Multiple MyelomaPhase 2NCT02159365
Study of Safety of Elotuzumab Administered Over Approximately 60 Minutes in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed or Relapsed/Refractory Multiple Myeloma Patients
A Phase 2 study testing Elotuzumab, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Bristol-Myers Squibb at 29 sites in United States.
Trial summary
To explore whether Elotuzumab dose administration over approximately 60 minutes is feasible and safe. 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, Lenalidomide 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
- 84 participants
- Where
- 29 sitesUnited States
- Study dates
- 8 Mar 2014to 11 Jul 2018
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Documented evidence of active multiple myeloma:
- Newly diagnosed, not candidate for transplant
- Relapsed/refractory who have received up to 3 prior lines of therapy
- Prior Lenalidomide exposure is permitted only if the following criteria are fulfilled:
- Not refractory to prior Lenalidomide which is defined as no progression while receiving Lenalidomide or within 60 days of last dose of Lenalidomide
- Subject did not discontinue Lenalidomide due to a Grade ≥3 related adverse event (AE)
Who cannot join
- Target Disease Exceptions
- Plasma cell leukemia
- Monoclonal gammopathy of undetermined significance (MGUS)
- Smoldering Myeloma
- Primary amyloidosis
- Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Comprehensive Blood And Cancer Center
Bakersfield, California, 93309
Blue Ridge Cancer Care
Blacksburg, Virginia, 24060
Texas Oncology
Dallas, Texas, 75231
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Rocky Mountain Cancer Centers Llp
Denver, Colorado, 80218
California Cancer Associates for Research and Excellence
Encinitas, California, 92024
Highland Oncology Group
Fayetteville, Arkansas, 72703
Compassionate Cancer Res Grp
Fountain Valley, California, 92708
Robert A. Moss, Md Facp, Inc.
Fountain Valley, California, 92708
St Francis Hospital
Greenville, South Carolina, 29607
Greenville Health System
Greenville, South Carolina, 29615
Local Institution
Houston, Texas, 77090
Investigative Clinical Research Of Indiana, Llc
Indianapolis, Indiana, 46260
Cancer Specialists Of North Florida
Jacksonville, Florida, 32204
Horizon Oncology Research, Inc
Lafayette, Indiana, 47905
Center For Cancer Care & Research
Lakeland, Florida, 33805
Loma Linda University Cancer Center
Loma Linda, California, 92354
Baptist Health Medical Group Oncology
Miami, Florida, 33176
Pacific Cancer Care
Monterey, California, 93940
Clinical Research Alliance, Inc.
New York, New York, 10021
Vista Oncology Inc., PS
Olympia, Washington, 98502
Ventura County Hematology-Oncology Specialists
Oxnard, California, 93030
Oncology Specialists,S.C
Park Ridge, Illinois, 60068
Cancer Centers of South Texas
San Antonio, Texas, 78229
Acrc/Arizona Clinical Research Center, Inc.
Tucson, Arizona, 85715
Blood & Cancer Center of East Texas
Tyler, Texas, 75701
Texas Oncology-McAllen South Second Street
Weslaco, Texas, 78596
Wellness Oncology & Hematology
West Hills, California, 91307
James R. Berenson, MD, Inc.
West Hollywood, California, 90069
About this study
Official title: A Phase 2 Single Arm Study of Safety of Elotuzumab Administered Over Approximately 60 Minutes in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed or Relapsed/Refractory Multiple Myeloma Patients
To explore whether Elotuzumab dose administration over approximately 60 minutes is feasible and safe.
- Conditions
- Multiple Myeloma
- Being tested
- Elotuzumab, Lenalidomide, Dexamethasone
- 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
LenalidomideDrug
Also called Revlimid
DexamethasoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Elotuzumab + Lenalidomide/Dexamethasone | Experimental | Elotuzumab 10 mg/kg solution intravenously weekly in cycle 1 and 2, then every other week, Lenalidomide 25 mg tablet by mouth Days 1-21 of each cycle / Dexamethasone 40 mg tablet by mouth / solution intravenously weekly until progression or discontinuation of Elotuzumab Receives: Drug: Elotuzumab; Drug: Lenalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Grade 3 or Grade 4 (G3/4) Infusion Reactions by the End of Treatment Cycle 2
Infusion reaction was defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.
Measured: From Day 1 to End of cycle 2 treatment (approximately 56 days)
Secondary outcomes (1)
Number of Participants With Any Grade and Grade 3 or Grade 4 (G3/4) Infusion Reactions Over the Entire Study Period
An infusion reaction in this study is defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.
Measured: Date of first dose up to 60 days post last dose (approximately 4 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study start8 Mar 2014
- Primary completion30 Jun 2016
- Study completion11 Jul 2018
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 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
- NCT02159365
- Sponsor's protocol ID
- CA204-112
- Status last verified
- Jul 2019
- First submitted
- 6 Jun 2014
- Last updated
- 16 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Single Arm Study of Safety of Elotuzumab Administered Over Approximately 60 Minutes in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed or Relapsed/Refractory Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT02159365
- Acronym / sponsor ID
- CA204-112
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2014 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 11 Jul 2018 (actual)
- First posted
- 9 Jun 2014 (estimated)
- Results
- Posted 11 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore whether Elotuzumab dose administration over approximately 60 minutes is feasible and safe.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elotuzumab + Lenalidomide/Dexamethasone | Experimental | Drug: Elotuzumab, Drug: Lenalidomide, Drug: DexamethasoneElotuzumab 10 mg/kg solution intravenously weekly in cycle 1 and 2, then every other week, Lenalidomide 25 mg tablet by mouth Days 1-21 of each cycle / Dexamethasone 40 mg tablet by mouth / solution intravenously weekly until progression or discontinuation of Elotuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Documented evidence of active multiple myeloma:
- Prior Lenalidomide exposure is permitted only if the following criteria are fulfilled:
Key exclusion criteria (6 listed)
- Target Disease Exceptions
- Primary amyloidosis
- Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome
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 | Elotuzumab + Lenalidomide/Dexamethasone |
| LenalidomideAlso: Revlimid | Drug | Elotuzumab + Lenalidomide/Dexamethasone |
| Dexamethasone | Drug | Elotuzumab + Lenalidomide/Dexamethasone |
Primary outcome
Number of Participants With Grade 3 or Grade 4 (G3/4) Infusion Reactions by the End of Treatment Cycle 2
Time frame: From Day 1 to End of cycle 2 treatment (approximately 56 days)
Infusion reaction was defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.
1 secondary outcome
Number of Participants With Any Grade and Grade 3 or Grade 4 (G3/4) Infusion Reactions Over the Entire Study Period
Time frame: Date of first dose up to 60 days post last dose (approximately 4 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- 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
29 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, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Bristol-Myers Squibb at 29 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 7 inclusion and 6 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 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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 11 Jan 2017). 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?
Number of Participants With Grade 3 or Grade 4 (G3/4) Infusion Reactions by the End of Treatment Cycle 2 (time frame: From Day 1 to End of cycle 2 treatment (approximately 56 days)). 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 16 Jul 2019.