Relapsed and/or Refractory Multiple MyelomaPhase 2NCT01632150
Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma
A Phase 2 study testing Elotuzumab, Thalidomide and Dexamethasone in people with Relapsed and/or Refractory Multiple Myeloma, run by Bristol-Myers Squibb at 10 sites in Spain.
Trial summary
The purpose of this study is to determine the safety and tolerability of elotuzumab administered in combination with thalidomide and dexamethasone in the treatment of relapsed and/or refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed and/or Refractory Multiple Myeloma
- What is being tested?
- Elotuzumab, Thalidomide 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
- 51 participants
- Where
- 10 sitesSpain
- Study dates
- May 2012to Mar 2016
- 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
- Confirmed diagnosis of previously treated multiple myeloma with progression documented by criteria of the International Myeloma Working Group after or during the most recent therapy
- Patient received 5 or fewer prior lines of therapy
- Eastern Cooperative Oncology Group performance status of 0 or 1 (safety lead-in cohort) or 0 to 2 (additional patients)
- Measurable disease as defined by at least 1 of the following:
- Serum immunoglobulin (Ig)G, IgA, IgM, or monoclonal (M) protein level ≥0.5 g/dL or serum IgD M protein level ≥0.05 g/dL; or
- Urine M protein level ≥200 mg excreted in a 24-hour collection sample; or
- Involved serum free light chain level ≥10 mg/dL, provided the free light chain ratio is abnormal
Who cannot join
- Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
- Monoclonal gammopathy of undetermined significance, smoldering myeloma, or Waldenström's macroglobulinemia
- Left ventricular ejection fraction by echocardiogram or Multi Gated Acquisition ≤50%
- Electrocardiogram finding of QTc ≥450 msec
- Active plasma cell leukemia (defined as either 20% of peripheral white blood cells, composed of plasma/CD138+ cells or an absolute plasma cell count of 2*10^9/L)
- Diagnosis of nonsecretory myeloma
- Active hepatitis A, B, or C virus infection
- Grade ≥2 neuropathy
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Local Institution
Barcelona, Barcelona, 08916
Local Institution
Barcelona, 08035
Local Institution
Barcelona, 08036
Local Institution
Barcelona, 08041
Local Institution
LaLaguna, S Cruz Tener, 38320
Local Institution
Madrid, 28034
Local Institution
Madrid, 28041
Local Institution
Salamanca, 37007
Local Institution
Seville, 41013
Local Institution
Zaragoza, 50009
About this study
Official title: Phase 2a Single-Arm Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Subjects With Relapsed and/or Refractory Multiple Myeloma
The purpose of this study is to determine the safety and tolerability of elotuzumab administered in combination with thalidomide and dexamethasone in the treatment of relapsed and/or refractory multiple myeloma.
- Being tested
- Elotuzumab, Thalidomide, Dexamethasone, Cyclophosphamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElotuzumabBiological
Also called BMS-901608, HuLuc63
Powder for solution, 400-mg vials, for infusion
ThalidomideBiological
Also called Thalomid®
50-mg capsules administered orally
DexamethasoneBiological
Also called Decadron®, Dexamethasone Intensol®, Dexpak®, Taperpak®
2- and 4-mg tablets (and various other strengths, as needed) administered orally and in 4- and 8-mg/mL (and various other strengths, as needed) solutions for intravenous administration
CyclophosphamideBiological
Also called Cytoxan, Endoxan, Neosar
50-mg tablets administered orally
| Study group | Role | What they receive |
|---|---|---|
| Elotuzumab + Thalidomide + Dexamethasone + Cyclophosphamide | Experimental | Not described Receives: Biological: Elotuzumab; Biological: Thalidomide; Biological: Dexamethasone; Biological: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Received Treatment Including Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Measured: From the first dose of study drug until the last dose of treatment, including cyclophosphamide treatment
Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Measured: From the first dose of study drug until the earlier of discontinuation from E-Td or the time when cyclophosphamide was initiated
Secondary outcomes (2)
Percentage of All Participants Who Received Treatment Including Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event
Elotuzumab dose reduction was not permitted. Thalidomide dose reduction, delay, interruptions, or discontinuation was permitted in the event of toxicity. Dexamethasone dose reduction was also permitted in the event of toxicity and in the setting of infusion reactions;dose delays were allowed as clinically indicated at the discretion of the investigator. Cyclophosphamide dose reduction, delay, interruption, or discontinuation was permitted in the event of toxicity.
Measured: From the first dose of study drug until the last dose of treatment, including cyclophosphamide treatment
Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event
Elotuzumab dose reduction was not permitted. Thalidomide dose reduction, delay, interruptions, or discontinuation was permitted in the event of toxicity. Dexamethasone dose reduction was also permitted in the event of toxicity and in the setting of infusion reactions;dose delays were allowed as clinically indicated at the discretion of the investigator.
Measured: From the first dose of study drug until the earlier of discontinuation from E-Td or the time when cyclophosphamide was initiated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionOct 2013
- Study completionMar 2016
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 Relapsed and/or Refractory 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
- 51 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
- NCT01632150
- Sponsor's protocol ID
- CA204-010
- Other IDs
- 2011-005121-49
- Status last verified
- Mar 2017
- First submitted
- 28 Jun 2012
- Last updated
- 14 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2a Single-Arm Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Subjects With Relapsed and/or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01632150
- Acronym / sponsor ID
- CA204-010
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- AbbVie
- Study start
- May 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 2 Jul 2012 (estimated)
- Results
- Posted 26 Feb 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 this study is to determine the safety and tolerability of elotuzumab administered in combination with thalidomide and dexamethasone in the treatment of relapsed and/or refractory multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elotuzumab + Thalidomide + Dexamethasone + Cyclophosphamide | Experimental | Biological: Elotuzumab, Biological: Thalidomide, Biological: Dexamethasone, Biological: Cyclophosphamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed diagnosis of previously treated multiple myeloma with progression documented by criteria of the International Myeloma Working Group after or during the most recent therapy
- Patient received 5 or fewer prior lines of therapy
- Eastern Cooperative Oncology Group performance status of 0 or 1 (safety lead-in cohort) or 0 to 2 (additional patients)
- Measurable disease as defined by at least 1 of the following:
Key exclusion criteria (8 listed)
- Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
- Monoclonal gammopathy of undetermined significance, smoldering myeloma, or Waldenström's macroglobulinemia
- Left ventricular ejection fraction by echocardiogram or Multi Gated Acquisition ≤50%
- Electrocardiogram finding of QTc ≥450 msec
- Active plasma cell leukemia (defined as either 20% of peripheral white blood cells, composed of plasma/CD138+ cells or an absolute plasma cell count of 2*10^9/L)
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, HuLuc63Powder for solution, 400-mg vials, for infusion | Biological | Elotuzumab + Thalidomide + Dexamethasone + Cyclophosphamide |
| ThalidomideAlso: Thalomid®50-mg capsules administered orally | Biological | Elotuzumab + Thalidomide + Dexamethasone + Cyclophosphamide |
| DexamethasoneAlso: Decadron®, Dexamethasone Intensol®, Dexpak®, Taperpak®2- and 4-mg tablets (and various other strengths, as needed) administered orally and in 4- and 8-mg/mL (and various other strengths, as needed) solutions for intravenous administration | Biological | Elotuzumab + Thalidomide + Dexamethasone + Cyclophosphamide |
| CyclophosphamideAlso: Cytoxan, Endoxan, Neosar50-mg tablets administered orally | Biological | Elotuzumab + Thalidomide + Dexamethasone + Cyclophosphamide |
Primary outcome
Percentage of Participants Who Received Treatment Including Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)
Time frame: From the first dose of study drug until the last dose of treatment, including cyclophosphamide treatment
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)
Time frame: From the first dose of study drug until the earlier of discontinuation from E-Td or the time when cyclophosphamide was initiated
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
2 secondary outcomes
Percentage of All Participants Who Received Treatment Including Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event
Time frame: From the first dose of study drug until the last dose of treatment, including cyclophosphamide treatment
Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event
Time frame: From the first dose of study drug until the earlier of discontinuation from E-Td or the time when cyclophosphamide was initiated
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
10 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, Thalidomide and Dexamethasone in people with Relapsed and/or Refractory Multiple Myeloma, run by Bristol-Myers Squibb at 10 sites in Spain.
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 8 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 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in 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 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 Feb 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?
Percentage of Participants Who Received Treatment Including Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs) (time frame: From the first dose of study drug until the last dose of treatment, including cyclophosphamide treatment). 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 14 Apr 2017.