Trial · NCT01592370

An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma

NCT01592370, Phase 1, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2022-02-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma. Trials, record NCT01592370. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01592370

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Trial

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

Title: An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma
NCT number: NCT01592370
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 320 participants, actual
Lead sponsor: Bristol-Myers Squibb
Conditions: Non-Hodgkin's Lymphoma, Hodgkin Lymphoma, Multiple Myeloma
Interventions: Nivolumab, Ipilimumab, Lirilumab, Daratumumab, Pomalidomide, Dexamethasone
First posted: 2012-05-07
Last updated: 2025-10-22
Other registries' IDs: eudract:2018-001030-17
Results first posted: 2022-02-17

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 That Experienced Drug Related Grade 3-4 AEs	Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month	Number and percent of participants that experienced drug related Grade 3-4 AEs occurring up to 100 days after the last dose of study drug.
Primary	Number of Participants That Experienced Drug Related Grade 3-4 SAEs	Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month	Number and percent of participants that experienced drug related Grade 3-4 SAEs occurring up to 100 days after the last dose of study drug.
Primary	Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver	Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month	Number and percent of participants that experienced drug related Grade 3-4 AEs occurring up to 100 days after the last dose of study drug.
Primary	Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid	Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month
Primary	Number of Participants That Experienced Drug-related Grade 3-4 AEs in the Nivolumab + Daratumumab Cohort	approximately up to 4 years
Primary	Number of Participants That Experienced Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohort	approximately up to 4 years
Primary	Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology	approximately up to 4 years
Primary	Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver	approximately up to 4 years
Primary	Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid	approximately up to 4 years
Secondary	Best Overall Response	Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month	the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy. Measured in Complete Response and Partial Response

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 That Experienced Drug Related Grade 3-4 AEs	Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month	All Treated Participants	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants That Experienced Drug Related Grade 3-4 SAEs	Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month	All Treated Participants	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver	Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month	All Treated Participants	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid	Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month	All Treated Participants	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants That Experienced Drug-related Grade 3-4 AEs in the Nivolumab + Daratumumab Cohort	approximately up to 4 years	All treated participants in the nivo dara cohort	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants That Experienced Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohort	approximately up to 4 years	All treated participants in the nivo dara cohort	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology	approximately up to 4 years	All treated participants in the nivo dara cohort	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver	approximately up to 4 years	All treated participants in the nivo dara cohort	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid	approximately up to 4 years	All treated participants in the nivo dara cohort with at Least One On-Treatment TSH Measurement	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Best Overall Response	Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month	All treated participants with available measurements (excluding Multiple Myeloma (MM) Group)	Percentage of participants	NUMBER

1 to 10 of 28Source ClinicalTrials.gov

See all 28 outcomes

Results by group318

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

Outcome	Group	Category	Value	Units
Number of Participants That Experienced Drug Related Grade 3-4 AEs	Nivolumab Monotherapy (Expansion)		19	Participants
Number of Participants That Experienced Drug Related Grade 3-4 AEs	Nivolumab + Ipilimumab		18	Participants
Number of Participants That Experienced Drug Related Grade 3-4 AEs	Nivolumab + Lirilumab		0	Participants
Number of Participants That Experienced Drug Related Grade 3-4 SAEs	Nivolumab Monotherapy (Expansion)		28	Participants
Number of Participants That Experienced Drug Related Grade 3-4 SAEs	Nivolumab + Ipilimumab		8	Participants
Number of Participants That Experienced Drug Related Grade 3-4 SAEs	Nivolumab + Lirilumab		3	Participants
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver	Nivolumab Monotherapy (Expansion)	ALT OR AST > 3XULN	3	Participants
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver	Nivolumab + Ipilimumab	ALT OR AST > 3XULN	1	Participants
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver	Nivolumab + Lirilumab	ALT OR AST > 3XULN	4	Participants
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver	Nivolumab Monotherapy (Expansion)	ALT OR AST > 5XULN	1	Participants

1 to 10 of 318Source ClinicalTrials.gov

See all 318 results by group

Participant flow21

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Nivolumab Monotherapy (Expansion)	105
Overall Study	STARTED	Nivolumab + Ipilimumab	65
Overall Study	STARTED	Nivolumab + Lirilumab	72
Overall Study	STARTED	Nivolumab + Daratumumab_Cohort A1	6
Overall Study	STARTED	Nivolumab + Daratumumab_Cohort A2	7
Overall Study	STARTED	Nivolumab + Daratumumab_Cohort B1	43
Overall Study	STARTED	Nivolumab + Daratumumab_Cohort B2	22
Overall Study	COMPLETED	Nivolumab Monotherapy (Expansion)	1
Overall Study	COMPLETED	Nivolumab + Ipilimumab	40
Overall Study	COMPLETED	Nivolumab + Lirilumab	0

1 to 10 of 21Source ClinicalTrials.gov

See all 21 participant flow

Adverse events2,268

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	Nivolumab Monotherapy (Expansion)	23	105
other	Anaemia	Blood and lymphatic system disorders	Nivolumab + Ipilimumab	12	65
other	Anaemia	Blood and lymphatic system disorders	Nivolumab + Lirilumab	18	72
other	Anaemia	Blood and lymphatic system disorders	Nivolumab + Daratumumab Cohort A1	3	6
other	Anaemia	Blood and lymphatic system disorders	Nivolumab + Daratumumab_Cohort A2	4	5
other	Anaemia	Blood and lymphatic system disorders	Nivolumab + Daratumumab_Cohort B1	10	41
other	Anaemia	Blood and lymphatic system disorders	Nivolumab + Daratumumab_Cohort B2	4	22
other	Neutropenia	Blood and lymphatic system disorders	Nivolumab Monotherapy (Expansion)	12	105
other	Neutropenia	Blood and lymphatic system disorders	Nivolumab + Ipilimumab	6	65
other	Neutropenia	Blood and lymphatic system disorders	Nivolumab + Lirilumab	7	72

1 to 10 of 2,268Source ClinicalTrials.gov

See all 2,268 adverse events

Adverse event totals21

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nivolumab Monotherapy (Expansion)	53	105
Total, all-cause mortality	Nivolumab + Ipilimumab	33	65
Total, all-cause mortality	Nivolumab + Lirilumab	42	72
Total, all-cause mortality	Nivolumab + Daratumumab Cohort A1	1	6
Total, all-cause mortality	Nivolumab + Daratumumab_Cohort A2	3	7
Total, all-cause mortality	Nivolumab + Daratumumab_Cohort B1	24	42
Total, all-cause mortality	Nivolumab + Daratumumab_Cohort B2	13	23
Total, other adverse events	Nivolumab Monotherapy (Expansion)	102	105
Total, other adverse events	Nivolumab + Ipilimumab	62	65
Total, other adverse events	Nivolumab + Lirilumab	69	72

1 to 10 of 21Source ClinicalTrials.gov

See all 21 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25482239	DERIVED	PubMed
27269947	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 comparisons0

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

None in this release.

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.

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