期刊
FUTURE ONCOLOGY
卷 16, 期 11, 页码 631-641出版社
FUTURE MEDICINE LTD
DOI: 10.2217/fon-2020-0024
关键词
alkylating agent; melflufen; MM; multiple myeloma; Phase III study; relapsed refractory multiple myeloma; RRMM
类别
资金
- Oncopeptides AB
- Celgene
Melflufen is a novel peptide-drug conjugate that rapidly delivers a cytotoxic payload into tumor cells. It has emerged as a potential new multiple myeloma treatment, particularly for late-stage forms of the disease. Here we describe the rationale and design of OCEAN (NCT03151811), a randomized, head-to-head, superiority, open-label, global, Phase III study evaluating the efficacy and safety of melflufen + dexamethasone versus pomalidomide + dexamethasone. Eligible patients with relapsed refractory multiple myeloma have received 2-4 previous treatments and are refractory to both lenalidomide and their last treatment. Patients are excluded if they have previously received pomalidomide. The primary endpoint is progression-free survival, and key secondary endpoints include overall response rate, duration of response and overall survival.
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