Randomized Trial of Lenalidomide Versus Observation in Smoldering Multiple Myeloma
Year: 2019
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
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 to the observation arm. Median follow-up is 35 months. Response to therapy was observed in 50% (95% CI, 39% to 61%) of patients in the lenalidomide arm, with no responses in the observation arm. Progression-free survival was significantly longer with lenalidomide compared with observation (hazard ratio, 0.28; 95% CI, 0.12 to 0.62; P = .002). One-, 2-, and 3-year progression-free survival was 98%, 93%, and 91% for the lenalidomide arm versus 89%, 76%, and 66% for the observation arm, respectively. Only six deaths have been reported, two in the lenalidomide arm versus four in the observation arm (hazard ratio for death, 0.46; 95% CI, 0.08 to 2.53). Grade 3 or 4 nonhematologic adverse events occurred in 25 patients (28%) on lenalidomide. CONCLUSION Early intervention with lenalidomide in smoldering multiple myeloma significantly delays progression to symptomatic multiple myeloma and the development of end-organ damage.
Source: Journal of Clinical Oncology
DOI: 10.1200/jco.19.01740
Authors: Sagar Lonial, Susanna Jacobus, Rafael Fonseca, Matthias Weiss, Shaji Kumar, Robert Z. Orlowski, Jonathan L. Kaufman, Abdulraheem M. Yacoub, Francis K. Buadi, Timothy O’Brien, Jeffrey V. Matous, Daniel M. Anderson, Robert V. Emmons, Anuj Mahindra, Lynne I. Wagner, Madhav V. Dhodapkar, S. Vincent Rajkumar
Institutions: Emory University, Dana-Farber Cancer Institute, Mayo Clinic, Mayo Clinic in Arizona, ThedaCare, The University of Texas MD Anderson Cancer Center, The University of Kansas Cancer Center, MetroHealth Medical Center, Colorado Blood Cancer Institute, Park Nicollet Clinic, University of Louisville, Scripps Clinic, Wake Forest University Health Sciences
Language: English
Subfield: Hematology
Field: Medicine
Domain: Health Sciences
Open Access status: green
Awards: G1000381934, G1016754749, G1044130170, G111615301, G1141282278, G1489263424, G182302839, ECOG-ACRIN Network Group Operations Center, G1938688226, G2056719604, G2269554244, Western States Cancer Research NCORP, G3475623468, G363982925, SWOG Network Group Operations Center of the NCTN, ECOG-ACRIN NCORP Research Base, ECOG-ACRIN Network Group Statistics and Data Management Center, G686564698, Yale Cancer Center NCTN, G7415956581, Cancer Center Support Grant, Yale Clinical and Translational Science Award
OpenAlex ID: W2981617674