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NCT02761187

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

Terminated Results posted Last updated 24 February 2025
What this trial tests

trial testing No Intervention in Multiple Myeloma in 4,253 participants. Terminated before completion.

Timeline
1 July 2016
Primary endpoint
30 September 2021
30 September 2021

Quick facts

Lead sponsorTakeda
StatusTerminated
Study typeOBSERVATIONAL
Enrollment4,253
Start date1 July 2016
Primary completion30 September 2021
Estimated completion30 September 2021
Sites137 locations across France, Colombia, Italy, Greece, Belgium, Taiwan, United Kingdom, Germany

Drugs / interventions tested

Conditions studied

Sponsor

Takeda — full company profile →

Who can join

18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Co-morbidities Primary · 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 u

0-1
GroupValue95% CI
NDMM1279
RRMM1064
2-3
GroupValue95% CI
NDMM307
RRMM247
4-5
GroupValue95% CI
NDMM66
RRMM60
>5
GroupValue95% CI
NDMM38
RRMM19
Missing
GroupValue95% CI
NDMM71
RRMM50
Number of Participants Diagnosed With Newly Diagnosed Multiple Myeloma (NDMM) and Relapsed/Refractory Multiple Myeloma (R/RMM) Primary · At Baseline

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

GroupValue95% CI
NDMM2338
RRMM1915
Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status Primary · 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/cha

Grade 0
GroupValue95% CI
NDMM714
RRMM710
Grade 1
GroupValue95% CI
NDMM727
RRMM559
Grade 2
GroupValue95% CI
NDMM171
RRMM113
Grade 3
GroupValue95% CI
NDMM61
RRMM22
Grade 4
GroupValue95% CI
NDMM13
RRMM2
Missing
GroupValue95% CI
NDMM75
RRMM34
Number of Participants With Myeloma Frailty Index Primary · 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.

0: Fit
GroupValue95% CI
1st Line of Therapy517
2nd Line of Therapy428
1: Intermediate
GroupValue95% CI
1st Line of Therapy218
2nd Line of Therapy202
≥2: Frail
GroupValue95% CI
1st Line of Therapy190
2nd Line of Therapy130
Missing
GroupValue95% CI
1st Line of Therapy836
2nd Line of Therapy680
Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) Primary · 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) \[t(14,16)\].

Del(17p)/p53
GroupValue95% CI
1st Line of Therapy208
2nd Line of Therapy20
3rd Line of Therapy7
4th Line of Therapy4
>4th Line of Therapy0
1st Line of Therapy126
2nd Line of Therapy23
3rd Line of Therapy12
4th Line of Therapy5
>4th Line of Therapy0
1st Line of Therapy950
2nd Line of Therapy147
3rd Line of Therapy55
4th Line of Therapy24
>4th Line of Therapy12
1st Line of Therapy399
2nd Line of Therapy17
3rd Line of Therapy2
4th Line of Therapy2
>4th Line of Therapy0
t(4,14)
GroupValue95% CI
1st Line of Therapy208
2nd Line of Therapy20
3rd Line of Therapy7
4th Line of Therapy4
>4th Line of Therapy0
1st Line of Therapy116
2nd Line of Therapy24
3rd Line of Therapy4
4th Line of Therapy5
>4th Line of Therapy3
1st Line of Therapy957
2nd Line of Therapy144
3rd Line of Therapy63
4th Line of Therapy25
>4th Line of Therapy9
1st Line of Therapy401
2nd Line of Therapy18
3rd Line of Therapy2
4th Line of Therapy2
>4th Line of Therapy0
t(14,16)
GroupValue95% CI
1st Line of Therapy208
2nd Line of Therapy20
3rd Line of Therapy7
4th Line of Therapy4
>4th Line of Therapy0
1st Line of Therapy50
2nd Line of Therapy7
3rd Line of Therapy0
4th Line of Therapy3
>4th Line of Therapy0
1st Line of Therapy1007
2nd Line of Therapy157
3rd Line of Therapy67
4th Line of Therapy27
>4th Line of Therapy12
1st Line of Therapy416
2nd Line of Therapy18
3rd Line of Therapy2
4th Line of Therapy2
>4th Line of Therapy0
Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage Primary · 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).

ISS Stage I
GroupValue95% CI
NDMM395
RRMM236
ISS Stage II
GroupValue95% CI
NDMM387
RRMM267
ISS Stage III
GroupValue95% CI
NDMM520
RRMM297
ISS Not Available
GroupValue95% CI
NDMM138
RRMM376
ISS Missing
GroupValue95% CI
NDMM321
RRMM264
R-ISS Stage I
GroupValue95% CI
NDMM127
RRMM40
R-ISS Stage II
GroupValue95% CI
NDMM319
RRMM145
R-ISS Stage III
GroupValue95% CI
NDMM76
RRMM24
Duration of Treatment for Participants With and Without Stem Cell Transplant Primary · 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.

GroupValue95% CI
1st Line of Therapy4.50 – 45
2nd Line of Therapy6.40 – 57
3rd Line of Therapy9.20 – 80
4th Line of Therapy11.50 – 68
>4th Line of Therapy11.50 – 52
Overall Survival (OS) Primary · 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.

GroupValue95% CI
1st Line of TherapyNANA – NA
2nd Line of Therapy47.6745.34 – NA
3rd Line of Therapy32.0726.84 – 39.56
4th Line of Therapy20.6017.51 – 23.36
>4th Line of Therapy13.4410.91 – 15.90
Time to Next Therapy Primary · Baseline up to 5 years

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

GroupValue95% CI
1st Line of Therapy30.3926.87 – 33.74
2nd Line of Therapy15.4413.63 – 17.08
3rd Line of Therapy9.468.34 – 10.81
4th Line of Therapy6.906.11 – 7.82
>4th Line of Therapy5.955.16 – 6.70
Number of Participants With Stem Cell Transplant Primary · Baseline up to 5 years
GroupValue95% CI
1st Line of Therapy1790
2nd Line of Therapy686
3rd Line of Therapy458
4th Line of Therapy249
>4th Line of Therapy80
Number of Participants Receiving Different Treatment Combinations Secondary · Baseline up to 5 years
Bortezomib and Lenalidomide (VR)
GroupValue95% CI
1st Line of Therapy560
2nd Line of Therapy86
3rd Line of Therapy19
4th Line of Therapy10
Bortezomib and Cyclophosphamide (VC)
GroupValue95% CI
1st Line of Therapy497
2nd Line of Therapy99
3rd Line of Therapy43
4th Line of Therapy18
Bortezomib and Thalidomide (VT)
GroupValue95% CI
1st Line of Therapy272
2nd Line of Therapy60
3rd Line of Therapy10
4th Line of Therapy11
Bortezomib and Melphalan (VM)
GroupValue95% CI
1st Line of Therapy75
2nd Line of Therapy16
3rd Line of Therapy8
4th Line of Therapy3
Lenalidomide (R)
GroupValue95% CI
1st Line of Therapy21
2nd Line of Therapy39
3rd Line of Therapy22
4th Line of Therapy5
Lenalidomide and Dexamethasone (RD)
GroupValue95% CI
1st Line of Therapy86
2nd Line of Therapy218
3rd Line of Therapy126
4th Line of Therapy30
Cyclophosphamide and Thalidomide (CT)
GroupValue95% CI
1st Line of Therapy60
2nd Line of Therapy37
3rd Line of Therapy11
4th Line of Therapy5
Melphalan and Thalidomide (MT)
GroupValue95% CI
1st Line of Therapy10
2nd Line of Therapy3
3rd Line of Therapy4
4th Line of Therapy3
Number of Treatment Sequencing Secondary · Baseline up to 5 years

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.

mAB based
GroupValue95% CI
1st Line of Therapy41
2nd Line of Therapy77
3rd Line of Therapy129
mAB/IMID based
GroupValue95% CI
1st Line of Therapy290
2nd Line of Therapy213
3rd Line of Therapy128
mAB/PI based
GroupValue95% CI
1st Line of Therapy156
2nd Line of Therapy119
3rd Line of Therapy69
mAB/alkalytor based
GroupValue95% CI
1st Line of Therapy2
2nd Line of Therapy7
3rd Line of Therapy6
mAB/IMID/PI based
GroupValue95% CI
1st Line of Therapy36
2nd Line of Therapy14
3rd Line of Therapy12
Cytotoxic
GroupValue95% CI
1st Line of Therapy74
2nd Line of Therapy59
3rd Line of Therapy49
IMID based
GroupValue95% CI
1st Line of Therapy515
2nd Line of Therapy361
3rd Line of Therapy118
PI based
GroupValue95% CI
1st Line of Therapy366
2nd Line of Therapy204
3rd Line of Therapy101

Adverse events — posted to ClinicalTrials.gov

Time frame: From start of study, until death, or the end of the study, whichever comes first (up to 5 years). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

1st Line of Therapy
Serious: 269/1849 (15%)
Deaths: 351/1790
2nd Line of Therapy
Serious: 101/773 (13%)
Deaths: 418/1331
3rd Line of Therapy
Serious: 82/455 (18%)
Deaths: 420/1050
4th Line of Therapy
Serious: 43/239 (18%)
Deaths: 348/739
>4th Line of Therapy
Serious: 38/181 (21%)
Deaths: 234/453
Robustness Concerns: 1st Line of Therapy
Serious: 0
Deaths: 58/340
Robustness Concerns: 2nd Line of Therapy
Serious: 0
Deaths: 72/303
Robustness Concerns: 3rd Line of Therapy
Serious: 0
Deaths: 65/222
Robustness Concerns: 4th Line of Therapy
Serious: 0
Deaths: 32/86
Robustness Concerns: >4th Line of Therapy
Serious: 0
Deaths: 6/24
Robustness Concerns: Unknown Line of Therapy
Serious: 0
Deaths: 28/147

Serious adverse events (295 terms)

ReactionSystem1st Line of Therapy2nd Line of Therapy3rd Line of Therapy4th Line of Therapy>4th Line of TherapyRobustness Concerns: 1st L…Robustness Concerns: 2nd L…Robustness Concerns: 3rd L…Robustness Concerns: 4th L…Robustness Concerns: >4th …Robustness Concerns: Unkno…
PneumoniaInfections and infestations
PyrexiaGeneral disorders
Acute kidney injuryRenal and urinary disorders
Cardiac failure congestiveCardiac disorders
DiarrhoeaGastrointestinal disorders
Lower respiratory tract infectionInfections and infestations
SepsisInfections and infestations
Atrial fibrillationCardiac disorders
AnaemiaBlood and lymphatic system disorders
VomitingGastrointestinal disorders
Septic shockInfections and infestations
DehydrationMetabolism and nutrition disorders
Respiratory failureRespiratory, thoracic and mediastinal disorders
Febrile neutropeniaBlood and lymphatic system disorders
PancytopeniaBlood and lymphatic system disorders
Respiratory tract infectionInfections and infestations
HyponatraemiaMetabolism and nutrition disorders
Back painMusculoskeletal and connective tissue disorders
Plasma cell myelomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)
SyncopeNervous system disorders
DyspnoeaRespiratory, thoracic and mediastinal disorders
Deep vein thrombosisVascular disorders
ThrombocytopeniaBlood and lymphatic system disorders
CellulitisInfections and infestations
GastroenteritisInfections and infestations
Other adverse events (250 terms — click to expand)

ReactionSystem1st Line of Therapy2nd Line of Therapy3rd Line of Therapy4th Line of Therapy>4th Line of TherapyRobustness Concerns: 1st L…Robustness Concerns: 2nd L…Robustness Concerns: 3rd L…Robustness Concerns: 4th L…Robustness Concerns: >4th …Robustness Concerns: Unkno…
Neuropathy peripheralNervous system disorders
Peripheral sensory neuropathyNervous system disorders
FatigueGeneral disorders
DiarrhoeaGastrointestinal disorders
NeutropeniaBlood and lymphatic system disorders
ThrombocytopeniaBlood and lymphatic system disorders
ConstipationGastrointestinal disorders
Oedema peripheralGeneral disorders
RashSkin and subcutaneous tissue disorders
Pain in extremityMusculoskeletal and connective tissue disorders
Back painMusculoskeletal and connective tissue disorders
PyrexiaGeneral disorders
Upper respiratory tract infectionInfections and infestations
DizzinessNervous system disorders
NauseaGastrointestinal disorders
Rash maculo-papularSkin and subcutaneous tissue disorders
PneumoniaInfections and infestations
ArthralgiaMusculoskeletal and connective tissue disorders
Bone painMusculoskeletal and connective tissue disorders
PolyneuropathyNervous system disorders
CoughRespiratory, thoracic and mediastinal disorders
AnaemiaBlood and lymphatic system disorders
Abdominal painGastrointestinal disorders
AstheniaGeneral disorders
BronchitisInfections and infestations
InfluenzaInfections and infestations
Respiratory tract infectionInfections and infestations
Neutrophil count decreasedInvestigations
MalaiseGeneral disorders
Platelet count decreasedInvestigations
Decreased appetiteMetabolism and nutrition disorders
HeadacheNervous system disorders
HypoaesthesiaNervous system disorders
InsomniaPsychiatric disorders
Rash pruriticSkin and subcutaneous tissue disorders
BradycardiaCardiac disorders
HaematocheziaGastrointestinal disorders
Urinary tract infectionInfections and infestations
FallInjury, poisoning and procedural complications
White blood cell count decreasedInvestigations

Most-reported serious reactions: Pneumonia, Pyrexia, Acute kidney injury, Cardiac failure congestive, Diarrhoea, Lower respiratory tract infection, Sepsis, Atrial fibrillation.

Data from ClinicalTrials.gov NCT02761187 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. INSIGHT MM: a large, global, prospective, non-interventional, real-world study of patients with multiple myeloma.
    Costello C, Davies FE, Cook G, Vela-Ojeda J, et al · · 2019 · cited 24× · PMID 30816809 · DOI 10.2217/fon-2019-0013
  2. Ixazomib-lenalidomide-dexamethasone in routine clinical practice: effectiveness in relapsed/refractory multiple myeloma.
    Hájek R, Minařík J, Straub J, Pour L, et al · · 2021 · cited 21× · PMID 33769076 · DOI 10.2217/fon-2020-1225
  3. New developments in the management of relapsed/refractory multiple myeloma - the role of ixazomib.
    Richardson PG, Kumar S, Laubach JP, Paba-Prada C, et al · · 2017 · cited 15× · PMID 28860887 · DOI 10.2147/jbm.s102328
  4. Rates of Influenza and Pneumococcal Vaccination and Correlation With Survival in Multiple Myeloma Patients.
    Thompson MA, Boccadoro M, Leleu X, Vela-Ojeda J, et al · · 2023 · cited 8× · PMID 36641358 · DOI 10.1016/j.clml.2022.12.003
  5. The EMMY longitudinal, cohort study: real-world data to describe multiple myeloma management and outcomes as more therapeutic options emerge.
    Decaux O, Garlantézec R, Belhadj-Merzoug K, Macro M, et al · · 2024 · cited 7× · PMID 39050939 · DOI 10.46989/001c.121371
  6. &lt;i&gt;In&lt;/i&gt;-class transition from bortezomib-based therapy to IRd is an effective approach in newly diagnosed multiple myeloma.
    Rifkin RM, Costello CL, Birhiray RE, Kambhampati S, et al · · 2024 · cited 3× · PMID 37807952 · DOI 10.2217/fon-2023-0272
  7. Comparative Effectiveness and Safety of PI-Rd Triplets in Relapsed/Refractory Multiple Myeloma: INSIGHT-MM Data Analysis.
    Puig N, Leleu X, Lee HC, Davies FE, et al · · 2026 · PMID 41528195 · DOI 10.1111/ejh.70079
  8. Abstract Book: 25th Congress of the European Hematology Association Virtual Edition, 2020
    · 2020

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02761187.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing