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

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Takeda
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT02761187
First received: April 28, 2016
Last updated: August 3, 2017
Last verified: August 2017
  Purpose
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.

Condition Intervention
Multiple Myeloma Other: No Intervention

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 5000
Actual Study Start Date: July 1, 2016
Estimated Study Completion Date: July 31, 2024
Estimated Primary Completion Date: July 31, 2024 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Relapsed/refractory (R/R) MM Other: No Intervention
Newly diagnosed (ND) multiple myeloma (MM) Other: No Intervention

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02761187

Contacts
Contact: Takeda Study Registration Call Center +1-866-835-2233 GlobalOncologyMedinfo@takeda.com

  Show 116 Study Locations
Sponsors and Collaborators
Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02761187     History of Changes
Other Study ID Numbers: NSMM-5001
Study First Received: April 28, 2016
Last Updated: August 3, 2017

Keywords provided by Takeda:
Drug Therapy

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on August 22, 2017