PH III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Previously Untreated Multiple Myeloma (ELO 1 Substudy)
Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Terminated
CT.gov ID
NCT01891643
Collaborator
Abbott (Industry)
23
14
2
80.8
1.6
0
Study Details
Study Description
Brief Summary
The purpose of the study is to look at subjects who receive Lenalidomide, Dexamethasone, and Elotuzumab and determine if they will have lower surface CS1 expression on malignant plasma cells at the time of progression than those who receive Lenalidomide and Dexamethasone without Elotuzumab
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
23 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma
Actual Study Start Date
:
Sep 30, 2013
Actual Primary Completion Date
:
Jun 25, 2020
Actual Study Completion Date
:
Jun 25, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1: Lenalidomide + Dexamethasone Lenalidomide 25 mg capsules by mouth once daily (on Days 1-21), repeat every 28 days until subject meets criteria for discontinuation of study drug Dexamethasone 40 mg tablets by mouth weekly (on Days 1, 8, 15, 22), repeat every 28 days until subject meets criteria for discontinuation of study drug |
Drug: Lenalidomide
Other Names:
Drug: Dexamethasone
Other Names:
|
| Experimental: Arm 2: Lenalidomide + Dexamethasone + Elotuzumab Lenalidomide 25 mg capsules by mouth once daily (Days 1-21) Dexamethasone 28 mg tablets by mouth once daily [Days 1, 8, 15, 22 (cycles 1 & 2); Days 1 & 15(cycles 3-18); Day 1 (cycle 19 & beyond)] Dexamethasone 40 mg tablets by mouth once daily [Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 & beyond)] Dexamethasone 8 mg IV (intravenous) solution once daily [Days 1, 8, 15, 22 (cycles 1 & 2); Days 1 & 15 (cycles 3-18); Day 1 (cycle 19 & beyond)] Elotuzumab 10 mg/kg IV solution weekly [Days 1, 8, 15, 22 (cycles 1 & 2); Days 1 & 15 (cycles 3-18)] Elotuzumab 20 mg/kg IV solution on Day 1 (cycle 19 & beyond) Repeat above-mentioned dose cycles every 28 days until subject meets criteria for discontinuation of study drug |
Drug: Lenalidomide
Other Names:
Drug: Dexamethasone
Other Names:
Biological: Elotuzumab
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline to Progression of the Cell Surface Expression of CS1 From Bone Marrow-Derived Multiple Myeloma (MM) Cells [From baseline (screening) to time of progression (up to approximately 54 months)]
CS1 (CD2 subset-1, also known as CRACC, SLAMF7, CD319) expression levels in multiple myeloma cells were analyzed from bone-marrow aspirates collected at baseline and at time of progression through mean fluorescent intensity. The following conditions were considered to describe multiple myeloma cells expressing CS1 (CS1+/CD38++/CD138+/CD56+/CD19-/CD45DIM)
Secondary Outcome Measures
- Percent of Bone Marrow-Derived Multiple Myeloma (MM) Cells Expressing Cell Surface CS1 at Time of Progression [Time of progression (up to approximately 54 months from pre-treatment screening)]
CS1 (CD2 subset-1, also known as CRACC, SLAMF7, CD319) expression levels in multiple myeloma cells were analyzed from bone-marrow aspirates collected at time of progression. The following conditions were considered to describe multiple myeloma cells expressing CS1 (CS1+/CD38++/CD138+/CD56+/CD19-/CD45DIM)
- Levels of CS1 Soluble Form (sCS1) in Serum [At baseline (screening), during main study therapy (cycle 3 day 1, up to 64 days) and at time of progression (up to approximately 31 months)]
Expression levels of the free form of soluble CS1 were analyzed at different timepoints from serum samples derived from peripheral blood collection
- Change From Baseline in the Levels of CS1 Soluble Form (sCS1) in Serum During Therapy and At Progression [From baseline (screening) to cycle 3 day 1 of the main study therapy (up to 64 days) and from baseline (screening) to time of progression (up to approximately 31 months)]
Expression levels of the free form of soluble CS1 were analyzed at different timepoints from serum samples derived from peripheral blood collection
- Change From Baseline in the Number of Circulating Multiple Myeloma (MM) Cells [From baseline (screening) to cycle 3 day 1 of the main study therapy (up to 64 days) and from baseline (screening) to the time of progression (up to approximately 54 months)]
Circulating MM cells isolated from peripheral blood
- Change From Baseline in Cell Surface CS1 Expression Levels in Circulating Multiple Myeloma (MM) Cells [From baseline (screening) to cycle 3 day 1 of the main study therapy (up to 64 days) and from baseline (screening) to the time of progression (up to approximately 54 months)]
Circulating MM cells isolated from peripheral blood
- CS1 Expression Levels in Matched Samples of Bone Marrow-Derived Multiple Myeloma (MM) Cells and Circulating MM Cells [At baseline (screening), during main study therapy (cycle 3 day 1) and at time of progression (up to approximately 54 months)]
CS1 expression levels analyzed from matching bone marrow aspirates (for bone marrow-derived MM cells) and from peripheral blood (for circulating tumor cells) collected from the same participants
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:
Subjects who are newly diagnosed with symptomatic MM and who:
-
Have not received any prior systemic anti-myeloma therapy
-
Have measurable disease
-
And are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because of age (≥65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204-006 for a subject <65 years old. There must be a comorbidity that prevents SCT for a subject <65 years old
Exclusion Criteria:
-
Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
-
Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
-
Monoclonal Gammopathy of Undetermined Significance (MGUS)
-
Active plasma cell leukemia
-
Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pacific Hematology Oncology Associates | San Francisco | California | United States | 94115 |
| 2 | Memorial Cancer Institute | Hollywood | Florida | United States | 33021 |
| 3 | Illinois Cancercare, Pc | Peoria | Illinois | United States | 61615 |
| 4 | Franciscan St. Francis Health | Indianapolis | Indiana | United States | 46237 |
| 5 | Crescent City Research Consortium, LLC | Marrero | Louisiana | United States | 70072 |
| 6 | Ohio State University Medical Center | Columbus | Ohio | United States | 43210 |
| 7 | Medical University Of South Carolina Hollings Cancer Center | Charleston | South Carolina | United States | 29425 |
| 8 | Baptist Cancer Center | Memphis | Tennessee | United States | 38120 |
| 9 | Northern Utah Associates | Ogden | Utah | United States | 84405 |
| 10 | Local Institution | Athens | Greece | 11528 | |
| 11 | Local Institution | Genova | Italy | 16132 | |
| 12 | Local Institution | Rome | Italy | 00161 | |
| 13 | Local Institution | Chorzow | Poland | 41-500 | |
| 14 | Local Institution | Lublin | Poland | 20-081 |
Sponsors and Collaborators
- Bristol-Myers Squibb
- Abbott
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01891643
Other Study ID Numbers:
- CA204-006 (Biomarker Substudy)
- 2010-022445-20
First Posted:
Jul 3, 2013
Last Update Posted:
Jul 1, 2021
Last Verified:
Jun 1, 2021
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 23 participants treated in the main CA204-006 study (NCT01335399) were recruited for the CA204-006 biomarker sub-study (NCT01891643). No additional treatment (other than what administered in the main study) was dosed during the biomarker sub-study. |
| Arm/Group Title | E-Ld Cohort | Ld Cohort |
|---|---|---|
| Arm/Group Description | Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle | Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle |
| Period Title: Overall Study | ||
| STARTED | 13 | 10 |
| COMPLETED | 3 | 0 |
| NOT COMPLETED | 10 | 10 |
Baseline Characteristics
| Arm/Group Title | E-Ld Cohort | Ld Cohort | Total |
|---|---|---|---|
| Arm/Group Description | Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle | Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle | Total of all reporting groups |
| Overall Participants | 13 | 10 | 23 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
74.8
(6.77)
|
71.3
(6.53)
|
73.3
(6.75)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
6
46.2%
|
6
60%
|
12
52.2%
|
| Male |
7
53.8%
|
4
40%
|
11
47.8%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
2
15.4%
|
3
30%
|
5
21.7%
|
| Unknown or Not Reported |
11
84.6%
|
7
70%
|
18
78.3%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
1
7.7%
|
1
10%
|
2
8.7%
|
| White |
12
92.3%
|
9
90%
|
21
91.3%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Change From Baseline to Progression of the Cell Surface Expression of CS1 From Bone Marrow-Derived Multiple Myeloma (MM) Cells |
|---|---|
| Description | CS1 (CD2 subset-1, also known as CRACC, SLAMF7, CD319) expression levels in multiple myeloma cells were analyzed from bone-marrow aspirates collected at baseline and at time of progression through mean fluorescent intensity. The following conditions were considered to describe multiple myeloma cells expressing CS1 (CS1+/CD38++/CD138+/CD56+/CD19-/CD45DIM) |
| Time Frame | From baseline (screening) to time of progression (up to approximately 54 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants with measurements available at baseline and at time of progression. No participants in any of the 2 cohorts had available measurements both at baseline and time of progression |
| Arm/Group Title | E-Ld Cohort | Ld Cohort |
|---|---|---|
| Arm/Group Description | Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle | Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle |
| Measure Participants | 0 | 0 |
| Title | Percent of Bone Marrow-Derived Multiple Myeloma (MM) Cells Expressing Cell Surface CS1 at Time of Progression |
|---|---|
| Description | CS1 (CD2 subset-1, also known as CRACC, SLAMF7, CD319) expression levels in multiple myeloma cells were analyzed from bone-marrow aspirates collected at time of progression. The following conditions were considered to describe multiple myeloma cells expressing CS1 (CS1+/CD38++/CD138+/CD56+/CD19-/CD45DIM) |
| Time Frame | Time of progression (up to approximately 54 months from pre-treatment screening) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants with measurements available at time of progression. |
| Arm/Group Title | E-Ld Cohort | Ld Cohort |
|---|---|---|
| Arm/Group Description | Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle | Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle |
| Measure Participants | 4 | 1 |
| Median (Full Range) [Percent of cells expressing CS1] |
46.59
|
84.62
|
| Title | Levels of CS1 Soluble Form (sCS1) in Serum |
|---|---|
| Description | Expression levels of the free form of soluble CS1 were analyzed at different timepoints from serum samples derived from peripheral blood collection |
| Time Frame | At baseline (screening), during main study therapy (cycle 3 day 1, up to 64 days) and at time of progression (up to approximately 31 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants with measurements available either at baseline, at cycle 3 day 1 of study therapy or at time of progression. |
| Arm/Group Title | E-Ld Cohort | Ld Cohort |
|---|---|---|
| Arm/Group Description | Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle | Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle |
| Measure Participants | 13 | 10 |
| Baseline |
3.60
|
13.27
|
| Cycle 3 day 1 of main study therapy |
0.15
|
0.72
|
| Time of progression |
0.39
|
49.85
|
| Title | Change From Baseline in the Levels of CS1 Soluble Form (sCS1) in Serum During Therapy and At Progression |
|---|---|
| Description | Expression levels of the free form of soluble CS1 were analyzed at different timepoints from serum samples derived from peripheral blood collection |
| Time Frame | From baseline (screening) to cycle 3 day 1 of the main study therapy (up to 64 days) and from baseline (screening) to time of progression (up to approximately 31 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants with measurements available at baseline and at cycle 3 day 1 of study therapy or at baseline and at the time of progression. |
| Arm/Group Title | E-Ld Cohort | Ld Cohort |
|---|---|---|
| Arm/Group Description | Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle | Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle |
| Measure Participants | 13 | 10 |
| From baseline to Cycle 3 day 1 of main study therapy |
-3.51
|
-4.08
|
| From baseline to time of progression |
-0.85
|
-17.41
|
| Title | Change From Baseline in the Number of Circulating Multiple Myeloma (MM) Cells |
|---|---|
| Description | Circulating MM cells isolated from peripheral blood |
| Time Frame | From baseline (screening) to cycle 3 day 1 of the main study therapy (up to 64 days) and from baseline (screening) to the time of progression (up to approximately 54 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants with available circulating MM cells. Circulating MM cells were not collected for any of the participants. |
| Arm/Group Title | E-Ld Cohort | Ld Cohort |
|---|---|---|
| Arm/Group Description | Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle | Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle |
| Measure Participants | 0 | 0 |
| Title | Change From Baseline in Cell Surface CS1 Expression Levels in Circulating Multiple Myeloma (MM) Cells |
|---|---|
| Description | Circulating MM cells isolated from peripheral blood |
| Time Frame | From baseline (screening) to cycle 3 day 1 of the main study therapy (up to 64 days) and from baseline (screening) to the time of progression (up to approximately 54 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants with available circulating MM cells and CS1 expression levels. Circulating MM cells were not collected for any of the participants. |
| Arm/Group Title | E-Ld Cohort | Ld Cohort |
|---|---|---|
| Arm/Group Description | Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle | Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle |
| Measure Participants | 0 | 0 |
| Title | CS1 Expression Levels in Matched Samples of Bone Marrow-Derived Multiple Myeloma (MM) Cells and Circulating MM Cells |
|---|---|
| Description | CS1 expression levels analyzed from matching bone marrow aspirates (for bone marrow-derived MM cells) and from peripheral blood (for circulating tumor cells) collected from the same participants |
| Time Frame | At baseline (screening), during main study therapy (cycle 3 day 1) and at time of progression (up to approximately 54 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants with matched samples of bone marrow-derived MM cells and circulating MM cells. Circulating MM cells were not collected for any of the participants. |
| Arm/Group Title | E-Ld Cohort | Ld Cohort |
|---|---|---|
| Arm/Group Description | Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle | Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle |
| Measure Participants | 0 | 0 |
Adverse Events
| Time Frame | From first dose to 60 days following last dose (up to approximately 80 months) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | E-Ld Cohort | Ld Cohort | ||
| Arm/Group Description | Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle | Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle | ||
All Cause Mortality |
||||
| E-Ld Cohort | Ld Cohort | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/13 (61.5%) | 5/10 (50%) | ||
Serious Adverse Events |
||||
| E-Ld Cohort | Ld Cohort | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/13 (69.2%) | 7/10 (70%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 1/13 (7.7%) | 1/10 (10%) | ||
| Cardiac disorders | ||||
| Atrial flutter | 1/13 (7.7%) | 0/10 (0%) | ||
| Cardiac arrest | 1/13 (7.7%) | 0/10 (0%) | ||
| Sinus tachycardia | 0/13 (0%) | 1/10 (10%) | ||
| Eye disorders | ||||
| Cataract | 1/13 (7.7%) | 1/10 (10%) | ||
| Gastrointestinal disorders | ||||
| Colitis | 1/13 (7.7%) | 0/10 (0%) | ||
| Inguinal hernia | 1/13 (7.7%) | 0/10 (0%) | ||
| General disorders | ||||
| Multiple organ dysfunction syndrome | 0/13 (0%) | 1/10 (10%) | ||
| Infections and infestations | ||||
| Bronchitis | 1/13 (7.7%) | 1/10 (10%) | ||
| Pneumonia | 1/13 (7.7%) | 2/10 (20%) | ||
| Septic shock | 1/13 (7.7%) | 0/10 (0%) | ||
| Urinary tract infection | 1/13 (7.7%) | 0/10 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Femur fracture | 0/13 (0%) | 2/10 (20%) | ||
| Pelvic fracture | 1/13 (7.7%) | 0/10 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Electrolyte imbalance | 0/13 (0%) | 1/10 (10%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Acute lymphocytic leukaemia | 0/13 (0%) | 1/10 (10%) | ||
| Refractory anaemia with ringed sideroblasts | 1/13 (7.7%) | 0/10 (0%) | ||
| Nervous system disorders | ||||
| Syncope | 1/13 (7.7%) | 0/10 (0%) | ||
| Transient ischaemic attack | 0/13 (0%) | 1/10 (10%) | ||
| Psychiatric disorders | ||||
| Delusional disorder, unspecified type | 1/13 (7.7%) | 0/10 (0%) | ||
| Renal and urinary disorders | ||||
| Acute kidney injury | 0/13 (0%) | 1/10 (10%) | ||
| Renal failure | 1/13 (7.7%) | 0/10 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Chronic obstructive pulmonary disease | 0/13 (0%) | 1/10 (10%) | ||
| Pleural effusion | 0/13 (0%) | 1/10 (10%) | ||
| Pulmonary congestion | 0/13 (0%) | 1/10 (10%) | ||
| Pulmonary embolism | 0/13 (0%) | 1/10 (10%) | ||
| Respiratory failure | 0/13 (0%) | 1/10 (10%) | ||
| Restrictive pulmonary disease | 1/13 (7.7%) | 0/10 (0%) | ||
| Vascular disorders | ||||
| Deep vein thrombosis | 0/13 (0%) | 1/10 (10%) | ||
| Thrombosis | 0/13 (0%) | 1/10 (10%) | ||
Other (Not Including Serious) Adverse Events |
||||
| E-Ld Cohort | Ld Cohort | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 13/13 (100%) | 10/10 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 3/13 (23.1%) | 6/10 (60%) | ||
| Lymphopenia | 1/13 (7.7%) | 0/10 (0%) | ||
| Neutropenia | 2/13 (15.4%) | 2/10 (20%) | ||
| Thrombocytopenia | 1/13 (7.7%) | 0/10 (0%) | ||
| Cardiac disorders | ||||
| Arrhythmia | 0/13 (0%) | 1/10 (10%) | ||
| Atrial tachycardia | 0/13 (0%) | 1/10 (10%) | ||
| Left ventricular dysfunction | 0/13 (0%) | 1/10 (10%) | ||
| Palpitations | 0/13 (0%) | 1/10 (10%) | ||
| Tachycardia | 0/13 (0%) | 1/10 (10%) | ||
| Ear and labyrinth disorders | ||||
| Hypoacusis | 0/13 (0%) | 1/10 (10%) | ||
| Endocrine disorders | ||||
| Hypothyroidism | 0/13 (0%) | 1/10 (10%) | ||
| Eye disorders | ||||
| Cataract | 2/13 (15.4%) | 1/10 (10%) | ||
| Macular degeneration | 0/13 (0%) | 1/10 (10%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 1/13 (7.7%) | 0/10 (0%) | ||
| Abdominal pain upper | 2/13 (15.4%) | 1/10 (10%) | ||
| Constipation | 4/13 (30.8%) | 3/10 (30%) | ||
| Diarrhoea | 5/13 (38.5%) | 6/10 (60%) | ||
| Dyspepsia | 0/13 (0%) | 1/10 (10%) | ||
| Gastritis | 1/13 (7.7%) | 0/10 (0%) | ||
| Gastrooesophageal reflux disease | 0/13 (0%) | 1/10 (10%) | ||
| Inguinal hernia | 1/13 (7.7%) | 0/10 (0%) | ||
| Nausea | 2/13 (15.4%) | 3/10 (30%) | ||
| Retching | 0/13 (0%) | 1/10 (10%) | ||
| Vomiting | 0/13 (0%) | 2/10 (20%) | ||
| General disorders | ||||
| Asthenia | 0/13 (0%) | 2/10 (20%) | ||
| Chest pain | 0/13 (0%) | 1/10 (10%) | ||
| Fatigue | 6/13 (46.2%) | 2/10 (20%) | ||
| Fibrosis | 0/13 (0%) | 1/10 (10%) | ||
| Influenza like illness | 1/13 (7.7%) | 0/10 (0%) | ||
| Mucosal inflammation | 1/13 (7.7%) | 0/10 (0%) | ||
| Oedema | 1/13 (7.7%) | 0/10 (0%) | ||
| Oedema peripheral | 2/13 (15.4%) | 5/10 (50%) | ||
| Pyrexia | 1/13 (7.7%) | 3/10 (30%) | ||
| Immune system disorders | ||||
| Hypersensitivity | 2/13 (15.4%) | 0/10 (0%) | ||
| Hypogammaglobulinaemia | 0/13 (0%) | 1/10 (10%) | ||
| Infections and infestations | ||||
| Bronchitis | 1/13 (7.7%) | 0/10 (0%) | ||
| Cellulitis | 0/13 (0%) | 2/10 (20%) | ||
| Conjunctivitis | 0/13 (0%) | 1/10 (10%) | ||
| Gastrointestinal infection | 0/13 (0%) | 1/10 (10%) | ||
| Genitourinary tract infection | 1/13 (7.7%) | 0/10 (0%) | ||
| Herpes zoster | 1/13 (7.7%) | 0/10 (0%) | ||
| Influenza | 0/13 (0%) | 2/10 (20%) | ||
| Intervertebral discitis | 1/13 (7.7%) | 0/10 (0%) | ||
| Nasopharyngitis | 0/13 (0%) | 1/10 (10%) | ||
| Onychomycosis | 1/13 (7.7%) | 0/10 (0%) | ||
| Oral herpes | 1/13 (7.7%) | 0/10 (0%) | ||
| Otitis externa | 0/13 (0%) | 1/10 (10%) | ||
| Pharyngitis | 1/13 (7.7%) | 1/10 (10%) | ||
| Pneumonia | 0/13 (0%) | 1/10 (10%) | ||
| Respiratory tract infection | 2/13 (15.4%) | 0/10 (0%) | ||
| Skin infection | 0/13 (0%) | 1/10 (10%) | ||
| Upper respiratory tract infection | 3/13 (23.1%) | 2/10 (20%) | ||
| Urinary tract infection | 2/13 (15.4%) | 1/10 (10%) | ||
| Injury, poisoning and procedural complications | ||||
| Infusion related reaction | 1/13 (7.7%) | 0/10 (0%) | ||
| Pelvic fracture | 2/13 (15.4%) | 0/10 (0%) | ||
| Skin abrasion | 1/13 (7.7%) | 0/10 (0%) | ||
| Investigations | ||||
| Alanine aminotransferase increased | 0/13 (0%) | 1/10 (10%) | ||
| Aspartate aminotransferase increased | 0/13 (0%) | 1/10 (10%) | ||
| Blood albumin decreased | 0/13 (0%) | 1/10 (10%) | ||
| Blood creatinine increased | 2/13 (15.4%) | 1/10 (10%) | ||
| Blood lactate dehydrogenase decreased | 0/13 (0%) | 1/10 (10%) | ||
| Blood magnesium decreased | 0/13 (0%) | 1/10 (10%) | ||
| Blood uric acid increased | 0/13 (0%) | 1/10 (10%) | ||
| Creatinine renal clearance decreased | 1/13 (7.7%) | 0/10 (0%) | ||
| Glomerular filtration rate decreased | 2/13 (15.4%) | 2/10 (20%) | ||
| Neutrophil count decreased | 1/13 (7.7%) | 2/10 (20%) | ||
| Neutrophil count increased | 0/13 (0%) | 1/10 (10%) | ||
| Transaminases increased | 0/13 (0%) | 1/10 (10%) | ||
| Weight decreased | 2/13 (15.4%) | 0/10 (0%) | ||
| Weight increased | 1/13 (7.7%) | 1/10 (10%) | ||
| White blood cell count decreased | 0/13 (0%) | 1/10 (10%) | ||
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 2/13 (15.4%) | 1/10 (10%) | ||
| Dehydration | 1/13 (7.7%) | 0/10 (0%) | ||
| Hyperglycaemia | 3/13 (23.1%) | 2/10 (20%) | ||
| Hyperphosphataemia | 1/13 (7.7%) | 0/10 (0%) | ||
| Hyperuricaemia | 1/13 (7.7%) | 1/10 (10%) | ||
| Hypocalcaemia | 1/13 (7.7%) | 1/10 (10%) | ||
| Hypokalaemia | 1/13 (7.7%) | 3/10 (30%) | ||
| Metabolic acidosis | 1/13 (7.7%) | 0/10 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 2/13 (15.4%) | 1/10 (10%) | ||
| Arthritis | 2/13 (15.4%) | 0/10 (0%) | ||
| Back pain | 2/13 (15.4%) | 4/10 (40%) | ||
| Bone pain | 1/13 (7.7%) | 2/10 (20%) | ||
| Groin pain | 1/13 (7.7%) | 0/10 (0%) | ||
| Joint effusion | 0/13 (0%) | 1/10 (10%) | ||
| Kyphosis | 1/13 (7.7%) | 0/10 (0%) | ||
| Muscle spasms | 1/13 (7.7%) | 2/10 (20%) | ||
| Muscular weakness | 2/13 (15.4%) | 1/10 (10%) | ||
| Musculoskeletal chest pain | 1/13 (7.7%) | 0/10 (0%) | ||
| Myalgia | 0/13 (0%) | 1/10 (10%) | ||
| Neck pain | 1/13 (7.7%) | 0/10 (0%) | ||
| Osteoarthritis | 0/13 (0%) | 1/10 (10%) | ||
| Osteonecrosis of jaw | 1/13 (7.7%) | 0/10 (0%) | ||
| Pain in extremity | 1/13 (7.7%) | 1/10 (10%) | ||
| Spinal pain | 1/13 (7.7%) | 1/10 (10%) | ||
| Nervous system disorders | ||||
| Carotid arteriosclerosis | 0/13 (0%) | 1/10 (10%) | ||
| Cerebrovascular disorder | 0/13 (0%) | 1/10 (10%) | ||
| Dizziness | 0/13 (0%) | 1/10 (10%) | ||
| Facial paralysis | 0/13 (0%) | 1/10 (10%) | ||
| Headache | 0/13 (0%) | 1/10 (10%) | ||
| Memory impairment | 1/13 (7.7%) | 0/10 (0%) | ||
| Neuralgia | 1/13 (7.7%) | 1/10 (10%) | ||
| Neuropathy peripheral | 1/13 (7.7%) | 0/10 (0%) | ||
| Paraesthesia | 1/13 (7.7%) | 1/10 (10%) | ||
| Peripheral sensory neuropathy | 3/13 (23.1%) | 1/10 (10%) | ||
| Sciatica | 1/13 (7.7%) | 0/10 (0%) | ||
| Speech disorder | 1/13 (7.7%) | 0/10 (0%) | ||
| Spinal cord compression | 1/13 (7.7%) | 0/10 (0%) | ||
| Spinal cord herniation | 0/13 (0%) | 1/10 (10%) | ||
| Syncope | 1/13 (7.7%) | 1/10 (10%) | ||
| Tremor | 1/13 (7.7%) | 2/10 (20%) | ||
| Psychiatric disorders | ||||
| Agitation | 0/13 (0%) | 1/10 (10%) | ||
| Anxiety | 1/13 (7.7%) | 0/10 (0%) | ||
| Confusional state | 2/13 (15.4%) | 0/10 (0%) | ||
| Depressed mood | 1/13 (7.7%) | 0/10 (0%) | ||
| Depression | 1/13 (7.7%) | 0/10 (0%) | ||
| Insomnia | 0/13 (0%) | 3/10 (30%) | ||
| Mood altered | 1/13 (7.7%) | 1/10 (10%) | ||
| Renal and urinary disorders | ||||
| Dysuria | 0/13 (0%) | 1/10 (10%) | ||
| Glomerulonephritis minimal lesion | 1/13 (7.7%) | 0/10 (0%) | ||
| Renal tubular necrosis | 1/13 (7.7%) | 0/10 (0%) | ||
| Reproductive system and breast disorders | ||||
| Pelvic pain | 0/13 (0%) | 1/10 (10%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 3/13 (23.1%) | 3/10 (30%) | ||
| Dysphonia | 1/13 (7.7%) | 0/10 (0%) | ||
| Dyspnoea | 0/13 (0%) | 2/10 (20%) | ||
| Dyspnoea exertional | 0/13 (0%) | 1/10 (10%) | ||
| Hiccups | 1/13 (7.7%) | 0/10 (0%) | ||
| Hypoxia | 0/13 (0%) | 1/10 (10%) | ||
| Oropharyngeal pain | 1/13 (7.7%) | 0/10 (0%) | ||
| Pneumonitis | 0/13 (0%) | 2/10 (20%) | ||
| Pulmonary hypertension | 0/13 (0%) | 1/10 (10%) | ||
| Rales | 1/13 (7.7%) | 0/10 (0%) | ||
| Restrictive pulmonary disease | 1/13 (7.7%) | 0/10 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Acne | 1/13 (7.7%) | 0/10 (0%) | ||
| Angioedema | 0/13 (0%) | 1/10 (10%) | ||
| Eczema | 0/13 (0%) | 1/10 (10%) | ||
| Erythema | 1/13 (7.7%) | 0/10 (0%) | ||
| Hyperhidrosis | 1/13 (7.7%) | 1/10 (10%) | ||
| Pruritus | 1/13 (7.7%) | 1/10 (10%) | ||
| Rash | 4/13 (30.8%) | 1/10 (10%) | ||
| Skin hyperpigmentation | 0/13 (0%) | 1/10 (10%) | ||
| Skin lesion | 0/13 (0%) | 1/10 (10%) | ||
| Skin ulcer | 0/13 (0%) | 1/10 (10%) | ||
| Vascular disorders | ||||
| Haematoma | 1/13 (7.7%) | 0/10 (0%) | ||
| Hypertension | 2/13 (15.4%) | 2/10 (20%) | ||
| Orthostatic hypotension | 1/13 (7.7%) | 0/10 (0%) | ||
| Venous thrombosis limb | 1/13 (7.7%) | 0/10 (0%) | ||
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.
Results Point of Contact
| Name/Title | Bristol-Myers Squibb Study Director |
|---|---|
| Organization | Bristol-Myers Squibb |
| Phone | Please email |
| Clinical.Trials@bms.com |
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01891643
Other Study ID Numbers:
- CA204-006 (Biomarker Substudy)
- 2010-022445-20
First Posted:
Jul 3, 2013
Last Update Posted:
Jul 1, 2021
Last Verified:
Jun 1, 2021