Randomized Trial of Lenalidomide Versus Observation in Smoldering Multiple Myeloma.

ABSTRACT:

Purpose

Observation is the current standard of care for smoldering multiple myeloma. We hypothesized that early intervention with lenalidomide could delay progression to symptomatic multiple myeloma.

Methods

We conducted a randomized trial that assessed the efficacy of single-agent lenalidomide compared with observation in patients with intermediate- or high-risk smoldering multiple myeloma. Lenalidomide was administered orally at a dose of 25 mg on days 1 to 21 of a 28-day cycle. The primary end point was progression-free survival, with disease progression requiring the development of end-organ damage attributable to multiple myeloma and biochemical progression.

Results

One hundred eighty-two patients were randomly assigned-92 patients to the lenalidomide arm and 90

SUBMITTER: Lonial S 

PROVIDER: S-EPMC7145586 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature