Lenalidomide maintenance extends PFS in multiple myeloma after transplantation

NEW ORLEANS — Patients with multiple myeloma who underwent a first-line autologous stem-cell transplant and received maintenance lenalidomide demonstrated benefits in PFS but not OS, according to results of a phase 3 study presented at the ASH Annual Meeting and Exposition.

The analysis included 614 patients aged younger than 65 years who were assigned 10 mg to 15 mg a day maintenance lenalidomide (Revlimid, Celgene) or placebo until disease progression or unacceptable toxicity.

Median follow-up was 60 months. Overall, 403 patients had disease progression and 364 started a second-line therapy.

Five-year PFS was significantly improved with lenalidomide compared with placebo (42% vs. 18%; P<.0001).

The median second PFS — defined as time from progression in first-line therapy to the second progression, last follow-up or death — was 10 months in the lenalidomide arm and 18 months in the placebo arm (P<.0001).

Five-year OS was 68% in the lenalidomide arm and 67% in the placebo arm.

In a multivariate analysis, OS was significantly associated with age (P=.001), International Staging System stage (P=.03) and poor cytogenetics (P=.008).

Median OS after first progression was 29 months in the lenalidomide arm vs. 48 months in the placebo arm (P<.0001).

The incidence of secondary malignancies was higher in the lenalidomide arm (44 cases in 35 patients vs. 28 cases in 20 patients).

“The correct conclusion to draw from this is that the benefit of lenalidomide is an early benefit,” researcher Michel Attal, MD, of the Centre Hospitalier Regional Universitaire Hôpital Purpan in Toulouse, France, said during a presentation. “Even if you stop it after 24 months, you can obtain and observe PFS after 72 months. The benefit which you are able to gain with lenalidomide maintenance is already obtained after 2 years.”

For more information:
Attal M. Abstract #406. Presented at: ASH Annual Meeting and Exposition; Dec. 7-10, 2013; New Orleans.

Disclosure: The researchers report honoraria from and speakers’ bureau roles with Celgene and Janssen.