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Lenalidomide and low-dose dexamethasone in Japanese patients with newly diagnosed multiple myeloma: A phase II study
- Source :
- Cancer Science
- Publication Year :
- 2016
- Publisher :
- Wiley, 2016.
-
Abstract
- In the FIRST trial (MM-020), lenalidomide plus low-dose dexamethasone (Rd) reduced the risk of disease progression or death compared with combination melphalan-prednisone-thalidomide. As the FIRST trial did not include any Japanese patients, the efficacy and safety of continuous treatment with Rd was evaluated in 26 Japanese patients with newly diagnosed multiple myeloma (NDMM) in a single-arm, multicenter, open-label phase II trial (MM-025). Patients received lenalidomide on days 1-21 of each 28-day cycle, with a starting dose of 25 mg/day (dose adjusted for renal impairment), and 40 mg/day dexamethasone (dose adjusted for age) on days 1, 8, 15 and 22 of each 28-day cycle until disease progression or discontinuation for any reason. In the efficacy evaluable population, overall response rate was 87.5%, including 29.2% of patients who achieved a complete response/very good partial response. Median durations of response, progression-free survival and overall survival have not been reached. The most common grade 3-4 adverse events were neutropenia (23%) and anemia (19%). The efficacy and safety of Rd were consistent with data from larger studies, including the FIRST trial, thereby supporting the use of Rd continuous in Japanese patients with NDMM who are ineligible for stem cell transplantation.
- Subjects :
- Male
Oncology
Cancer Research
medicine.medical_specialty
lenalidomide
Population
Phases of clinical research
Kaplan-Meier Estimate
030204 cardiovascular system & hematology
Pharmacology
Neutropenia
Dexamethasone
03 medical and health sciences
0302 clinical medicine
Japan
Clinical Research
Internal medicine
medicine
Humans
education
Multiple myeloma
Aged
Lenalidomide
Aged, 80 and over
education.field_of_study
business.industry
Original Articles
General Medicine
Middle Aged
medicine.disease
Survival Analysis
Thalidomide
Discontinuation
multiple myeloma
Transplantation
030220 oncology & carcinogenesis
Japanese
Disease Progression
Original Article
Female
business
medicine.drug
Subjects
Details
- ISSN :
- 13479032
- Volume :
- 107
- Database :
- OpenAIRE
- Journal :
- Cancer Science
- Accession number :
- edsair.doi.dedup.....52059111c91ed828023737c8441236c0
- Full Text :
- https://doi.org/10.1111/cas.12916