TriangleNCT02761187 · REGISTRY CONDITION SEARCH
An Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Participants
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- Not reported
- Status at capture
- TERMINATED
- Registry last update
- 2025-02-24
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Number of Participants With Co-morbidities
Number of Participants Diagnosed With Newly Diagnosed Multiple Myeloma (NDMM) and Relapsed/Refractory Multiple Myeloma (R/RMM)
Number of Participants Diagnosed With Symptoms of ND MM and R/R MM During the Study
Sites of Disease Diagnosed With ND MM and R/R MM
Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status
Number of Participants With Myeloma Frailty Index
Number of Participants Evaluated for Minimal Residual Disease (MRD)
Number of Participants Evaluated for Gene Expression Profiling (GEP)
Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH)
Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage
Duration of Treatment for Participants With and Without Stem Cell Transplant
Overall Survival (OS)
Disease Progression Status on Each Regimen
Response to Each Regimen
Time to Next Therapy
Number of Participants With Stem Cell Transplant
Number of Participants Receiving Different Treatment Combinations
Number of Treatment Sequencing
Number of Participants in the Treatment Rechallenge
Number of Clinical Outcomes for Different Strategies
Number of Clinical Outcomes Between Continuous Treatment and Intermittent Treatment Strategy
Triggers of Treatment Initiation at Relapse Including Biochemical Progression or Symptomatic Progression
Reasons for Treatment Modifications
Number of Participants With Global Health Status Scale/Quality of Life (QoL) Among MM Participants
Healthcare Resource Utilization (HRU) Among MM Participants
Associations Between Presentation and Disease Characteristics
Associations Between Choice Of Therapy and Clinical Outcomes
Number of Participants With Atleast One Treatment-emergent Adverse Events Leading to Treatment Discontinuation
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- 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.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sampling Method
- PROBABILITY_SAMPLE
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
- study Population
- Participants with Multiple Myeloma
Treatment arms and interventions
- arm Groups
- 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).
- intervention Names
- Other: No Intervention
- label
- Newly Diagnosed 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).
- intervention Names
- Other: No Intervention
- label
- Relapsed/Refractory Multiple Myeloma
- interventions
- arm Group Labels
- Newly Diagnosed Multiple Myeloma
- Relapsed/Refractory Multiple Myeloma
- description
- As this was an observational study, no intervention was administered.
- name
- No Intervention
- type
- OTHER
Study design
- observational Model
- CASE_ONLY
- time Perspective
- PROSPECTIVE
Enrollment
- count
- 4253
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- measure
- Number of Participants With Co-morbidities
- time Frame
- Baseline up to 5 years
- description
- Participants diagnosed with NDMM and R/RMM were determined at the start of the study.
- measure
- Number of Participants Diagnosed With Newly Diagnosed Multiple Myeloma (NDMM) and Relapsed/Refractory Multiple Myeloma (R/RMM)
- time Frame
- At Baseline
- measure
- Number of Participants Diagnosed With Symptoms of ND MM and R/R MM During the Study
- time Frame
- Baseline up to 5 years
- measure
- Sites of Disease Diagnosed With ND MM and R/R MM
- time Frame
- Baseline up to 5 years
- description
- 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.
- measure
- Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status
- time Frame
- At Baseline
- description
- 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.
- measure
- Number of Participants With Myeloma Frailty Index
- time Frame
- At Baseline
- measure
- Number of Participants Evaluated for Minimal Residual Disease (MRD)
- time Frame
- Baseline up to 5 years
- measure
- Number of Participants Evaluated for Gene Expression Profiling (GEP)
- time Frame
- Baseline up to 5 years
- description
- 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) \[t(14,16)\].
- measure
- Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH)
- time Frame
- At Baseline
- description
- 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).
- measure
- Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage
- time Frame
- At Baseline
- description
- 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.
- measure
- Duration of Treatment for Participants With and Without Stem Cell Transplant
- time Frame
- Baseline up to 5 years
- description
- 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.
- measure
- Overall Survival (OS)
- time Frame
- Baseline up to 5 years
- secondary Outcomes
- measure
- Number of Participants Receiving Different Treatment Combinations
- time Frame
- Baseline up to 5 years
- description
- Drug classes were based on the earliest regimen in each corresponding Line of Therapy. The data for this outcome measure was analyzed as per line of therapy.
- measure
- Number of Treatment Sequencing
- time Frame
- Baseline up to 5 years
- measure
- Number of Participants in the Treatment Rechallenge
- time Frame
- Baseline up to 5 years
- measure
- Number of Clinical Outcomes for Different Strategies
- time Frame
- Baseline up to 5 years
- measure
- Number of Clinical Outcomes Between Continuous Treatment and Intermittent Treatment Strategy
- time Frame
- Baseline up to 5 years
- measure
- Triggers of Treatment Initiation at Relapse Including Biochemical Progression or Symptomatic Progression
- time Frame
- Baseline up to 5 years
- measure
- Reasons for Treatment Modifications
- time Frame
- Baseline up to 5 years
- measure
- Healthcare Resource Utilization (HRU) Among MM Participants
- time Frame
- Baseline up to 5 years
- measure
- Associations Between Presentation and Disease Characteristics
- time Frame
- Baseline up to 5 years
- measure
- Associations Between Choice Of Therapy and Clinical Outcomes
- time Frame
- Baseline up to 5 years
- description
- An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. Treatment discontinuation includes temporary and permanent discontinuation, drug modification, and second primary malignancies.
- measure
- Number of Participants With Atleast One Treatment-emergent Adverse Events Leading to Treatment Discontinuation
- time Frame
- Baseline up to 5 years
Full study description
- brief Summary
- 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.
- detailed Description
- This is a prospective, non-interventional, observational study. This study will look at contemporary, real-world patterns of participant 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.
Source references
- references
- citation
- Puig 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
- type
- DERIVED
- citation
- Rifkin 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
- type
- DERIVED
- citation
- Thompson 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
- type
- DERIVED
- citation
- Hajek 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
- type
- DERIVED
- citation
- Costello 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.
- pmid
- 30816809
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice