BACKGROUND:Lenalidomide, an oral immunomodulatory drug that is similar to thalidomide but has a different safety profile, has clinical activity in relapsed or refractory multiple myeloma. METHODS:Patients in the United States and Canada who had received at least one previous therapy for multiple myeloma but who required additional treatment were randomly assigned to receive either 25 mg of lenalidomide or placebo on days 1 to 21 of a 28-day cycle. Both groups also received 40 mg of oral dexamethasone on days 1 to 4, 9 to 12, and 17 to 20 for the first four cycles. After the fourth cycle, 40 mg of dexamethasone was administered only on days 1 to 4. Safety, clinical response, time to progression, and overall survival were assessed. RESULTS: We assigned 177 patients to the lenalidomide group and 176 to theplacebo group. Complete, near-complete, or partial responses occurred in 108 patients (61.0%) in the lenalidomide group and in 35 patients (19.9%) in the placebo group (P<0.001); complete responses occurred in 14.1% and 0.6%, respectively (P<0.001). The median time to progression was 11.1 months in the lenalidomide group and 4.7 months in the placebo group (P<0.001). Median overall survival times in the two groups were 29.6 months and 20.2 months, respectively (P<0.001). Grade 3 or 4 adverse events were reported in 85.3% of the lenalidomide group and in 73.1% of the placebo group; these events resulted in study discontinuation in 19.8% and 10.2%, respectively. Grade 3 or 4 neutropenia and venous thromboembolism were more common in the lenalidomide group than in the placebo group (41.2% vs. 4.6% and 14.7% vs. 3.4%, respectively; P<0.001 for both comparisons). CONCLUSIONS:Lenalidomide plus dexamethasone is superior to placebo plus dexamethasone in patients with relapsed or refractory multiple myeloma. (ClinicalTrials.gov number, NCT00056160 [ClinicalTrials.gov].). Copyright 2007 Massachusetts Medical Society.
RCT Entities:
BACKGROUND:Lenalidomide, an oral immunomodulatory drug that is similar to thalidomide but has a different safety profile, has clinical activity in relapsed or refractory multiple myeloma. METHODS:Patients in the United States and Canada who had received at least one previous therapy for multiple myeloma but who required additional treatment were randomly assigned to receive either 25 mg of lenalidomide or placebo on days 1 to 21 of a 28-day cycle. Both groups also received 40 mg of oral dexamethasone on days 1 to 4, 9 to 12, and 17 to 20 for the first four cycles. After the fourth cycle, 40 mg of dexamethasone was administered only on days 1 to 4. Safety, clinical response, time to progression, and overall survival were assessed. RESULTS: We assigned 177 patients to the lenalidomide group and 176 to the placebo group. Complete, near-complete, or partial responses occurred in 108 patients (61.0%) in the lenalidomide group and in 35 patients (19.9%) in the placebo group (P<0.001); complete responses occurred in 14.1% and 0.6%, respectively (P<0.001). The median time to progression was 11.1 months in the lenalidomide group and 4.7 months in the placebo group (P<0.001). Median overall survival times in the two groups were 29.6 months and 20.2 months, respectively (P<0.001). Grade 3 or 4 adverse events were reported in 85.3% of the lenalidomide group and in 73.1% of the placebo group; these events resulted in study discontinuation in 19.8% and 10.2%, respectively. Grade 3 or 4 neutropenia and venous thromboembolism were more common in the lenalidomide group than in the placebo group (41.2% vs. 4.6% and 14.7% vs. 3.4%, respectively; P<0.001 for both comparisons). CONCLUSIONS:Lenalidomide plus dexamethasone is superior to placebo plus dexamethasone in patients with relapsed or refractory multiple myeloma. (ClinicalTrials.gov number, NCT00056160 [ClinicalTrials.gov].). Copyright 2007 Massachusetts Medical Society.
Authors: Hakan Kaya; Benjamin Peressini; Irfan Jawed; Danko Martincic; Ameer L Elaimy; Wayne T Lamoreaux; Robert K Fairbanks; Kevin A Weeks; Christopher M Lee Journal: Int J Hematol Date: 2011-12-09 Impact factor: 2.490
Authors: Suzanne Lentzsch; Amy O'Sullivan; Ryan C Kennedy; Mohammad Abbas; Lijun Dai; Silvana Lalo Pregja; Steve Burt; Michael Boyiadzis; G David Roodman; Markus Y Mapara; Mounzer Agha; John Waas; Yongli Shuai; Daniel Normolle; Jeffrey A Zonder Journal: Blood Date: 2012-03-26 Impact factor: 22.113
Authors: Katarina Luptakova; Jacalyn Rosenblatt; Brett Glotzbecker; Heidi Mills; Dina Stroopinsky; Turner Kufe; Baldev Vasir; Jon Arnason; Dimitri Tzachanis; Jeffrey I Zwicker; Robin M Joyce; James D Levine; Kenneth C Anderson; Donald Kufe; David Avigan Journal: Cancer Immunol Immunother Date: 2012-06-24 Impact factor: 6.968
Authors: Rafael Fonseca; Paul Richardson; Sergio Giralt; Sagar Lonial; S Vincent Rajkumar; A Keith Stewart; William Bensinger; George Somlo; Robert Vescio; Joseph Mikhael; Craig Reeder; Rodger Tiedemann; Guido Tricot; Robert Rifkin; John Shaughnessy; Nikhil Munshi; Noopur Raje; Irene Ghobrial; Jacob Laubach; Robert Schlossman; Steven Treon; Anuj Mahindra; David Avigan; Jacalyn Rosenblatt; Sundar Jagannath; Ruben Niesvizky; Heather Landau; Selina Chen-Kiang; David S Siegel; Todd Zimmerman; Jayesh Mehta; David Vesole; Steven Rosen; Craig Hofmeister; Martha Lacy; Angela Dispenzieri; Ivan Borrello; Suzanne R Hayman; Shaji Kumar; Frances Buadi; David Dingli; Stephen Russell; Melissa Alsina Melissa Alsina; Hugo Fernandez; Vivek Roy; Denise Pereira; Edward Stadtmauer; Ravi Vij; Andrzej Jakubowiak; Suzanne Lentzsch; Kevin Song; Suzanne Trudel; Christine Chen; Donna Reece; Douglas Stewart; Seema Singhal; Raymond Comenzo; Morie A Gertz; Philip R Greipp; Brian Durie; Bart Barlogie; Kenneth Anderson; William Dalton; Morton Coleman; Susie Novis; Robert A Kyle Journal: Mayo Clin Proc Date: 2010-02 Impact factor: 7.616
Authors: Alan R Katritzky; C Dennis Hall; Bahaa El-Dien M El-Gendy; Bogdan Draghici Journal: J Comput Aided Mol Des Date: 2010-05-20 Impact factor: 3.686
Authors: Jatin J Shah; Edward A Stadtmauer; Rafat Abonour; Adam D Cohen; William I Bensinger; Cristina Gasparetto; Jonathan L Kaufman; Suzanne Lentzsch; Dan T Vogl; Christina L Gomes; Natalia Pascucci; David D Smith; Robert Z Orlowski; Brian G M Durie Journal: Blood Date: 2015-09-17 Impact factor: 22.113