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Trial record 1 of 3 for:    insight | Myeloma Multiple
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An Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Participants

This study is currently recruiting participants.
Verified November 2017 by Takeda
Sponsor:
ClinicalTrials.gov Identifier:
NCT02761187
First Posted: May 4, 2016
Last Update Posted: December 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda
April 28, 2016
May 4, 2016
December 4, 2017
July 1, 2016
July 31, 2024   (Final data collection date for primary outcome measure)
  • Number of Participants with Co-morbidities [ Time Frame: Baseline up to 5 years ]
  • Number of Participants Diagnosed with ND MM and R/R MM [ Time Frame: Baseline up to 5 years ]
  • Number of Participants Presenting Symptoms of ND MM and R/R MM [ Time Frame: Baseline up to 5 years ]
  • Sites of Disease [ Time Frame: Baseline up to 5 years ]
  • ECOG (Eastern Cooperative Oncology Group) Performance Status [ Time Frame: Baseline up to 5 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 5 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 5 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.
  • Number of Participants With Stem Cell Transplant [ Time Frame: Baseline up to 5 years ]
  • Number of Participants With Stem Cell Transplant Treatment [ Time Frame: Baseline up to 5 years ]
  • Duration for Treatment With Stem Cell Transplant [ Time Frame: Baseline up to 5 years ]
  • Number of Participants Reporting Overall Survival [ Time Frame: Baseline up to 5 years ]
  • Progression Status on Each Regimen [ Time Frame: Baseline up to 5 years ]
  • Response to Each Regimen [ Time Frame: Baseline up to 5 years ]
  • Time to Next therapy [ Time Frame: Baseline up to 5 years ]
  • 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 ]
Complete list of historical versions of study NCT02761187 on ClinicalTrials.gov Archive Site
  • Number of Treatment Combinations [ Time Frame: Baseline up to 5 years ]
  • Number of Treatment Sequencing [ Time Frame: Baseline up to 5 years ]
  • Number of Treatment Rechallenge [ Time Frame: Baseline up to 5 years ]
  • Number of Clinical Outcomes for Different Strategies [ Time Frame: Baseline up to 5 years ]
  • Number of Clinical Outcomes Between Continuous Treatment and Intermittent Treatment Strategy [ Time Frame: Baseline up to 5 years ]
  • Triggers of Treatment Initiation at Relapse Including Biochemical Progression or Symptomatic Progression [ Time Frame: Baseline up to 5 years ]
  • Reasons for Treatment Modifications [ Time Frame: Baseline up to 5 years ]
  • Health Related Quality of Life (HRQoL) Among MM Participants [ Time Frame: Baseline up to 5 years ]
  • Healthcare Resource Utilization (HRU) Among MM Participants [ Time Frame: Baseline up to 5 years ]
  • Associations Between Presentation and Disease Characteristics [ Time Frame: Baseline up to 5 years ]
  • Associations Between Choice Of Therapy and Clinical Outcomes [ Time Frame: Baseline up to 5 years ]
  • Number of Participants Reporting Discontinuation One or More Treatment-emergent Adverse Events [ Time Frame: Baseline up to 5 years ]
    Treatment discontinuation includes temporary and permanent discontinuation, drug modification, and second primary malignancies.
  • 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 ]
Not Provided
Not Provided
 
An Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Participants
A Global, Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Patients - the INSIGHT-MM Study
The purpose of this study is to describe contemporary, real-world disease and participant presentation, therapies, and clinical outcomes in both participants with newly diagnosed and not yet relapsed [ND] multiple myeloma (MM), and participants with relapsed/refractory [R/R] MM.

This is a non-interventional, observational. This study will look at contemporary, real-world presentation, therapies, and clinical outcomes in participants with MM. Participants will not be asked to change their routine clinical treatment. Participants will have to complete a patient self-reported outcomes (PROs) survey at home or during routine visits.

The study will enroll approximately 5000 participants. Participants will be assigned to one of the following cohorts based upon the diagnosis of MM:

  • ND MM
  • R/R MM

This multi-center trial will be conducted worldwide. The overall time to participate in this study is 5 years. Participants will be evaluated and followed-up for a period of at least 5 years, until death, or the end of the study, whichever comes first.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Participants with Multiple Myeloma
Multiple Myeloma
Other: No Intervention
  • Relapsed/refractory (R/R) MM
    Intervention: Other: No Intervention
  • Newly diagnosed (ND) multiple myeloma (MM)
    Intervention: Other: No Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5000
July 31, 2024
July 31, 2024   (Final data collection date for primary outcome measure)

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.

Is unable or unwilling to complete health related quality of life (HRQoL) and Patient self-reported outcomes (PROs).

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Takeda Study Registration Call Center 1-844-662-8532 GlobalOncologyMedinfo@takeda.com
Belgium,   Brazil,   China,   Colombia,   France,   Germany,   Greece,   Israel,   Italy,   Mexico,   Spain,   Taiwan,   Turkey,   United Kingdom,   United States
 
 
NCT02761187
NSMM-5001
No
Not Provided
Not Provided
Takeda
Takeda
Not Provided
Not Provided
Takeda
November 2017