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

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. Identifier: NCT02761187
Recruitment Status : Recruiting
First Posted : May 4, 2016
Last Update Posted : October 8, 2018
Information provided by (Responsible Party):

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 Type : Observational
Estimated Enrollment : 4200 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
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

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

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.

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

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.

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 identifier (NCT number): NCT02761187

Contact: Takeda Study Registration Call Center 1-866-835-2233

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Little Rock, Arkansas, United States, 72205
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Saint Louis Park, Minnesota, United States, 55416
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Farmington, New Mexico, United States, 87401
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Martinsburg, West Virginia, United States, 25401
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Green Bay, Wisconsin, United States, 54307
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Charleroi, Belgium, 6000
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Gent, Belgium, 9000
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Haine-Saint-Paul, Belgium, 7100
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Leuven, Belgium, 3000
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Liege, Belgium, 4000
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Campinas, Brazil, 13083-970
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Florianopolis, Brazil, 88034
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Salvador, Brazil, 40110-090
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Sao Paulo, Brazil, 04537-081
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Chemnitz, Germany
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Koblenz, Germany
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Mainz, Germany
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Mannheim, Germany
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Marburg, Germany
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Tubingen, Germany
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Alexandroupoli, Greece, 68100
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Athens, Greece, 10676
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Athens, Greece, 11525
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Ioannina, Greece, 45500
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Larisa, Greece, 41110
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Patras, Greece, 26500
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Bologna, Italy, 40138
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Roma, Italy, 00161
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Torino, Italy
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Udine, Italy, 33100
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Guadalajara, Mexico, 44670
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Huixquilucan, Mexico
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Mexico City, Mexico, 14000
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Monterrey, Mexico, 64460
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Barcelona, Spain, 8036
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Granada, Spain, 18014
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Leon, Spain, 24080
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Madrid, Spain, 28041
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Salamanca, Spain, 37007
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Valencia, Spain
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Kaohsiung, Taiwan, 807
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Kaohsiung, Taiwan
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Puzih, Taiwan, 613
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Tainan, Taiwan, 70403
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Taipei, Taiwan, 10002
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Adana, Turkey
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Ankara, Turkey
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Antalya, Turkey
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Gebze, Turkey
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Istanbul, Turkey
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Istanbul, Turkey
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Izmir, Turkey
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Kayseri, Turkey
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Samsun, Turkey
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Trabzon, Turkey
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Bath, United Kingdom
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Birmingham, United Kingdom, B15 2TH
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Birmingham, United Kingdom, B9 5SS
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Bournemouth, United Kingdom, Bh7 7dw
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Dundee, United Kingdom, DD1 9SY
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Leeds, United Kingdom, LS1 3EX
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Leicester, United Kingdom, LE1 5WW
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Nottingham, United Kingdom, NG5 1PB
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Sutton, United Kingdom, SM2 5PT
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Wakefield, United Kingdom, WF1 4DG
Sponsors and Collaborators

Responsible Party: Takeda Identifier: NCT02761187     History of Changes
Other Study ID Numbers: NSMM-5001
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Keywords provided by Takeda:
Drug Therapy

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases