Multiple MyelomaPhase 2NCT02719613
Continuing Treatment for Participants Who Have Participated in a Prior Protocol Investigating Elotuzumab
A Phase 2 study testing Elotuzumab, Dexamethasone and Lenalidomide in people with Multiple Myeloma, run by Bristol-Myers Squibb at 41 sites in 13 countries.
Trial summary
The purpose of this study is to continue to provide elotuzumab and/or other study drugs to participants who have participated on a prior protocol investigating elotuzumab who are not able to receive commercial drug supply. 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, Dexamethasone and Lenalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 41 sitesin 13 countries
- Study dates
- 15 Jul 2016to 23 Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Participated in a previous elotuzumab protocol (including, but not limited to HuLuc63-1703, CA204007, CA204009, or CA204011) and is deemed by the investigator to be deriving benefit from elotuzumab and/or other study drugs as defined by the previous protocol
- Receiving elotuzumab and/or other study drugs at the time of signature of informed consent
- Males and Females, ages 18 and older
Who cannot join
- All participants previously discontinued from an elotuzumab study for any reason
- Participants not receiving clinical benefit from previous study therapy
- Participants who are not medically well enough to receive study therapy as determined by the investigator
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
41 sites in 13 countries.
41 sites in 13 countries
United States14 sites
Local Institution - 0009
Atlanta, Georgia, 30322
Local Institution - 0017
Bakersfield, California, 93309
Local Institution - 0001
Bethlehem, Pennsylvania, 18015
Local Institution - 0002
Boston, Massachusetts, 02215
Local Institution - 0018
Dallas, Texas, 75231
Local Institution - 0019
Denver, Colorado, 80218
Local Institution - 0022
Fountain Valley, California, 92708
Local Institution - 0003
Indianapolis, Indiana, 46260
Local Institution - 0021
Jacksonville, Florida, 32256
Local Institution - 0004
New York, New York, 10029
Local Institution - 0008
St Louis, Missouri, 63110
Local Institution - 0042
St. Petersburg, Florida, 33705
Local Institution - 0020
Tucson, Arizona, 85715
Local Institution - 0016
West Hollywood, California, 90069
Italy6 sites
Local Institution - 0015
Ancona, 60126
Local Institution - 0012
Florence, 50134
Local Institution - 0013
Genova, 16132
Local Institution - 0043
Ravenna, 48121
Local Institution - 0044
Terni, 05100
Local Institution - 0014
Torino, 10126
Japan6 sites
Local Institution - 0046
Aomori, Aomori, 0308553
Local Institution - 0050
Chiba, 260-8677
Local Institution - 0045
Kasama-shi, 3091793
Local Institution - 0048
Koto-ku, Tokyo, 135-8550
Local Institution - 0049
Osaka, Osaka, 5300012
Local Institution - 0047
Shibukawa-shi, Gunma, 3770280
Poland3 sites
Local Institution - 0027
Chorzów, 41-500
Local Institution - 0026
Warsaw, 02-106
Local Institution - 0039
Warsaw, 02-776
Canada2 sites
Local Institution - 0010
Halifax, B3H 2Y9
Local Institution - 0011
Toronto, Ontario, M5G 2M9
Romania2 sites
Local Institution - 0028
Bucharest, 030171
Local Institution - 0029
Iași, 700483
Spain2 sites
Local Institution - 0041
Barcelona, 08036
Local Institution - 0030
Toledo, 45004
About this study
Official title: Continuing Treatment for Subjects Who Have Participated in a Prior Protocol Investigating Elotuzumab
The purpose of this study is to continue to provide elotuzumab and/or other study drugs to participants who have participated on a prior protocol investigating elotuzumab who are not able to receive commercial drug supply.
- Conditions
- Multiple Myeloma
- Being tested
- Elotuzumab, Dexamethasone, Lenalidomide, Bortezomib, Pomalidomide
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElotuzumabDrug
Also called BMS-901608, HuLuc63, Empliciti
Patients will continue to receive treatment with the investigational study drug by intravenous (IV) solution administration at the last dose and schedule received in the previous study.
DexamethasoneDrug
Patients will continue to receive treatment with non-investigational study drug by oral tablet administration at the last dose and schedule received in the previous study.
DexamethasoneDrug
Patients will continue to receive treatment with non-investigational study drug by intravenous (IV) solution administration at the last dose and schedule received in the previous study.
LenalidomideDrug
Also called Revlimid®
Patients will continue to receive treatment with non-investigational study drug by oral capsule administration at the last dose and schedule received in the previous study.
BortezomibDrug
Also called Velcade®
Patients will continue to receive treatment with non-investigational study drug by intravenous (IV) or subcutaneous injection solution administration at the last dose and schedule received in the previous study.
PomalidomideDrug
Also called Pomalyst ®
Patients will continue to receive treatment with non-investigational study drug by oral capsule administration at the last dose and schedule received in the previous study.
NivolumabDrug
Also called Opdivo ®
Patients will continue to receive treatment with the investigational study drug by intravenous (IV) solution administration at the last dose and schedule received in the previous study.
| Study group | Role | What they receive |
|---|---|---|
| Elotuzumab | Experimental | This is a continuation roll-over study for patients receiving benefit from prior elotuzumab protocols. All participants will receive elotuzumab and/or other study drugs as per previous protocol. Receives: Drug: Elotuzumab; Drug: Dexamethasone; Drug: Lenalidomide; Drug: Bortezomib; Drug: Pomalidomide; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants who received at least one dose of elotuzumab or backbone therapy (other study drugs) and the duration of treatment will be collected.
Measured: Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study.
Secondary outcomes (4)
All serious adverse events (SAEs) will be collected.
Measured: Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study.
All Grade 5 adverse events (AEs) will be collected.
Measured: Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study.
All adverse events (AEs) previously not reported will be collected.
Measured: Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study.
All adverse events (AEs) leading to discontinuation will be collected.
Measured: Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study start15 Jul 2016
- Primary completion23 Feb 2026
- Study completion23 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 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
- NCT02719613
- Sponsor's protocol ID
- CA204-185
- Other IDs
- 2016-000037-51, 2016
- Status last verified
- Apr 2026
- First submitted
- 16 Mar 2016
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuing Treatment for Subjects Who Have Participated in a Prior Protocol Investigating Elotuzumab
- ClinicalTrials.gov ID
- NCT02719613
- Acronym / sponsor ID
- CA204-185
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- AbbVie
- Study start
- 15 Jul 2016 (actual)
- Primary completion
- 23 Feb 2026 (actual)
- Study completion
- 23 Feb 2026 (actual)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Not posted in the source record
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 this study is to continue to provide elotuzumab and/or other study drugs to participants who have participated on a prior protocol investigating elotuzumab who are not able to receive commercial drug supply.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elotuzumab | Experimental | Drug: Elotuzumab, Drug: Dexamethasone, Drug: Lenalidomide, Drug: Bortezomib, Drug: Pomalidomide, Drug: NivolumabThis is a continuation roll-over study for patients receiving benefit from prior elotuzumab protocols. All participants will receive elotuzumab and/or other study drugs as per previous protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participated in a previous elotuzumab protocol (including, but not limited to HuLuc63-1703, CA204007, CA204009, or CA204011) and is deemed by the investigator to be deriving benefit from elotuzumab and/or other study drugs as defined by the previous protocol
- Receiving elotuzumab and/or other study drugs at the time of signature of informed consent
- Males and Females, ages 18 and older
Key exclusion criteria (4 listed)
- All participants previously discontinued from an elotuzumab study for any reason
- Participants not receiving clinical benefit from previous study therapy
- Participants who are not medically well enough to receive study therapy as determined by the investigator
- Other protocol defined inclusion/exclusion criteria could apply
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-901608, HuLuc63, EmplicitiPatients will continue to receive treatment with the investigational study drug by intravenous (IV) solution administration at the last dose and schedule received in the previous study. | Drug | Elotuzumab |
| DexamethasonePatients will continue to receive treatment with non-investigational study drug by oral tablet administration at the last dose and schedule received in the previous study. | Drug | Elotuzumab |
| DexamethasonePatients will continue to receive treatment with non-investigational study drug by intravenous (IV) solution administration at the last dose and schedule received in the previous study. | Drug | Elotuzumab |
| LenalidomideAlso: Revlimid®Patients will continue to receive treatment with non-investigational study drug by oral capsule administration at the last dose and schedule received in the previous study. | Drug | Elotuzumab |
| BortezomibAlso: Velcade®Patients will continue to receive treatment with non-investigational study drug by intravenous (IV) or subcutaneous injection solution administration at the last dose and schedule received in the previous study. | Drug | Elotuzumab |
| PomalidomideAlso: Pomalyst ®Patients will continue to receive treatment with non-investigational study drug by oral capsule administration at the last dose and schedule received in the previous study. | Drug | Elotuzumab |
| NivolumabAlso: Opdivo ®Patients will continue to receive treatment with the investigational study drug by intravenous (IV) solution administration at the last dose and schedule received in the previous study. | Drug | Elotuzumab |
Primary outcome
The number of participants who received at least one dose of elotuzumab or backbone therapy (other study drugs) and the duration of treatment will be collected.
Time frame: Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study.
4 secondary outcomes
All serious adverse events (SAEs) will be collected.
Time frame: Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study.
All Grade 5 adverse events (AEs) will be collected.
Time frame: Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study.
All adverse events (AEs) previously not reported will be collected.
Time frame: Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study.
All adverse events (AEs) leading to discontinuation will be collected.
Time frame: Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
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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
41 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Elotuzumab, Dexamethasone and Lenalidomide in people with Multiple Myeloma, run by Bristol-Myers Squibb at 41 sites in 13 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 3 inclusion and 4 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 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Italy, Japan, Poland, Canada and 8 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The number of participants who received at least one dose of elotuzumab or backbone therapy (other study drugs) and the duration of treatment will be collected. (time frame: Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2026.