The INSIGHT MM Study: A global, prospective, non-interventional, observational study of presentation, treatment patterns, and outcomes in multiple myeloma

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Overview

Clinical studies are meant to evaluate and improve treatment and care of patients.

In an observational study, investigators (healthcare professionals) watch people diagnosed with a specific disease, such as multiple myeloma, and record various aspects of their health. People involved in observational studies do not get any treatment in addition to what they are already getting as part of their everyday care.

What is INSIGHT MM?

The INSIGHT MM study will be the largest pharmaceutical company-sponsored study of its kind in multiple myeloma, with the goal to enroll up to 4,200 patients 18 years or older with newly diagnosed or relapsed/refractory multiple myeloma globally.

The INSIGHT MM study is led by a steering committee of myeloma experts.

The purpose of this observational study is to collect information regarding your medical history and how your condition is managed during your routine treatment.

The study may provide a better understanding of current multiple myeloma patients globally, and ways in which they are cared for after they are diagnosed.

What does participation in the study look like?

  • If you agree to join the study, the study team will go over the details of participation using a document called an Informed Consent Form (ICF). After you read the form, you can ask whatever questions you have about the study before you sign the consent form. 
  • If you decide to participate, you will be asked to complete a patient survey and validated questionnaires during the course of the study. Data will be gathered via routine visits, medical records, and patient self-reported outcomes. However, no additional procedures or examinations are required to take part in the study. 

The study is split into 2 periods:

  1. Enrollment Period. This period will consist of the informed consent process, obtaining your signature on the Patient Information Sheet and Informed Consent Signature Form, and collection of the historical and initial data. 
  2. Follow-Up Period. You will participate in the study for (1) at least 5 years up to a maximum of 8 years or (2) until you leave the study or (3) the observational study ends, whichever comes first. During this time, you will be asked to complete questionnaires which are distributed every 3 months.
SparkCures ID 819
Trial Phase Observational Trial
Enrollment 4200 Patients
Trial Sponsors
  • Takeda Oncology
NCT Identifier

NCT02761187

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Is 18 years of age or older.
  • Is newly diagnosed and not yet relapsed MM with documented month and year of diagnosis, criteria met for diagnosis, stage, and MM-directed treatment history, including duration, or
  • Has relapsed/refractory MM with documented data in the medical record regarding diagnosis (month and year), prior exposure to classes of medications (example, proteosome inhibitors, immunomodulatory drugs), and number of previous lines of therapies.
  • Is willing and able to sign informed consent to participate.
  • Is willing and able to complete patient assessment questionnaires.

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.

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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Trial Resources

Trial Resources

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