Iceland Screens, Treats or Prevents Multiple Myeloma

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

Interventions

OTHER

Clinical follow-up 1

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

OTHER

Mental Health and Quality of Life questionnaire

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

OTHER

Standard follow-up or treatment.

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

OTHER

Clinical follow-up 2

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

OTHER

Clinical follow-up 3

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

OTHER

Clinical follow-up control

Control clinical visit

Sponsors & Collaborators

• Landspitali University Hospital

  collaborator OTHER

• Union for International Cancer Control

  collaborator OTHER

• Icelandic Heart Association

  collaborator OTHER

• deCODE genetics

  collaborator INDUSTRY

• International Myeloma Foundation/Black Swan Research Initiative

  collaborator UNKNOWN

• The Binding Site

  collaborator UNKNOWN

• Memorial Sloan Kettering Cancer Center

  collaborator OTHER

• European Research Council

  collaborator OTHER

• The Icelandic Centre for Research

  collaborator UNKNOWN

• University of Iceland

  lead OTHER

Principal Investigators

• Sigurdur Y Kristinsson, Professor · University of Iceland

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-09-01

Primary Completion

2026-09-01

Completion

2026-09-01

Countries

• Iceland

Study Locations