Abstract
Pomalidomide is a third generation immunomodulatory drug which in combination with dexamethasone, has been shown to be active in relapsed/refractory multiple myeloma. However, the data in Asian patients remain limited. We conducted a prospective phase two clinical trial in major cancer centers in Singapore, South Korea, Taiwan, Japan and Hong Kong to assess the efficacy and safety of pomalidomide and dexamethasone combination (PomDex) +/− cyclophosphamide in Asian patients with relapsed/refractory multiple myeloma who failed lenalidomide and bortezomib. Patients were treated with pomalidomide (4 mg daily for 21 days every 4 weeks) and dexamethasone (40 mg weekly). If there is less than a minimal response after three cycles of PomDex, cyclophosphamide 300 mg/m2 can be added (PomCyDex). A total of 136 patients were enrolled. The median PFS was 9 and 10.8 months for the PomDex and PomCyDex group, respectively. The median OS was 16.3 months. This regimen appears to be active across age groups and prior lines of treatment. This combination was overall well tolerated with grade 3 and 4 adverse events of mainly cytopenias. PomDex is highly active and well-tolerated in Asian patients. The addition of cyclophosphamide can improve the response and outcomes further in patients with suboptimal response to PomDex.
Highlights
Multiple myeloma (MM) is a hematological malignancy characterized by clonal expansion of plasma cells in the bone marrow1
This study showed that the use of pomalidomide and low-dose dexamethasone improved the median progression-free survival (PFS) of these patients compared to high-dose dexamethasone alone (4.0 months vs. 1.9 months; hazard ratio = 0·48; p < 0·0001)7
Our study aimed to evaluate the efficacy of the addition of weekly cyclophosphamide to pomalidomide and dexamethasone combination (PomCyDex) for patients who had minimal response (MR) or progressive disease with PomDex
Summary
Multiple myeloma (MM) is a hematological malignancy characterized by clonal expansion of plasma cells in the bone marrow1. We undertook a prospective phase 2 study to assess the efficacy and safety of pomalidomide and dexamethasone combination (PomDex) in Asian patients with relapsed and/or refractory MM who had failed lenalidomide and relapsed from previous treatment with bortezomib.
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