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A multicenter phase 2 study of pomalidomide plus dexamethasone in patients with relapsed and refractory multiple myeloma: the Japanese MM-011 trial.

Ichinohe T, Kuroda Y, Okamoto S, Matsue K, Iida S, Sunami K, Komeno T, Suzuki K, Ando K, Taniwaki M, Tobinai K, Chou T, Kaneko H, Iwasaki H, Uemura C, Tamakoshi H, Zaki MH, Doerr T, Hagiwara S - Exp Hematol Oncol (2016)

Bottom Line: The most frequent grade ≥3 adverse events (AEs) were neutropenia (64 %), anemia (42 %), and thrombocytopenia (31 %).The most frequent nonhematologic grade ≥3 AEs were pneumonia and decreased appetite (8 % each).Collectively, the results of this study demonstrate that pomalidomide plus low-dose dexamethasone is an effective and safe treatment for Japanese patients with RRMM, although careful attention needs to be paid to serious infections.

View Article: PubMed Central - PubMed

Affiliation: Department of Hematology and Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, 1-2-3 Kasumi, Minami-Ku, Hiroshima 734-8553 Japan.

ABSTRACT

Background: The immunomodulatory agent pomalidomide in combination with low-dose dexamethasone has demonstrated efficacy and safety for the treatment of relapsed and refractory multiple myeloma (RRMM) in phase 2 and 3 trials. However, these trials enrolled very few Asian patients.

Methods: This phase 2 study investigated pomalidomide plus low-dose dexamethasone in 36 Japanese patients with RRMM after ≥2 prior therapies.

Results: Patients enrolled in the study had a relatively high disease burden (81 % Durie-Salmon stage II or III) and were heavily pretreated (median, 6.5 prior antimyeloma regimens). The overall response rate was 42 % (1 patient with complete response and 14 with partial response), with an additional 44 % (16 patients) achieving stable disease (SD). Response rates in patients aged ≤65 years and >65 years were 47 and 35 %, respectively. None of the five patients with extramedullary disease achieved a response, with three of them maintaining SD of short duration. Median progression-free survival was 10.1 months after a 7.7-month median follow-up, and the median overall survival was not reached. The most frequent grade ≥3 adverse events (AEs) were neutropenia (64 %), anemia (42 %), and thrombocytopenia (31 %). The most frequent nonhematologic grade ≥3 AEs were pneumonia and decreased appetite (8 % each). Adverse events in patients aged >65 years were similar to those in patients aged ≤65 years, except for a higher rate of grade ≥3 pneumonia.

Conclusions: Collectively, the results of this study demonstrate that pomalidomide plus low-dose dexamethasone is an effective and safe treatment for Japanese patients with RRMM, although careful attention needs to be paid to serious infections.

Trial registration: Clinicaltrials.gov NCT02011113.

No MeSH data available.


Related in: MedlinePlus

Patient screening, enrollment, and follow-up in the trial
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Fig1: Patient screening, enrollment, and follow-up in the trial

Mentions: A total of 36 patients were enrolled between December 2013 and July 2014 at 13 sites in Japan; all patients were of Asian origin (Fig. 1). The median age was 64.5 years, and 11 % of the patients were aged >75 years (Table 1). The median time from first diagnosis was 4.7 years. Five patients (14 %) presented with extramedullary plasmacytoma in bone (n = 4) and liver (n = 1). Patients had a relatively high disease burden, including Durie–Salmon stage II or III disease in 81 %, and were heavily pretreated, with a median of 6.5 prior antimyeloma regimens. All but 1 patient (97 %) were refractory to lenalidomide, and 58 % were refractory to both lenalidomide and bortezomib.Fig. 1


A multicenter phase 2 study of pomalidomide plus dexamethasone in patients with relapsed and refractory multiple myeloma: the Japanese MM-011 trial.

Ichinohe T, Kuroda Y, Okamoto S, Matsue K, Iida S, Sunami K, Komeno T, Suzuki K, Ando K, Taniwaki M, Tobinai K, Chou T, Kaneko H, Iwasaki H, Uemura C, Tamakoshi H, Zaki MH, Doerr T, Hagiwara S - Exp Hematol Oncol (2016)

Patient screening, enrollment, and follow-up in the trial
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4835896&req=5

Fig1: Patient screening, enrollment, and follow-up in the trial
Mentions: A total of 36 patients were enrolled between December 2013 and July 2014 at 13 sites in Japan; all patients were of Asian origin (Fig. 1). The median age was 64.5 years, and 11 % of the patients were aged >75 years (Table 1). The median time from first diagnosis was 4.7 years. Five patients (14 %) presented with extramedullary plasmacytoma in bone (n = 4) and liver (n = 1). Patients had a relatively high disease burden, including Durie–Salmon stage II or III disease in 81 %, and were heavily pretreated, with a median of 6.5 prior antimyeloma regimens. All but 1 patient (97 %) were refractory to lenalidomide, and 58 % were refractory to both lenalidomide and bortezomib.Fig. 1

Bottom Line: The most frequent grade ≥3 adverse events (AEs) were neutropenia (64 %), anemia (42 %), and thrombocytopenia (31 %).The most frequent nonhematologic grade ≥3 AEs were pneumonia and decreased appetite (8 % each).Collectively, the results of this study demonstrate that pomalidomide plus low-dose dexamethasone is an effective and safe treatment for Japanese patients with RRMM, although careful attention needs to be paid to serious infections.

View Article: PubMed Central - PubMed

Affiliation: Department of Hematology and Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, 1-2-3 Kasumi, Minami-Ku, Hiroshima 734-8553 Japan.

ABSTRACT

Background: The immunomodulatory agent pomalidomide in combination with low-dose dexamethasone has demonstrated efficacy and safety for the treatment of relapsed and refractory multiple myeloma (RRMM) in phase 2 and 3 trials. However, these trials enrolled very few Asian patients.

Methods: This phase 2 study investigated pomalidomide plus low-dose dexamethasone in 36 Japanese patients with RRMM after ≥2 prior therapies.

Results: Patients enrolled in the study had a relatively high disease burden (81 % Durie-Salmon stage II or III) and were heavily pretreated (median, 6.5 prior antimyeloma regimens). The overall response rate was 42 % (1 patient with complete response and 14 with partial response), with an additional 44 % (16 patients) achieving stable disease (SD). Response rates in patients aged ≤65 years and >65 years were 47 and 35 %, respectively. None of the five patients with extramedullary disease achieved a response, with three of them maintaining SD of short duration. Median progression-free survival was 10.1 months after a 7.7-month median follow-up, and the median overall survival was not reached. The most frequent grade ≥3 adverse events (AEs) were neutropenia (64 %), anemia (42 %), and thrombocytopenia (31 %). The most frequent nonhematologic grade ≥3 AEs were pneumonia and decreased appetite (8 % each). Adverse events in patients aged >65 years were similar to those in patients aged ≤65 years, except for a higher rate of grade ≥3 pneumonia.

Conclusions: Collectively, the results of this study demonstrate that pomalidomide plus low-dose dexamethasone is an effective and safe treatment for Japanese patients with RRMM, although careful attention needs to be paid to serious infections.

Trial registration: Clinicaltrials.gov NCT02011113.

No MeSH data available.


Related in: MedlinePlus