NCT03327597

Iceland Screens, Treats or Prevents Multiple Myeloma

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80,761 (actual)
• Sponsor: University of Iceland · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

Monoclonal gammopathy of undetermined significance (MGUS) is an asymptomatic premalignant stage that almost always precedes multiple myeloma (MM) and amyloidosis. It is defined by a monoclonal-(M)-protein detected on serum protein electrophoresis or immunofixation electrophoresis and can be diagnosed with a blood sample. Approximately four percent of individuals 50 years or older have MGUS which is associated with a 1-2% annual risk of malignant transformation but it is impossible to predict which individuals diagnosed as having MGUS will progress and receive a diagnosis of malignant disease. To date, no evidence is available on the benefits and harms of population-based screening for MGUS and data from prospective studies that assess the optimal follow-up of MGUS are lacking. All individuals that are registered as inhabitants in Iceland and born in 1975 or earlier have been invited to participate in the study. After signing informed consent, serum from the participants will be analysed for MGUS. The participants will not be contacted for blood sampling. Instead, an innovative approach will be used by taking advantage of the fact that most people 40 years or older do a blood test for various reasons during a three year period. The ID-list of participants in the study will be cross-linked with all major laboratories in Iceland, covering approximately 90% of all blood sampling in Iceland. When a participant has a blood test, a small amount (1 ml) of serum will be sampled and put in a separate test tube belonging to the study and used for diagnosis of MGUS. Participants diagnosed as having MGUS will be randomized to three different arms, of which two arms will be called into a clinical study center for two separate types of follow-up. In arm one the participants will be asked to answer an electronic Mental Health and Quality of Life questionnaire annually but receive no active follow-up. In arm two and three the participants will be asked to answer the Mental Health and QoL questionnaire but also receive follow-up according to the International Myeloma Working Group (IMWG) guidelines (arm two) or intensive (arm three) clinical follow-up. Participants without MGUS will be asked to answer Mental Health and QoL questionnaire annually. Results from two recent, population-based studies shows that early detection of MM through follow-up of MGUS is associated with fewer major complications and 13-14% better overall survival as compared to individuals presenting with MM without previous diagnosis of MGUS. This study aims to assess the benefits and harms of population-based screening for MGUS by analyzing overall and disease specific survival, complications associated with screening and the effects screening has on mental health and quality of life. Furthermore, the aim of the study is to evaluate the optimal follow-up strategy of MGUS and the cost-effectiveness of screening for MGUS.

Conditions

• Monoclonal Gammopathy of Undetermined Significance

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-09-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2017-10-31
• Last updated: 2025-09-30

Locations

1 site across 1 country: Iceland