Abstract
In this report, a panel of European myeloma experts discuss the role of pomalidomide in the treatment of relapsed and refractory multiple myeloma (RRMM). Based on the available evidence, the combination of pomalidomide and low-dose dexamethasone is a well-tolerated and effective treatment option for patients with RRMM who have exhausted treatment with lenalidomide and bortezomib. The optimal starting dose of pomalidomide is 4 mg given on days 1–21 of each 28-day cycle, whereas dexamethasone is administered at a dose of 40 mg weekly (reduced to 20 mg for patients aged >75 years). The treatment should continue until evidence of disease progression or unacceptable toxicity. Dose-modification schemes have been established for patients who develop neutropenia, thrombocytopaenia and other grade 3–4 adverse events during pomalidomide therapy. Guidance on the prevention and management of infections and venous thromboembolism is provided, based on the available clinical evidence and the experience of panel members. The use of pomalidomide in special populations, such as patients with advanced age, renal impairment or unfavourable cytogenetic features, is also discussed.
Highlights
Despite recent treatment advances, multiple myeloma (MM)remains an incurable disease in the majority of patients.The management of patients who have already received multiple prior therapies poses a distinct clinical challenge.[1]
With a median follow-up of 10 months, pomalidomide plus low-dose dexamethasone decreased the rate of progression by 52% (PFS 4.0 vs 1.9 months; hazard ratio (HR) 1⁄4 0.48; 95% confidence interval (CI) 0.39–0.60; Po0.001) and significantly improved overall survival (OS) (12.7 vs 8.1 months; HR 1⁄4 0.74; 95% CI 0.56–0.97; P 1⁄4 0.03)
In 200 consecutive MM patients treated with lenalidomide at a single institution, the incidence of Venous thromboembolism (VTE) was higher in previously untreated patients than in refractory multiple myeloma (RRMM) patients (9.4% vs 4.5%); among RRMM patients, the incidence of VTE was increased in patients aged 465 years compared with younger patients (8.1% vs 1.6%), despite increased use of low-molecular-weight heparin or vitamin K antagonists in older patients.[84]
Summary
Remains an incurable disease in the majority of patients. The management of patients who have already received multiple prior therapies poses a distinct clinical challenge.[1]. Immunomodulatory compounds, erythropoietin) and patientrelated factors (obesity, prior VTE, central venous catheter or pacemaker, infection, immobilisation, surgery, trauma, organ dysfunction, blood-clotting disorders).[82,83] In a large multicentre observational study (MELISSE), factors that predicted VTE in MM patients treated with immunomodulatory drugs (thalidomide or lenalidomide) include shorter time from diagnosis and concomitant use of erythropoietin.[79] Evidence suggested that development of deep vein thrombosis was unlikely to negatively affect survival outcomes.[79] In 200 consecutive MM patients treated with lenalidomide at a single institution, the incidence of VTE was higher in previously untreated patients than in RRMM patients (9.4% vs 4.5%); among RRMM patients, the incidence of VTE was increased in patients aged 465 years compared with younger patients (8.1% vs 1.6%), despite increased use of low-molecular-weight heparin or vitamin K antagonists in older patients.[84] In the 108 patients who received aspirin prophylaxis, a single-nucleotide polymorphism in the NFkB1 gene was identified that was associated with increased risk of VTE.[84] From a practical point of view, in patients treated with pomalidomide and low-dose dexamethasone, the main high-risk features for VTE are: a history of prior VTE, immobilisation and concomitant use of an erythropoiesis-stimulating agent. No dose adjustments of pomalidomide according to age are required Reduce the dose of dexamethasone to 20 mg weekly in patients 475 years of age
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