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Round Table Discussion on Optimal Clinical Trial Design in Precursor Multiple Myeloma.
Ghobrial, Irene M; Gormley, Nicole; Kumar, Shaji K; Mateos, Maria-Victoria; Bergsagel, P Leif; Chesi, Marta; Dhodapkar, Madhav V; Dispenzieri, Angela; Fonseca, Rafael; Getz, Gad; Kastritis, Efstathios; Kristinsson, Sigurdur Y; Martinez-Climent, Jose Angel; Manier, Salomon; Marinac, Catherine R; Maura, Francesco; Morgan, Gareth J; Davies, Faith E; Nadeem, Omar; Nuvolone, Mario; Paiva, Bruno; O'Donnell, Elizabeth; Prosper, Felipe; Shah, Urvi A; Sklavenitis-Pistofidis, Romanos; Sperling, Adam S; Vassiliou, George S; Munshi, Nikhil C; Castle, Philip E; Anderson, Kenneth C; San Miguel, Jesus F.
Affiliation
  • Ghobrial IM; Dana-Farber Cancer Institute, Boston, Massachusetts.
  • Gormley N; Division of Hematology, Food and Drug Administration, Silver Spring, Maryland.
  • Kumar SK; Division of Hematology, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota.
  • Mateos MV; Hospital Universitario de Salamanca, Instituto de Investigacion Biomedica de Salamanca (IBSAL), Centro de Investigación del Cancer (IBMCC-USAL, CSIC), CIBER-ONC number CB16/12/00233, Salamanca, Spain.
  • Bergsagel PL; Division of Hematology/Oncology, Mayo Clinic, Scottsdale, Arizona.
  • Chesi M; Division of Hematology/Oncology, Mayo Clinic, Scottsdale, Arizona.
  • Dhodapkar MV; Winship Cancer Institute of Emory University, Atlanta, Georgia.
  • Dispenzieri A; Division of Hematology, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota.
  • Fonseca R; Division of Hematology/Oncology, Mayo Clinic, Scottsdale, Arizona.
  • Getz G; Broad Institute of MIT and Harvard, Cambridge, Massachusetts.
  • Kastritis E; Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Athens, Greece.
  • Kristinsson SY; Faculty of Medicine, University of Iceland, Reykjavík, Iceland.
  • Martinez-Climent JA; Cancer Center Clinica Universidad de Navarra (CCUN), Centro de Investigacion Medica Aplicada (CIMA), Instituto de Investigacion Sanitaria de Navarra (IDISNA), CIBER-ONC numbers CB16/12/00369, CB16/12/00489, Pamplona, Spain.
  • Manier S; Hematology Department, CHU Lille, Lille University, INSERM UMR-S1277, Lille, France.
  • Marinac CR; Dana-Farber Cancer Institute, Boston, Massachusetts.
  • Maura F; Myeloma Division, Sylvester Comprehensive Cancer Center, University of Miami, Miami, Florida.
  • Morgan GJ; Myeloma Research Program, NYU Langone, Perlmutter Cancer Center, New York, New York.
  • Davies FE; Myeloma Research Program, NYU Langone, Perlmutter Cancer Center, New York, New York.
  • Nadeem O; Dana-Farber Cancer Institute, Boston, Massachusetts.
  • Nuvolone M; Department of Molecular Medicine, University of Pavia, Pavia, Italy.
  • Paiva B; Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
  • O'Donnell E; Cancer Center Clinica Universidad de Navarra (CCUN), Centro de Investigacion Medica Aplicada (CIMA), Instituto de Investigacion Sanitaria de Navarra (IDISNA), CIBER-ONC numbers CB16/12/00369, CB16/12/00489, Pamplona, Spain.
  • Prosper F; Dana-Farber Cancer Institute, Boston, Massachusetts.
  • Shah UA; Hematology Service and Cell Therapy Unit and Program of Hematology-Oncology CIMA, Clinica Universidad de Navarra, Cancer Center Clínica Universidad de Navarra (CCUN) and Instituto de Investigación Sanitaria de Navarra (IdISNA), Pamplona, Spain.
  • Sklavenitis-Pistofidis R; Centro de Investigación Biomedica en Red Cancer (CIBERONC) and RICORS TERAV, Madrid, Spain.
  • Sperling AS; Department of Medicine, Myeloma Service, Memorial Sloan Kettering Cancer Center, New York, New York.
  • Vassiliou GS; Dana-Farber Cancer Institute, Boston, Massachusetts.
  • Munshi NC; Broad Institute of MIT and Harvard, Cambridge, Massachusetts.
  • Castle PE; Dana-Farber Cancer Institute, Boston, Massachusetts.
  • Anderson KC; Wellcome-MRC Cambridge Stem Cell Institute, University of Cambridge, Cambridge, United Kingdom.
  • San Miguel JF; Department of Haematology, University of Cambridge, Cambridge, United Kingdom.
Blood Cancer Discov ; 5(3): 146-152, 2024 May 01.
Article in En | MEDLINE | ID: mdl-38441243
ABSTRACT

SUMMARY:

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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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Clinical Trials as Topic / Multiple Myeloma Limits: Humans Language: En Journal: Blood Cancer Discov Year: 2024 Document type: Article Country of publication:
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Clinical Trials as Topic / Multiple Myeloma Limits: Humans Language: En Journal: Blood Cancer Discov Year: 2024 Document type: Article Country of publication: