An Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Participants

Study Overview
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Brief Summary
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The purpose of this study is to describe contemporary, real-world patterns of patient characteristics, clinical disease presentation, therapeutic regimen chosen, and clinical outcomes in participants with newly diagnosed [ND] multiple myeloma (MM) and participants with relapsed/refractory [R/R] MM.

Detailed Description
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This is a prospective, non-interventional, observational study. This study will look at contemporary, real-world patterns of patient characteristics, clinical disease presentation, therapeutic regimen chosen, and clinical outcomes in participants with MM. Participants will not be asked to change their routine clinical treatment. Participants will have to complete patient reported outcomes (PROs) surveys during on-site routine office visits. The study will enroll approximately 4200 participants. Participants will be assigned to one of the following cohorts based upon the diagnosis of MM: ND MM within 3 months from initiation of treatment R/R MM who have received 1 to 3 prior lines of therapy This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 8 years. Participants will be evaluated and followed-up for a period of at least 5 years, until death, are lost to follow-up, or the end of the study, whichever comes first.

Official Title
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A Global, Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Patients - the INSIGHT - MM Study

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Other: No Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is 18 years of age or older. Is experiencing the following: Newly diagnosed MM within 3 months from initiation of treatment with documented month and year of diagnosis, criteria met for diagnosis, stage, and MM-directed treatment history, including duration, or Relapsed/refractory MM who have received 1 to 3 prior lines of therapy with documented data in the medical record regarding diagnosis (month and year), the regimens used in 1st, 2nd, and 3rd line as applicable, whether stem cell transplant was part of 1st, 2nd, and 3rd line of therapy, whether consolidation/maintenance was part of 1st, 2nd, and 3rd line of therapy, also whether investigational therapy/treated on a clinical trial was part of any of these regimens. Is willing and able to sign informed consent to participate. Is willing and able to complete patient-reported outcomes (PROs) in accordance with local regulatory and data protection requirements. Exclusion Criteria: Is reporting to a site in this study for a second opinion (consultation only) or participants whose frequency of consult and follow-up are not adequate for quarterly electronic case report form (eCRF) completion. Has participated in another study (observational or interventional) that prohibits participation in this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Relapsed/refractory (R/R) MM<br>Patients who have received 1 to 3 prior lines of therapy | Other: No Intervention<br> <br> |
| Newly diagnosed (ND) MM<br>Patients within 3 months from initiation of treatment | Other: No Intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Co-morbidities |  | Baseline up to 8 years | 
| Number of Participants Diagnosed with ND MM and R/R MM |  | Baseline up to 8 years | 
| Number of Participants Presenting Symptoms of ND MM and R/R MM |  | Baseline up to 8 years | 
| Sites of Disease |  | Baseline up to 8 years | 
| ECOG (Eastern Cooperative Oncology Group) Performance Status | ECOG-PS measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (>50% of waking hrs), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. | Baseline up to 8 years | 
| Frailty Index | Frailty is defined as the combination of unintentional weight loss, exhaustion, low physical activity, slow walking speed, and muscular weakness. | Baseline up to 8 years | 
| Number of Participants Evaluated for Laboratory Test | Laboratory tests include minimal residual disease (MRD), gene expression profiling (GEP), fluorescence in situ hybridization (FISH), and cytogenetic results, international staging system (ISS)/R-ISS stage, imaging results. | Baseline up to 8 years | 
| Duration for Treatment With Stem Cell Transplant |  | Baseline up to 8 years | 
| Number of Participants Reporting Overall Survival |  | Baseline up to 8 years | 
| Progression Status on Each Regimen | Disease progression status was assessed by IMWG Response criteria | Baseline up to 8 years | 
| Response to Each Regimen | Disease progression status was assessed by IMWG Response criteria | Baseline up to 8 years | 
| Time to Next therapy |  | Baseline up to 8 years | 
| Number of Participants With Stem Cell Transplant |  | Baseline up to 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Treatment Combinations |  | Baseline up to 8 years | 
| Number of Treatment Sequencing |  | Baseline up to 8 years | 
| Number of Treatment Rechallenge |  | Baseline up to 8 years | 
| Number of Clinical Outcomes for Different Strategies |  | Baseline up to 8 years | 
| Number of Clinical Outcomes Between Continuous Treatment and Intermittent Treatment Strategy |  | Baseline up to 8 years | 
| Triggers of Treatment Initiation at Relapse Including Biochemical Progression or Symptomatic Progression |  | Baseline up to 8 years | 
| Reasons for Treatment Modifications |  | Baseline up to 8 years | 
| Health Related Quality of Life (HRQoL) Among MM Participants |  | Baseline up to 8 years | 
| Healthcare Resource Utilization (HRU) Among MM Participants |  | Baseline up to 8 years | 
| Associations Between Presentation and Disease Characteristics |  | Baseline up to 8 years | 
| Associations Between Choice Of Therapy and Clinical Outcomes |  | Baseline up to 8 years | 
| Number of Participants Reporting Discontinuation One or More Treatment-emergent Adverse Events | Treatment discontinuation includes temporary and permanent discontinuation, drug modification, and second primary malignancies. | Baseline up to 8 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy