An Investigational Immuno-therapy Trial of Pomalidomide and Low-dose Dexamethasone With or Without Elotuzumab to Treat Refractory and Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02654132
• Collaborator: Celgene (Industry), AbbVie (Industry)
• Enrollment: 157
• Locations: 55
• Arms: 2
• Actual Duration (Months): 67.1
• Patients Per Site: 2.9
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if adding Elotuzumab to Pomalidomide and low-dose dexamethasone is a more effective treatment of relapsed and refractory multiple myeloma compared to pomalidomide and low-dose dexamethasone by itself.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: Elotuzumab; Drug: Pomalidomide; Drug: Dexamethasone	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 157 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Label, Randomized Phase 2 Trial of Pomalidomide/Dexamethasone With or Without Elotuzumab in Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)
• Actual Study Start Date: Mar 18, 2016
• Actual Primary Completion Date: Jan 17, 2018
• Actual Study Completion Date: Oct 21, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Elotuzumab Arm Biological:Elotuzumab (BMS-901608; HuLuc63) Solution, Intravenous(IV),10 mg/kg(Cycles 1 and 2 weekly, on Days 1,8,15,22) Solution, Intravenous(IV),20 mg/kg(Cycle 3 and Beyond: Day 1) Drug: Pomalidomide •Capsules,Oral,4 mg,once daily, on Days 1-21 Other Name: Pomalyst Drug: Dexamethasone Subjects ≤ 75 years old: •Tablets, Oral,28 mg, once daily on: Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond) •Solution, Intravenous(IV), 8 mg, once daily on: Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond) •Tablets, Oral,40 mg, once daily on: Days 8,15,22(Cycle 3 and Beyond) Subjects > 75 years old: •Tablets, Oral,8 mg, once daily on: Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond) •Solution, Intravenous(IV), 8 mg, once daily on: Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond) •Tablets, Oral, 20 mg, once daily on: Days 8,15,22(Cycle 3 and Beyond) Other Names: Decadron,Dexamethasone ,Intensol,Dexpak,Taperpak	Drug: Elotuzumab; Drug: Pomalidomide; Other Names: Pomalyst ; Drug: Dexamethasone; Other Names: Decadron, Dexamethasone, Intensol, Dexpak, Taperpak
Active Comparator: Control Arm Drug: Pomalidomide • Capsules, Oral, 4 mg, once daily, on Days 1-21 Other Name: Pomalyst Drug: Dexamethasone Subjects ≤ 75 years old: • Tablets, Oral, 40 mg, weekly on Days 1, 8, 15 and 22 Subjects > 75 years old: • Tablets, Oral, 20 mg, weekly on Days 1, 8, 15 and 22, Other Names: Decadron Dexamethasone Intensol Dexpak Taperpak	Drug: Pomalidomide; Other Names: Pomalyst ; Drug: Dexamethasone; Other Names: Decadron, Dexamethasone, Intensol, Dexpak, Taperpak

Outcome Measures

Primary Outcome Measures

1. Progression-free Survival (PFS) [Approximately 14 months]

   PFS will be defined as the time, in months, from randomization to the date of the first documented tumor progression or death due to any cause. Progressive disease response criteria were defined as an increase of 25% from lowest response value in any one or more of the following: 1. Serum M-component and/or 2. Urine M-component and/or 3. Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels 4. Bone marrow plasma cell percentage; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder

Secondary Outcome Measures

1. Objective Response Rate (ORR) [Approximately 14 months]

   ORR is the proportion of randomized subjects who achieve a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) using the modified International Myeloma Working Group (IMWG) criteria described as follows, as per investigator's assessment CR: Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow; sCR: CR, as defined above, plus the following: Normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >= 90% reduction in serum M-protein level plus urine M-protein level < 100 mg per 24 hour; PR: >= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90% or to < 200 mg per 24 hour.

2. Overall Survival (OS) [Approximately 32 months]

   OS is the time from randomization to the date of death from any cause. The survival time for subjects who had not died was censored at the last known alive date. OS was censored at the date of randomization for subjects who were randomized but had no follow-up. NOTE: This data is immature and will be analyzed again at time of LPLV final.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• ≥ 2 prior lines of therapy which must have included at least 2 consecutive cycles of lenalidomide and a proteosome inhibitor alone or in combination

• Documented refractory or relapsed and refractory multiple myeloma

• Refractory to proteosome inhibitor and lenalidomide, and to last treatment

• Relapsed and refractory patients must have achieved at least a partial response to previous treatment with proteosome inhibitor or lenalidomide, or both, but progressed within 6 months, and were refractory to their last treatment

• Measurable disease at screening

• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

• Active plasma cell leukemia

• Prior treatment with pomalidomide

• Unable to tolerate thromboembolic prophylaxis while on the study

• Prior autologous stem cell transplant within 12 weeks

• Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Winship Cancer Institute	Atlanta	Georgia	United States	30322
2	Rush University Medical Center	Chicago	Illinois	United States	60612
3	Investigative Clinical Research Of Indiana, Llc	Indianapolis	Indiana	United States	46260
4	Beth Israel Comprehensive Cancer Center	Boston	Massachusetts	United States	02215
5	Dana Farber Cancer Institute.	Boston	Massachusetts	United States	02215
6	Rochester General Hospital	Rochester	New York	United States	14621
7	Carolinas Healthcare System	Charlotte	North Carolina	United States	28204
8	Va Pittsburgh Healthcare System	Pittsburgh	Pennsylvania	United States	15240
9	St Francis Hospital	Greenville	South Carolina	United States	29607
10	Tennessee Cancer Specialists	Knoxville	Tennessee	United States	37909
11	Northern Utah Associates	Ogden	Utah	United States	84403
12	University Of Washington	Seattle	Washington	United States	98109
13	Local Institution	South Brisbane	Queensland	Australia	4101
14	Local Institution	London	Ontario	Canada	N6A 4G5
15	CISSS de l'Outaouais	Gatineau	Quebec	Canada	J8P 7H2
16	CIUSSS de l'Est-de-L'Ile-de-Montreal - Hopital Maisonneuve-Rosemont	Montreal	Quebec	Canada	H1T 2M4
17	Local Institution	Nantes Cedex 1		France	44000
18	Local Institution	Paris Cedex 12		France	75571
19	Local Institution	Pessac		France	33604
20	Local Institution	Poitiers Cedex		France	86021
21	Local Institution	Saint Pierre Cedex		France	97448
22	Universitaetsklinikum Carl Gustav Carus	Dresden		Germany	01307
23	Universitaetsklinikum Freiburg	Freiburg		Germany	79106
24	St. Barbara-Klinik	Hamm		Germany	59075
25	Universitasklinikum Heidelberg	Heidelberg		Germany	69120
26	Universitasklinikum Schleswig-Holstein	Kiel		Germany	24105
27	Klinikum Der Johannes Gutenberg Universitaet Mainz	Mainz		Germany	55101
28	Universitaetsklinikum Tuebingen	Tuebingen		Germany	72076
29	Laiko University Hospital	Athens		Greece	11527
30	Alexandra General Hospital Of Athens	Athens		Greece	11528
31	Azienda Ospedaliero Universitaria Ospedali Riuniti Di Ancona	Ancona		Italy	60126
32	A. O. U. Di Bologna, Policlinico S. Orsola Malpighi	Bologna		Italy	40138
33	Azienda Ospedaliera Universitaria Careggi	Firenze		Italy	50134
34	Local Institution	Roma		Italy	00144
35	Universita' La Sapienza	Roma		Italy	00161
36	Azienda Ospedaliera Citta' Della Salute E Della Scienza Di Torino	Torino		Italy	10126
37	Local Institution	Nagoya-shi	Aichi	Japan	4678602
38	Local Institution	Morioka-shi	Iwate	Japan	0208505
39	Local Institution	Kyoto-shi	Kyoto	Japan	6028566
40	Local Institution	Niigata-shi	Niigata	Japan	9518566
41	Local Institution	Okayama-shi	Okayama	Japan	7011192
42	Local Institution	Shibuya-ku	Tokyo	Japan	1508935
43	Local Institution	Tachikawa-shi	Tokyo	Japan	1900014
44	Local Institution	Kasama-shi		Japan	3091793
45	Local Institution	Amsterdam		Netherlands	1081 HV
46	Local Institution	Groningen		Netherlands	9713 GZ
47	Local Institution	Maastrict		Netherlands	6229 HX
48	Local Institution	Utrecht		Netherlands	3584 CX
49	Oddzial Kliniczny Hematologii i Profilaktyki Chorob Nowotworowych	Chorzow		Poland	41-500
50	Local Institution	Lublin		Poland	20-090
51	Oddzial Hematologii i Transplantacji Szpiku	Poznan		Poland	60-569
52	Local Institution	Pamplona	Navarra	Spain	31008
53	Local Institution	Barcelona		Spain	08025
54	Local Institution	Madrid		Spain	28041
55	Local Institution	Valencia		Spain	46017

Sponsors and Collaborators

• Bristol-Myers Squibb
• Celgene
• AbbVie

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

• Study Protocol - Nov 11, 2015
• Statistical Analysis Plan - May 1, 2018

More Information

Additional Information:

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT02654132
• Other Study ID Numbers: CA204-125; 2014-003282-19
• First Posted: Jan 13, 2016
• Last Update Posted: Jan 20, 2022
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Dexamethasone; Dexamethasone acetate; Pomalidomide; Elotuzumab; BB 1101

Study Results

Participant Flow

Pre-assignment Detail	157 participants were enrolled, 117 were randomized at 39 sites in 10 countries. Of the 117, 60 participants were randomized into the E-Pd group and 57 were randomized into the Pd group.

Arm/Group Title	Experiemental Arm	Control Arm
Arm/Group Description	Elotuzumab + Pomalidomide + Dexamethasone	Pomalidomide + Dexamethasone
Period Title: Overall Study
STARTED	60	57
COMPLETED	24	11
NOT COMPLETED	36	46

Baseline Characteristics

Arm/Group Title	Experiemental Arm	Control Arm	Total
Arm/Group Description	Elotuzumab + Pomalidomide + Dexamethasone	Pomalidomide + Dexamethasone	Total of all reporting groups
Overall Participants	60	57	117
Age (Number) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Number]	66.2 (9.92)	65.5 (9.95)	65.9 (9.90)
Sex: Female, Male (Count of Participants)
Female	28 46.7%	22 38.6%	50 42.7%
Male	32 53.3%	35 61.4%	67 57.3%
Race/Ethnicity, Customized (Count of Participants)
White	45 75%	45 78.9%	90 76.9%
Black or African American	0 0%	1 1.8%	1 0.9%
Asian	15 25%	9 15.8%	24 20.5%
Other	0 0%	2 3.5%	2 1.7%

Outcome Measures

1. Primary Outcome

Title	Progression-free Survival (PFS)
Description	PFS will be defined as the time, in months, from randomization to the date of the first documented tumor progression or death due to any cause. Progressive disease response criteria were defined as an increase of 25% from lowest response value in any one or more of the following: 1. Serum M-component and/or 2. Urine M-component and/or 3. Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels 4. Bone marrow plasma cell percentage; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder
Time Frame	Approximately 14 months

Outcome Measure Data

Analysis Population Description

All randomized participants

Arm/Group Title	Experiemental Arm	Control Arm
Arm/Group Description	Elotuzumab + Pomalidomide + Dexamethasone	Pomalidomide + Dexamethasone
Measure Participants	60	57
Median (95% Confidence Interval) [Months]	10.25	4.67

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experiemental Arm, Control Arm
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0078
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.54
	Confidence Interval	(2-Sided) 95%; 0.34 to 0.86
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Objective Response Rate (ORR)
Description	ORR is the proportion of randomized subjects who achieve a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) using the modified International Myeloma Working Group (IMWG) criteria described as follows, as per investigator's assessment CR: Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow; sCR: CR, as defined above, plus the following: Normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >= 90% reduction in serum M-protein level plus urine M-protein level < 100 mg per 24 hour; PR: >= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90% or to < 200 mg per 24 hour.
Time Frame	Approximately 14 months

Outcome Measure Data

Analysis Population Description

All randomized participants

Arm/Group Title	Experimental Arm	Control Arm
Arm/Group Description	Elotuzumab + Pomalidomide + Dexamethasone	Pomalidomide + Dexamethasone
Measure Participants	60	57
Number [Proportion of participants]	0.5333 0.9%	0.2632 0.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experiemental Arm, Control Arm
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0029
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.25
	Confidence Interval	(2-Sided) 95%; 1.49 to 7.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Overall Survival (OS)
Description	OS is the time from randomization to the date of death from any cause. The survival time for subjects who had not died was censored at the last known alive date. OS was censored at the date of randomization for subjects who were randomized but had no follow-up. NOTE: This data is immature and will be analyzed again at time of LPLV final.
Time Frame	Approximately 32 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	From randomization up 60 days after last dose, an average of 24 months
Adverse Event Reporting Description	Of the 57 participants who were randomized to "Pomalidomide" Arm as mentioned in the Participant Flow section, 2 were never treated. Hence Total Number of Participants at Risk in the "Pomalidomide" Arm is 55
Arm/Group Title	Elotuzimab - Pomalidomide		Pomalidomide
Arm/Group Description	Biological: Elotuzumab (BMS-901608; HuLuc63) Solution Intravenous(IV),10 mg/kg(Cycles 1 and 2 weekly, on Days 1,8,15,22) Solution, Intravenous(IV),20 mg/kg(Cycle 3 and Beyond: Day 1) Drug: Pomalidomide Capsules,Oral,4 mg,once daily, on Days 1-21 Other Name: Pomalyst Drug: Dexamethasone -Subjects ≤ 75 years old: Tablets, Oral,28 mg, once daily on: Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond) Solution, Intravenous(IV), 8 mg, once daily on: Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond) Tablets, Oral,40 mg, once daily on: Days 8,15,22(Cycle 3 and Beyond) -Subjects > 75 years old: Tablets, Oral,8 mg, once daily on: Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond) Solution, Intravenous(IV), 8 mg, once daily on: Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond) Tablets, Oral, 20 mg, once daily on: Days 8,15,22(Cycle 3 and Beyond) Other Names: Decadron,Dexamethasone ,Intensol,Dexpak,Taperpak		Drug: Pomalidomide • Capsules, Oral, 4 mg, once daily, on Days 1-21 Other Name: Pomalyst Drug: Dexamethasone Subjects ≤ 75 years old: • Tablets, Oral, 40 mg, weekly on Days 1, 8, 15 and 22 Subjects > 75 years old: • Tablets, Oral, 20 mg, weekly on Days 1, 8, 15 and 22, Other Names: Decadron Dexamethasone Intensol Dexpak Taperpak
All Cause Mortality
	Elotuzimab - Pomalidomide		Pomalidomide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/60 (21.7%)		18/55 (32.7%)
Serious Adverse Events
	Elotuzimab - Pomalidomide		Pomalidomide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	32/60 (53.3%)		30/55 (54.5%)
Blood and lymphatic system disorders
Anaemia	1/60 (1.7%)		1/55 (1.8%)
Febrile neutropenia	3/60 (5%)		2/55 (3.6%)
Thrombocytopenia	2/60 (3.3%)		0/55 (0%)
Cardiac disorders
Acute myocardial infarction	1/60 (1.7%)		0/55 (0%)
Angina unstable	0/60 (0%)		1/55 (1.8%)
Atrial fibrillation	0/60 (0%)		1/55 (1.8%)
Cardiac disorder	1/60 (1.7%)		0/55 (0%)
Cardiac failure	2/60 (3.3%)		0/55 (0%)
Myocardial infarction	0/60 (0%)		1/55 (1.8%)
Eye disorders
Cataract	1/60 (1.7%)		0/55 (0%)
Gastrointestinal disorders
Diverticular perforation	1/60 (1.7%)		0/55 (0%)
Intestinal obstruction	1/60 (1.7%)		0/55 (0%)
General disorders
Chest pain	1/60 (1.7%)		0/55 (0%)
Fatigue	0/60 (0%)		1/55 (1.8%)
General physical health deterioration	1/60 (1.7%)		0/55 (0%)
Multiple organ dysfunction syndrome	0/60 (0%)		1/55 (1.8%)
Pyrexia	0/60 (0%)		3/55 (5.5%)
Immune system disorders
Amyloidosis	1/60 (1.7%)		0/55 (0%)
Infections and infestations
Adenovirus infection	1/60 (1.7%)		0/55 (0%)
Atypical pneumonia	0/60 (0%)		1/55 (1.8%)
Bacterial sepsis	1/60 (1.7%)		0/55 (0%)
Bronchitis	1/60 (1.7%)		1/55 (1.8%)
Diverticulitis	1/60 (1.7%)		0/55 (0%)
Escherichia sepsis	0/60 (0%)		1/55 (1.8%)
Infection	1/60 (1.7%)		1/55 (1.8%)
Lower respiratory tract infection	2/60 (3.3%)		0/55 (0%)
Pneumococcal sepsis	2/60 (3.3%)		0/55 (0%)
Pneumocystis jirovecii infection	1/60 (1.7%)		0/55 (0%)
Pneumonia	3/60 (5%)		5/55 (9.1%)
Pneumonia influenzal	1/60 (1.7%)		0/55 (0%)
Pseudomonal sepsis	0/60 (0%)		1/55 (1.8%)
Respiratory syncytial virus infection	1/60 (1.7%)		0/55 (0%)
Respiratory tract infection	4/60 (6.7%)		2/55 (3.6%)
Sepsis	0/60 (0%)		1/55 (1.8%)
Septic shock	2/60 (3.3%)		2/55 (3.6%)
Spinal cord infection	0/60 (0%)		1/55 (1.8%)
Systemic infection	1/60 (1.7%)		0/55 (0%)
Upper respiratory tract infection	0/60 (0%)		1/55 (1.8%)
Wound infection	0/60 (0%)		1/55 (1.8%)
Injury, poisoning and procedural complications
Infusion related reaction	1/60 (1.7%)		0/55 (0%)
Thoracic vertebral fracture	0/60 (0%)		1/55 (1.8%)
Metabolism and nutrition disorders
Diabetes mellitus inadequate control	1/60 (1.7%)		0/55 (0%)
Hypercalcaemia	2/60 (3.3%)		0/55 (0%)
Musculoskeletal and connective tissue disorders
Bone pain	1/60 (1.7%)		0/55 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma	0/60 (0%)		1/55 (1.8%)
Malignant neoplasm progression	1/60 (1.7%)		6/55 (10.9%)
Metastases to bone	0/60 (0%)		1/55 (1.8%)
Plasma cell leukaemia	0/60 (0%)		2/55 (3.6%)
Plasma cell myeloma	0/60 (0%)		1/55 (1.8%)
Nervous system disorders
Cerebrovascular accident	0/60 (0%)		1/55 (1.8%)
Presyncope	1/60 (1.7%)		0/55 (0%)
Transient ischaemic attack	1/60 (1.7%)		0/55 (0%)
Psychiatric disorders
Confusional state	0/60 (0%)		1/55 (1.8%)
Renal and urinary disorders
Acute kidney injury	2/60 (3.3%)		3/55 (5.5%)
Renal failure	0/60 (0%)		3/55 (5.5%)
Respiratory, thoracic and mediastinal disorders
Asthma	1/60 (1.7%)		0/55 (0%)
Pleural effusion	1/60 (1.7%)		0/55 (0%)
Pulmonary embolism	1/60 (1.7%)		0/55 (0%)
Respiratory failure	0/60 (0%)		1/55 (1.8%)
Vascular disorders
Peripheral ischaemia	1/60 (1.7%)		0/55 (0%)
Other (Not Including Serious) Adverse Events
	Elotuzimab - Pomalidomide		Pomalidomide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	54/60 (90%)		48/55 (87.3%)
Blood and lymphatic system disorders
Anaemia	15/60 (25%)		20/55 (36.4%)
Leukopenia	5/60 (8.3%)		3/55 (5.5%)
Lymphopenia	6/60 (10%)		1/55 (1.8%)
Neutropenia	14/60 (23.3%)		17/55 (30.9%)
Thrombocytopenia	8/60 (13.3%)		10/55 (18.2%)
Eye disorders
Cataract	3/60 (5%)		0/55 (0%)
Gastrointestinal disorders
Constipation	13/60 (21.7%)		6/55 (10.9%)
Diarrhoea	11/60 (18.3%)		5/55 (9.1%)
Nausea	1/60 (1.7%)		5/55 (9.1%)
General disorders
Asthenia	7/60 (11.7%)		5/55 (9.1%)
Fatigue	9/60 (15%)		8/55 (14.5%)
Malaise	3/60 (5%)		1/55 (1.8%)
Oedema peripheral	8/60 (13.3%)		4/55 (7.3%)
Pyrexia	8/60 (13.3%)		11/55 (20%)
Infections and infestations
Bronchitis	5/60 (8.3%)		4/55 (7.3%)
Herpes zoster	3/60 (5%)		1/55 (1.8%)
Influenza	2/60 (3.3%)		3/55 (5.5%)
Nasopharyngitis	10/60 (16.7%)		8/55 (14.5%)
Oral candidiasis	0/60 (0%)		3/55 (5.5%)
Pharyngitis	4/60 (6.7%)		1/55 (1.8%)
Respiratory tract infection	8/60 (13.3%)		5/55 (9.1%)
Upper respiratory tract infection	7/60 (11.7%)		8/55 (14.5%)
Urinary tract infection	3/60 (5%)		2/55 (3.6%)
Injury, poisoning and procedural complications
Contusion	3/60 (5%)		2/55 (3.6%)
Investigations
Blood creatinine increased	3/60 (5%)		6/55 (10.9%)
Neutrophil count decreased	3/60 (5%)		5/55 (9.1%)
Platelet count decreased	2/60 (3.3%)		4/55 (7.3%)
White blood cell count decreased	2/60 (3.3%)		3/55 (5.5%)
Metabolism and nutrition disorders
Decreased appetite	4/60 (6.7%)		4/55 (7.3%)
Hypercalcaemia	2/60 (3.3%)		5/55 (9.1%)
Hyperglycaemia	12/60 (20%)		8/55 (14.5%)
Hyperkalaemia	3/60 (5%)		2/55 (3.6%)
Hypokalaemia	4/60 (6.7%)		7/55 (12.7%)
Hypomagnesaemia	5/60 (8.3%)		3/55 (5.5%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/60 (1.7%)		4/55 (7.3%)
Back pain	4/60 (6.7%)		4/55 (7.3%)
Bone pain	9/60 (15%)		5/55 (9.1%)
Muscle spasms	8/60 (13.3%)		3/55 (5.5%)
Muscular weakness	2/60 (3.3%)		4/55 (7.3%)
Musculoskeletal pain	1/60 (1.7%)		4/55 (7.3%)
Nervous system disorders
Dizziness	2/60 (3.3%)		3/55 (5.5%)
Headache	3/60 (5%)		2/55 (3.6%)
Neuropathy peripheral	3/60 (5%)		2/55 (3.6%)
Polyneuropathy	4/60 (6.7%)		1/55 (1.8%)
Tremor	4/60 (6.7%)		2/55 (3.6%)
Psychiatric disorders
Depression	3/60 (5%)		2/55 (3.6%)
Insomnia	8/60 (13.3%)		6/55 (10.9%)
Respiratory, thoracic and mediastinal disorders
Cough	5/60 (8.3%)		5/55 (9.1%)
Dyspnoea	9/60 (15%)		4/55 (7.3%)
Productive cough	4/60 (6.7%)		3/55 (5.5%)
Skin and subcutaneous tissue disorders
Pruritus	3/60 (5%)		2/55 (3.6%)
Rash	6/60 (10%)		6/55 (10.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.