Open AccessPomalidomide alone or in combination with dexamethasone in Japanese patients with refractory or relapsed and refractory multiple myeloma
Author(s) -
Matsue Kosei,
Iwasaki Hiromi,
Chou Takaaki,
Tobinai Kensei,
Sunami Kazutaka,
Ogawa Yoshiaki,
Kurihara Mari,
Midorikawa Shuichi,
Zaki Mohamed,
Doerr Thomas,
Iida Shinsuke
Publication year - 2015
Publication title -
cancer science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.035
H-Index - 141
eISSN - 1349-7006
pISSN - 1347-9032
DOI - 10.1111/cas.12772
Subject(s) - pomalidomide , medicine , multiple myeloma , neutropenia , cohort , refractory (planetary science) , dexamethasone , lenalidomide , adverse effect , febrile neutropenia , gastroenterology , surgery , chemotherapy , physics , astrobiology
This phase 1, open‐label, dose‐escalation study investigated the tolerated dose (recommended dose), safety, efficacy, and pharmacokinetics of pomalidomide alone or pomalidomide plus low‐dose dexamethasone in Japanese patients with refractory or relapsed and refractory multiple myeloma. Twelve patients were enrolled. Patients received pomalidomide 2 mg (Cohort 1) or 4 mg (Cohort 2) orally on day 1 and days 3–21 of a 28‐day cycle. The tolerated dose of pomalidomide was determined to be 4 mg given on days 1–21 of a 28‐day cycle. Efficacy outcomes with pomalidomide plus low‐dose dexamethasone were consistent with those of previous studies. Responses (partial response or better) were achieved by three patients (25%; 1 [17%] in Cohort 1 and 2 [33%] in Cohort 2), and the median time to response was 6.4 months overall (9.0 months for Cohort 1 and 4.2 months for Cohort 2). The median progression‐free survival was 5.5 months overall (5.1 months for Cohort 1 and not reached for Cohort 2). The most frequently occurring grade ≥3 adverse events were neutropenia (67%), anemia (25%), lymphopenia (25%), and pneumonia (25%), consistent with previous studies of pomalidomide plus low‐dose dexamethasone in refractory or relapsed and refractory multiple myeloma. Further investigation of pomalidomide is recommended for Japanese patients with refractory or relapsed and refractory multiple myeloma. This study was registered with ClinicalTrials.gov ( NCT 01568294).