Study of Pomalidomide and Low Dose Dexamethasone With or Without Pembrolizumab (MK-3475) in Refractory or Relapsed and Refractory Multiple Myeloma (rrMM) (MK-3475-183/KEYNOTE-183)

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ClinicalTrials.gov Identifier: NCT02576977

Recruitment Status : Terminated (The study was terminated early due to business reasons)

First Posted : October 15, 2015

Results First Posted : August 2, 2019

Last Update Posted : October 8, 2021

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Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme LLC

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Multiple Myeloma
Interventions	Biological: Pembrolizumab Drug: Pomalidomide Drug: Dexamethasone
Enrollment	251

Participant Flow

Recruitment Details	Subject Disposition as per database cutoff date of August 3, 2020.
Pre-assignment Details	Note: For administrative reasons (a noncompliant site), one participant in the SOC arm was recorded as "Ongoing in Trial" in the CSR Disposition Table and "Final Disposition Unknown" here.


Arm/Group Title	Pembrolizumab+Pomalidomide+Dexamethasone	Standard of Care (SOC) Pomalidomide+Dexamethasone
Arm/Group Description	Participants receive pembrolizumab ...	Participants receive pomalidomide 4...
Arm/Group Description	Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W) PLUS pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.	Participants receive pomalidomide 4 mg PO on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
Period Title: Overall Study
Started	126	125
Treated	122	123
Completed	0	0
Not Completed	126	125
Reason Not Completed
Adverse Event	13	2
Death	73	60
Screen failure	1	0
Study Terminated at Selected Sites	27	50
Withdrawal by Subject	11	11
Final Disposition Unknown	0	1
Lost to Follow-up	1	0
Progressive Disease	0	1

Baseline Characteristics

Arm/Group Title		Pembrolizumab+Pomalidomide+Dexamethasone	Standard of Care (SOC) Pomalidomide+Dexamethasone	Total
Arm/Group Description		Participants receive pembrolizumab ...	Participants receive pomalidomide 4...	Total of all reporting groups
Arm/Group Description		Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W) PLUS pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.	Participants receive pomalidomide 4 mg PO on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.	Total of all reporting groups
Overall Number of Baseline Participants		126	125	251
Baseline Analysis Population Description		...
Baseline Analysis Population Description		The analysis population included all randomized participants.
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	126 participants	125 participants	251 participants
		65.5 (9.3)	66.4 (10.0)	65.9 (9.6)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	126 participants	125 participants	251 participants
	Female	48 38.1%	46 36.8%	94 37.5%
	Male	78 61.9%	79 63.2%	157 62.5%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	126 participants	125 participants	251 participants
	Hispanic or Latino	8 6.3%	5 4.0%	13 5.2%
	Not Hispanic or Latino	110 87.3%	117 93.6%	227 90.4%
	Unknown or Not Reported	8 6.3%	3 2.4%	11 4.4%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	126 participants	125 participants	251 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	17 13.5%	12 9.6%	29 11.6%
	Native Hawaiian or Other Pacific Islander	2 1.6%	1 0.8%	3 1.2%
	Black or African American	10 7.9%	14 11.2%	24 9.6%
	White	92 73.0%	95 76.0%	187 74.5%
	More than one race	1 0.8%	2 1.6%	3 1.2%
	Unknown or Not Reported	4 3.2%	1 0.8%	5 2.0%
Disease Status (Refractory vs. Sensitive to Lenalidomide) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	126 participants	125 participants	251 participants
	Refractory to Lenalidomide	108 85.7%	108 86.4%	216 86.1%
	Sensitive to Lenalidomide	18 14.3%	17 13.6%	35 13.9%

Outcome Measures

1.Primary Outcome


Title	Progression Free Survival (PFS) Assessed by Clinical Adjudication Committee (CAC) Blinded Central Review According to the International Myeloma Working Group (IMWG) Response Criteria
Description	Progression free survival was defined as the time from randomization t...
Description	Progression free survival was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. PFS was assessed by CAC blinded central review according to the IMWG criteria based on the development of new bone lesions or soft tissue plasmacytomas or on a definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Median PFS was calculated from the product-limit (Kaplan-Meier) method for censored data. The database cutoff date was July 9, 2018.
Time Frame	Up to approximately 30 months

Outcome Measure Data

Analysis Population Description

The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.


Arm/Group Title	Pembrolizumab+Pomalidomide+Dexamethasone	Standard of Care (SOC) Pomalidomide+Dexamethasone
Arm/Group Description:	Participants receive pembrolizumab ...	Participants receive pomalidomide 4...
Arm/Group Description:	Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W) PLUS pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.	Participants receive pomalidomide 4 mg PO on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
Overall Number of Participants Analyzed	126	125
Median (95% Confidence Interval) Unit of Measure: Months
	5.7 (4.5 to 7.5)	7.4 (5.6 to 11.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pembrolizumab+Pomalidomide+Dexamethasone, Standard of Care (SOC) Pomalidomide+Dexamethasone
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.99324
	Comments	[Not Specified]
	Method	Log Rank
	Comments	One-sided p-value based on Stratified log-rank test.

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.50
	Confidence Interval	(2-Sided) 95% 1.08 to 2.08
	Estimation Comments	Based on Cox regression model with treatment as a covariate stratified by disease status (refractory vs. sensitive to Lenalidomide) and Lines of previous treatments (two vs. three or more).

2.Primary Outcome


Title	Overall Survival (OS)
Description	Overall survival is defined as the time from randomization to death du...
Description	Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Median overall survival was calculated from the product-limit (Kaplan-Meier) method for censored data. The database cutoff date was August 3, 2020.
Time Frame	Up to approximately 54 months

Outcome Measure Data

Analysis Population Description

The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.


Arm/Group Title	Pembrolizumab+Pomalidomide+Dexamethasone	Standard of Care (SOC) Pomalidomide+Dexamethasone
Arm/Group Description:	Participants receive pembrolizumab ...	Participants receive pomalidomide 4...
Arm/Group Description:	Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W) PLUS pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.	Participants receive pomalidomide 4 mg PO on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
Overall Number of Participants Analyzed	126	125
Median (95% Confidence Interval) Unit of Measure: Months
	21.0 (14.2 to 29.1)	39.6 ^[1] (28.5 to NA)

[1]

OS upper limit was not reached due to an insufficient number of deaths.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pembrolizumab+Pomalidomide+Dexamethasone, Standard of Care (SOC) Pomalidomide+Dexamethasone
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.99989
	Comments	[Not Specified]
	Method	Log Rank
	Comments	One-sided p-value based on Stratified log-rank test.

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.84
	Confidence Interval	(2-Sided) 95% 1.32 to 2.55
	Estimation Comments	[Not Specified]

Other Statistical Analysis		The Hazard Ratio and 95% confidence intervals were based on Cox regression model with treatment as a covariate stratified by disease status (refractory vs. sensitive to Lenalidomide) and Lines of previous treatments (two vs. three or more).

3.Secondary Outcome


Title	Overall Response Rate (ORR) Evaluated According to the IMWG Response Criteria by CAC Blinded Central Review
Description	ORR was defined as the percentage of the participants in the analysis ...
Description	ORR was defined as the percentage of the participants in the analysis population who achieved at least a partial response (stringent complete response [sCR]+complete response [CR]+very good partial response [VGPR]+partial response [PR]) according to the IMWG. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 hr; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. The database cutoff date was July 9, 2018.
Time Frame	Up to approximately 30 months

Outcome Measure Data

Analysis Population Description

The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.


Arm/Group Title	Pembrolizumab+Pomalidomide+Dexamethasone	Standard of Care (SOC) Pomalidomide+Dexamethasone
Arm/Group Description:	Participants receive pembrolizumab ...	Participants receive pomalidomide 4...
Arm/Group Description:	Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W) PLUS pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.	Participants receive pomalidomide 4 mg PO on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
Overall Number of Participants Analyzed	126	125
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: Percentage of participants
	37.3 (28.9 to 46.4)	42.4 (33.6 to 51.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pembrolizumab+Pomalidomide+Dexamethasone, Standard of Care (SOC) Pomalidomide+Dexamethasone
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.79921
	Comments	[Not Specified]
	Method	Miettinen & Nurminen method
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Difference in % vs. SOC
	Estimated Value	-5.2
	Confidence Interval	(2-Sided) 95% -17.1 to 6.9
	Estimation Comments	[Not Specified]

Other Statistical Analysis		Based on Miettinen & Nurminen method stratified by disease status (refractory vs. sensitive to Lenalidomide) and Lines of previous treatments (two vs. three or more); If there were no participants in one of the treatment groups involved in a comparison for a particular stratum, then that stratum was excluded from the treatment comparison.

4.Secondary Outcome


Title	Participants Experiencing One or More Adverse Events (AEs)
Description	An adverse event (AE) was defined as any unfavorable and unintended si...
Description	An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. Database cutoff was August 3, 2020.
Time Frame	Up to approximately 54 months

Outcome Measure Data

Analysis Population Description

The analysis population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.


Arm/Group Title	Pembrolizumab+Pomalidomide+Dexamethasone	Standard of Care (SOC) Pomalidomide+Dexamethasone
Arm/Group Description:	Participants receive pembrolizumab ...	Participants receive pomalidomide 4...
Arm/Group Description:	Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W) PLUS pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.	Participants receive pomalidomide 4 mg PO on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
Overall Number of Participants Analyzed	122	123
Measure Type: Count of Participants Unit of Measure: Participants
	122 100.0%	119 96.7%

5.Secondary Outcome


Title	Participants Discontinuing Study Investigational Product Due to an AE
Description	An adverse event was defined as any unfavorable and unintended sign in...
Description	An adverse event was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. Database cutoff was August 3, 2020.
Time Frame	Up to approximately 54 months

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Pembrolizumab+Pomalidomide+Dexamethasone	Standard of Care (SOC) Pomalidomide+Dexamethasone
Arm/Group Description:	Participants receive pembrolizumab ...	Participants receive pomalidomide 4...
Arm/Group Description:	Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W) PLUS pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.	Participants receive pomalidomide 4 mg PO on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
Overall Number of Participants Analyzed	122	123
Measure Type: Count of Participants Unit of Measure: Participants
	26 21.3%	10 8.1%

6.Secondary Outcome


Title	Disease Control Rate (DCR) Evaluated According to the IMWG Response Criteria by CAC Blinded Central Review
Description	Disease control rate was the percentage of participants who achieved c...
Description	Disease control rate was the percentage of participants who achieved confirmed sCR, CR, VGPR, PR, minimal response (MR) or have demonstrated stable disease (SD) for at least 12 weeks prior to any evidence of progression. PD was development of or an increase in the size of bone lesions or soft tissue plasmacytomas. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum FLC assay ratio and absence of clonal cells in bone marrow by immunohistochemistry/fluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 hr; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. The data cutoff date was July 9, 2018.
Time Frame	Up to approximately 30 months

Outcome Measure Data

Analysis Population Description

The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.


Arm/Group Title	Pembrolizumab+Pomalidomide+Dexamethasone	Standard of Care (SOC) Pomalidomide+Dexamethasone
Arm/Group Description:	Participants receive pembrolizumab ...	Participants receive pomalidomide 4...
Arm/Group Description:	Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W) PLUS pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.	Participants receive pomalidomide 4 mg PO on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
Overall Number of Participants Analyzed	126	125
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: Percentage of participants
	88.1 (81.1 to 93.2)	84.8 (77.3 to 90.6)

7.Secondary Outcome


Title	Second Progression Free Survival (PFS2)
Description	PFS2 was defined as the time from randomization to subsequent disease ...
Description	PFS2 was defined as the time from randomization to subsequent disease progression after initiation of new anti-cancer therapy, or death from any cause, whichever occurred first, by investigator assessment. As a result of a full clinical hold by FDA that led to discontinuation of study enrollment, no data was collected for analysis of PFS2.
Time Frame	Up to approximately 30 months

Outcome Measure Data

Analysis Population Description

The analysis population was to include all randomized participants. Study treatment was terminated early and no data was collected for analysis of PFS2.


Arm/Group Title	Pembrolizumab+Pomalidomide+Dexamethasone	Standard of Care (SOC) Pomalidomide+Dexamethasone
Arm/Group Description:	Participants receive pembrolizumab ...	Participants receive pomalidomide 4...
Arm/Group Description:	Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W) PLUS pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.	Participants receive pomalidomide 4 mg PO on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Time Frame	Up to approximately 54 months
Adverse Event Reporting Description	The analysis population for all-cause mortality was all randomized participants and for adverse events was the treated participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment, therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs. The database cutoff date was August 3, 2020.

Arm/Group Title	Pembrolizumab+Pomalidomide+Dexamethasone		Standard of Care (SOC) Pomalidomide+Dexamethasone
Arm/Group Description	Participants receive pembrolizumab ...		Participants receive pomalidomide 4...
Arm/Group Description	Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W) PLUS pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.		Participants receive pomalidomide 4 mg PO on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
All-Cause Mortality
	Pembrolizumab+Pomalidomide+Dexamethasone		Standard of Care (SOC) Pomalidomide+Dexamethasone
	Affected / at Risk (%)		Affected / at Risk (%)
Total	86/126 (68.25%)		64/125 (51.20%)
Serious Adverse Events Serious Adverse Events
	Pembrolizumab+Pomalidomide+Dexamethasone		Standard of Care (SOC) Pomalidomide+Dexamethasone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	79/122 (64.75%)		57/123 (46.34%)
Blood and lymphatic system disorders
Anaemia ^† 1	1/122 (0.82%)	1	4/123 (3.25%)	4
Anaemia of malignant disease ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Disseminated intravascular coagulation ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Febrile bone marrow aplasia ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Febrile neutropenia ^† 1	4/122 (3.28%)	4	4/123 (3.25%)	5
Pancytopenia ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Thrombocytopenia ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Cardiac disorders
Atrial fibrillation ^† 1	2/122 (1.64%)	2	1/123 (0.81%)	1
Cardiac failure ^† 1	1/122 (0.82%)	1	1/123 (0.81%)	1
Cardiogenic shock ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Myocardial infarction ^† 1	2/122 (1.64%)	2	0/123 (0.00%)	0
Myocarditis ^† 1	1/122 (0.82%)	2	0/123 (0.00%)	0
Pericardial haemorrhage ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Supraventricular tachycardia ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Ear and labyrinth disorders
Vertigo ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Vertigo positional ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Endocrine disorders
Adrenal insufficiency ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Eye disorders
Cataract ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Gastrointestinal disorders
Constipation ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Diarrhoea ^† 1	1/122 (0.82%)	1	1/123 (0.81%)	1
Ileus ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Inguinal hernia ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Large intestine perforation ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Tooth disorder ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Upper gastrointestinal haemorrhage ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
General disorders
Chest pain ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Death ^† 1	3/122 (2.46%)	3	0/123 (0.00%)	0
Fatigue ^† 1	0/122 (0.00%)	0	2/123 (1.63%)	2
Oedema peripheral ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Pain ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Pyrexia ^† 1	3/122 (2.46%)	3	5/123 (4.07%)	5
Hepatobiliary disorders
Hepatitis ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Infections and infestations
Anal abscess ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Arthritis bacterial ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Bacteraemia ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Bacterial infection ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Bacterial sepsis ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Bronchitis ^† 1	1/122 (0.82%)	1	1/123 (0.81%)	1
Bronchitis bacterial ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Cellulitis ^† 1	2/122 (1.64%)	2	0/123 (0.00%)	0
Clostridium difficile colitis ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Clostridium difficile infection ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Escherichia bacteraemia ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Genital herpes simplex ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Infective exacerbation of chronic obstructive airways disease ^† 1	1/122 (0.82%)	4	0/123 (0.00%)	0
Influenza ^† 1	1/122 (0.82%)	1	3/123 (2.44%)	3
Lower respiratory tract infection ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Neutropenic sepsis ^† 1	2/122 (1.64%)	2	0/123 (0.00%)	0
Parainfluenzae virus infection ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Parotitis ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Pneumocystis jirovecii pneumonia ^† 1	3/122 (2.46%)	3	0/123 (0.00%)	0
Pneumonia ^† 1	23/122 (18.85%)	29	17/123 (13.82%)	21
Pneumonia bacterial ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Pneumonia influenzal ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Pneumonia parainfluenzae viral ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Pulmonary sepsis ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Respiratory tract infection ^† 1	1/122 (0.82%)	1	1/123 (0.81%)	1
Respiratory tract infection viral ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Rhinovirus infection ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Sepsis ^† 1	3/122 (2.46%)	3	3/123 (2.44%)	3
Septic shock ^† 1	2/122 (1.64%)	2	1/123 (0.81%)	1
Sinusitis ^† 1	1/122 (0.82%)	1	1/123 (0.81%)	1
Subcutaneous abscess ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Upper respiratory tract infection ^† 1	1/122 (0.82%)	1	3/123 (2.44%)	3
Urinary tract infection ^† 1	1/122 (0.82%)	1	1/123 (0.81%)	1
Viral infection ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Wound infection ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Injury, poisoning and procedural complications
Accidental overdose ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Femoral neck fracture ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Femur fracture ^† 1	1/122 (0.82%)	2	0/123 (0.00%)	0
Fibula fracture ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Hip fracture ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Infusion related reaction ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Muscle strain ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Post procedural fever ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Subdural haematoma ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Upper limb fracture ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Investigations
Alanine aminotransferase increased ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Aspartate aminotransferase increased ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Neutrophil count decreased ^† 1	2/122 (1.64%)	2	0/123 (0.00%)	0
Metabolism and nutrition disorders
Dehydration ^† 1	0/122 (0.00%)	0	2/123 (1.63%)	2
Gout ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	2
Hypercalcaemia ^† 1	2/122 (1.64%)	3	1/123 (0.81%)	1
Hypokalaemia ^† 1	1/122 (0.82%)	1	1/123 (0.81%)	1
Hyponatraemia ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Hypovolaemia ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Steroid diabetes ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Musculoskeletal and connective tissue disorders
Fracture pain ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Muscular weakness ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Osteonecrosis of jaw ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Pathological fracture ^† 1	1/122 (0.82%)	1	3/123 (2.44%)	4
Polyarthritis ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma ^† 1	1/122 (0.82%)	2	1/123 (0.81%)	1
Basosquamous carcinoma of skin ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Colorectal adenocarcinoma ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Intestinal adenocarcinoma ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Malignant ascites ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Squamous cell carcinoma ^† 1	2/122 (1.64%)	2	1/123 (0.81%)	1
Squamous cell carcinoma of skin ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Nervous system disorders
Balance disorder ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Central nervous system lesion ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Cerebral haemorrhage ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Cerebrovascular accident ^† 1	2/122 (1.64%)	2	1/123 (0.81%)	1
Cognitive disorder ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
IIIrd nerve disorder ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Seizure ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Somnolence ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Syncope ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Psychiatric disorders
Delirium ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Renal and urinary disorders
Acute kidney injury ^† 1	4/122 (3.28%)	4	4/123 (3.25%)	4
Chronic kidney disease ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Cystitis haemorrhagic ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Renal failure ^† 1	2/122 (1.64%)	2	2/123 (1.63%)	2
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Acute respiratory failure ^† 1	1/122 (0.82%)	1	1/123 (0.81%)	1
Asthma ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Chronic obstructive pulmonary disease ^† 1	2/122 (1.64%)	2	0/123 (0.00%)	0
Cough ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Dyspnoea ^† 1	1/122 (0.82%)	1	2/123 (1.63%)	2
Haemoptysis ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Hypoxia ^† 1	1/122 (0.82%)	1	1/123 (0.81%)	1
Interstitial lung disease ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Pleural effusion ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Pneumonitis ^† 1	5/122 (4.10%)	5	0/123 (0.00%)	0
Pulmonary congestion ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Pulmonary embolism ^† 1	0/122 (0.00%)	0	4/123 (3.25%)	4
Pulmonary haemorrhage ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Skin and subcutaneous tissue disorders
Panniculitis ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Rash ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Stevens-Johnson syndrome ^† 1	1/122 (0.82%)	1	0/123 (0.00%)	0
Vascular disorders
Aortic stenosis ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Deep vein thrombosis ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
Hypotension ^† 1	1/122 (0.82%)	1	1/123 (0.81%)	1
Orthostatic hypotension ^† 1	0/122 (0.00%)	0	1/123 (0.81%)	1
1 Term from vocabulary, MedDRA 21.0 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Pembrolizumab+Pomalidomide+Dexamethasone		Standard of Care (SOC) Pomalidomide+Dexamethasone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	115/122 (94.26%)		114/123 (92.68%)
Blood and lymphatic system disorders
Anaemia ^† 1	34/122 (27.87%)	53	40/123 (32.52%)	57
Leukopenia ^† 1	10/122 (8.20%)	21	9/123 (7.32%)	16
Neutropenia ^† 1	49/122 (40.16%)	120	33/123 (26.83%)	63
Thrombocytopenia ^† 1	26/122 (21.31%)	49	19/123 (15.45%)	27
Gastrointestinal disorders
Constipation ^† 1	30/122 (24.59%)	37	26/123 (21.14%)	27
Diarrhoea ^† 1	21/122 (17.21%)	30	27/123 (21.95%)	35
Gastrooesophageal reflux disease ^† 1	4/122 (3.28%)	4	7/123 (5.69%)	7
Nausea ^† 1	23/122 (18.85%)	26	16/123 (13.01%)	19
Vomiting ^† 1	10/122 (8.20%)	17	13/123 (10.57%)	14
General disorders
Asthenia ^† 1	15/122 (12.30%)	21	14/123 (11.38%)	17
Chest pain ^† 1	9/122 (7.38%)	11	5/123 (4.07%)	6
Fatigue ^† 1	33/122 (27.05%)	36	37/123 (30.08%)	44
Oedema peripheral ^† 1	22/122 (18.03%)	25	20/123 (16.26%)	23
Pyrexia ^† 1	26/122 (21.31%)	35	19/123 (15.45%)	23
Infections and infestations
Nasopharyngitis ^† 1	7/122 (5.74%)	7	6/123 (4.88%)	8
Pneumonia ^† 1	7/122 (5.74%)	7	2/123 (1.63%)	2
Upper respiratory tract infection ^† 1	21/122 (17.21%)	27	25/123 (20.33%)	33
Urinary tract infection ^† 1	1/122 (0.82%)	1	8/123 (6.50%)	9
Investigations
Alanine aminotransferase increased ^† 1	10/122 (8.20%)	11	4/123 (3.25%)	4
Blood creatinine increased ^† 1	7/122 (5.74%)	10	4/123 (3.25%)	4
Neutrophil count decreased ^† 1	16/122 (13.11%)	28	17/123 (13.82%)	26
Platelet count decreased ^† 1	7/122 (5.74%)	11	10/123 (8.13%)	12
Weight decreased ^† 1	7/122 (5.74%)	7	5/123 (4.07%)	5
White blood cell count decreased ^† 1	13/122 (10.66%)	19	11/123 (8.94%)	21
Metabolism and nutrition disorders
Decreased appetite ^† 1	9/122 (7.38%)	9	8/123 (6.50%)	8
Hyperglycaemia ^† 1	7/122 (5.74%)	7	5/123 (4.07%)	5
Hypokalaemia ^† 1	11/122 (9.02%)	16	8/123 (6.50%)	9
Hypomagnesaemia ^† 1	3/122 (2.46%)	6	8/123 (6.50%)	8
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	10/122 (8.20%)	11	16/123 (13.01%)	17
Back pain ^† 1	14/122 (11.48%)	15	21/123 (17.07%)	23
Muscle spasms ^† 1	15/122 (12.30%)	16	14/123 (11.38%)	15
Muscular weakness ^† 1	6/122 (4.92%)	10	11/123 (8.94%)	13
Musculoskeletal chest pain ^† 1	12/122 (9.84%)	14	6/123 (4.88%)	6
Pain in extremity ^† 1	6/122 (4.92%)	8	7/123 (5.69%)	7
Nervous system disorders
Dizziness ^† 1	16/122 (13.11%)	19	14/123 (11.38%)	15
Headache ^† 1	16/122 (13.11%)	20	5/123 (4.07%)	7
Neuropathy peripheral ^† 1	8/122 (6.56%)	8	5/123 (4.07%)	5
Tremor ^† 1	10/122 (8.20%)	11	10/123 (8.13%)	10
Psychiatric disorders
Depression ^† 1	7/122 (5.74%)	7	3/123 (2.44%)	3
Insomnia ^† 1	10/122 (8.20%)	11	17/123 (13.82%)	18
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	19/122 (15.57%)	23	18/123 (14.63%)	21
Dyspnoea ^† 1	21/122 (17.21%)	26	19/123 (15.45%)	25
Epistaxis ^† 1	9/122 (7.38%)	9	3/123 (2.44%)	5
Skin and subcutaneous tissue disorders
Pruritus ^† 1	6/122 (4.92%)	6	10/123 (8.13%)	10
Rash ^† 1	12/122 (9.84%)	13	10/123 (8.13%)	12
1 Term from vocabulary, MedDRA 21.0 † Indicates events were collected by systematic assessment

Limitations and Caveats

The MK-3475-183 study was stopped/terminated early. Endpoint statistics may be biased due to the incomplete treatment and follow-up of participants after study termination

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Senior Vice President, Global Clinical Development
Organization:	Merck Sharp & Dohme Corp.
Phone:	1-800-672-6372
EMail:	ClinicalTrialsDisclosure@merck.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Liao JJZ, Farooqui MZH, Marinello P, Hartzel J, Anderson K, Ma J, Gause CK. Using artificial intelligence tools in answering important clinical questions: The KEYNOTE-183 multiple myeloma experience. Contemp Clin Trials. 2020 Dec;99:106179. doi: 10.1016/j.cct.2020.106179. Epub 2020 Oct 18.

Mateos MV, Blacklock H, Schjesvold F, Oriol A, Simpson D, George A, Goldschmidt H, Larocca A, Chanan-Khan A, Sherbenou D, Avivi I, Benyamini N, Iida S, Matsumoto M, Suzuki K, Ribrag V, Usmani SZ, Jagannath S, Ocio EM, Rodriguez-Otero P, San Miguel J, Kher U, Farooqui M, Liao J, Marinello P, Lonial S; KEYNOTE-183 Investigators. Pembrolizumab plus pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma (KEYNOTE-183): a randomised, open-label, phase 3 trial. Lancet Haematol. 2019 Sep;6(9):e459-e469. doi: 10.1016/S2352-3026(19)30110-3. Epub 2019 Jul 18.

Layout table for additonal information

Responsible Party:	Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:	NCT02576977
Other Study ID Numbers:	3475-183 2015-002509-13 ( EudraCT Number ) 163146 ( Registry Identifier: JAPAN-CTI ) MK-3475-183 ( Other Identifier: Merck Protocol Number ) KEYNOTE-183 ( Other Identifier: Merck )
First Submitted:	October 14, 2015
First Posted:	October 15, 2015
Results First Submitted:	July 8, 2019
Results First Posted:	August 2, 2019
Last Update Posted:	October 8, 2021

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