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

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Global, Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Patients - the INSIGHT - MM Study

ClinicalTrials.gov ID

NCT02761187

Acronym / sponsor ID

NSMM-5001

Conditions

Multiple Myeloma

Keywords

Drug Therapy

Study type

Observational

Recruitment status

TerminatedReason stopped: This study was stopped 3 years early due to business reprioritization within Takeda

Enrolment

4,253 participants (actual)

Lead sponsor

TakedaIndustry (pharma, biotech, devices)

Study start

1 Jul 2016 (actual)

Primary completion

30 Sep 2021 (actual)

Study completion

30 Sep 2021 (actual)

First posted

4 May 2016 (estimated)

Results

Posted 24 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Case only

Time perspective

Prospective

Number of arms

2

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

Participants with Multiple Myeloma

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Number of Participants With Co-morbidities

   Time frame: Baseline up to 5 years

   Charlson Comorbidity Index (CCI) was used to represent number of participants with co-morbidities. CCI is a method of categorizing comorbidities of participants. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a participant. A score of 0 = no comorbidities found, 1 = not ill, 2 = mildly ill, 3 = moderately ill, 4 = severely ill, and ≥5 = moribund. The higher the score, the more likely the predicted outcome resulted in mortality or higher resource use.

2. Number of Participants Diagnosed With Newly Diagnosed Multiple Myeloma (NDMM) and Relapsed/Refractory Multiple Myeloma (R/RMM)

   Time frame: At Baseline

   Participants diagnosed with NDMM and R/RMM were determined at the start of the study.

3. Number of Participants Diagnosed With Symptoms of ND MM and R/R MM During the Study

   Time frame: Baseline up to 5 years

4. Sites of Disease Diagnosed With ND MM and R/R MM

   Time frame: Baseline up to 5 years

5. Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status

   Time frame: At Baseline

   ECOG-PS measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on 6 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 hours), 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 hours; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. The line of Therapy was determined at study entry.

6. Number of Participants With Myeloma Frailty Index

   Time frame: At Baseline

   Frailty is defined as the combination of unintentional weight loss, exhaustion, low physical activity, slow walking speed, and muscular weakness. The Myeloma Frailty Index is a composite index that was calculated using the points system, which produces a range of values from 0 to 5. Participants with score 0= fit, score 1= intermediate, and score ≥2= frail. Higher score indicates likeliness that the predicted outcome will result in frailty. The line of Therapy was determined at study entry.

7. Number of Participants Evaluated for Minimal Residual Disease (MRD)

   Time frame: Baseline up to 5 years

8. Number of Participants Evaluated for Gene Expression Profiling (GEP)

   Time frame: Baseline up to 5 years

9. Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH)

   Time frame: At Baseline

   FISH methodology was reported with Yes/No results for the following tests: deletion (17p)/p53 [Del(17p)/p53], translocation (4,14) [t(4,14)], and translocation (14,16) [t(14,16)].

10. Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage

    Time frame: At Baseline

    ISS disease stages were defined as I:low risk, β2-Microglobulin<3.5mg/L, albumin≥3.5g/dL, II:not stage I or III, III:high risk,β2-Microglobulin≥5.5mg/L). R-ISS is based on ISS, chromosomal abnormalities (CA), and lactate dehydrogenase (LDH). R-ISS disease stages were defined as I: ISS Stage I and standard risk CA by FISH and normal LDH (i.e. <=300 U/L), II: Neither R-ISS Stage I nor Stage III, III: ISS Stage III and either high risk CA by FISH or high LDH (i.e. >300 U/L).

11. Duration of Treatment for Participants With and Without Stem Cell Transplant

    Time frame: Baseline up to 5 years

    Data was analyzed for participants with and without stem cell transplant for all enrolled population, included all participants who signed the inform consent form, out of which 990 participants were excluded during the final analysis due to concerns around robustness of data.

12. Overall Survival (OS)

    Time frame: Baseline up to 5 years

    Overall Survival was defined as the number of months from the index regimen start date within each line of therapy, starting with the line during study entry, until the date of death. The Kaplan Meier estimates was used for the analysis.

13. Disease Progression Status on Each Regimen

    Time frame: Baseline up to 5 years

    Disease progression status was assessed by physician interpretation of IMWG Response criteria.

14. Response to Each Regimen

    Time frame: Baseline up to 5 years

15. Time to Next Therapy

    Time frame: Baseline up to 5 years

    The line of Therapy was determined at study entry. The Kaplan Meier estimates was used for the analysis.

16. Number of Participants With Stem Cell Transplant

    Time frame: Baseline up to 5 years

17. Number of Participants With Global Health Status Scale/Quality of Life (QoL) Among MM Participants

    Time frame: Baseline up to 5 years

    The Global Health Status scale/QoL scale included 2 questions measured with a 7-point numeric rating scale (very poor to excellent). Raw scores are converted into scale scores ranging from 0 to 100. A higher score represents better HRQoL.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 41528195Puig N, Leleu X, Lee HC, Davies FE, Hajek R, Hungria V, Thompson MA, Cook G, Ojeda JV, Weisel KC, Berdeja JG, Usmani SZ, Symeonidis A, Nascimento-Ferreira I, Arthur D, Mokra L, Ren K, Cherepanov D, Terpos E. Comparative Effectiveness and Safety of PI-Rd Triplets in Relapsed/Refractory Multiple Myeloma: INSIGHT-MM Data Analysis. Eur J Haematol. 2026 Apr;116(4):458-470. doi: 10.1111/ejh.70079. Epub 2026 Jan 13.
• Derived from this study: PubMed 37807952Rifkin RM, Costello CL, Birhiray RE, Kambhampati S, Richter J, Abonour R, Lee HC, Stokes M, Ren K, Stull DM, Cherepanov D, Bogard K, Noga SJ, Girnius S. In-class transition from bortezomib-based therapy to IRd is an effective approach in newly diagnosed multiple myeloma. Future Oncol. 2024 Jan;20(3):131-143. doi: 10.2217/fon-2023-0272. Epub 2023 Oct 9.
• Derived from this study: PubMed 36641358Thompson MA, Boccadoro M, Leleu X, Vela-Ojeda J, van Rhee F, Weisel KC, Rifkin RM, Usmani SZ, Hajek R, Cook G, Abonour R, Armour M, Morgan KE, Yeh SP, Costello CL, Berdeja JG, Davies FE, Zonder JA, Lee HC, Omel J, Spencer A, Terpos E, Hungria VTM, Puig N, Fu C, Ferrari RH, Ren K, Stull DM, Chari A. Rates of Influenza and Pneumococcal Vaccination and Correlation With Survival in Multiple Myeloma Patients. Clin Lymphoma Myeloma Leuk. 2023 Mar;23(3):e171-e181. doi: 10.1016/j.clml.2022.12.003. Epub 2022 Dec 7.
• Derived from this study: PubMed 33769076Hajek R, Minarik J, Straub J, Pour L, Jungova A, Berdeja JG, Boccadoro M, Brozova L, Spencer A, van Rhee F, Vela-Ojeda J, Thompson MA, Abonour R, Chari A, Cook G, Costello CL, Davies FE, Hungria VT, Lee HC, Leleu X, Puig N, Rifkin RM, Terpos E, Usmani SZ, Weisel KC, Zonder JA, Barinova M, Kuhn M, Silar J, Capkova L, Galvez K, Lu J, Elliott J, Stull DM, Ren K, Maisnar V. Ixazomib-lenalidomide-dexamethasone in routine clinical practice: effectiveness in relapsed/refractory multiple myeloma. Future Oncol. 2021 Jul;17(19):2499-2512. doi: 10.2217/fon-2020-1225. Epub 2021 Mar 26.
• Derived from this study: PubMed 30816809Costello C, Davies FE, Cook G, Vela-Ojeda J, Omel J, Rifkin RM, Berdeja J, Puig N, Usmani SZ, Weisel K, Zonder JA, Terpos E, Spencer A, Leleu X, Boccadoro M, Thompson MA, Romanus D, Stull DM, Hungria V. INSIGHT MM: a large, global, prospective, non-interventional, real-world study of patients with multiple myeloma. Future Oncol. 2019 May;15(13):1411-1428. doi: 10.2217/fon-2019-0013. Epub 2019 Feb 28.
• Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

137 sites in 15 countries: see every site and its status.