Iceland Screens, Treats or Prevents Multiple Myeloma

NCT03327597 | Active Not Recruiting DMC

• 1 other identifier: UI-2017-MGUS
• Study Type: interventional
• Target: 80,761
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the benefits and harms of screening for monoclonal gammopathy of undetermined significance (MGUS). The overall and disease-specific mortality will be compared between screened and not screened participants. All individuals registered as inhabitants in Iceland and born in 1975 or earlier have been invited to participate. The hypothesis is that an early detection of multiple myeloma (MM), through follow-up of MGUS, will improve overall survival and decrease complications associated with diagnosis and treatment of MM.

Conditions

Monoclonal Gammopathy of Undetermined Significance

Keywords

MGUS; Screening; Population-based

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Number of participants alive in each study arm

  5 years from study start.

Secondary Outcomes (13)

• Cause specific survival

  5 years from study start

• Cost-effectiveness of screening for MGUS

  5 years from study start

• Global satisfaction with one´s life as assessed by the Satisfaction with life (SWLS)

  5 years from study start.

• Happiness as assessed by the Single item measure for happiness

  5 years from study start

• Resilience as assessed by The Connor-Davidson resilience scale (CD-RISC)

  5 years from study start

Study Arms (6)

Abnormal Non-MGUS

ACTIVE COMPARATOR

Participants previously diagnosed with MGUS, multiple myeloma or other lymphoproliferative disease.

Other: Mental Health and Quality of Life questionnaire; Other: Standard follow-up or treatment.

MGUS group arm 1

EXPERIMENTAL

Participants diagnosed with MGUS, randomized to group 1.

Other: Clinical follow-up 1; Other: Mental Health and Quality of Life questionnaire

MGUS group arm 2

EXPERIMENTAL

Participants diagnosed with MGUS, randomized to group 2.

Other: Mental Health and Quality of Life questionnaire; Other: Clinical follow-up 2

MGUS group arm 3

EXPERIMENTAL

Participants diagnosed with MGUS, randomized to group 3.

Other: Mental Health and Quality of Life questionnaire; Other: Clinical follow-up 3

Normal group

ACTIVE COMPARATOR

Participants without MGUS.

Other: Mental Health and Quality of Life questionnaire

Controls

ACTIVE COMPARATOR

Participants without MGUS, matched to MGUS participants by age and gender.

Other: Mental Health and Quality of Life questionnaire; Other: Clinical follow-up control

Interventions

Clinical follow-up 1 OTHER

Participants receive routine care outside the bounds of the trial. No further work-up.

MGUS group arm 1

Mental Health and Quality of Life questionnaire OTHER

Participants receive a Mental Health and Quality of Life questionnaire that will be answered electronically on the study website (www.blodskimun.is)

Abnormal Non-MGUS; Controls; MGUS group arm 1; MGUS group arm 2; MGUS group arm 3; Normal group

Standard follow-up or treatment. OTHER

Participants previously diagnosed as having MGUS or participants that have multiple myeloma or other lymphoproliferative diseases will receive standard clinical follow-up and treatment.

Abnormal Non-MGUS

Clinical follow-up 2 OTHER

Standard clinical follow-up according to International Myeloma Working Group (IMWG) guidelines.

MGUS group arm 2

Clinical follow-up 3 OTHER

Intensive clinical follow-up with regular clinical assessment, laboratory testing and radiology imaging.

MGUS group arm 3

Clinical follow-up control OTHER

Control clinical visit

Controls

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Born 1975 or earlier
• With registered address in Iceland on November 1st 2016

You may not qualify if:

• Prior multiple myeloma
• Lymphoproliferative disease
• Amyloidosis
• M-protein \>30 g/L or involved:uninvolved serum FLC ratio \>100
• Individuals with prior history of MGUS will be offered to be randomized into either moderate or intensive clinical follow-up (arms 2 or 3).

Sponsors & Collaborators

• University of Iceland: lead
• Landspitali University Hospital: collaborator
• Union for International Cancer Control: collaborator
• Icelandic Heart Association: collaborator
• deCODE genetics: collaborator
• International Myeloma Foundation/Black Swan Research Initiative: collaborator
• The Binding Site: collaborator
• Memorial Sloan Kettering Cancer Center: collaborator
• European Research Council: collaborator
• The Icelandic Centre for Research: collaborator

Study Sites (1)

University of Iceland

Reykjavik, Iceland

Location

Related Publications (3)

• Eythorsson E, Rognvaldsson S, Thorsteinsdottir S, Einarsson Long T, Reed ER, Sigurdardottir GA, Vidarsson B, Onundarson PT, Agnarsson BA, Sigurdardottir M, Olafsson I, Thorsteinsdottir I, Sveinsdottir SV, Sigurdsson F, Thordardottir AR, Palsson R, Indridason OS, Jonsson A, Gislason GK, Olafsson A, Sigurdsson J, Steingrimsdottir H, Hultcrantz M, Durie BGM, Harding S, Landgren O, Aspelund T, Love TJ, Kristinsson SY. 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. Ann Intern Med. 2024 Apr;177(4):449-457. doi: 10.7326/M23-2540. Epub 2024 Apr 2.

  PMID: 38560901 DERIVED

• Sigurbergsdottir AY, Rognvaldsson S, Thorsteinsdottir S, Sverrisdottir I, Sigurethardottir GA, Vietharsson B, Onundarson PT, Agnarsson BA, Sigurethardottir M, Thornorsteinsdottir I, Olafsson I, Thornorethardottir AR, Gislason GK, Olafsson A, Hultcrantz M, Durie BGM, Harding S, Landgren O, Love TJ, Kristinsson SY. Disease associations with monoclonal gammopathy of undetermined significance can only be evaluated using screened cohorts: results from the population-based iStopMM study. Haematologica. 2023 Dec 1;108(12):3392-3398. doi: 10.3324/haematol.2023.283191.

  PMID: 37439374 DERIVED

• Thorsteinsdottir S, Gislason GK, Aspelund T, Rognvaldsson S, Oskarsson JThorn, Sigurethardottir GA, Thornorethardottir AR, Vietharsson B, Onundarson PT, Agnarsson BA, Sigurethardottir M, Thornorsteinsdottir I, Olafsson I, Eythornorsson E, Jonsson A, Berlanga O, Hultcrantz M, Durie BGM, Love TJ, Harding S, Landgren O, Kristinsson SY. Prevalence of smoldering multiple myeloma based on nationwide screening. Nat Med. 2023 Feb;29(2):467-472. doi: 10.1038/s41591-022-02183-6. Epub 2023 Feb 6.

  PMID: 36747117 DERIVED

MeSH Terms

Conditions

Monoclonal Gammopathy of Undetermined Significance

Interventions

Mental Health; Therapeutics

Condition Hierarchy (Ancestors)

Hypergammaglobulinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Paraproteinemias; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Health; Population Characteristics

Study Officials

• Sigurdur Y Kristinsson, Professor

  University of Iceland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators and participants will be blinded to what participants are in the normal group and which participants are in arm 1 in the MGUS-group.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 31, 2017
• Study Start: September 1, 2016
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IC (1)