April 28, 2016
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May 4, 2016
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December 17, 2020
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July 1, 2016
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December 31, 2021 (Final data collection date for primary outcome measure)
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- Number of Participants with Co-morbidities [ Time Frame: Baseline up to 8 years ]
- Number of Participants Diagnosed with ND MM and R/R MM [ Time Frame: Baseline up to 8 years ]
- Number of Participants Presenting Symptoms of ND MM and R/R MM [ Time Frame: Baseline up to 8 years ]
- Sites of Disease [ Time Frame: Baseline up to 8 years ]
- ECOG (Eastern Cooperative Oncology Group) Performance Status [ Time Frame: Baseline up to 8 years ]
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.
- Frailty Index [ Time Frame: Baseline up to 8 years ]
Frailty is defined as the combination of unintentional weight loss, exhaustion, low physical activity, slow walking speed, and muscular weakness.
- Number of Participants Evaluated for Laboratory Test [ Time Frame: Baseline up to 8 years ]
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.
- Duration for Treatment With Stem Cell Transplant [ Time Frame: Baseline up to 8 years ]
- Number of Participants Reporting Overall Survival [ Time Frame: Baseline up to 8 years ]
- Progression Status on Each Regimen [ Time Frame: Baseline up to 8 years ]
Disease progression status was assessed by IMWG Response criteria
- Response to Each Regimen [ Time Frame: Baseline up to 8 years ]
Disease progression status was assessed by IMWG Response criteria
- Time to Next therapy [ Time Frame: Baseline up to 8 years ]
- Number of Participants With Stem Cell Transplant [ Time Frame: Baseline up to 8 years ]
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- Age of Participants at Baseline [ Time Frame: Baseline ]
- Gender of Participants at Baseline [ Time Frame: Baseline ]
- Race of Participants at Baseline [ Time Frame: Baseline ]
- Presence or Absence of Co-morbidities in Participants at Baseline [ Time Frame: Baseline up to 8 years ]
- ECOG (Eastern Cooperative Oncology Group) Performance Status of Participants at Baseline [ Time Frame: Baseline up to 8 years ]
- Frailty Index [ Time Frame: Baseline up to 8 years ]
The frailty index will be based on the Charlson Co-morbidity Index, the Katz Index of Independence in ADL, and the Lawton IADL scales.
- International Staging System (ISS)/Revised ISS (R-ISS) of Participants at Diagnosis of Multiple Myeloma [ Time Frame: Baseline ]
- Number of Participants With Symptoms or Sites of Disease [ Time Frame: Baseline up to 8 years ]
- Treatment Regimens Prescribed to Participants Throughout the Study [ Time Frame: Baseline up to 8 years ]
- Number of Participants Who Receive a Stem Cell Transplant [ Time Frame: Baseline up to 8 years ]
- Number of Participants who undergo Cytogenetic, FISH, MRD, and GEP Laboratory Analysis [ Time Frame: Baseline up to 8 years ]
Laboratory tests include minimal residual disease (MRD), gene expression profiling (GEP), fluorescence in situ hybridization (FISH), and cytogenetic results.
- Participant Response to Different Treatment Regimens Throughout the Study [ Time Frame: Baseline up to 8 years ]
- Progression Status on Different Treatment Regimens [ Time Frame: Baseline up to 8 years ]
- Time to Next therapy [ Time Frame: Baseline up to 8 years ]
- Overall Survival [ Time Frame: Baseline up to 8 years ]
- Progression Free Survival [ Time Frame: Baseline up to 8 years ]
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- Clinical Outcome of Participants on Different Treatment Regimens [ Time Frame: Baseline up to 8 years ]
- Clinical Outcome of Participants in Different Treatment Sequences or Combinations, or Retreatment with Prior Therapy [ Time Frame: Baseline up to 8 years ]
- Clinical Outcome of Participants on Continuous Treatment [ Time Frame: Baseline up to 8 years ]
- Clinical Outcome of Participants with Intermittent/Fixed Treatment [ Time Frame: Baseline up to 8 years ]
- Reasons for Treatment Initiation or Treatment Change for Participants at Relapse Including Biochemical Progression or Symptomatic Progression Throughout the Study [ Time Frame: Baseline up to 8 years ]
- Health Related Quality of Life (HRQoL) Among Multiple Myeloma (MM) Participants [ Time Frame: Baseline up to 8 years ]
- The Effect of Prescribed Treatment on Healthcare Resource Utilization (HRU) Among MM Participants [ Time Frame: Baseline up to 8 years ]
- Clinical Outcome of Participants Associated with Participant Presentation, Disease Characteristics, and Choice Of Therapy [ Time Frame: Baseline up to 8 years ]
- Number of Participants With Serious Adverse Events [ Time Frame: Baseline up to 8 years ]
- Number of Participants with Non-serious Adverse Events Leading to treatment discontinuation or modification [ Time Frame: Baseline up to 8 years ]
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Not Provided
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Not Provided
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An Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Participants
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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
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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.
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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.
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Observational
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Observational Model: Case-Only Time Perspective: Prospective
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Not Provided
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Not Provided
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Probability Sample
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Participants with Multiple Myeloma
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Multiple Myeloma
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Other: No Intervention
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- Relapsed/refractory (R/R) MM
Patients who have received 1 to 3 prior lines of therapy
Intervention: Other: No Intervention
- Newly diagnosed (ND) MM
Patients within 3 months from initiation of treatment
Intervention: Other: No Intervention
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- Hájek R, Minařík J, Straub J, Pour L, Jungova A, Berdeja JG, Boccadoro M, Brozova L, Spencer A, Rhee FV, Vela-Ojeda J, Thompson MA, Abonour R, Chari A, Cook G, Costello CL, Davies FE, Hungria VT, Lee HC, Leleu X, Puig N, Rifkin RM, Terpos E, Usmani SZ, Weisel KC, Zonder JA, Bařinová M, Kuhn M, Šilar J, Čápková L, Galvez K, Lu J, Elliott J, Stull DM, Ren K, Maisnar V. Ixazomib-lenalidomide-dexamethasone in routine clinical practice: effectiveness in relapsed/refractory multiple myeloma. Future Oncol. 2021 Mar 26. doi: 10.2217/fon-2020-1225. [Epub ahead of print]
- Costello C, Davies FE, Cook G, Vela-Ojeda J, Omel J, Rifkin RM, Berdeja J, Puig N, Usmani SZ, Weisel K, Zonder JA, Terpos E, Spencer A, Leleu X, Boccadoro M, Thompson MA, Romanus D, Stull DM, Hungria V. INSIGHT MM: a large, global, prospective, non-interventional, real-world study of patients with multiple myeloma. Future Oncol. 2019 May;15(13):1411-1428. doi: 10.2217/fon-2019-0013. Epub 2019 Feb 28.
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Active, not recruiting
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4200
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5000
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December 31, 2021
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December 31, 2021 (Final data collection date for primary outcome measure)
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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.
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Sexes Eligible for Study: |
All |
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18 Years and older (Adult, Older Adult)
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No
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Contact information is only displayed when the study is recruiting subjects
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Belgium, Brazil, China, Colombia, France, Germany, Greece, Israel, Italy, Mexico, Spain, Taiwan, Turkey, United Kingdom, United States
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NCT02761187
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NSMM-5001
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No
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Not Provided
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Plan to Share IPD: |
Yes |
Plan Description: |
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement. |
Supporting Materials: |
Study Protocol |
Supporting Materials: |
Statistical Analysis Plan (SAP) |
Supporting Materials: |
Informed Consent Form (ICF) |
Supporting Materials: |
Clinical Study Report (CSR) |
Access Criteria: |
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement. |
URL: |
https://vivli.org/ourmember/takeda/ |
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Takeda
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Takeda
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Not Provided
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Not Provided
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Takeda
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December 2020
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