Refractory Plasma Cell MyelomaPhase 2NCT03713294
Dexamethasone, Elotuzumab, and Pomalidomide in Treating Patients With Refractory Multiple Myeloma
A Phase 2 study testing Dexamethasone, Elotuzumab and Pomalidomide in people with Refractory Plasma Cell Myeloma, run by Mayo Clinic at 1 site in United States.
Trial summary
This phase II trial studies how well dexamethasone, elotuzumab, pomalidomide work in treating patients with multiple myeloma that has not responded to previous treatment. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Plasma Cell Myeloma
- What is being tested?
- Dexamethasone, Elotuzumab and Pomalidomide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2019to 14 Nov 2024
- 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
- Age >= 18 years
- Pathologically confirmed diagnosis of multiple myeloma and noted to have progressive disease (International Myeloma Working Group [IMWG] criteria).
- At least one prior line of therapy.
- Disease refractory to daratumumab as defined by disease progression while on or =< 60 days of completing treatment with a daratumumab-containing regimen as part of any prior line of therapy.
- Measurable disease =< 14 days prior to registration.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2.
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- Absolute neutrophil count (ANC) >= 1,000 cell/mm^3 without growth factor support (obtained =< 14 days prior to registration).
- Platelet >= 50,000 cells/mm^3 for patients who have bone marrow plasmacytosis < 50% or >= 30,000 cells/mm^3 for patients who have bone marrow plasmacytosis of >= 50% (obtained =< 14 days prior to registration).
- Total bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilbert's syndrome, in which case the direct bilirubin must be =< 1.5 x ULN (obtained =< 14 days prior to registration).
- Alanine aminotransferase (ALT) and aspartate transaminase (AST) =< 3 x ULN (obtained =< 14 days prior to registration).
- Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) =< 1.5 x ULN OR if patient is receiving anticoagulant therapy and PT/INR or aPTT is within target range of therapy (obtained =< 14 days prior to registration).
- Calculated or measured creatinine clearance >= 30 ml/min (obtained =< 14 days prior to registration).
- Negative urine or serum pregnancy test done =< 14 days prior to registration, for persons of childbearing potential only.
- NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Provide written informed consent.
- Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
- Willing to follow the requirements of the (Revlimid/Pomalyst) Risk Evaluation and Mitigation Strategies (REMS) program.
Who cannot join
- Non-secretory multiple myeloma (MM) or known immunoglobulin light chain (AL) amyloidosis.
- Clinically significant active infection requiring intravenous antibiotics (=< 14 days prior to registration).
- >= Grade 3 neuropathy and/or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
- Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy.
- NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
- Concurrent therapy considered investigational.
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- NOTE: Patients must not be planning to receive any radiation therapy (except localized radiation for palliative care that must be completed prior to starting Cycle 1, Day 1).
- Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
- Pregnant women.
- Nursing women (lactating females are eligible provided that they agree not to breast feed while taking lenalidomide).
- Men or women of childbearing potential who are unwilling to employ adequate contraception.
- Other active malignancy =< 3 years prior to registration.
- EXCEPTIONS:
- Adequately treated basal cell or squamous cell skin cancer.
- Any in situ cancer.
- Adequately treated Stage I or II cancer from which the patient is currently in complete remission, or
- NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer.
- Major surgery =< 4 weeks prior to registration.
- History of stroke/intracranial hemorrhage =< 6 months prior to registration.
- Clinically significant cardiac illness including New York Heart Association (NYHA) Class III or Class IV heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, or >= Grade 3 cardiac arrhythmias noted =< 14 days prior to registration.
- Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification.
- Exhibiting clinical signs of meningeal involvement of multiple myeloma.
- Known severe chronic obstructive pulmonary disease or asthma defined as forced expiratory volume (FEV1) in 1 second < 60% of expected.
- Prior exposure to elotuzumab.
- Prior history of disease refractory to pomalidomide.
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
- Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection.
- Symptomatic congestive heart failure.
- Unstable angina pectoris.
- Cardiac arrhythmia.
- Or psychiatric illness/social situations that would limit compliance with study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
About this study
Official title: Phase II Trial of Sequential Treatment of Multiple Myeloma With Antibody Therapy
This phase II trial studies how well dexamethasone, elotuzumab, pomalidomide work in treating patients with multiple myeloma that has not responded to previous treatment. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as elotuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pomalidomide may stop the growth of multiple myeloma by blocking the growth of new blood vessels necessary for tumor growth. Giving dexamethasone, elotuzumab, pomalidomide may work better in treating patients with multiple myeloma.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the overall response rate (ORR) of utilizing elotuzumab, pomalidomide and dexamethasone in patients with disease refractory to daratumumab.
SECONDARY OBJECTIVES:
- To determine percentage of patients achieving complete response (CR) with the elotuzumab combination.
II. To determine progression-free survival (PFS) for treatment with the elotuzumab combination.
III. To determine safety profile for treatment with the elotuzumab combination. IV. To determine the overall survival (OS) for patients receiving treatment with the elotuzumab combination.
OUTLINE:
Patients receive dexamethasone intravenously (IV) on days 1, 8, 15, and 22 of cycles 1-2 and IV on day 1 and orally (PO) on days 8, 15, and 22 of subsequent cycles and elotuzumab IV on days 1, 8, 15, and 22 of cycles 1-2 and day 1 of subsequent cycles. Patients also receive pomalidomide PO on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months until progressive disease, then every 6 months thereafter.
- Conditions
- Refractory Plasma Cell Myeloma
- Being tested
- Dexamethasone, Elotuzumab, 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.
DexamethasoneDrug
Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex
Given IV and PO
ElotuzumabBiological
Also called BMS-901608, Empliciti, HuLuc-63, HuLuc63
Given IV
PomalidomideDrug
Also called 4-Aminothalidomide, Actimid, CC-4047, Imnovid
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (dexamethasone, elotuzumab, pomalidomide) | Experimental | Patients receive dexamethasone IV on days 1, 8, 15, and 22 of cycles 1-2 and IV on day 1 and PO on days 8, 15, and 22 of subsequent cycles and elotuzumab IV on days 1, 8, 15, and 22 of cycles 1-2 and day 1 of subsequent cycles. Patients also receive pomalidomide PO on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Dexamethasone; Biological: Elotuzumab; Drug: Pomalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Overall response rate (ORR) defined as a partial response (PR), very good partial response (VGPR), complete response (CR) or stringent CR (sCR). CR and sCR are defined in Outcome 2. VGPR requires: serum and urine M-protein detectable by immunofixation but not on electrophoresis OR >= 90% reduction in serum M-protein and urine M-protein <100 mg/24 h. If the only measurable disease is FLC, a >90% reduction in the difference between involved and uninvolved FLC levels. PR requires: if present at baseline, >= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90% or to <200 mg/24hrs. If the only measurable disease is FLC, a ≥50% reduction in the difference between involved and uninvolved FLC levels. If the only measurable disease is BM, a ≥ 50% reduction in BM PCs (provided the baseline PCs was ≥ 30%). If present at baseline, ≥ 50% reduction in the size (SPD) of soft tissue plasmacytomas.
Measured: 3 years
Secondary outcomes (4)
Percentage of Patients Achieving CR
Will be estimated by the number of patients who achieve a sCR or CR divided by the total number of evaluable patients. Complete Response (CR) is defined by all of the following: negative immunofixation of serum and urine; disappearance of any soft tissue plasmacytoma; <5% PCs in bone marrow; and if the only measurable disease is Free Light Chain (FLC), a normal FLC ratio. Stringent Complete Response (sCR) is defined as CR plus normal FLC ratio and absence of clonal circulating plasma cells (PCs) immunohistochemistry or 2- to 4- color flow cytometry.
Measured: 3 years
Progression-free Survival (PFS)
PFS is defined as the time from registration to time of disease progression or death due to any cause.
Measured: 3 years
Count of Patients That Experienced a Grade 3 or Greater Adverse Events
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. The table of these events is located in the adverse events section of this report.
Measured: 37 months
Overall Survival (OS)
OS is defined as the time from registration to death due to any cause.
Measured: 62 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start14 Jan 2019
- Primary completion20 Feb 2024
- Study completion14 Nov 2024
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 Refractory Plasma Cell MyelomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sikander Ailawadhi, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713294
- Sponsor's protocol ID
- MC1884
- Other IDs
- NCI-2018-02140, MC1884, 18-003574
- Status last verified
- Nov 2024
- First submitted
- 17 Oct 2018
- Last updated
- 24 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Sequential Treatment of Multiple Myeloma With Antibody Therapy
- ClinicalTrials.gov ID
- NCT03713294
- Acronym / sponsor ID
- MC1884
- Conditions
- Refractory Plasma Cell Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 14 Nov 2024 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Posted 24 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well dexamethasone, elotuzumab, pomalidomide work in treating patients with multiple myeloma that has not responded to previous treatment. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as elotuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pomalidomide may stop the growth of multiple myeloma by blocking the growth of new blood vessels necessary for tumor growth. Giving dexamethasone, elotuzumab, pomalidomide may work better in treating patients with multiple myeloma.
Detailed description
PRIMARY OBJECTIVE:
- To determine the overall response rate (ORR) of utilizing elotuzumab, pomalidomide and dexamethasone in patients with disease refractory to daratumumab.
SECONDARY OBJECTIVES:
- To determine percentage of patients achieving complete response (CR) with the elotuzumab combination.
II. To determine progression-free survival (PFS) for treatment with the elotuzumab combination.
III. To determine safety profile for treatment with the elotuzumab combination. IV. To determine the overall survival (OS) for patients receiving treatment with the elotuzumab combination.
OUTLINE:
Patients receive dexamethasone intravenously (IV) on days 1, 8, 15, and 22 of cycles 1-2 and IV on day 1 and orally (PO) on days 8, 15, and 22 of subsequent cycles and elotuzumab IV on days 1, 8, 15, and 22 of cycles 1-2 and day 1 of subsequent cycles. Patients also receive pomalidomide PO on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months until progressive disease, then every 6 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (dexamethasone, elotuzumab, pomalidomide) | Experimental | Drug: Dexamethasone, Biological: Elotuzumab, Drug: PomalidomidePatients receive dexamethasone IV on days 1, 8, 15, and 22 of cycles 1-2 and IV on day 1 and PO on days 8, 15, and 22 of subsequent cycles and elotuzumab IV on days 1, 8, 15, and 22 of cycles 1-2 and day 1 of subsequent cycles. Patients also receive pomalidomide PO on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age >= 18 years
- Pathologically confirmed diagnosis of multiple myeloma and noted to have progressive disease (International Myeloma Working Group [IMWG] criteria).
- At least one prior line of therapy.
- Disease refractory to daratumumab as defined by disease progression while on or =< 60 days of completing treatment with a daratumumab-containing regimen as part of any prior line of therapy.
- Measurable disease =< 14 days prior to registration.
Key exclusion criteria (32 listed)
- Non-secretory multiple myeloma (MM) or known immunoglobulin light chain (AL) amyloidosis.
- Clinically significant active infection requiring intravenous antibiotics (=< 14 days prior to registration).
- >= Grade 3 neuropathy and/or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
- Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy.
- Concurrent therapy considered investigational.
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 |
|---|---|---|
| DexamethasoneAlso: Aacidexam, Adexone, Aknichthol Dexa, Alba-DexGiven IV and PO | Drug | Treatment (dexamethasone, elotuzumab, pomalidomide) |
| ElotuzumabAlso: BMS-901608, Empliciti, HuLuc-63, HuLuc63Given IV | Biological | Treatment (dexamethasone, elotuzumab, pomalidomide) |
| PomalidomideAlso: 4-Aminothalidomide, Actimid, CC-4047, ImnovidGiven PO | Drug | Treatment (dexamethasone, elotuzumab, pomalidomide) |
Primary outcome
Overall Response Rate
Time frame: 3 years
Overall response rate (ORR) defined as a partial response (PR), very good partial response (VGPR), complete response (CR) or stringent CR (sCR). CR and sCR are defined in Outcome 2. VGPR requires: serum and urine M-protein detectable by immunofixation but not on electrophoresis OR >= 90% reduction in serum M-protein and urine M-protein <100 mg/24 h. If the only measurable disease is FLC, a >90% reduction in the difference between involved and uninvolved FLC levels. PR requires: if present at baseline, >= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90% or to <200 mg/24hrs. If the only measurable disease is FLC, a ≥50% reduction in the difference between involved and uninvolved FLC levels. If the only measurable disease is BM, a ≥ 50% reduction in BM PCs (provided the baseline PCs was ≥ 30%). If present at baseline, ≥ 50% reduction in the size (SPD) of soft tissue plasmacytomas.
4 secondary outcomes
Percentage of Patients Achieving CR
Time frame: 3 years
Progression-free Survival (PFS)
Time frame: 3 years
Count of Patients That Experienced a Grade 3 or Greater Adverse Events
Time frame: 37 months
Overall Survival (OS)
Time frame: 62 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink 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.
Sikander Ailawadhi, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone, Elotuzumab and Pomalidomide in people with Refractory Plasma Cell Myeloma, run by Mayo Clinic at 1 site 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 17 inclusion and 32 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 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 24 Jun 2025). 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?
Overall Response Rate (time frame: 3 years). 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 24 Jun 2025.