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Trial record 9 of 50 for:    Elotuzumab

Study of Safety of Elotuzumab Administered Over Approximately 60 Minutes in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed or Relapsed/Refractory Multiple Myeloma Patients

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ClinicalTrials.gov Identifier: NCT02159365
Recruitment Status : Completed
First Posted : June 9, 2014
Results First Posted : January 11, 2017
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Elotuzumab
Drug: Lenalidomide
Drug: Dexamethasone
Enrollment 81
Recruitment Details 81 participants were enrolled. 70 participants were randomized and treated. Reasons for non-randomization/non-treatment were 8 no longer met study criteria, 1 withdrew consent, and 2 unspecified reasons.
Pre-assignment Details  
Arm/Group Title E-Ld
Hide Arm/Group Description

E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.

During cycles 1 and 2, elotuzumab was provided weekly as a intravenous 10 mg/kg solution on days 1, 8, 15, and 22. During cycles 3 and beyond, elotuzumab was provided every other week on days 1 and 15.

During each cycle, Lenalidomide was provided as a 25 mg tablet by mouth on days 1-21 and Dexamethasone at a dose of 40 mg/week was administered orally on weeks without elotuzumab infusion. On weeks of elotuzumab infusion, 28 mg was to be administered orally and 8 mg was administered intravenously as part of elotuzumab premedication regimen until progression or discontinuation of Elotuzumab.

A cycle was defined as 28 days. Treatment with study drug continued until disease progression, unacceptable toxicity, or subject met other criteria for discontinuation of study drugs.

Period Title: Overall Study
Started 70
Completed 48 [1]
Not Completed 22
Reason Not Completed
Disease Progression             11
Adverse Event Unrelated to Study Drug             6
Lost to Follow-up             1
Study Drug Toxicity             1
Subject Request to Discontinue Treatment             1
Subject Withdrew Consent             1
Other             1
[1]
Completed = Still on Treatment
Arm/Group Title E-Ld
Hide Arm/Group Description

E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.

During cycles 1 and 2, elotuzumab was provided weekly as a intravenous 10 mg/kg solution on days 1, 8, 15, and 22. During cycles 3 and beyond, elotuzumab was provided every other week on days 1 and 15.

During each cycle, Lenalidomide was provided as a 25 mg tablet by mouth on days 1-21 and Dexamethasone at a dose of 40 mg/week was administered orally on weeks without elotuzumab infusion. On weeks of elotuzumab infusion, 28 mg was to be administered orally and 8 mg was administered intravenously as part of elotuzumab premedication regimen until progression or discontinuation of Elotuzumab.

A cycle was defined as 28 days. Treatment with study drug continued until disease progression, unacceptable toxicity, or subject met other criteria for discontinuation of study drugs.

Overall Number of Baseline Participants 70
Hide Baseline Analysis Population Description
All Treated Participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 70 participants
67.4  (9.40)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants
< 75 years
49
  70.0%
>= 75 years
21
  30.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants
Female
35
  50.0%
Male
35
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants
Hispanic or Latino
8
  11.4%
Not Hispanic or Latino
62
  88.6%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants
White
57
  81.4%
Black or African American
6
   8.6%
Asian
3
   4.3%
American Indian or Alaska Native
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Other
4
   5.7%
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants
0
34
  48.6%
1
32
  45.7%
2
4
   5.7%
[1]
Measure Description: ECOG is a 6-item scale used to discern patient status by rating categories such as disease progression, daily functioning, appropriate treatment, and prognosis. Performance status is scored on a scale ranging from 0-5, with (best score) 0=fully active and able to carry on all pre-disease performance without restriction and (worst score) 5=death.
1.Primary Outcome
Title Number of Participants With Grade 3 or Grade 4 (G3/4) Infusion Reactions by the End of Treatment Cycle 2 at Primary Endpoint
Hide Description Infusion reaction was defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.
Time Frame From Day 1 to End of cycle 2 treatment (approximately 56 days)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Participants
Arm/Group Title E-Ld
Hide Arm/Group Description:

E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.

During cycles 1 and 2, elotuzumab was provided weekly as a intravenous 10 mg/kg solution on days 1, 8, 15, and 22. During cycles 3 and beyond, elotuzumab was provided every other week on days 1 and 15.

During each cycle, Lenalidomide was provided as a 25 mg tablet by mouth on days 1-21 and Dexamethasone at a dose of 40 mg/week was administered orally on weeks without elotuzumab infusion. On weeks of elotuzumab infusion, 28 mg was to be administered orally and 8 mg was administered intravenously as part of elotuzumab premedication regimen until progression or discontinuation of Elotuzumab.

A cycle was defined as 28 days. Treatment with study drug continued until disease progression, unacceptable toxicity, or subject met other criteria for discontinuation of study drugs.

Overall Number of Participants Analyzed 70
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: participants
0
(0 to 5.1)
2.Secondary Outcome
Title Number of Participants With Any Grade and Grade 3 or Grade 4 (G3/4) Infusion Reactions Over the Entire Study Period
Hide Description An infusion reaction in this study is defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.
Time Frame Date of first dose up to 60 days post last dose (approximately 4 years)
Outcome Measure Data Not Reported
Time Frame From Day 1 up to 60 days post last dose of study drug (approximately 116 days)
Adverse Event Reporting Description Study Initiated: June 2014. Study is on-going.
 
Arm/Group Title E-Ld
Hide Arm/Group Description

E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.

During cycles 1 and 2, elotuzumab was provided weekly as a intravenous 10 mg/kg solution on days 1, 8, 15, and 22. During cycles 3 and beyond, elotuzumab was provided every other week on days 1 and 15.

During each cycle, Lenalidomide was provided as a 25 mg tablet by mouth on days 1-21 and Dexamethasone at a dose of 40 mg/week was administered orally on weeks without elotuzumab infusion. On weeks of elotuzumab infusion, 28 mg was to be administered orally and 8 mg was administered intravenously as part of elotuzumab premedication regimen until progression or discontinuation of Elotuzumab.

A cycle was defined as 28 days. Treatment with study drug continued until disease progression, unacceptable toxicity, or subject met other criteria for discontinuation of study drugs.

All-Cause Mortality
E-Ld
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
E-Ld
Affected / at Risk (%)
Total   27/70 (38.57%) 
Blood and lymphatic system disorders   
Neutropenia  1  1/70 (1.43%) 
Anaemia  1  1/70 (1.43%) 
Cardiac disorders   
Atrial fibrillation  1  3/70 (4.29%) 
Gastrointestinal disorders   
Haematochezia  1  1/70 (1.43%) 
Diarrhoea  1  1/70 (1.43%) 
Colitis ischaemic  1  1/70 (1.43%) 
General disorders   
Pain  1  1/70 (1.43%) 
Pyrexia  1  2/70 (2.86%) 
Hepatobiliary disorders   
Cholecystitis acute  1  1/70 (1.43%) 
Infections and infestations   
Gastroenteritis  1  1/70 (1.43%) 
Pneumonia  1  3/70 (4.29%) 
Bronchitis  1  2/70 (2.86%) 
Urosepsis  1  1/70 (1.43%) 
Septic shock  1  1/70 (1.43%) 
Cavernous sinus thrombosis  1  1/70 (1.43%) 
Clostridium difficile infection  1  1/70 (1.43%) 
Clostridium difficile colitis  1  1/70 (1.43%) 
Injury, poisoning and procedural complications   
Femur fracture  1  1/70 (1.43%) 
Subdural haematoma  1  1/70 (1.43%) 
Metabolism and nutrition disorders   
Metabolic acidosis  1  1/70 (1.43%) 
Hypoglycaemia  1  2/70 (2.86%) 
Musculoskeletal and connective tissue disorders   
Pain in extremity  1  1/70 (1.43%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Plasma cell myeloma  1  1/70 (1.43%) 
Nervous system disorders   
Spinal cord compression  1  2/70 (2.86%) 
Renal and urinary disorders   
Acute kidney injury  1  2/70 (2.86%) 
Renal failure  1  1/70 (1.43%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure  1  1/70 (1.43%) 
Respiratory failure  1  1/70 (1.43%) 
Dyspnoea  1  1/70 (1.43%) 
Pulmonary embolism  1  2/70 (2.86%) 
Pulmonary oedema  1  1/70 (1.43%) 
Vascular disorders   
Deep vein thrombosis  1  1/70 (1.43%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
E-Ld
Affected / at Risk (%)
Total   66/70 (94.29%) 
Blood and lymphatic system disorders   
Neutropenia  1  13/70 (18.57%) 
Anaemia  1  14/70 (20.00%) 
Thrombocytopenia  1  5/70 (7.14%) 
Eye disorders   
Vision blurred  1  6/70 (8.57%) 
Gastrointestinal disorders   
Dry mouth  1  4/70 (5.71%) 
Stomatitis  1  4/70 (5.71%) 
Diarrhoea  1  22/70 (31.43%) 
Gastrooesophageal reflux disease  1  4/70 (5.71%) 
Vomiting  1  6/70 (8.57%) 
Abdominal pain  1  8/70 (11.43%) 
Constipation  1  16/70 (22.86%) 
Nausea  1  13/70 (18.57%) 
General disorders   
Malaise  1  4/70 (5.71%) 
Asthenia  1  6/70 (8.57%) 
Chills  1  5/70 (7.14%) 
Oedema peripheral  1  10/70 (14.29%) 
Pyrexia  1  13/70 (18.57%) 
Fatigue  1  35/70 (50.00%) 
Infections and infestations   
Nasopharyngitis  1  5/70 (7.14%) 
Urinary tract infection  1  10/70 (14.29%) 
Upper respiratory tract infection  1  11/70 (15.71%) 
Metabolism and nutrition disorders   
Decreased appetite  1  6/70 (8.57%) 
Hyperglycaemia  1  6/70 (8.57%) 
Dehydration  1  7/70 (10.00%) 
Hypokalaemia  1  6/70 (8.57%) 
Musculoskeletal and connective tissue disorders   
Muscular weakness  1  5/70 (7.14%) 
Muscle spasms  1  17/70 (24.29%) 
Arthralgia  1  6/70 (8.57%) 
Back pain  1  9/70 (12.86%) 
Myalgia  1  4/70 (5.71%) 
Pain in extremity  1  5/70 (7.14%) 
Nervous system disorders   
Neuropathy peripheral  1  5/70 (7.14%) 
Headache  1  9/70 (12.86%) 
Dizziness  1  9/70 (12.86%) 
Psychiatric disorders   
Insomnia  1  15/70 (21.43%) 
Anxiety  1  4/70 (5.71%) 
Respiratory, thoracic and mediastinal disorders   
Productive cough  1  4/70 (5.71%) 
Cough  1  7/70 (10.00%) 
Epistaxis  1  6/70 (8.57%) 
Dysphonia  1  5/70 (7.14%) 
Dyspnoea  1  13/70 (18.57%) 
Hiccups  1  4/70 (5.71%) 
Skin and subcutaneous tissue disorders   
Hyperhidrosis  1  6/70 (8.57%) 
Rash  1  11/70 (15.71%) 
Night sweats  1  4/70 (5.71%) 
Pruritus  1  15/70 (21.43%) 
Vascular disorders   
Hot flush  1  4/70 (5.71%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
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.
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.
Results Point of Contact
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02159365     History of Changes
Other Study ID Numbers: CA204-112
First Submitted: June 6, 2014
First Posted: June 9, 2014
Results First Submitted: November 15, 2016
Results First Posted: January 11, 2017
Last Update Posted: January 3, 2019