Multiple MyelomaPhase 2NCT01478048
Study of Bortezomib and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma
A Phase 2 study testing Elotuzumab, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by Bristol-Myers Squibb at 77 sites in 5 countries.
Trial summary
The purpose of the study is to determine whether the addition of Elotuzumab to Bortezomib/ Dexamethasone will prolong the time before myeloma worsens [progression free survival (PFS)]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Elotuzumab, Bortezomib and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 77 sitesin 5 countries
- Study dates
- 30 Nov 2011to 21 Apr 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented progression from most recent line of therapy
- Measurable disease
- 1 to 3 prior lines of therapy
- Subjects may be proteasome inhibitor naive or have received prior proteasome inhibitor therapy provided all the following criteria are met:
- The subject did not discontinue any proteasome inhibitor due to intolerance or grade ≥ 3 toxicity
- The subject is not refractory to any proteasome inhibitor, defined as progression during treatment or within 60 days after the last dose
- The subject previously achieved a partial response (PR) or better to previous proteasome inhibitor (PI)
Who cannot join
- Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, or Waldenstrom's macroglobulinemia
- Active plasma cell leukemia
- Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C
Trial locations and contacts
77 sites in 5 countries.
77 sites in 5 countries
United States42 sites
Local Institution
Baltimore, Maryland, 21204
St. Agnes Hospital
Baltimore, Pennsylvania, 21229
Cancer Care Associates
Bethlehem, Pennsylvania, 18015
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Waverly Hematology Oncology
Cary, North Carolina, 27518
Medical University Of South Carolina
Charleston, South Carolina, 29425
University Of Chicago Medical Center
Chicago, Illinois, 60637
Compassionate Cancer Res Grp
Corona, California, 92879
Local Institution
Corona, California, 92879
Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Local Institution
Decatur, Illinois, 62526
Henry Ford Health System
Detroit, Michigan, 48202
Local Institution
Fairfax, Virginia, 22031
Local Institution
Greenville, South Carolina, 29615
Local Institution
Hazard, Kentucky, 41701
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, 17033
Penn State Hershey Cancer Inst
Hershey, Pennsylvania, 17033
Kaiser Permanente-Moanalua Medical Center
Honolulu, Hawaii, 96819
Northwest Cancer Center
Houston, Texas, 77090
Investigative Clinical Research Of Indiana, Llc
Indianapolis, Indiana, 46260
Cancer Specialists of North FL
Jacksonville, Florida, 32256
Cancer Center Of Acadiana
Lafayette, Louisiana, 70503
Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
University Of Kentucky Markey Cancer Center
Lexington, Kentucky, 40536
Local Institution
Long Beach, California, 90806
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Ucla Department Of Medicine
Los Angeles, California, 90095
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
Medical Oncology Care Associates
Orange, California, 92868
Oncology Specialists, S.C.
Park Ridge, Illinois, 60068
Pikeville Medical Center Leonard Lawson Cancer Center
Pikeville, Kentucky, 41501
The Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
Sharp Clinical Oncology Research
San Diego, California, 92123
Local Institution
Seattle, Washington, 98108
Local Institution
Shreveport, Louisiana, 71101
Mercy Medical Research Institute
Springfield, Missouri, 65807
Washington University School Of Medicine
St Louis, Missouri, 63110
Local Institution
Urbana, Illinois, 61801
Kaiser Permanente Medical Center
Vallejo, California, 94589
Local Institution
Vallejo, California, 94589
Palm Beach Cancer Institute
West Palm Beach, Florida, 33401
Local Institution
Worcester, Massachusetts, 01608
Italy18 sites
Local Institution
Ancona, 60126
Local Institution
Bari, 70124
Local Institution
Bologna, 40138
Local Institution
Brescia, 25123
Local Institution
Florence, 50134
Local Institution
Genova, 16132
Local Institution
Lecce, 73100
Local Institution
Meldola (fc), 47014
Local Institution
Milan, Parma, 20132
Local Institution
Modena, 41124
Local Institution
Pescara, 65124
Local Institution
Ravenna, 48100
Local Institution
Rimini, 47900
Local Institution
Roma, Parma, 00144
Local Institution
Roma, 00168
Local Institution
Roma, 161
Local Institution
Rome, 00144
Local Institution
Torino, 10126
Spain9 sites
Local Institution
Barcelona, 08003
Local Institution
Madrid, 28006
Local Institution
Murcia, 30008
Local Institution
Salamanca, 37007
Local Institution
Santiago Compostela, 15706
Local Institution
Toledo, 45004
Local Institution
Valencia, 46010
Local Institution
Valencia, 46026
Local Institution
Zaragoza, 50009
France7 sites
Local Institution
Grenoble, 38043
Local Institution
Le Mans, 72037
Local Institution
Lille, 59037
Local Institution
Nantes, 44093
Local Institution
Paris, 75012
Local Institution
Toulouse, 31059
Local Institution
Vandœuvre-lès-Nancy, 54500
About this study
Official title: A Phase 2, Randomized Study of Bortezomib/Dexamethasone With or Without Elotuzumab in Subjects With Relapsed/Refractory Multiple Myeloma
The purpose of the study is to determine whether the addition of Elotuzumab to Bortezomib/ Dexamethasone will prolong the time before myeloma worsens [progression free survival (PFS)].
- Conditions
- Multiple Myeloma
- Being tested
- Elotuzumab, Bortezomib, Dexamethasone
- Keywords
- Relapsed/Refractory Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElotuzumabBiological
Also called BMS-901608
Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 \& 2: Days 1, 8 \& 15; Cycles 3-8: Days 1 \& 11; Cycle 9+: Days 1 \& 15); Until subject meets criteria for discontinuation of study drug
BortezomibDrug
Also called Velcade®
Solution; IV; 1.3 mg/m2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until subject meets criteria for discontinuation of study drug
DexamethasoneDrug
Also called Decadron®, Intensol®, Dexpak®, Taperpak®
Tablets; Oral; 20 mg; (Cycles 1\& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until subject meets criteria for discontinuation of study drug
DexamethasoneDrug
Also called Decadron®, Intensol®, Dexpak®, Taperpak®
Tablets; Oral; 8 mg; (Cycles 1\& 2: Days 1, 8, 15; Cycles 3-8: Days 1 \&11; Cycles 9+; Days 1 \& 15); Until subject meets criteria for discontinuation of study drug
DexamethasoneDrug
Also called Decadron®, Intensol®, Dexpak®, Taperpak®
Solution; IV; 8 mg; (Cycles 1\& 2: Days 1, 8, 15; Cycles 3-8: Days 1 \&11; Cycles 9+; Days 1 \& 15); Until subject meets criteria for discontinuation of study drug
DexamethasoneDrug
Also called Decadron®, Intensol®, Dexpak®, Taperpak®
Tablets; Oral; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until subject meets criteria for discontinuation of study drug
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Elotuzumab + Bortezomib + Dexamethasone | Experimental | On days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) will be administered other days Dexamethasone 20 mg Oral will be administered Receives: Biological: Elotuzumab; Drug: Bortezomib; Drug: Dexamethasone |
| Arm B: Bortezomib + Dexamethasone | Active comparator | Not described Receives: Drug: Bortezomib; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Investigator-Assessed Progression-free Survival (PFS) Time (Months) From Randomization to Date of First Tumor Progression or Death Due to Any Cause - Randomized Participants
PE was planned for after at least 103 events; it was analyzed after 111 events. Response was assessed: Day 1 (± 7 days) of each cycle per modified International Myeloma Working Group (IMWG) criteria; assessed using adequate tumor assessment (ATA) (ie, serum and urine M-protein tests performed within 14 days of each other; imaging if baseline measurable extramedullary plasmacytoma existed). Progression: Any of following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/L); Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder.
Measured: Randomization until 111 events (disease progression or death), up to May 2014, approximately 2 years
Number of Investigator-Assessed Progression-free Survival Events From Randomization to Date of First Tumor Progression or Death Due to Any Cause - All Randomized Participants
PE planned for after at least 103 events (progression/death); analyzed at 111 events. Those who neither progressed nor died were censored on the date of last adequate tumor assessment (ATA), which requires both serum and urine M-protein tests. If no post-baseline tumor assessments/no death, then censored on randomization day. Response assessed: Day 1 (± 7 days) each cycle; 30 and 60 days post treatment. Modified IMWG criteria used. Progression: Any of following: Increase of 25% in serum and/or urine M-component; if no measurable serum, urine M-protein levels, then difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/L) ; Bone marrow plasma cell percentage (≥10%). New bone lesions or soft tissue plasmacytomas or increase in size of existing lesions, plasmacytomas. Development of hypercalcemia attributed solely to plasma cell proliferative disorder. First dose occurs within 3 days of randomization.
Measured: Randomization until 111 events, up to May 2014, approximately 2 years
1 Year Progression-Free Survival Rate - Randomized Participants
PFS rate=Percentage probability of participants experiencing no progression or death up to 1 year, estimated using the Kaplan-Meier method. Response assessed by the investigator: Day 1 (± 7 days) of each cycle per modified IMWG criteria; assessed using ATA (ie, serum and urine M-protein tests performed within 14 days of each other; imaging done if baseline measurable extramedullary plasmacytoma existed). Progression: Any of the following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved FLC levels (absolute increase > 100 mg/L) ; Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder.
Measured: Year 1 after last participant was randomized
Secondary outcomes (3)
Median Progression-free Survival Time (Months) From Randomization to Date of First Tumor Progression or Death Due to Any Cause, in Randomized Participants With at Least One FcγRIIIa V Allele
PE was planned for after at least 103 events; it was analyzed after 111 events. Response was assessed: Day 1 (± 7 days) of each cycle per modified IMWG criteria; assessed using adequate tumor assessment (ATA) (ie, serum and urine M-protein tests performed within 14 days of each other; imaging if baseline measurable extramedullary plasmacytoma existed). Progression: Any of following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved FLC levels (absolute increase > 100 mg/L); Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder. Randomized participants with at least 1 FcγRIIIa V allele were a sub-set of all randomized participants.
Measured: Randomization until 111 events, up to May 2014, approximately 2 years
Investigator-Assessed Objective Response Rate (ORR) - All Randomized Participants
ORR was calculated for participants with a best overall response (BOR) of partial response (PR) or better, including stringent complete response (sCR), complete response (CR), and very good partial response (VGPR). BOR was determined by the investigator based on myeloma tumor assessments using IMWG criteria: CR=Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow; sCR= CR + normal FLC ratio and absence of clonal cells in bone marrow; VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein level + 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. ORR= number of participants responding divided by total number of participants randomized, measured as a percentage.
Measured: Randomization until 111 events, up to May 2014, approximately 2 years
Investigator-Assessed Objective Response Rate in Randomized Participants With at Least One FcγRIIIa V Allele
ORR was calculated for participants with a BOR of PR or better, sCR, CR, and VGPR. BOR was determined by the investigator based on myeloma tumor assessments using IMWG criteria: CR=Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow; sCR= CR + normal FLC ratio and absence of clonal cells in bone marrow; VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein level + 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. ORR= number of participants responding divided by total number of participants randomized, measured as a percentage. Randomized participants with at least 1 FcγRIIIa V allele were a sub-set of all randomized participants.
Measured: Randomization until 111 events, up to May 2014, approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study start30 Nov 2011
- Primary completion30 May 2014
- Study completion21 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AbbVie
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478048
- Sponsor's protocol ID
- CA204-009
- Other IDs
- 2011-002695-16
- Status last verified
- Apr 2018
- First submitted
- 2 Nov 2011
- Last updated
- 21 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Jakubowiak A, Offidani M, Pegourie B, De La Rubia J, Garderet L, Laribi K, Bosi A, Marasca R, Laubach J, Mohrbacher A, Carella AM, Singhal AK, Tsao LC, Lynch M, Bleickardt E, Jou YM, Robbins M, Palumbo A. Randomized phase 2 study: elotuzumab plus bortezomib/dexamethasone vs bortezomib/dexamethasone for relapsed/refractory MM. Blood. 2016 Jun 9;127(23):2833-40. doi: 10.1182/blood-2016-01-694604. Epub 2016 Apr 18.
PubMed 27091875
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized Study of Bortezomib/Dexamethasone With or Without Elotuzumab in Subjects With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01478048
- Acronym / sponsor ID
- CA204-009
- Conditions
- Multiple Myeloma
- Keywords
- Relapsed/Refractory Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- AbbVie
- Study start
- 30 Nov 2011 (actual)
- Primary completion
- 30 May 2014 (actual)
- Study completion
- 21 Apr 2017 (actual)
- First posted
- 23 Nov 2011 (estimated)
- Results
- Posted 26 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine whether the addition of Elotuzumab to Bortezomib/ Dexamethasone will prolong the time before myeloma worsens [progression free survival (PFS)].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Elotuzumab + Bortezomib + Dexamethasone | Experimental | Biological: Elotuzumab, Drug: Bortezomib, Drug: DexamethasoneOn days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) will be administered other days Dexamethasone 20 mg Oral will be administered |
| Arm B: Bortezomib + Dexamethasone | Active comparator | Drug: Bortezomib, Drug: Dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Documented progression from most recent line of therapy
- Measurable disease
- 1 to 3 prior lines of therapy
Key exclusion criteria (3 listed)
- Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, or Waldenstrom's macroglobulinemia
- Active plasma cell leukemia
- Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElotuzumabAlso: BMS-901608Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 \& 2: Days 1, 8 \& 15; Cycles 3-8: Days 1 \& 11; Cycle 9+: Days 1 \& 15); Until subject meets criteria for discontinuation of study drug | Biological | Arm A: Elotuzumab + Bortezomib + Dexamethasone |
| BortezomibAlso: Velcade®Solution; IV; 1.3 mg/m2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until subject meets criteria for discontinuation of study drug | Drug | Arm A: Elotuzumab + Bortezomib + Dexamethasone, Arm B: Bortezomib + Dexamethasone |
| DexamethasoneAlso: Decadron®, Intensol®, Dexpak®, Taperpak®Tablets; Oral; 20 mg; (Cycles 1\& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until subject meets criteria for discontinuation of study drug | Drug | Arm A: Elotuzumab + Bortezomib + Dexamethasone |
| DexamethasoneAlso: Decadron®, Intensol®, Dexpak®, Taperpak®Tablets; Oral; 8 mg; (Cycles 1\& 2: Days 1, 8, 15; Cycles 3-8: Days 1 \&11; Cycles 9+; Days 1 \& 15); Until subject meets criteria for discontinuation of study drug | Drug | Arm A: Elotuzumab + Bortezomib + Dexamethasone |
| DexamethasoneAlso: Decadron®, Intensol®, Dexpak®, Taperpak®Solution; IV; 8 mg; (Cycles 1\& 2: Days 1, 8, 15; Cycles 3-8: Days 1 \&11; Cycles 9+; Days 1 \& 15); Until subject meets criteria for discontinuation of study drug | Drug | Arm A: Elotuzumab + Bortezomib + Dexamethasone |
| DexamethasoneAlso: Decadron®, Intensol®, Dexpak®, Taperpak®Tablets; Oral; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until subject meets criteria for discontinuation of study drug | Drug | Arm B: Bortezomib + Dexamethasone |
Primary outcome
Median Investigator-Assessed Progression-free Survival (PFS) Time (Months) From Randomization to Date of First Tumor Progression or Death Due to Any Cause - Randomized Participants
Time frame: Randomization until 111 events (disease progression or death), up to May 2014, approximately 2 years
PE was planned for after at least 103 events; it was analyzed after 111 events. Response was assessed: Day 1 (± 7 days) of each cycle per modified International Myeloma Working Group (IMWG) criteria; assessed using adequate tumor assessment (ATA) (ie, serum and urine M-protein tests performed within 14 days of each other; imaging if baseline measurable extramedullary plasmacytoma existed). Progression: Any of following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/L); Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder.
Number of Investigator-Assessed Progression-free Survival Events From Randomization to Date of First Tumor Progression or Death Due to Any Cause - All Randomized Participants
Time frame: Randomization until 111 events, up to May 2014, approximately 2 years
PE planned for after at least 103 events (progression/death); analyzed at 111 events. Those who neither progressed nor died were censored on the date of last adequate tumor assessment (ATA), which requires both serum and urine M-protein tests. If no post-baseline tumor assessments/no death, then censored on randomization day. Response assessed: Day 1 (± 7 days) each cycle; 30 and 60 days post treatment. Modified IMWG criteria used. Progression: Any of following: Increase of 25% in serum and/or urine M-component; if no measurable serum, urine M-protein levels, then difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/L) ; Bone marrow plasma cell percentage (≥10%). New bone lesions or soft tissue plasmacytomas or increase in size of existing lesions, plasmacytomas. Development of hypercalcemia attributed solely to plasma cell proliferative disorder. First dose occurs within 3 days of randomization.
1 Year Progression-Free Survival Rate - Randomized Participants
Time frame: Year 1 after last participant was randomized
PFS rate=Percentage probability of participants experiencing no progression or death up to 1 year, estimated using the Kaplan-Meier method. Response assessed by the investigator: Day 1 (± 7 days) of each cycle per modified IMWG criteria; assessed using ATA (ie, serum and urine M-protein tests performed within 14 days of each other; imaging done if baseline measurable extramedullary plasmacytoma existed). Progression: Any of the following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved FLC levels (absolute increase > 100 mg/L) ; Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder.
3 secondary outcomes
Median Progression-free Survival Time (Months) From Randomization to Date of First Tumor Progression or Death Due to Any Cause, in Randomized Participants With at Least One FcγRIIIa V Allele
Time frame: Randomization until 111 events, up to May 2014, approximately 2 years
Investigator-Assessed Objective Response Rate (ORR) - All Randomized Participants
Time frame: Randomization until 111 events, up to May 2014, approximately 2 years
Investigator-Assessed Objective Response Rate in Randomized Participants With at Least One FcγRIIIa V Allele
Time frame: Randomization until 111 events, up to May 2014, approximately 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27091875Jakubowiak A, Offidani M, Pegourie B, De La Rubia J, Garderet L, Laribi K, Bosi A, Marasca R, Laubach J, Mohrbacher A, Carella AM, Singhal AK, Tsao LC, Lynch M, Bleickardt E, Jou YM, Robbins M, Palumbo A. Randomized phase 2 study: elotuzumab plus bortezomib/dexamethasone vs bortezomib/dexamethasone for relapsed/refractory MM. Blood. 2016 Jun 9;127(23):2833-40. doi: 10.1182/blood-2016-01-694604. Epub 2016 Apr 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
77 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Elotuzumab, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by Bristol-Myers Squibb at 77 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 77 sites in United States, Italy, Spain, France, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Investigator-Assessed Progression-free Survival (PFS) Time (Months) From Randomization to Date of First Tumor Progression or Death Due to Any Cause - Randomized Participants (time frame: Randomization until 111 events (disease progression or death), up to May 2014, approximately 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01478048, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2018.