating an acceptable safety profile. To evaluate the safety and efficacy of POM + LoDEX in Asian patients with RRMM, an additional study enrolling only Japanese patients was conducted.
Aims
This multicenter, single-arm, open-label phase 2 trial (MM-011) aimed to evaluate the efficacy and safety of POM + LoDEX in Japanese patients with RRMM.
Methods
Patients with progressive disease on or within 60 days of their last prior therapy and who had received ≥ 2 prior therapies, including ≥ 2 cycles of lenalidomide and of bortezomib (either separately or in combination) were included. Patients received oral POM 4 mg per day on days 1-21 and oral LoDEX 40 mg per day (20 mg if aged > 75 years) on days 1, 8, 15, and 22, and the course was repeated every 28 days until disease progression, unacceptable toxicity, or withdrawal. The primary endpoint was overall response rate (ORR; ≥ partial response) of POM + LoDEX according to the International Myeloma Working Group criteria. All pts provided written informed consent.
Results
Thirty-six patients were enrolled between December 2013 and July 2014 at 13 sites in Japan. The median age of patients was 64.5 years (range, 43-78 years); 11% were aged > 75 years. Patients received a median of 6.5 prior anti-myeloma regimens (range, 2-15) and had a high tumor burden (81% had Durie-Salmon stage II or III disease). Thirty-five patients (97%) were refractory to lenalidomide, and 21 patients (58%) were refractory to both lenalidomide and bortezomib.At the data cutoff (February 3, 2015), 16 patients (44%) remained on treatment, and study drugs were discontinued in 20 patients due to disease progression (n = 14 [39%]), adverse event (AE; n = 2 [6%]), death (n = 1 [3%]), and other reasons (n = 3 [8%]). The ORR was 42% (n = 15 [95% CI, 26% - 58%]), including complete response in 3% (n = 1) and partial response in 39% (n = 14) of patients. Median PFS was 10.1 months (median follow-up, 7.7 months), and at a data cutoff of September 25, 2015, 1-year OS was 58.5% (median follow-up, 11.3 months). In the 15 responders, median time to response was 1.9 months (range, 0.9-5.5 months), and median duration of response was not reached.The most common grade 3/4 hematologic AEs were neutropenia (n = 23 [64%]), anemia (n = 15 [42%]), and thrombocytopenia (n = 11 [31%]). Pneumonia (n = 3 [8%]) and decreased appetite (n = 3 [8%]) were the most common grade 3/4 non-hematologic AEs. Peripheral neuropathy (all grades) occurred in 8% (n = 3) of patients. No deep vein thrombosis or pulmonary embolism was reported. Overall, AEs were similar to those seen in other POM studies, and no new significant AEs were reported in patients in this study. Nine patients died on study (or within 28 days of the last dose of study drug), 8 due to multiple myeloma and 1 due to AE (pneumonia and aggravated asthma, suspected to be related to study drug).
Conclusion
POM + LoDEX is an effective treatment in heavily pretreated Japanese patients with RRMM, with an acceptable safety profile that is comparable to those seen on POM studies in RRMM in other regions.
Session topic: E-poster
Type: Publication Only
Background
Pomalidomide in combination with low-dose dexamethasone (POM + LoDEX) has shown efficacy in patients with relapsed and refractory multiple myeloma (RRMM). In this patient population, POM + LoDEX prolonged progression-free survival (PFS) compared with POM alone (Richardson et al, Blood, 2014) and provided a PFS and overall survival (OS) benefit compared with high-dose DEX alone (San Miguel et al, Lancet Oncol, 2013), while demonstrating an acceptable safety profile. To evaluate the safety and efficacy of POM + LoDEX in Asian patients with RRMM, an additional study enrolling only Japanese patients was conducted.
Aims
This multicenter, single-arm, open-label phase 2 trial (MM-011) aimed to evaluate the efficacy and safety of POM + LoDEX in Japanese patients with RRMM.
Methods
Patients with progressive disease on or within 60 days of their last prior therapy and who had received ≥ 2 prior therapies, including ≥ 2 cycles of lenalidomide and of bortezomib (either separately or in combination) were included. Patients received oral POM 4 mg per day on days 1-21 and oral LoDEX 40 mg per day (20 mg if aged > 75 years) on days 1, 8, 15, and 22, and the course was repeated every 28 days until disease progression, unacceptable toxicity, or withdrawal. The primary endpoint was overall response rate (ORR; ≥ partial response) of POM + LoDEX according to the International Myeloma Working Group criteria. All pts provided written informed consent.
Results
Thirty-six patients were enrolled between December 2013 and July 2014 at 13 sites in Japan. The median age of patients was 64.5 years (range, 43-78 years); 11% were aged > 75 years. Patients received a median of 6.5 prior anti-myeloma regimens (range, 2-15) and had a high tumor burden (81% had Durie-Salmon stage II or III disease). Thirty-five patients (97%) were refractory to lenalidomide, and 21 patients (58%) were refractory to both lenalidomide and bortezomib.At the data cutoff (February 3, 2015), 16 patients (44%) remained on treatment, and study drugs were discontinued in 20 patients due to disease progression (n = 14 [39%]), adverse event (AE; n = 2 [6%]), death (n = 1 [3%]), and other reasons (n = 3 [8%]). The ORR was 42% (n = 15 [95% CI, 26% - 58%]), including complete response in 3% (n = 1) and partial response in 39% (n = 14) of patients. Median PFS was 10.1 months (median follow-up, 7.7 months), and at a data cutoff of September 25, 2015, 1-year OS was 58.5% (median follow-up, 11.3 months). In the 15 responders, median time to response was 1.9 months (range, 0.9-5.5 months), and median duration of response was not reached.The most common grade 3/4 hematologic AEs were neutropenia (n = 23 [64%]), anemia (n = 15 [42%]), and thrombocytopenia (n = 11 [31%]). Pneumonia (n = 3 [8%]) and decreased appetite (n = 3 [8%]) were the most common grade 3/4 non-hematologic AEs. Peripheral neuropathy (all grades) occurred in 8% (n = 3) of patients. No deep vein thrombosis or pulmonary embolism was reported. Overall, AEs were similar to those seen in other POM studies, and no new significant AEs were reported in patients in this study. Nine patients died on study (or within 28 days of the last dose of study drug), 8 due to multiple myeloma and 1 due to AE (pneumonia and aggravated asthma, suspected to be related to study drug).
Conclusion
POM + LoDEX is an effective treatment in heavily pretreated Japanese patients with RRMM, with an acceptable safety profile that is comparable to those seen on POM studies in RRMM in other regions.
Session topic: E-poster
Abstract: PB1968
Type: Publication Only
Background
Pomalidomide in combination with low-dose dexamethasone (POM + LoDEX) has shown efficacy in patients with relapsed and refractory multiple myeloma (RRMM). In this patient population, POM + LoDEX prolonged progression-free survival (PFS) compared with POM alone (Richardson et al, Blood, 2014) and provided a PFS and overall survival (OS) benefit compared with high-dose DEX alone (San Miguel et al, Lancet Oncol, 2013), while demonstrating an acceptable safety profile. To evaluate the safety and efficacy of POM + LoDEX in Asian patients with RRMM, an additional study enrolling only Japanese patients was conducted.
Aims
This multicenter, single-arm, open-label phase 2 trial (MM-011) aimed to evaluate the efficacy and safety of POM + LoDEX in Japanese patients with RRMM.
Methods
Patients with progressive disease on or within 60 days of their last prior therapy and who had received ≥ 2 prior therapies, including ≥ 2 cycles of lenalidomide and of bortezomib (either separately or in combination) were included. Patients received oral POM 4 mg per day on days 1-21 and oral LoDEX 40 mg per day (20 mg if aged > 75 years) on days 1, 8, 15, and 22, and the course was repeated every 28 days until disease progression, unacceptable toxicity, or withdrawal. The primary endpoint was overall response rate (ORR; ≥ partial response) of POM + LoDEX according to the International Myeloma Working Group criteria. All pts provided written informed consent.
Results
Thirty-six patients were enrolled between December 2013 and July 2014 at 13 sites in Japan. The median age of patients was 64.5 years (range, 43-78 years); 11% were aged > 75 years. Patients received a median of 6.5 prior anti-myeloma regimens (range, 2-15) and had a high tumor burden (81% had Durie-Salmon stage II or III disease). Thirty-five patients (97%) were refractory to lenalidomide, and 21 patients (58%) were refractory to both lenalidomide and bortezomib.At the data cutoff (February 3, 2015), 16 patients (44%) remained on treatment, and study drugs were discontinued in 20 patients due to disease progression (n = 14 [39%]), adverse event (AE; n = 2 [6%]), death (n = 1 [3%]), and other reasons (n = 3 [8%]). The ORR was 42% (n = 15 [95% CI, 26% - 58%]), including complete response in 3% (n = 1) and partial response in 39% (n = 14) of patients. Median PFS was 10.1 months (median follow-up, 7.7 months), and at a data cutoff of September 25, 2015, 1-year OS was 58.5% (median follow-up, 11.3 months). In the 15 responders, median time to response was 1.9 months (range, 0.9-5.5 months), and median duration of response was not reached.The most common grade 3/4 hematologic AEs were neutropenia (n = 23 [64%]), anemia (n = 15 [42%]), and thrombocytopenia (n = 11 [31%]). Pneumonia (n = 3 [8%]) and decreased appetite (n = 3 [8%]) were the most common grade 3/4 non-hematologic AEs. Peripheral neuropathy (all grades) occurred in 8% (n = 3) of patients. No deep vein thrombosis or pulmonary embolism was reported. Overall, AEs were similar to those seen in other POM studies, and no new significant AEs were reported in patients in this study. Nine patients died on study (or within 28 days of the last dose of study drug), 8 due to multiple myeloma and 1 due to AE (pneumonia and aggravated asthma, suspected to be related to study drug).
Conclusion
POM + LoDEX is an effective treatment in heavily pretreated Japanese patients with RRMM, with an acceptable safety profile that is comparable to those seen on POM studies in RRMM in other regions.
Session topic: E-poster
Type: Publication Only
Background
Pomalidomide in combination with low-dose dexamethasone (POM + LoDEX) has shown efficacy in patients with relapsed and refractory multiple myeloma (RRMM). In this patient population, POM + LoDEX prolonged progression-free survival (PFS) compared with POM alone (Richardson et al, Blood, 2014) and provided a PFS and overall survival (OS) benefit compared with high-dose DEX alone (San Miguel et al, Lancet Oncol, 2013), while demonstrating an acceptable safety profile. To evaluate the safety and efficacy of POM + LoDEX in Asian patients with RRMM, an additional study enrolling only Japanese patients was conducted.
Aims
This multicenter, single-arm, open-label phase 2 trial (MM-011) aimed to evaluate the efficacy and safety of POM + LoDEX in Japanese patients with RRMM.
Methods
Patients with progressive disease on or within 60 days of their last prior therapy and who had received ≥ 2 prior therapies, including ≥ 2 cycles of lenalidomide and of bortezomib (either separately or in combination) were included. Patients received oral POM 4 mg per day on days 1-21 and oral LoDEX 40 mg per day (20 mg if aged > 75 years) on days 1, 8, 15, and 22, and the course was repeated every 28 days until disease progression, unacceptable toxicity, or withdrawal. The primary endpoint was overall response rate (ORR; ≥ partial response) of POM + LoDEX according to the International Myeloma Working Group criteria. All pts provided written informed consent.
Results
Thirty-six patients were enrolled between December 2013 and July 2014 at 13 sites in Japan. The median age of patients was 64.5 years (range, 43-78 years); 11% were aged > 75 years. Patients received a median of 6.5 prior anti-myeloma regimens (range, 2-15) and had a high tumor burden (81% had Durie-Salmon stage II or III disease). Thirty-five patients (97%) were refractory to lenalidomide, and 21 patients (58%) were refractory to both lenalidomide and bortezomib.At the data cutoff (February 3, 2015), 16 patients (44%) remained on treatment, and study drugs were discontinued in 20 patients due to disease progression (n = 14 [39%]), adverse event (AE; n = 2 [6%]), death (n = 1 [3%]), and other reasons (n = 3 [8%]). The ORR was 42% (n = 15 [95% CI, 26% - 58%]), including complete response in 3% (n = 1) and partial response in 39% (n = 14) of patients. Median PFS was 10.1 months (median follow-up, 7.7 months), and at a data cutoff of September 25, 2015, 1-year OS was 58.5% (median follow-up, 11.3 months). In the 15 responders, median time to response was 1.9 months (range, 0.9-5.5 months), and median duration of response was not reached.The most common grade 3/4 hematologic AEs were neutropenia (n = 23 [64%]), anemia (n = 15 [42%]), and thrombocytopenia (n = 11 [31%]). Pneumonia (n = 3 [8%]) and decreased appetite (n = 3 [8%]) were the most common grade 3/4 non-hematologic AEs. Peripheral neuropathy (all grades) occurred in 8% (n = 3) of patients. No deep vein thrombosis or pulmonary embolism was reported. Overall, AEs were similar to those seen in other POM studies, and no new significant AEs were reported in patients in this study. Nine patients died on study (or within 28 days of the last dose of study drug), 8 due to multiple myeloma and 1 due to AE (pneumonia and aggravated asthma, suspected to be related to study drug).
Conclusion
POM + LoDEX is an effective treatment in heavily pretreated Japanese patients with RRMM, with an acceptable safety profile that is comparable to those seen on POM studies in RRMM in other regions.
Session topic: E-poster
{{ help_message }}
{{filter}}