Multiple MyelomaPhase 1NCT02252263
A Phase I Open Label Study of the Safety and Tolerability of Elotuzumab (BMS-901608) Administered in Combination With Either Lirilumab (BMS-986015) or Urelumab (BMS-663513) in Subjects With Multiple Myeloma
A Phase 1 study testing Elotuzumab, Lirilumab and Urelumab in people with Multiple Myeloma, run by Bristol-Myers Squibb at 7 sites in 2 countries.
Trial summary
To assess the safety and tolerability, characterize the dose limiting toxicities (DLTs) and identify the maximally tolerated dose (MTD) of Elotuzumab administered in combination with either Lirilumab or Urelumab in subjects with multiple myeloma. 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, Lirilumab and Urelumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 9 Dec 2014to 10 Oct 2017
- Phase
- Phase 1
- 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
- Subjects must have histological confirmation of multiple myeloma with measurable disease (per International Myeloma Working Group (IMWG) criteria):
- Relapsed/refractory multiple myeloma, subjects who are post autologous transplant and have achieved very good partial response (VGPR) or complete response (nCR) with minimal residual disease (MRD)
Who cannot join
None listed.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287
The Ohio State University
Columbus, Ohio, 43210
University Of Arkansas For Medical Sciences
Little Rock, Arkansas
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: A Phase I Open Label Dose Escalation and Randomized Cohort Expansion Study of the Safety and Tolerability of Elotuzumab (BMS-901608) Administered in Combination With Either Lirilumab (BMS-986015) or Urelumab (BMS-663513) in Subjects With Multiple Myeloma
To assess the safety and tolerability, characterize the dose limiting toxicities (DLTs) and identify the maximally tolerated dose (MTD) of Elotuzumab administered in combination with either Lirilumab or Urelumab in subjects with multiple myeloma.
Read the detailed description
Allocation:
- Part1: Non-randomized
- Part2: Randomized
- Conditions
- Multiple Myeloma
- Being tested
- Elotuzumab, Lirilumab, Urelumab
- 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
LirilumabDrug
Also called BMS-986015
UrelumabDrug
Also called BMS-663513
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Elotuzumab + Lirilumab | Experimental | Elotuzumab weekly for 8 wks and every 2 wks thereafter + Lirilumab every 4 wks Intravenous solution for Up to 2 yrs, depending on response Receives: Drug: Elotuzumab; Drug: Lirilumab |
| Arm 2: Elotuzumab + Urelumab | Experimental | Elotuzumab weekly for 8 wks and every 2 wks thereafter + Urelumab every 4 wks Intravenous solution for Up to 26 weeks, depending on response Receives: Drug: Elotuzumab; Drug: Urelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by the rate of AEs, SAEs, deaths is the primary endpoint of this Phase 1 study. All subjects who receive at least one (full or partial) dose of Elotuzumab, Lirilumab or Urelumab will be evaluated for safety
adverse events (AEs), serious adverse events (SAEs)
Measured: During treatment and first 100 days after treatment
Secondary outcomes (20)
Best Overall Response (BOR)
Measured: At different timepoints approximately up to 2.5 years
Objective Response rate (ORR)
Measured: At different timepoints approximately up to 2.5 years
Median Duration of Response (mDOR)
Measured: At different timepoints approximately up to 2.5 years
Median Time to Response (mTTR)
Measured: At different timepoints approximately up to 2.5 years
Progression-free survival rate (PFSR)
Measured: At different timepoints approximately up to 2.5 years
M-protein levels
Measured: At different timepoints approximately up to 2.5 years
Minimal Residual Disease (MRD) status for Post Autologous Transplant subjects
Measured: At different timepoints approximately up to 2.5 years
Maximum concentration of Urelumab (Cmax)
Measured: At different timepoints approximately up to 2.5 years
Maximum concentration of Lirilumab (Cmax)
Measured: At different timepoints approximately up to 2.5 years
Area under the Curve (AUCTAU) of Urelumab
Measured: At different timepoints approximately up to 2.5 years
Area under the Curve (AUCTAU) of Lirilumab
Measured: At different timepoints approximately up to 2.5 years
Volume of distribution (Vz) for Urelumab
Measured: At different timepoints approximately up to 2.5 years
Total Clearance (CLT) of Urelumab
Measured: At different timepoints approximately up to 2.5 years
Total Clearance (CLT) of Lirilumab
Measured: At different timepoints approximately up to 2.5 years
Concentration at the end of infusion (ceoinf) of Urelumab
Measured: At different timepoints approximately up to 2.5 years
Concentration at the end of infusion (ceoinf) of Elotuzumab
Measured: At different timepoints approximately up to 2.5 years
Concentration at the end of infusion (ceoinf) of Lirilumab
Measured: At different timepoints approximately up to 2.5 years
Cmin will be capture at steady state of all study subjects
Measured: At different timepoints approximately up to 2.5 years
Occurence of Specific anti-drug antibodies (ADA) to each study drug
Measured: At different timepoints approximately up to 2.5 years
ADA status of the subject Biomarkers: NK and T cell numbers, Phenotypic and functional measures in cohort expansion subjects
Measured: At different timepoints approximately up to 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study start9 Dec 2014
- Primary completion10 Oct 2017
- Study completion10 Oct 2017
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 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
- NCT02252263
- Sponsor's protocol ID
- CA223-028
- Status last verified
- Oct 2017
- First submitted
- 26 Sep 2014
- Last updated
- 1 Nov 2017
- Results posted
- No
- 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 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open Label Dose Escalation and Randomized Cohort Expansion Study of the Safety and Tolerability of Elotuzumab (BMS-901608) Administered in Combination With Either Lirilumab (BMS-986015) or Urelumab (BMS-663513) in Subjects With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02252263
- Acronym / sponsor ID
- CA223-028
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2014 (actual)
- Primary completion
- 10 Oct 2017 (actual)
- Study completion
- 10 Oct 2017 (actual)
- First posted
- 30 Sep 2014 (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.
To assess the safety and tolerability, characterize the dose limiting toxicities (DLTs) and identify the maximally tolerated dose (MTD) of Elotuzumab administered in combination with either Lirilumab or Urelumab in subjects with multiple myeloma.
Detailed description
Allocation:
- Part1: Non-randomized
- Part2: Randomized
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Elotuzumab + Lirilumab | Experimental | Drug: Elotuzumab, Drug: LirilumabElotuzumab weekly for 8 wks and every 2 wks thereafter + Lirilumab every 4 wks Intravenous solution for Up to 2 yrs, depending on response |
| Arm 2: Elotuzumab + Urelumab | Experimental | Drug: Elotuzumab, Drug: UrelumabElotuzumab weekly for 8 wks and every 2 wks thereafter + Urelumab every 4 wks Intravenous solution for Up to 26 weeks, depending on response |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects must have histological confirmation of multiple myeloma with measurable disease (per International Myeloma Working Group (IMWG) criteria):
Key exclusion criteria (0 listed)
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 | Drug | Arm 1: Elotuzumab + Lirilumab, Arm 2: Elotuzumab + Urelumab |
| LirilumabAlso: BMS-986015 | Drug | Arm 1: Elotuzumab + Lirilumab |
| UrelumabAlso: BMS-663513 | Drug | Arm 2: Elotuzumab + Urelumab |
Primary outcome
Safety as measured by the rate of AEs, SAEs, deaths is the primary endpoint of this Phase 1 study. All subjects who receive at least one (full or partial) dose of Elotuzumab, Lirilumab or Urelumab will be evaluated for safety
Time frame: During treatment and first 100 days after treatment
adverse events (AEs), serious adverse events (SAEs)
20 secondary outcomes
Best Overall Response (BOR)
Time frame: At different timepoints approximately up to 2.5 years
Objective Response rate (ORR)
Time frame: At different timepoints approximately up to 2.5 years
Median Duration of Response (mDOR)
Time frame: At different timepoints approximately up to 2.5 years
Median Time to Response (mTTR)
Time frame: At different timepoints approximately up to 2.5 years
Progression-free survival rate (PFSR)
Time frame: At different timepoints approximately up to 2.5 years
M-protein levels
Time frame: At different timepoints approximately up to 2.5 years
Minimal Residual Disease (MRD) status for Post Autologous Transplant subjects
Time frame: At different timepoints approximately up to 2.5 years
Maximum concentration of Urelumab (Cmax)
Time frame: At different timepoints approximately up to 2.5 years
Maximum concentration of Lirilumab (Cmax)
Time frame: At different timepoints approximately up to 2.5 years
Area under the Curve (AUCTAU) of Urelumab
Time frame: At different timepoints approximately up to 2.5 years
Area under the Curve (AUCTAU) of Lirilumab
Time frame: At different timepoints approximately up to 2.5 years
Volume of distribution (Vz) for Urelumab
Time frame: At different timepoints approximately up to 2.5 years
Total Clearance (CLT) of Urelumab
Time frame: At different timepoints approximately up to 2.5 years
Total Clearance (CLT) of Lirilumab
Time frame: At different timepoints approximately up to 2.5 years
Concentration at the end of infusion (ceoinf) of Urelumab
Time frame: At different timepoints approximately up to 2.5 years
Concentration at the end of infusion (ceoinf) of Elotuzumab
Time frame: At different timepoints approximately up to 2.5 years
Concentration at the end of infusion (ceoinf) of Lirilumab
Time frame: At different timepoints approximately up to 2.5 years
Cmin will be capture at steady state of all study subjects
Time frame: At different timepoints approximately up to 2.5 years
Occurence of Specific anti-drug antibodies (ADA) to each study drug
Time frame: At different timepoints approximately up to 2.5 years
ADA status of the subject Biomarkers: NK and T cell numbers, Phenotypic and functional measures in cohort expansion subjects
Time frame: At different timepoints approximately up to 2.5 years
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 1 Nov 2017.
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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
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Elotuzumab, Lirilumab and Urelumab in people with Multiple Myeloma, run by Bristol-Myers Squibb at 7 sites in 2 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 2 inclusion and 0 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 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Spain. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety as measured by the rate of AEs, SAEs, deaths is the primary endpoint of this Phase 1 study. All subjects who receive at least one (full or partial) dose of Elotuzumab, Lirilumab or Urelumab will be evaluated for safety (time frame: During treatment and first 100 days after treatment). 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 1 Nov 2017.