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

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ClinicalTrials.gov Identifier: NCT02761187
Recruitment Status : Completed
First Posted : May 4, 2016
Last Update Posted : February 23, 2022
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Multiple Myeloma Other: No Intervention

Detailed Description:

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.

Study Design
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Study Type : Observational
Actual Enrollment : 4310 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Global, Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Patients - the INSIGHT - MM Study
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : September 30, 2021
Actual Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Groups and Cohorts
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Group/Cohort Intervention/treatment
Relapsed/refractory (R/R) MM
Patients who have received 1 to 3 prior lines of therapy
 Other: No Intervention
Newly diagnosed (ND) MM
Patients within 3 months from initiation of treatment
 Other: No Intervention


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Co-morbidities [ Time Frame: Baseline up to 8 years ]
  2. Number of Participants Diagnosed with ND MM and R/R MM [ Time Frame: Baseline up to 8 years ]
  3. Number of Participants Presenting Symptoms of ND MM and R/R MM [ Time Frame: Baseline up to 8 years ]
  4. Sites of Disease [ Time Frame: Baseline up to 8 years ]
  5. 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.

  6. 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.

  7. 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.

  8. Duration for Treatment With Stem Cell Transplant [ Time Frame: Baseline up to 8 years ]
  9. Number of Participants Reporting Overall Survival [ Time Frame: Baseline up to 8 years ]
  10. Progression Status on Each Regimen [ Time Frame: Baseline up to 8 years ]
    Disease progression status was assessed by IMWG Response criteria

  11. Response to Each Regimen [ Time Frame: Baseline up to 8 years ]
    Disease progression status was assessed by IMWG Response criteria

  12. Time to Next therapy [ Time Frame: Baseline up to 8 years ]
  13. Number of Participants With Stem Cell Transplant [ Time Frame: Baseline up to 8 years ]

Secondary Outcome Measures :
  1. Number of Treatment Combinations [ Time Frame: Baseline up to 8 years ]
  2. Number of Treatment Sequencing [ Time Frame: Baseline up to 8 years ]
  3. Number of Treatment Rechallenge [ Time Frame: Baseline up to 8 years ]
  4. Number of Clinical Outcomes for Different Strategies [ Time Frame: Baseline up to 8 years ]
  5. Number of Clinical Outcomes Between Continuous Treatment and Intermittent Treatment Strategy [ Time Frame: Baseline up to 8 years ]
  6. Triggers of Treatment Initiation at Relapse Including Biochemical Progression or Symptomatic Progression [ Time Frame: Baseline up to 8 years ]
  7. Reasons for Treatment Modifications [ Time Frame: Baseline up to 8 years ]
  8. Health Related Quality of Life (HRQoL) Among MM Participants [ Time Frame: Baseline up to 8 years ]
  9. Healthcare Resource Utilization (HRU) Among MM Participants [ Time Frame: Baseline up to 8 years ]
  10. Associations Between Presentation and Disease Characteristics [ Time Frame: Baseline up to 8 years ]
  11. Associations Between Choice Of Therapy and Clinical Outcomes [ Time Frame: Baseline up to 8 years ]
  12. Number of Participants Reporting Discontinuation One or More Treatment-emergent Adverse Events [ Time Frame: Baseline up to 8 years ]
    Treatment discontinuation includes temporary and permanent discontinuation, drug modification, and second primary malignancies.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with Multiple Myeloma
Criteria

Inclusion Criteria:

Is 18 years of age or older.

Is experiencing the following:

  1. 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
  2. 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.

Contacts and Locations
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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): NCT02761187


Locations
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Sponsors and Collaborators
Takeda
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02761187    
Other Study ID Numbers: NSMM-5001
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: February 23, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
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/
Keywords provided by Takeda:
Drug Therapy
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases