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Development of a Multivariable Model to Predict the Need for Bone Marrow Sampling in Persons With Monoclonal Gammopathy of Undetermined Significance : A Cohort Study Nested in a Clinical Trial.
Eythorsson, Elias; Rognvaldsson, Saemundur; Thorsteinsdottir, Sigrun; Einarsson Long, Thorir; Reed, Elin Ruth; Sigurdardottir, Gudrun Asta; Vidarsson, Brynjar; Onundarson, Pall Torfi; Agnarsson, Bjarni A; Sigurdardottir, Margret; Olafsson, Isleifur; Thorsteinsdottir, Ingunn; Sveinsdottir, Signy Vala; Sigurdsson, Fridbjorn; Thordardottir, Asdis Rosa; Palsson, Runolfur; Indridason, Olafur Skuli; Jonsson, Asbjorn; Gislason, Gauti Kjartan; Olafsson, Andri; Sigurdsson, Jon; Steingrimsdottir, Hlif; Hultcrantz, Malin; Durie, Brian G M; Harding, Stephen; Landgren, Ola; Aspelund, Thor; Love, Thorvardur Jon; Kristinsson, Sigurdur Yngvi.
Afiliación
  • Eythorsson E; Landspítali-The National University Hospital of Iceland and Faculty of Medicine, University of Iceland, Reykjavík, Iceland (E.E., S.R., P.T.O., B.A.A., R.P., O.S.I., S.Y.K.).
  • Rognvaldsson S; Landspítali-The National University Hospital of Iceland and Faculty of Medicine, University of Iceland, Reykjavík, Iceland (E.E., S.R., P.T.O., B.A.A., R.P., O.S.I., S.Y.K.).
  • Thorsteinsdottir S; Faculty of Medicine, University of Iceland, Reykjavík, Iceland, and Department of Hematology, Rigshospitalet, Copenhagen, Denmark (S.T.).
  • Einarsson Long T; Faculty of Medicine, University of Iceland, Reykjavík, Iceland, and Skåne University Hospital, Lund, Sweden (T.E.L.).
  • Reed ER; Faculty of Medicine, University of Iceland, Reykjavík, Iceland (E.R.R., G.A.S., A.R.T., G.K.G., A.O., J.S., T.J.L.).
  • Sigurdardottir GA; Faculty of Medicine, University of Iceland, Reykjavík, Iceland (E.R.R., G.A.S., A.R.T., G.K.G., A.O., J.S., T.J.L.).
  • Vidarsson B; Landspítali-The National University Hospital of Iceland, Reykjavík, Iceland (B.V., M.S., I.O., I.T., S.V.S., F.S., H.S.).
  • Onundarson PT; Landspítali-The National University Hospital of Iceland and Faculty of Medicine, University of Iceland, Reykjavík, Iceland (E.E., S.R., P.T.O., B.A.A., R.P., O.S.I., S.Y.K.).
  • Agnarsson BA; Landspítali-The National University Hospital of Iceland and Faculty of Medicine, University of Iceland, Reykjavík, Iceland (E.E., S.R., P.T.O., B.A.A., R.P., O.S.I., S.Y.K.).
  • Sigurdardottir M; Landspítali-The National University Hospital of Iceland, Reykjavík, Iceland (B.V., M.S., I.O., I.T., S.V.S., F.S., H.S.).
  • Olafsson I; Landspítali-The National University Hospital of Iceland, Reykjavík, Iceland (B.V., M.S., I.O., I.T., S.V.S., F.S., H.S.).
  • Thorsteinsdottir I; Landspítali-The National University Hospital of Iceland, Reykjavík, Iceland (B.V., M.S., I.O., I.T., S.V.S., F.S., H.S.).
  • Sveinsdottir SV; Landspítali-The National University Hospital of Iceland, Reykjavík, Iceland (B.V., M.S., I.O., I.T., S.V.S., F.S., H.S.).
  • Sigurdsson F; Landspítali-The National University Hospital of Iceland, Reykjavík, Iceland (B.V., M.S., I.O., I.T., S.V.S., F.S., H.S.).
  • Thordardottir AR; Faculty of Medicine, University of Iceland, Reykjavík, Iceland (E.R.R., G.A.S., A.R.T., G.K.G., A.O., J.S., T.J.L.).
  • Palsson R; Landspítali-The National University Hospital of Iceland and Faculty of Medicine, University of Iceland, Reykjavík, Iceland (E.E., S.R., P.T.O., B.A.A., R.P., O.S.I., S.Y.K.).
  • Indridason OS; Landspítali-The National University Hospital of Iceland and Faculty of Medicine, University of Iceland, Reykjavík, Iceland (E.E., S.R., P.T.O., B.A.A., R.P., O.S.I., S.Y.K.).
  • Jonsson A; Akureyri Hospital, Akureyri, Iceland (A.J.).
  • Gislason GK; Faculty of Medicine, University of Iceland, Reykjavík, Iceland (E.R.R., G.A.S., A.R.T., G.K.G., A.O., J.S., T.J.L.).
  • Olafsson A; Faculty of Medicine, University of Iceland, Reykjavík, Iceland (E.R.R., G.A.S., A.R.T., G.K.G., A.O., J.S., T.J.L.).
  • Sigurdsson J; Faculty of Medicine, University of Iceland, Reykjavík, Iceland (E.R.R., G.A.S., A.R.T., G.K.G., A.O., J.S., T.J.L.).
  • Steingrimsdottir H; Landspítali-The National University Hospital of Iceland, Reykjavík, Iceland (B.V., M.S., I.O., I.T., S.V.S., F.S., H.S.).
  • Hultcrantz M; Myeloma Service, Memorial Sloan Kettering Cancer Center, New York, New York (M.H.).
  • Durie BGM; Cedars-Sinai Samuel Oschin Cancer Center, Los Angeles, California (B.G.M.D.).
  • Harding S; The Binding Site, Birmingham, West Midlands, United Kingdom (S.H.).
  • Landgren O; Sylvester Comprehensive Cancer Center, University of Miami, Miami, Florida (O.L.).
  • Aspelund T; Center for Public Health Sciences, University of Iceland, Reykjavík, Iceland (T.A.).
  • Love TJ; Faculty of Medicine, University of Iceland, Reykjavík, Iceland (E.R.R., G.A.S., A.R.T., G.K.G., A.O., J.S., T.J.L.).
  • Kristinsson SY; Landspítali-The National University Hospital of Iceland and Faculty of Medicine, University of Iceland, Reykjavík, Iceland (E.E., S.R., P.T.O., B.A.A., R.P., O.S.I., S.Y.K.).
Ann Intern Med ; 177(4): 449-457, 2024 Apr.
Article en En | MEDLINE | ID: mdl-38560901
ABSTRACT

BACKGROUND:

Monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM) are asymptomatic precursor conditions to multiple myeloma and related disorders. Smoldering multiple myeloma is distinguished from MGUS by 10% or greater bone marrow plasma cells (BMPC) on sampling, has a higher risk for progression, and requires specialist management.

OBJECTIVE:

To develop a multivariable prediction model that predicts the probability that a person with presumed MGUS has 10% or greater BMPC (SMM or worse by bone marrow criteria) to inform the decision to obtain a bone marrow sample and compare its performance to the Mayo Clinic risk stratification model.

DESIGN:

iStopMM (Iceland Screens, Treats or Prevents Multiple Myeloma), a prospective population-based screening study of MGUS. (ClinicalTrials.gov NCT03327597).

SETTING:

Icelandic population of adults aged 40 years or older. PATIENTS 1043 persons with IgG, IgA, light-chain, and biclonal MGUS detected by screening and an interpretable bone marrow sample. MEASUREMENTS Monoclonal gammopathy of undetermined significance isotype; monoclonal protein concentration; free light-chain ratio; and total IgG, IgM, and IgA concentrations were used as predictors. Bone marrow plasma cells were categorized as 0% to 4%, 5% to 9%, 10% to 14%, or 15% or greater.

RESULTS:

The c-statistic for SMM or worse was 0.85 (95% CI, 0.82 to 0.88), and calibration was excellent (intercept, -0.07; slope, 0.95). At a threshold of 10% predicted risk for SMM or worse, sensitivity was 86%, specificity was 67%, positive predictive value was 32%, and negative predictive value was 96%. Compared with the Mayo Clinic model, the net benefit for the decision to refer for sampling was between 0.13 and 0.30 higher over a range of plausible low-risk thresholds.

LIMITATION:

The prediction model will require external validation.

CONCLUSION:

This accurate prediction model for SMM or worse was developed in a population-based cohort of persons with presumed MGUS and may be used to defer bone marrow sampling and referral to hematology. PRIMARY FUNDING SOURCE International Myeloma Foundation and the European Research Council.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Paraproteinemias / Gammopatía Monoclonal de Relevancia Indeterminada / Mieloma Múltiple Quiescente / Mieloma Múltiple Límite: Adult / Humans Idioma: En Revista: Ann Intern Med Año: 2024 Tipo del documento: Article
Texto completo
Imprimir
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Paraproteinemias / Gammopatía Monoclonal de Relevancia Indeterminada / Mieloma Múltiple Quiescente / Mieloma Múltiple Límite: Adult / Humans Idioma: En Revista: Ann Intern Med Año: 2024 Tipo del documento: Article