Round Table Discussion on Optimal Clinical Trial Design in Precursor Multiple Myeloma

Irene M Ghobrial; Nicole Gormley; Shaji K Kumar; Maria-Victoria Mateos; P Leif Bergsagel; Marta Chesi; Madhav V Dhodapkar; Angela Dispenzieri; Rafael Fonseca; Gad Getz; Efstathios Kastritis; Sigurdur Y Kristinsson; Jose Angel Martinez-Climent; Salomon Manier; Catherine R Marinac; Francesco Maura; Gareth J Morgan; Faith E Davies; Omar Nadeem; Mario Nuvolone; Bruno Paiva; Elizabeth O'Donnell; Felipe Prosper; Urvi A Shah; Romanos Sklavenitis-Pistofidis; Adam S Sperling; George S Vassiliou; Nikhil C Munshi; Philip E Castle; Kenneth C Anderson; Jesus F San Miguel

doi:10.1158/2643-3230.BCD-24-0022

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Round Table Discussion on Optimal Clinical Trial Design in Precursor Multiple Myeloma

Journal article

Peer reviewed

Round Table Discussion on Optimal Clinical Trial Design in Precursor Multiple Myeloma

Irene M Ghobrial, Nicole Gormley, Shaji K Kumar, Maria-Victoria Mateos, P Leif Bergsagel, Marta Chesi, Madhav V Dhodapkar, Angela Dispenzieri, Rafael Fonseca, Gad Getz, …

Blood cancer discovery, Vol.5(3), pp.146-152

2024-05-01

DOI: https://doi.org/10.1158/2643-3230.BCD-24-0022

PMID: 38441243

Appears in Miller School of Medicine - Latest Publications

Abstract

Clinical Trials as Topic - methods

Humans

Multiple Myeloma - drug therapy

Multiple Myeloma - therapy

Quality of Life

Research Design

While the current approach to precursor hematologic conditions is to "watch and wait," this may change with the development of therapies that are safe and extend survival or delay the onset of symptomatic disease. The goal of future therapies in precursor hematologic conditions is to improve survival and prevent or delay the development of symptomatic disease while maximizing safety. Clinical trial considerations in this field include identifying an appropriate at-risk population, safety assessments, dose selection, primary and secondary trial endpoints including surrogate endpoints, control arms, and quality-of-life metrics, all of which may enable more precise benefit-risk assessment.

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Title: Round Table Discussion on Optimal Clinical Trial Design in Precursor Multiple Myeloma
Creators: Irene M Ghobrial - Dana-Farber Cancer Institute
Nicole Gormley - United States Food and Drug Administration
Shaji K Kumar - Mayo Clinic
Maria-Victoria Mateos - Instituto de Investigación Biomédica de Salamanca
P Leif Bergsagel - Mayo Clinic in Arizona
Marta Chesi - Mayo Clinic in Arizona
Madhav V Dhodapkar - Emory University
Angela Dispenzieri - Mayo Clinic
Rafael Fonseca - Mayo Clinic in Arizona
Gad Getz - Broad Institute
Efstathios Kastritis - National and Kapodistrian University of Athens
Sigurdur Y Kristinsson - University of Iceland
Jose Angel Martinez-Climent - Centro de Investigación Biomédica en Red de Cáncer
Salomon Manier - Centre Hospitalier Universitaire de Lille
Catherine R Marinac - Dana-Farber Cancer Institute
Francesco Maura - Sylvester Comprehensive Cancer Center
Gareth J Morgan - NYU Langone Health
Faith E Davies - NYU Langone’s Laura and Isaac Perlmutter Cancer Center
Omar Nadeem - Dana-Farber Cancer Institute
Mario Nuvolone - Istituti di Ricovero e Cura a Carattere Scientifico
Bruno Paiva - Centro de Investigación Biomédica en Red de Cáncer
Elizabeth O'Donnell - Dana-Farber Cancer Institute
Felipe Prosper - Centro de Investigación Biomédica en Red de Cáncer
Urvi A Shah - Memorial Sloan Kettering Cancer Center
Romanos Sklavenitis-Pistofidis - Dana-Farber Cancer Institute
Adam S Sperling - Dana-Farber Cancer Institute
George S Vassiliou - Wellcome Sanger Institute
Nikhil C Munshi - Dana-Farber Cancer Institute
Philip E Castle - National Cancer Institute
Kenneth C Anderson - Dana-Farber Cancer Institute
Jesus F San Miguel - Centro de Investigación Médica Aplicada
Publication Details: Blood cancer discovery, Vol.5(3), pp.146-152
Grant note: P50 CA186781 / NCI NIH HHS K22 CA251648 / NCI NIH HHS P30 CA008748 / NCI NIH HHS K08 CA252174 / NCI NIH HHS
Academic Unit: Miller School of Medicine; UMMG Dept of Medicine - Hematology/Oncology
Language: English
Resource Type: Journal article
PMID: 38441243
Record Identifier: 991032860903202976