Multiple MyelomaPhase 2NCT02612779
A Study of Elotuzumab in Combination With Pomalidomide and Low Dose Dexamethasone and Elotuzumab in Combination With Nivolumab in Patients With Multiple Myeloma Relapsed or Refractory to Prior Treatment With Lenalidomide.
A Phase 2 study testing Elotuzumab, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by Bristol-Myers Squibb at 22 sites in United States.
Trial summary
Study of elotuzumab in combination with pomalidomide and low dose dexamethasone (EPd Cohort) and elotuzumab in combination with nivolumab (EN Cohort) to assess the safety and efficacy of these combination therapies for treatment of relapsed or refractory MM patients. 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, Pomalidomide and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 22 sitesUnited States
- Study dates
- 9 Feb 2016to 12 Jun 2020
- 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
- All subjects must have documented disease progression per IMWG criteria during or after their last anti-myeloma therapy.
- ECOG Performance Status less than or equal to 2
- Subject Re-enrollment: This study permits the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (ie, has not been treated). If re-enrolled, the subject must be re-consented.
- EPd Cohort:
- must have received at least 1 but no greater than 2 prior lines of therapy (note: induction and stem cell transplants with or without maintenance therapy is considered 1 line of therapy)
- Subjects must have received prior treatment with a lenalidomide-containing regimen for at least 2 consecutive cycles (full therapeutic dose) and must have been deemed as relapsed, refractory, or intolerant. Refractory is defined as progressing on-treatment or within 60 days of the last dose.
- EN Cohort:
- Subjects must have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent OR were double-refractory to both an IMID and a PI. Refractory is defined as progressing on-treatment or within 60 days of the last dose.
Who cannot join
- Subjects with solitary bone or extramedullary plasmacytoma as the only evidence of plasma cells dyscrasia
- Subjects with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis, Waldenstrom's macroglobulinemia, or POEMS syndrome (plasma cell dyscrasia with poly neuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Subjects with Central Nervous System involvement with multiple myeloma
- Other protocol defined inclusion/exclusion criteria could apply.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
University of Michigan
Ann Arbor, Michigan, 48109
American Oncology Partners of Maryland, PA
Bethesda, Maryland, 20817
Aurora Health Care
Burlington, Wisconsin, 53105
Colorado Blood Cancer Institute - PPDS
Denver, Colorado, 80218
Rocky Mountain Cancer Centers (Williams) - USOR
Denver, Colorado, 80218
Barbara Ann Karmanos Cancer Center
Detroit, Michigan, 48201
Bay Hematology Oncology
Easton, Maryland, 21601
Jones Clinic PC
Germantown, Tennessee, 38138
Greenville Health System
Greenville, South Carolina, 29615
Virginia Cancer Specialists (Leesburg) - USOR
Leesburg, Virginia, 20176
Southern Cancer Center
Mobile, Alabama, 36607
Tennessee Oncology NASH - SCRI - PPDS
Nashville, Tennessee, 37203
Mount Sinai Medical Center
New York, New York, 10029
Illinois Cancer Care
Peoria, Illinois, 61615
Texas Oncology (Loop) - USOR
San Antonio, Texas, 78217
Sansum Clinic - USOR
Santa Barbara, California, 93105
Swedish Medical Center
Seattle, Washington, 98104
Avera Health Care
Sioux Falls, South Dakota, 57105
Cancer Care Northwest
Spokane Valley, Washington, 99216
Washington University
St Louis, Missouri, 63110
Florida Cancer Specialists - EAST - SCRI - PPDS
St. Petersburg, Florida, 33705
Florida Cancer Specialists - NORTH - SCRI - PPDS
St. Petersburg, Florida, 33705
About this study
Official title: A Phase 2, Multiple Cohort Study of Elotuzumab in Combination With Pomalidomide and Low-Dose Dexamethasone (EPd), and in Combination With Nivolumab (EN), in Patients With Multiple Myeloma Relapsed or Refractory to Prior Treatment With Lenalidomide.
Study of elotuzumab in combination with pomalidomide and low dose dexamethasone (EPd Cohort) and elotuzumab in combination with nivolumab (EN Cohort) to assess the safety and efficacy of these combination therapies for treatment of relapsed or refractory MM patients.
- Conditions
- Multiple Myeloma
- Being tested
- Elotuzumab, Pomalidomide, Dexamethasone, Nivolumab
- 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
PomalidomideDrug
DexamethasoneDrug
NivolumabDrug
| Study group | Role | What they receive |
|---|---|---|
| Elotuzumab + Pomalidamide + Low Dose Dexamethasone (EPd) | Experimental | patients will receive treatment with elotuzumab in combination with pomalidomide and low-dose dexamethasone. Patients are eligible to receive Nivolumab at progression. Receives: Drug: Elotuzumab; Drug: Pomalidomide; Drug: Dexamethasone; Drug: Nivolumab |
| Elotuzumab + Nivolumab (EN) | Experimental | Patients will receive treatment with a combination of elotuzumab and nivolumab Receives: Drug: Elotuzumab; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
PFS is defined as the time from first dosing date to the date of the first documented progression or death due to any cause, whichever occurs first.
Progression is determined per International Myeloma Working Group (IMWG) uniform criteria.
Participants who die without a reported prior progression were considered to have progressed on the date of their death.
Participants who did not progress or die were censored on the date of their last evaluable assessment. Participants who did not have any on study efficacy assessments and did not die were censored on the first dosing date.
Participants who switched to subsequent therapy prior to documented progression were censored on the date of the last evaluable assessment prior to the initiation of the new therapy.
Measured: From first dose to study completion date (up to approximately 50 months)
Objective Response Rate (ORR)
ORR is defined as the percent of participants with best overall response of partial response (PR) or better. Response is determined per IMWG uniform criteria.
Measured: From first dose to study completion date (up to approximately 50 months)
Secondary outcomes (3)
Objective Response Rate (ORR)
ORR is defined as the percent of participants with best overall response of partial response (PR) or better. Response is determined per IMWG uniform criteria.
Measured: From first dose to study completion date (up to approximately 50 months)
Progression Free Survival (PFS)
PFS is defined as the time from first dosing date to the date of the first documented progression or death due to any cause, whichever occurs first.
Progression is determined per International Myeloma Working Group (IMWG) uniform criteria.
Participants who die without a reported prior progression were considered to have progressed on the date of their death.
Participants who did not progress or die were censored on the date of their last evaluable assessment. Participants who did not have any on study efficacy assessments and did not die were censored on the first dosing date.
Participants who switched to subsequent therapy prior to documented progression were censored on the date of the last evaluable assessment prior to the initiation of the new therapy.
Measured: From first dose to study completion date (up to approximately 50 months)
Overall Survival (OS)
OS is defined as the time from first dosing date to the date of death from any cause.
Measured: From first dose to study completion date (up to approximately 50 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study start9 Feb 2016
- Primary completion29 Jul 2019
- Study completion12 Jun 2020
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.
- 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612779
- Sponsor's protocol ID
- CA204-142
- Status last verified
- Jun 2021
- First submitted
- 20 Nov 2015
- Last updated
- 2 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multiple Cohort Study of Elotuzumab in Combination With Pomalidomide and Low-Dose Dexamethasone (EPd), and in Combination With Nivolumab (EN), in Patients With Multiple Myeloma Relapsed or Refractory to Prior Treatment With Lenalidomide.
- ClinicalTrials.gov ID
- NCT02612779
- Acronym / sponsor ID
- CA204-142
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2016 (actual)
- Primary completion
- 29 Jul 2019 (actual)
- Study completion
- 12 Jun 2020 (actual)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Posted 6 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of elotuzumab in combination with pomalidomide and low dose dexamethasone (EPd Cohort) and elotuzumab in combination with nivolumab (EN Cohort) to assess the safety and efficacy of these combination therapies for treatment of relapsed or refractory MM patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elotuzumab + Pomalidamide + Low Dose Dexamethasone (EPd) | Experimental | Drug: Elotuzumab, Drug: Pomalidomide, Drug: Dexamethasone, Drug: Nivolumabpatients will receive treatment with elotuzumab in combination with pomalidomide and low-dose dexamethasone. Patients are eligible to receive Nivolumab at progression. |
| Elotuzumab + Nivolumab (EN) | Experimental | Drug: Elotuzumab, Drug: NivolumabPatients will receive treatment with a combination of elotuzumab and nivolumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- All subjects must have documented disease progression per IMWG criteria during or after their last anti-myeloma therapy.
- ECOG Performance Status less than or equal to 2
- Subject Re-enrollment: This study permits the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (ie, has not been treated). If re-enrolled, the subject must be re-consented.
- EPd Cohort:
- EN Cohort:
Key exclusion criteria (4 listed)
- Subjects with solitary bone or extramedullary plasmacytoma as the only evidence of plasma cells dyscrasia
- Subjects with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis, Waldenstrom's macroglobulinemia, or POEMS syndrome (plasma cell dyscrasia with poly neuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Subjects with Central Nervous System involvement with multiple myeloma
- 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 |
|---|---|---|
| Elotuzumab | Drug | Elotuzumab + Nivolumab (EN), Elotuzumab + Pomalidamide + Low Dose Dexamethasone (EPd) |
| Pomalidomide | Drug | Elotuzumab + Pomalidamide + Low Dose Dexamethasone (EPd) |
| Dexamethasone | Drug | Elotuzumab + Pomalidamide + Low Dose Dexamethasone (EPd) |
| Nivolumab | Drug | Elotuzumab + Nivolumab (EN), Elotuzumab + Pomalidamide + Low Dose Dexamethasone (EPd) |
Primary outcome
Progression Free Survival (PFS)
Time frame: From first dose to study completion date (up to approximately 50 months)
PFS is defined as the time from first dosing date to the date of the first documented progression or death due to any cause, whichever occurs first. Progression is determined per International Myeloma Working Group (IMWG) uniform criteria. Participants who die without a reported prior progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable assessment. Participants who did not have any on study efficacy assessments and did not die were censored on the first dosing date. Participants who switched to subsequent therapy prior to documented progression were censored on the date of the last evaluable assessment prior to the initiation of the new therapy.
Objective Response Rate (ORR)
Time frame: From first dose to study completion date (up to approximately 50 months)
ORR is defined as the percent of participants with best overall response of partial response (PR) or better. Response is determined per IMWG uniform criteria.
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: From first dose to study completion date (up to approximately 50 months)
Progression Free Survival (PFS)
Time frame: From first dose to study completion date (up to approximately 50 months)
Overall Survival (OS)
Time frame: From first dose to study completion date (up to approximately 50 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Elotuzumab, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by Bristol-Myers Squibb at 22 sites in United States.
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 8 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 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. 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 6 Aug 2020). 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?
Progression Free Survival (PFS) (time frame: From first dose to study completion date (up to approximately 50 months)). The study lists 2 primary outcomes in all. 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 2 Jul 2021.