Trial · NCT01335399

Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma

NCT01335399, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2020-10-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma. Trials, record NCT01335399. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01335399

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Trial

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

Title: Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma
NCT number: NCT01335399
Status: Completed
Phases: Phase 3
Enrollment: 748 participants, actual
Lead sponsor: Bristol-Myers Squibb
Conditions: Multiple Myeloma
Interventions: Lenalidomide, Dexamethasone, Dexamethasone, Dexamethasone, Dexamethasone, Elotuzumab (BMS-901608; HuLuc63), Elotuzumab (BMS-901608; HuLuc63)
First posted: 2011-04-14
Last updated: 2022-09-30
Other registries' IDs: eudract:2010-022445-20
Results first posted: 2020-10-22

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Progression-Free Survival (PFS)	From randomization to date of first documented tumor progression or death due to any cause (up to 8 years)	PFS is defined as the time from randomization to the date of the first documented tumor progression (as determined by the Independent Review Committee (IRC)) or death due to any cause. The IRC conducted a blinded, independent review of the tumor assessments based on the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Censoring rules applied: * Participants receiving subsequent systemic anti-myeloma therapy prior to documented progression were censored at the date of the last adequate tumor assessment prior to new therapy. * Participants who had an event (progression or death) \> 10 weeks after their last tumor assessment were censored at their last adequate tumor assessment prior to the event. * Participants without progression or death (and not receiving subsequent therapy prior to progression) were censored at their last adequate tumor assessment. * Participants without any post-baseline tumor assessments were censored on the date of randomization
Secondary	Objective Response Rate (ORR)	From randomization to primary completion date (approximately 8 years)	ORR is defined as the percentage of participants with objective response among all randomized subjects. Participants with an objective response are those participants experiencing a partial response (PR) or better, based on Independent Review Committee (IRC) assessment, as per EBMT criteria.
Secondary	Overall Survival (OS)	From randomization to the date of death (up to 8 years)	Survival is defined as the time from randomization to the date of death. A participant who did not die had his or her survival duration censored at the date of last contact ('last known date alive").
Secondary	Mean Change From Baseline of Pain Severity Score and Pain Interference Score	From Baseline to End of Treatment (approximately 8 years)	Pain severity (sensory dimension) and pain interference (reactive dimension, assessing the degree to which pain interferes with function) are measured using the Brief Pain Inventory- Short Form (BPI-SF). BPI-SF numeric rating scale goes from 0 (No pain) to 10 (Pain as bad as you can imagine).
Secondary	Progression Free Survival (PFS) Rate at Specific Time-points	From randomization to the specified time-point (up to 5 years)	PFS rate is defined as the percentage of participants experiencing PFS at the defined time-points.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-Free Survival (PFS)	From randomization to date of first documented tumor progression or death due to any cause (up to 8 years)	All randomized participants	Months	MEDIAN
SECONDARY	Objective Response Rate (ORR)	From randomization to primary completion date (approximately 8 years)	All randomized participants	Percent of Participants	NUMBER
SECONDARY	Overall Survival (OS)	From randomization to the date of death (up to 8 years)	All randomized participants	Months	MEDIAN
SECONDARY	Mean Change From Baseline of Pain Severity Score and Pain Interference Score	From Baseline to End of Treatment (approximately 8 years)	All randomized participants	Rating score	MEAN
SECONDARY	Progression Free Survival (PFS) Rate at Specific Time-points	From randomization to the specified time-point (up to 5 years)	All randomized participants	Percent of participants	NUMBER

Source ClinicalTrials.gov

Results by group20

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

Outcome	Group	Category	Value	Spread	Units
Progression-Free Survival (PFS)	E-Ld Cohort		31.38	95% Confidence Interval 26.18 to 36.80	Months
Progression-Free Survival (PFS)	Ld Cohort		29.47	95% Confidence Interval 23.49 to 34.30	Months
Objective Response Rate (ORR)	E-Ld Cohort		82.9	95% Confidence Interval 78.7 to 86.6	Percent of Participants
Objective Response Rate (ORR)	Ld Cohort		79.4	95% Confidence Interval 75.0 to 83.4	Percent of Participants
Overall Survival (OS)	E-Ld Cohort		60.42	95% Confidence Interval 52.76 to 67.35	Months
Overall Survival (OS)	Ld Cohort		57.56	95% Confidence Interval 48.95 to 66.56	Months
Mean Change From Baseline of Pain Severity Score and Pain Interference Score	E-Ld Cohort	Pain Severity	0.02	Standard Deviation 2.645	Rating score
Mean Change From Baseline of Pain Severity Score and Pain Interference Score	Ld Cohort	Pain Severity	-0.25	Standard Deviation 2.721	Rating score
Mean Change From Baseline of Pain Severity Score and Pain Interference Score	E-Ld Cohort	Pain Interference	0.33	Standard Deviation 3.077	Rating score
Mean Change From Baseline of Pain Severity Score and Pain Interference Score	Ld Cohort	Pain Interference	-0.18	Standard Deviation 3.082	Rating score

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Pre-treatment Period	STARTED	E-Ld Cohort	374
Pre-treatment Period	STARTED	Ld Cohort	374
Pre-treatment Period	COMPLETED	E-Ld Cohort	371
Pre-treatment Period	COMPLETED	Ld Cohort	371
Pre-treatment Period	NOT COMPLETED	E-Ld Cohort	3
Pre-treatment Period	NOT COMPLETED	Ld Cohort	3
Treatment Period	STARTED	E-Ld Cohort	371
Treatment Period	STARTED	Ld Cohort	371
Treatment Period	COMPLETED	E-Ld Cohort	0
Treatment Period	COMPLETED	Ld Cohort	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events1,176

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	E-Ld Cohort	153	371
other	Anaemia	Blood and lymphatic system disorders	Ld Cohort	160	371
other	Leukopenia	Blood and lymphatic system disorders	E-Ld Cohort	23	371
other	Leukopenia	Blood and lymphatic system disorders	Ld Cohort	37	371
other	Neutropenia	Blood and lymphatic system disorders	E-Ld Cohort	93	371
other	Neutropenia	Blood and lymphatic system disorders	Ld Cohort	117	371
other	Thrombocytopenia	Blood and lymphatic system disorders	E-Ld Cohort	66	371
other	Thrombocytopenia	Blood and lymphatic system disorders	Ld Cohort	69	371
other	Atrial fibrillation	Cardiac disorders	E-Ld Cohort	28	371
other	Atrial fibrillation	Cardiac disorders	Ld Cohort	25	371

1 to 10 of 1,176Source ClinicalTrials.gov

See all 1,176 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	E-Ld Cohort	240	374
Total, all-cause mortality	Ld Cohort	232	374
Total, other adverse events	E-Ld Cohort	364	371
Total, other adverse events	Ld Cohort	365	371
Total, serious adverse events	E-Ld Cohort	293	371
Total, serious adverse events	Ld Cohort	279	371

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35550060	DERIVED

Source 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 comparisons2

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

Comparison	Source
E-Ld Cohort vs Ld Cohort: deaths from any cause	Trial comparisons
E-Ld Cohort vs Ld Cohort: serious adverse events	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/NCT01335399

GET https://conductscience.org/api/trials/v1/NCT01335399/events?page=2

API reference For AI assistants