Siegel, David S.
https://orcid.org/0000-0002-3604-2574
Mayo Clinic
Hackensack University Medical Center
Citations 112
Impact of gene expression profiling-based risk stratification in patients with myeloma receiving initial therapy with lenalidomide and dexamethasone
Kumar, Shaji , Uno, Hajime , Jacobus, Susanna , Wier, Scott A. Van, Ahmann, Greg, Henderson, Kimberly J., Haug, Jessica, Greipp, Philip R., Fonseca, Rafaël , Rajkumar, S. Vincent , Callander, Natalie S. , Siegel, David S. , Rajkumar, S Vincent , Uno, Hajime , Fonseca, Rafael
Blood | August 23, 2011 | Volume: 118 | Issue: 16 | Pages: 4359-4362
Abstract Detection of specific chromosomal abnormalities by FISH and metaphase cytogenetics allows risk stratification in multiple myeloma; however, gene expression profiling (GEP) based signatures may enable more specific risk categorization. We examined the utility of 2 GEP-based risk stratification systems among patients undergoing initial therapy with lenalidomide in the context of a phase 3 trial. Among 45 patients studied at baseline, 7 (16%) and 10 (22%), respectively, were high-risk using the GEP70 and GEP15 signatures. The median overall survival for the GEP70 high-risk group was 19 months versus not reached for the rest (hazard ratio = 14.1). Although the medians were not reached, the GEP15 also predicted a poor outcome among the high-risk patients. The C-statistic for the GEP70, GEP15, and FISH based risk stratification systems was 0.74, 0.7, and 0.7, respectively. Here we demonstrate the prognostic value for GEP risk stratification in a group of patients primarily treated with novel agents. This trial was registered at www.clinicaltrials.gov as #NCT00098475.
Consensus recommendations for the uniform reporting of clinical trials: report of the International Myeloma Workshop Consensus Panel 1
Rajkumar, S. Vincent , Harousseau, Jean‐Luc, Durie, Brian G.M. , Dimopoulos, Meletios Α. , Kyle, Robert A. , Bladé, Joan , Richardson, Paul G. , Orlowski, Robert Z. , Avet‐Loiseau, Hervé , Palumbo, Antonio , Zonder, Jeffrey A. , Vesole, David H., Sezer, Orhan , Munshi, Nikhil C. , Miguel, Jesús F. San , 1, on behalf of the International Myeloma Workshop Consensus Panel, Cavo, Michèle , García‐Sánz, Ramón , Anderson, Kenneth C. , Richardson, Paul Gerard Guy , Orlowski, Robert Z. , Siegel, David S. , Jagannath, Sundar , Facon, Thierry T.F. , Lonial, Sagar , Ludwig, Heinz , 1, on behalf of the International Myeloma Workshop Consensus Panel, Rajkumar, S Vincent , Dimopoulos, Meletios A , San-Miguel, Jesus , Garcia-Sanz, Ramon
Blood | February 4, 2011 | Volume: 117 | Issue: 18 | Pages: 4691-4695
Abstract It is essential that there be consistency in the conduct, analysis, and reporting of clinical trial results in myeloma. The goal of the International Myeloma Workshop Consensus Panel 1 was to develop a set of guidelines for the uniform reporting of clinical trial results in myeloma. This paper provides a summary of the current response criteria in myeloma, detailed definitions for patient populations, lines of therapy, and specific endpoints. We propose that future clinical trials in myeloma follow the guidelines for reporting results proposed in this manuscript.