Trial · NCT02761187

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

NCT02761187, Terminated, Takeda; results first posted 2025-02-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. An Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Participants. Trials, record NCT02761187. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02761187

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: An Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Participants
NCT number: NCT02761187
Status: Terminated
Enrollment: 4,253 participants, actual
Lead sponsor: Takeda
Conditions: Multiple Myeloma
Interventions: No Intervention
First posted: 2016-05-04
Last updated: 2025-02-24
Results first posted: 2025-02-24
Limitations and caveats: This study was terminated 3 years early due to business reprioritization within Takeda.

Source ClinicalTrials.gov

Registered outcomes28

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Co-morbidities	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.
Primary	Number of Participants Diagnosed With Newly Diagnosed Multiple Myeloma (NDMM) and Relapsed/Refractory Multiple Myeloma (R/RMM)	At Baseline	Participants diagnosed with NDMM and R/RMM were determined at the start of the study.
Primary	Number of Participants Diagnosed With Symptoms of ND MM and R/R MM During the Study	Baseline up to 5 years
Primary	Sites of Disease Diagnosed With ND MM and R/R MM	Baseline up to 5 years
Primary	Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status	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.
Primary	Number of Participants With Myeloma Frailty Index	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.
Primary	Number of Participants Evaluated for Minimal Residual Disease (MRD)	Baseline up to 5 years
Primary	Number of Participants Evaluated for Gene Expression Profiling (GEP)	Baseline up to 5 years
Primary	Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH)	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) \[t(14,16)\].
Primary	Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage	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).

1 to 10 of 28Source ClinicalTrials.gov

See all 28 registered outcomes

Outcomes28

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Co-morbidities	Baseline up to 5 years	All Enrolled Population included all participants who signed the inform consent form. Overall number of participants analyzed is the number of participants available for analysis.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants Diagnosed With Newly Diagnosed Multiple Myeloma (NDMM) and Relapsed/Refractory Multiple Myeloma (R/RMM)	At Baseline	All Enrolled Population included all participants who signed the inform consent form.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants Diagnosed With Symptoms of ND MM and R/R MM During the Study	Baseline up to 5 years	As the study was early terminated data was not collected for this outcome measure.
PRIMARY	Sites of Disease Diagnosed With ND MM and R/R MM	Baseline up to 5 years	As the study was early terminated data was not collected for this outcome measure.
PRIMARY	Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status	At Baseline	All Enrolled Population included all participants who signed informed consent. Overall number of participants analyzed is the number of participants available for analysis.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Myeloma Frailty Index	At Baseline	All Enrolled Population included all participants who signed the inform consent form. Overall number of participants analyzed is the number of participants available for analysis.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants Evaluated for Minimal Residual Disease (MRD)	Baseline up to 5 years	As the study was early terminated data was not collected for this outcome measure.
PRIMARY	Number of Participants Evaluated for Gene Expression Profiling (GEP)	Baseline up to 5 years	As the study was early terminated data was not collected for this outcome measure.
PRIMARY	Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH)	At Baseline	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. The data is reported as per the known line of therapies. Overall number of participants analyzed is the number of participants available for analysis.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage	At Baseline	All Enrolled Population included all participants who signed informed consent. Overall number of participants are the number of participants available for analysis.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 28Source ClinicalTrials.gov

See all 28 outcomes

Results by group380

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With Co-morbidities	NDMM	0-1	1279	Participants
Number of Participants With Co-morbidities	RRMM	0-1	1064	Participants
Number of Participants With Co-morbidities	NDMM	2-3	307	Participants
Number of Participants With Co-morbidities	RRMM	2-3	247	Participants
Number of Participants With Co-morbidities	NDMM	4-5	66	Participants
Number of Participants With Co-morbidities	RRMM	4-5	60	Participants
Number of Participants With Co-morbidities	NDMM	>5	38	Participants
Number of Participants With Co-morbidities	RRMM	>5	19	Participants
Number of Participants With Co-morbidities	NDMM	Missing	71	Participants
Number of Participants With Co-morbidities	RRMM	Missing	50	Participants

1 to 10 of 380Source ClinicalTrials.gov

See all 380 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Newly Diagnosed (ND) MM	2,338
Overall Study	STARTED	Relapsed/Refractory (R/R) MM	1,915
Overall Study	1st Line of Therapy	Newly Diagnosed (ND) MM	2,193
Overall Study	1st Line of Therapy	Relapsed/Refractory (R/R) MM	68
Overall Study	2nd Line of Therapy	Newly Diagnosed (ND) MM	928
Overall Study	2nd Line of Therapy	Relapsed/Refractory (R/R) MM	950
Overall Study	3rd Line of Therapy	Newly Diagnosed (ND) MM	406
Overall Study	3rd Line of Therapy	Relapsed/Refractory (R/R) MM	1,049
Overall Study	4th Line of Therapy	Newly Diagnosed (ND) MM	185
Overall Study	4th Line of Therapy	Relapsed/Refractory (R/R) MM	727

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events5,995

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	1st Line of Therapy	4	1,849
other	Anaemia	Blood and lymphatic system disorders	2nd Line of Therapy	2	773
other	Anaemia	Blood and lymphatic system disorders	3rd Line of Therapy	5	455
other	Anaemia	Blood and lymphatic system disorders	4th Line of Therapy	2	239
other	Anaemia	Blood and lymphatic system disorders	>4th Line of Therapy	3	181
other	Anaemia	Blood and lymphatic system disorders	Robustness Concerns: 1st Line of Therapy	0	0
other	Anaemia	Blood and lymphatic system disorders	Robustness Concerns: 2nd Line of Therapy	0	0
other	Anaemia	Blood and lymphatic system disorders	Robustness Concerns: 3rd Line of Therapy	0	0
other	Anaemia	Blood and lymphatic system disorders	Robustness Concerns: 4th Line of Therapy	0	0
other	Anaemia	Blood and lymphatic system disorders	Robustness Concerns: >4th Line of Therapy	0	0

1 to 10 of 5,995Source ClinicalTrials.gov

See all 5,995 adverse events

Adverse event totals33

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	1st Line of Therapy	351	1,790
Total, all-cause mortality	2nd Line of Therapy	418	1,331
Total, all-cause mortality	3rd Line of Therapy	420	1,050
Total, all-cause mortality	4th Line of Therapy	348	739
Total, all-cause mortality	>4th Line of Therapy	234	453
Total, all-cause mortality	Robustness Concerns: 1st Line of Therapy	58	340
Total, all-cause mortality	Robustness Concerns: 2nd Line of Therapy	72	303
Total, all-cause mortality	Robustness Concerns: 3rd Line of Therapy	65	222
Total, all-cause mortality	Robustness Concerns: 4th Line of Therapy	32	86
Total, all-cause mortality	Robustness Concerns: >4th Line of Therapy	6	24

1 to 10 of 33Source ClinicalTrials.gov

See all 33 adverse event totals

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30816809	DERIVED	PubMed
33769076	DERIVED	PubMed
36641358	DERIVED	PubMed
37807952	DERIVED	PubMed
41528195	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
NDMM vs RRMM: Number of Participants Diagnosed With Newly Diagnosed Multiple Myeloma (NDMM) and Relapsed/Refractory Multiple Myeloma (R/RMM)

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02761187

GET https://conductscience.org/api/trials/v1/NCT02761187/registered?page=2

API reference For AI assistants