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-morbiditiesPrimary· 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
Group
Value
95% CI
NDMM
1279
RRMM
1064
2-3
Group
Value
95% CI
NDMM
307
RRMM
247
4-5
Group
Value
95% CI
NDMM
66
RRMM
60
>5
Group
Value
95% CI
NDMM
38
RRMM
19
Missing
Group
Value
95% CI
NDMM
71
RRMM
50
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.
Group
Value
95% CI
NDMM
2338
RRMM
1915
Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance StatusPrimary· 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
Group
Value
95% CI
NDMM
714
RRMM
710
Grade 1
Group
Value
95% CI
NDMM
727
RRMM
559
Grade 2
Group
Value
95% CI
NDMM
171
RRMM
113
Grade 3
Group
Value
95% CI
NDMM
61
RRMM
22
Grade 4
Group
Value
95% CI
NDMM
13
RRMM
2
Missing
Group
Value
95% CI
NDMM
75
RRMM
34
Number of Participants With Myeloma Frailty IndexPrimary· 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
Group
Value
95% CI
1st Line of Therapy
517
2nd Line of Therapy
428
1: Intermediate
Group
Value
95% CI
1st Line of Therapy
218
2nd Line of Therapy
202
≥2: Frail
Group
Value
95% CI
1st Line of Therapy
190
2nd Line of Therapy
130
Missing
Group
Value
95% CI
1st Line of Therapy
836
2nd Line of Therapy
680
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
Group
Value
95% CI
1st Line of Therapy
208
2nd Line of Therapy
20
3rd Line of Therapy
7
4th Line of Therapy
4
>4th Line of Therapy
0
1st Line of Therapy
126
2nd Line of Therapy
23
3rd Line of Therapy
12
4th Line of Therapy
5
>4th Line of Therapy
0
1st Line of Therapy
950
2nd Line of Therapy
147
3rd Line of Therapy
55
4th Line of Therapy
24
>4th Line of Therapy
12
1st Line of Therapy
399
2nd Line of Therapy
17
3rd Line of Therapy
2
4th Line of Therapy
2
>4th Line of Therapy
0
t(4,14)
Group
Value
95% CI
1st Line of Therapy
208
2nd Line of Therapy
20
3rd Line of Therapy
7
4th Line of Therapy
4
>4th Line of Therapy
0
1st Line of Therapy
116
2nd Line of Therapy
24
3rd Line of Therapy
4
4th Line of Therapy
5
>4th Line of Therapy
3
1st Line of Therapy
957
2nd Line of Therapy
144
3rd Line of Therapy
63
4th Line of Therapy
25
>4th Line of Therapy
9
1st Line of Therapy
401
2nd Line of Therapy
18
3rd Line of Therapy
2
4th Line of Therapy
2
>4th Line of Therapy
0
t(14,16)
Group
Value
95% CI
1st Line of Therapy
208
2nd Line of Therapy
20
3rd Line of Therapy
7
4th Line of Therapy
4
>4th Line of Therapy
0
1st Line of Therapy
50
2nd Line of Therapy
7
3rd Line of Therapy
0
4th Line of Therapy
3
>4th Line of Therapy
0
1st Line of Therapy
1007
2nd Line of Therapy
157
3rd Line of Therapy
67
4th Line of Therapy
27
>4th Line of Therapy
12
1st Line of Therapy
416
2nd Line of Therapy
18
3rd Line of Therapy
2
4th Line of Therapy
2
>4th Line of Therapy
0
Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS StagePrimary· 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
Group
Value
95% CI
NDMM
395
RRMM
236
ISS Stage II
Group
Value
95% CI
NDMM
387
RRMM
267
ISS Stage III
Group
Value
95% CI
NDMM
520
RRMM
297
ISS Not Available
Group
Value
95% CI
NDMM
138
RRMM
376
ISS Missing
Group
Value
95% CI
NDMM
321
RRMM
264
R-ISS Stage I
Group
Value
95% CI
NDMM
127
RRMM
40
R-ISS Stage II
Group
Value
95% CI
NDMM
319
RRMM
145
R-ISS Stage III
Group
Value
95% CI
NDMM
76
RRMM
24
Duration of Treatment for Participants With and Without Stem Cell TransplantPrimary· 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.
Group
Value
95% CI
1st Line of Therapy
4.5
0 – 45
2nd Line of Therapy
6.4
0 – 57
3rd Line of Therapy
9.2
0 – 80
4th Line of Therapy
11.5
0 – 68
>4th Line of Therapy
11.5
0 – 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.
Group
Value
95% CI
1st Line of Therapy
NA
NA – NA
2nd Line of Therapy
47.67
45.34 – NA
3rd Line of Therapy
32.07
26.84 – 39.56
4th Line of Therapy
20.60
17.51 – 23.36
>4th Line of Therapy
13.44
10.91 – 15.90
Time to Next TherapyPrimary· Baseline up to 5 years
The line of Therapy was determined at study entry. The Kaplan Meier estimates was used for the analysis.
Group
Value
95% CI
1st Line of Therapy
30.39
26.87 – 33.74
2nd Line of Therapy
15.44
13.63 – 17.08
3rd Line of Therapy
9.46
8.34 – 10.81
4th Line of Therapy
6.90
6.11 – 7.82
>4th Line of Therapy
5.95
5.16 – 6.70
Number of Participants With Stem Cell TransplantPrimary· Baseline up to 5 years
Group
Value
95% CI
1st Line of Therapy
1790
2nd Line of Therapy
686
3rd Line of Therapy
458
4th Line of Therapy
249
>4th Line of Therapy
80
Number of Participants Receiving Different Treatment CombinationsSecondary· Baseline up to 5 years
Bortezomib and Lenalidomide (VR)
Group
Value
95% CI
1st Line of Therapy
560
2nd Line of Therapy
86
3rd Line of Therapy
19
4th Line of Therapy
10
Bortezomib and Cyclophosphamide (VC)
Group
Value
95% CI
1st Line of Therapy
497
2nd Line of Therapy
99
3rd Line of Therapy
43
4th Line of Therapy
18
Bortezomib and Thalidomide (VT)
Group
Value
95% CI
1st Line of Therapy
272
2nd Line of Therapy
60
3rd Line of Therapy
10
4th Line of Therapy
11
Bortezomib and Melphalan (VM)
Group
Value
95% CI
1st Line of Therapy
75
2nd Line of Therapy
16
3rd Line of Therapy
8
4th Line of Therapy
3
Lenalidomide (R)
Group
Value
95% CI
1st Line of Therapy
21
2nd Line of Therapy
39
3rd Line of Therapy
22
4th Line of Therapy
5
Lenalidomide and Dexamethasone (RD)
Group
Value
95% CI
1st Line of Therapy
86
2nd Line of Therapy
218
3rd Line of Therapy
126
4th Line of Therapy
30
Cyclophosphamide and Thalidomide (CT)
Group
Value
95% CI
1st Line of Therapy
60
2nd Line of Therapy
37
3rd Line of Therapy
11
4th Line of Therapy
5
Melphalan and Thalidomide (MT)
Group
Value
95% CI
1st Line of Therapy
10
2nd Line of Therapy
3
3rd Line of Therapy
4
4th Line of Therapy
3
Number of Treatment SequencingSecondary· 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
Group
Value
95% CI
1st Line of Therapy
41
2nd Line of Therapy
77
3rd Line of Therapy
129
mAB/IMID based
Group
Value
95% CI
1st Line of Therapy
290
2nd Line of Therapy
213
3rd Line of Therapy
128
mAB/PI based
Group
Value
95% CI
1st Line of Therapy
156
2nd Line of Therapy
119
3rd Line of Therapy
69
mAB/alkalytor based
Group
Value
95% CI
1st Line of Therapy
2
2nd Line of Therapy
7
3rd Line of Therapy
6
mAB/IMID/PI based
Group
Value
95% CI
1st Line of Therapy
36
2nd Line of Therapy
14
3rd Line of Therapy
12
Cytotoxic
Group
Value
95% CI
1st Line of Therapy
74
2nd Line of Therapy
59
3rd Line of Therapy
49
IMID based
Group
Value
95% CI
1st Line of Therapy
515
2nd Line of Therapy
361
3rd Line of Therapy
118
PI based
Group
Value
95% CI
1st Line of Therapy
366
2nd Line of Therapy
204
3rd Line of Therapy
101
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)
Reaction
System
1st Line of Therapy
2nd Line of Therapy
3rd Line of Therapy
4th Line of Therapy
>4th Line of Therapy
Robustness Concerns: 1st L…
Robustness Concerns: 2nd L…
Robustness Concerns: 3rd L…
Robustness Concerns: 4th L…
Robustness Concerns: >4th …
Robustness Concerns: Unkno…
Pneumonia
Infections and infestations
—
—
—
—
—
—
—
—
—
—
—
Pyrexia
General disorders
—
—
—
—
—
—
—
—
—
—
—
Acute kidney injury
Renal and urinary disorders
—
—
—
—
—
—
—
—
—
—
—
Cardiac failure congestive
Cardiac disorders
—
—
—
—
—
—
—
—
—
—
—
Diarrhoea
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
—
Lower respiratory tract infection
Infections and infestations
—
—
—
—
—
—
—
—
—
—
—
Sepsis
Infections and infestations
—
—
—
—
—
—
—
—
—
—
—
Atrial fibrillation
Cardiac disorders
—
—
—
—
—
—
—
—
—
—
—
Anaemia
Blood and lymphatic system disorders
—
—
—
—
—
—
—
—
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
—
Septic shock
Infections and infestations
—
—
—
—
—
—
—
—
—
—
—
Dehydration
Metabolism and nutrition disorders
—
—
—
—
—
—
—
—
—
—
—
Respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
—
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
—
—
—
—
—
—
—
—
—
Pancytopenia
Blood and lymphatic system disorders
—
—
—
—
—
—
—
—
—
—
—
Respiratory tract infection
Infections and infestations
—
—
—
—
—
—
—
—
—
—
—
Hyponatraemia
Metabolism and nutrition disorders
—
—
—
—
—
—
—
—
—
—
—
Back pain
Musculoskeletal and connective tissue disorders
—
—
—
—
—
—
—
—
—
—
—
Plasma cell myeloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
—
—
—
—
—
—
—
—
Syncope
Nervous system disorders
—
—
—
—
—
—
—
—
—
—
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
—
—
—
Deep vein thrombosis
Vascular disorders
—
—
—
—
—
—
—
—
—
—
—
Thrombocytopenia
Blood and lymphatic system disorders
—
—
—
—
—
—
—
—
—
—
—
Cellulitis
Infections and infestations
—
—
—
—
—
—
—
—
—
—
—
Gastroenteritis
Infections and infestations
—
—
—
—
—
—
—
—
—
—
—
Other adverse events (250 terms — click to expand)
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):
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NCT07429942 — A Study to Learn More About the Treatment of People With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Who Recei
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NCT07521917 — Child Abuse and Neglect Awareness Training in Nursing Students
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 24 February 2025
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.