Clinical trial · Observational
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
NCT02761187CI-TRIAL-00086342terminatedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This study was stopped 3 years early due to business reprioritization within Takeda
Summary
Brief summary (as posted)
The purpose of this study is to describe contemporary, real-world patterns of participant 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Newly Diagnosed Multiple Myeloma
- description
- Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
- interventionNames
- Other: No Intervention
- label
- Relapsed/Refractory Multiple Myeloma
- description
- Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
- interventionNames
- Other: No Intervention
Primary outcomes (17)
- measure
- Number of Participants With Co-morbidities
- timeFrame
- Baseline up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (5)
- DERIVEDPuig 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. PMID 41528195
- DERIVEDRifkin 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. PMID 37807952
- DERIVEDThompson 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. PMID 36641358
- DERIVEDHajek 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. PMID 33769076
- DERIVEDCostello 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.