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Iceland Screens, Treats or Prevents Multiple Myeloma (iStopMM)

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ClinicalTrials.gov Identifier: NCT03327597
Recruitment Status : Active, not recruiting
First Posted : October 31, 2017
Last Update Posted : September 4, 2019
Sponsor:
Collaborators:
Landspitali University Hospital
Union for International Cancer Control
Icelandic Heart Association
deCODE genetics
International Myeloma Foundation/Black Swan Research Initiative
The Binding Site
Memorial Sloan Kettering Cancer Center
European Research Council
The Icelandic Centre for Research
Information provided by (Responsible Party):
University of Iceland

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.

Condition or disease Intervention/treatment Phase
Monoclonal Gammopathy of Undetermined Significance Other: Clinical follow-up 1 Other: Mental Health and Quality of Life questionnaire Other: Standard follow-up or treatment. Other: Clinical follow-up 2 Other: Clinical follow-up 3 Other: Clinical follow-up control Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80761 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Screening
Official Title: Iceland Screens, Treats or Prevents Multiple Myeloma
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021


Arm Intervention/treatment
Active Comparator: Abnormal Non-MGUS
Participants previously diagnosed with MGUS, multiple myeloma or other lymphoproliferative disease.
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.

Experimental: MGUS group arm 1
Participants diagnosed with MGUS, randomized to group 1.
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)

Experimental: MGUS group arm 2
Participants diagnosed with MGUS, randomized to group 2.
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: Clinical follow-up 2
Standard clinical follow-up according to International Myeloma Working Group (IMWG) guidelines.

Experimental: MGUS group arm 3
Participants diagnosed with MGUS, randomized to group 3.
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: Clinical follow-up 3
Intensive clinical follow-up with regular clinical assessment, laboratory testing and radiology imaging.

Active Comparator: Normal group
Participants without MGUS.
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)

Active Comparator: Controls
Participants without MGUS, matched to MGUS participants by age and gender.
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: Clinical follow-up control
Control clinical visit




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years from study start. ]
    Number of participants alive in each study arm


Secondary Outcome Measures :
  1. Cause specific survival [ Time Frame: 5 years from study start ]
    Survival among participants diagnosed with multiple myeloma, lymphoproliferative disease and amyloidosis.

  2. Mental Health and Quality of Life: Patient Health Questionnaire (PHQ-9) [ Time Frame: 5 years from study start ]
    Patient Health Questionnaire (PHQ-9) used to assess QoL in each group. The PHQ-9 is a questionnaire with 9 questions where the answers to the questions are graded with a score from 0-3. Thus, the total score ranges from 0-27 with higher score indicating more severe depression. When interpreting the PHQ-9 score it can be divided into 5 groups of depression: Normal range (score 0-4), minimal depressive symptoms (score 5-9), major depression, mild severity (score 10-14), major depression, moderate severity (score 15-19) and major depression, severe severity (score 20 or higher).

  3. Cost-effectiveness of screening for MGUS [ Time Frame: 5 years from study start. ]
    Will be calculated in collaboration with the Department of economy at the University of Iceland and will include standard estimates as deemed appropriate.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All individuals, born 1975 or earlier, with registered address in Iceland on November 1st 2016 offered to participate.

Exclusion Criteria:

  • Prior multiple myeloma, lymphoproliferative disease and 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03327597


Locations
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Iceland
University of Iceland
Reykjavík, Iceland
Sponsors and Collaborators
University of Iceland
Landspitali University Hospital
Union for International Cancer Control
Icelandic Heart Association
deCODE genetics
International Myeloma Foundation/Black Swan Research Initiative
The Binding Site
Memorial Sloan Kettering Cancer Center
European Research Council
The Icelandic Centre for Research
Investigators
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Principal Investigator: Sigurdur Y Kristinsson, Professor University of Iceland

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Responsible Party: University of Iceland
ClinicalTrials.gov Identifier: NCT03327597     History of Changes
Other Study ID Numbers: UI-2017-MGUS
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Iceland:
MGUS
Screening
Population-based
Additional relevant MeSH terms:
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Multiple Myeloma
Paraproteinemias
Monoclonal Gammopathy of Undetermined Significance
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Hypergammaglobulinemia