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Randomized Controlled Trial
. 2021 May 17;11(5):94.
doi: 10.1038/s41408-021-00480-w.

Iceland screens, treats, or prevents multiple myeloma (iStopMM): a population-based screening study for monoclonal gammopathy of undetermined significance and randomized controlled trial of follow-up strategies

Sæmundur Rögnvaldsson  1 , Thorvardur Jon Love  1 , Sigrun Thorsteinsdottir  1   2 , Elín Ruth Reed  1 , Jón Þórir Óskarsson  1 , Íris Pétursdóttir  1 , Guðrún Ásta Sigurðardóttir  1 , Brynjar Viðarsson  3 , Páll Torfi Önundarson  1   3 , Bjarni A Agnarsson  1   3 , Margrét Sigurðardóttir  3 , Ingunn Þorsteinsdóttir  3 , Ísleifur Ólafsson  3 , Ásdís Rósa Þórðardóttir  1 , Elías Eyþórsson  3 , Ásbjörn Jónsson  3 , Andri S Björnsson  4 , Gunnar Þór Gunnarsson  1   5 , Runólfur Pálsson  1   3 , Ólafur Skúli Indriðason  1   3 , Gauti Kjartan Gíslason  1 , Andri Ólafsson  1 , Guðlaug Katrín Hákonardóttir  1 , Manje Brinkhuis  1 , Sara Lovísa Halldórsdóttir  1 , Tinna Laufey Ásgeirsdóttir  6 , Hlíf Steingrímsdóttir  3 , Ragnar Danielsen  3 , Inga Dröfn Wessman  4 , Petros Kampanis  7 , Malin Hultcrantz  8 , Brian G M Durie  9 , Stephen Harding  7 , Ola Landgren  10 , Sigurður Yngvi Kristinsson  11   12
Affiliations
Randomized Controlled Trial

Iceland screens, treats, or prevents multiple myeloma (iStopMM): a population-based screening study for monoclonal gammopathy of undetermined significance and randomized controlled trial of follow-up strategies

Sæmundur Rögnvaldsson et al. Blood Cancer J. .

Erratum in

Abstract

Monoclonal gammopathy of undetermined significance (MGUS) precedes multiple myeloma (MM). Population-based screening for MGUS could identify candidates for early treatment in MM. Here we describe the Iceland Screens, Treats, or Prevents Multiple Myeloma study (iStopMM), the first population-based screening study for MGUS including a randomized trial of follow-up strategies. Icelandic residents born before 1976 were offered participation. Blood samples are collected alongside blood sampling in the Icelandic healthcare system. Participants with MGUS are randomized to three study arms. Arm 1 is not contacted, arm 2 follows current guidelines, and arm 3 follows a more intensive strategy. Participants who progress are offered early treatment. Samples are collected longitudinally from arms 2 and 3 for the study biobank. All participants repeatedly answer questionnaires on various exposures and outcomes including quality of life and psychiatric health. National registries on health are cross-linked to all participants. Of the 148,704 individuals in the target population, 80 759 (54.3%) provided informed consent for participation. With a very high participation rate, the data from the iStopMM study will answer important questions on MGUS, including potentials harms and benefits of screening. The study can lead to a paradigm shift in MM therapy towards screening and early therapy.

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Conflict of interest statement

P.K. is an employee of The Binding Site. BGMD has done consultancy for Amgen, Janssen, Celgene, Takeda. S.H. is the director of The Binding Site. O.L. has received research funding from: National Institutes of Health (NIH), National Cancer Institute (NCI), U.S. Food and Drug Administration (FDA), Multiple Myeloma Research Foundation (MMRF), International Myeloma Foundation (IMF), Leukemia and Lymphoma Society (LLS), Perelman Family Foundation, Rising Tide Foundation, Amgen, Celgene, Janssen, Takeda, Glenmark, Seattle Genetics, Karyopharm; Honoraria/ad boards: Adaptive, Amgen, Binding Site, BMS, Celgene, Cellectis, Glenmark, Janssen, Juno, Pfizer; and serves on Independent Data Monitoring Committees (IDMCs) for clinical trials lead by Takeda, Merck, Janssen, Theradex. S.Y.K. has received research funding from International Myeloma Foundation, European Research Council, Icelandic Center for Research (Rannís), Amgen, Celgene. The remaining authors declare no competing interests.

Figures

Fig. 1
Fig. 1. Methods of blood sample acquisition.
A and B describe passive sampling starting during the fall of 2016, and C describes active sampling beginning during the fall of 2019. 1: Reykjavik Capital Area, Akureyri, Ísafjörður, Reykjanes Peninsula, Akranes, Healthcare Institution of Northern Iceland, Healthcare Institution of South Iceland, blood banks 2: Neskaupsstaður, Healthcare institution of West Iceland, Healthcare Institution of East Iceland. 3: Available for all Icelandic residents.
Fig. 2
Fig. 2. A flowchart outlining the study design for screening and randomization of individuals with MGUS.
MGUS Monoclonal gammopathy of undetermined significance, SPEP Serum protein electrophoresis, FLC Free light chain assay, SMM Smoldering multiple myeloma, MM Multiple myeloma.
Fig. 3
Fig. 3. Participant enrollment over the recruitment period.
The light green line represents the end of the pilot period and the initiation of nationwide recruitment.
See this image and copyright information in PMC

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