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Positive Phase III Results for Linalidomide (Revlimid) in Asymptomatic Myeloma

Combo therapy with dexamethasone improves 3-year survival (August 1)

Positive results have been reported from a phase III study that evaluated lenalidomide (Revlimid, Celgene) in combination with dexamethasone followed by lenalidomide maintenance therapy in patients with high-risk asymptomatic smoldering multiple myeloma. The new findings were published in the August 1 issue of the New England Journal of Medicine.

Smoldering multiple myeloma is an early, asymptomatic form of the disease characterized by a 10%-per-year risk of progression to symptomatic disease during the first 5 years.

After a median follow-up period of 40 months, the median time to progression to symptomatic disease — the study’s primary endpoint —was significantly longer in the treatment group compared with the observation group (not reached vs. 21 months, respectively; hazard ratio [HR] = 0.18; P < 0.001). The 3-year overall survival rate from study enrollment was also higher in the treatment group compared with the observation group (94% vs. 80%, respectively; HR = 0.31; P = 0.03). A partial response was observed in 79% of the patients in the treatment group during induction, and in 90% during the maintenance phase.

The most common grade 3 adverse events (AEs) in the treatment arm included infection (6%), asthenia (6%), neutropenia (5%), and rash (3%). No grade 4 AEs were reported. One patient had a grade 5 AE, reported as a respiratory infection.

Sources: Celgene; August 1, 2013; and NEJM; August 1, 2013.

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