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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

Treatment exposure and response duration of the enrolled patients. CR complete response, PD progressive disease, PR partial response, SD stable disease, VGPR very good partial response
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Fig2: Treatment exposure and response duration of the enrolled patients. CR complete response, PD progressive disease, PR partial response, SD stable disease, VGPR very good partial response

Mentions: All 36 patients received study treatment and were evaluable for efficacy. The overall response rate (ORR) was 42 % (15 patients; 95 % CI, 26–58 %), with 1 patient (3 %) achieving a complete response (CR) and 14 patients (39 %) achieving a partial response (PR; Table 2). Stable disease (SD) was recorded as the best response in 16 patients (44 %). Of these 36 evaluable patients, final pomalidomide doses at the last follow-up were 4 mg in 27 patiens, 3 mg in seven patients, and 2 mg in two patients with ORR of 44 % (12/27 patients, 1 CR and 11 PRs), 43 % (3/7 patients, all PRs) and 0 % in each dose group, respectively (Table 3). The median time to first response was 1.9 months, including 2 patients whose response improved from SD after ≥4 cycles of treatment (Fig. 2). The median duration of response (DOR) was not reached (95 % CI, 4.6 months-not estimable). After a median follow-up of 7.7 months, the median PFS was 10.1 months (Fig. 3). A prespecified final OS analysis was conducted using a data cutoff of September 25, 2015; after median follow-up of 11.3 months, the 1-year OS was 58.5 %.Table 2


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)

Treatment exposure and response duration of the enrolled patients. CR complete response, PD progressive disease, PR partial response, SD stable disease, VGPR very good partial response
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

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

Fig2: Treatment exposure and response duration of the enrolled patients. CR complete response, PD progressive disease, PR partial response, SD stable disease, VGPR very good partial response
Mentions: All 36 patients received study treatment and were evaluable for efficacy. The overall response rate (ORR) was 42 % (15 patients; 95 % CI, 26–58 %), with 1 patient (3 %) achieving a complete response (CR) and 14 patients (39 %) achieving a partial response (PR; Table 2). Stable disease (SD) was recorded as the best response in 16 patients (44 %). Of these 36 evaluable patients, final pomalidomide doses at the last follow-up were 4 mg in 27 patiens, 3 mg in seven patients, and 2 mg in two patients with ORR of 44 % (12/27 patients, 1 CR and 11 PRs), 43 % (3/7 patients, all PRs) and 0 % in each dose group, respectively (Table 3). The median time to first response was 1.9 months, including 2 patients whose response improved from SD after ≥4 cycles of treatment (Fig. 2). The median duration of response (DOR) was not reached (95 % CI, 4.6 months-not estimable). After a median follow-up of 7.7 months, the median PFS was 10.1 months (Fig. 3). A prespecified final OS analysis was conducted using a data cutoff of September 25, 2015; after median follow-up of 11.3 months, the 1-year OS was 58.5 %.Table 2

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