Multiple Myeloma in RelapsePhase 2NCT03030261
Elotuzumab, Pomalidomide, & Dexamethasone (Elo-Pom-Dex) With Second Autologous Stem Cell Transplantation for Relapsed Multiple Myeloma
A Phase 2 study testing Elotuzumab, Pomalidomide and Dexamethasone in people with Multiple Myeloma in Relapse, run by Washington University School of Medicine at 3 sites in 2 countries.
Trial summary
Based on the need to improve outcomes post second autologous stem cell transplant (ASCT) for multiple myeloma (MM) and the benefits seen of maintenance treatment following initial ASCT, the natural next step is to evaluate maintenance/continuation therapy following second ASCT. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma in Relapse
- What is being tested?
- Elotuzumab, Pomalidomide 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
- 25 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 22 Nov 2017to 26 Sep 2027
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of multiple myeloma.
- Received prior autologous stem cell transplantation as first line therapy for multiple myeloma with subsequent disease relapse/progression.
- Failed 1 or 2 lines of treatment for multiple myeloma. A line of treatment includes all therapy including induction, transplant, and maintenance administered in a sequence in the absence of relapse/progression. Once relapse/progression occurs and subsequently the anti-myeloma treatment is changed, a new line of treatment has begun. Local radiation or corticosteroids will not be considered treatment for multiple myeloma.
- Received 2 to 6 cycles of induction therapy per standard of care prior to 2nd autologous stem cell transplantation
- Received standard of care melphalan conditioning for 2nd autologous stem cell transplantation, is currently Day +80 to +120 following transplant, and is responding to therapy (partial response or better as compared to pre-induction assessment.
- All US study participants must be registered into the mandatory POMALYST REMS® program and be willing and able to comply with the requirements of the POMALYST REMS® program. For Canadian sites, patients will followed according to the Pomalidomide pregnancy prevention program
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- Females of reproductive potential within the US must agree to adhere to the scheduled pregnancy testing as required in the POMALYST REMS® program. For Canadian sites, patients will followed according to the Pomalidomide pregnancy prevention program
- At least 18 and no more than 75 years of age at enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Normal bone marrow and organ function as defined as ALL of the following:
- Absolute neutrophil count ≥ 1000/mm^3
- Platelets ≥ 75,000/mm^3 (transfusions not permitted within 7 days of screening)
- Total bilirubin ≤ 2.0 x institutional upper limit of normal (IULN)
- AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
- Creatinine clearance ≥ 15 mL/min
- Females of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry through Day +100 visit. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Able to understand and willing to sign an Institutional Review Board (IRB) approved written informed consent document.
Who cannot join
- Refractory to elotuzumab and/or pomalidomide, defined as progressive disease or clinical relapse on therapy or within 60 days following completion of therapy. Prior exposure to elotuzumab and/or pomalidomide is allowed as long as patient is not refractory to these agents.
- More than one prior transplant prior to study entry with the exception of tandem transplantation. Tandem transplantation is defined as two autologous stem cell transplants that occur within 9 months of one another, and the patient did not have disease progression in the period between the two transplants.
- Presence of peripheral neuropathy ≥ grade 3 based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.0
- History of plasma cell leukemia or MM central nervous system (CNS) involvement.
- Receiving renal replacement therapy, hemodialysis, or peritoneal dialysis.
- Diagnosed with another concurrent malignancy requiring treatment.
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- Known HIV or active hepatitis A, B, or C. Antidoby testing not required for screening
- Known hypersensitivity to pomalidomide, dexamethasone, or any excipients in elotuzumab, formulation, or recombinant protein
- Receiving any other investigational agents within 14 days prior to enrollment.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- Pregnant and/or breastfeeding. Females of childbearing potential must have two negative pregnancy tests. The first test should be performed within 10-14 days of study entry, and the second test within 24 hours prior to prescribing pomalidomide.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Colorado Blood Cancer Institute (Sarah Cannon)
Denver, Colorado, 80218
Washington University School of Medicine
St Louis, Missouri, 63110
Canada1 site
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
About this study
Official title: A Phase II Study of Elotuzumab, Pomalidomide, & Dexamethasone (Elo-Pom-Dex) With Second Autologous Stem Cell Transplantation for Relapsed Multiple Myeloma
Based on the need to improve outcomes post second autologous stem cell transplant (ASCT) for multiple myeloma (MM) and the benefits seen of maintenance treatment following initial ASCT, the natural next step is to evaluate maintenance/continuation therapy following second ASCT.
Pomalidomide is active against MM cells refractory to both bortezomib and lenalidomide, making it an ideal choice for continuation therapy following second ASCT. Adding elotuzumab may increase efficacy and also the durability of responses which is essential to improving outcomes following second ASCT.
- Conditions
- Multiple Myeloma in Relapse
- Being tested
- Elotuzumab, Pomalidomide, Dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElotuzumabDrug
Also called Empliciti
During continuation therapy, elotuzumab will be administered on a 28-day cycle as follows: on Days 1 and 15 for Cycles 1-6 and on Day 1 for Cycles 7+. For Cycles 1-6 elotuzumab will be administered intravenously at a dose of 10 mg/kg. For Cycles 7+ elotuzumab will be administered at a dose of 20 mg/kg.
PomalidomideDrug
Also called Pomalyst
During continuation therapy, pomalidomide will be taken by mouth daily on Days 1-21 of each 28-day cycle at a starting dose of 2 mg. During continuation, pomalidomide may be dose escalated to 4 mg at the discretion of the treating physician if the 2 mg dose is tolerated.
DexamethasoneDrug
Also called Decadron
During continuation therapy, dexamethasone will be taken by mouth at a starting dose of 40 mg. It will be given on a 28-day cycle as follows: on Days 1 and 15 for Cycles 1-6 and on Day 1 only for Cycles 7+. Sufficient quantity of drug for one cycle of therapy will be prescribed to the patient at a time.
| Study group | Role | What they receive |
|---|---|---|
| Elotuzumab + Pomalidomide + Dexamethasone | Experimental | * Patients will receive 2-6 cycles of salvage/induction per standard of care. After protocol version 02/13/2020, patients may have already received their induction therapy prior to enrolling in the study.
* Following induction, patients will undergo standard of care ASCT melphalan conditioning (ASCT). Administration of melphalan and the second ASCT will be done as part of routine care and procedures are not dictated by this protocol.
* Continuation therapy with Elo-Pom-Dex will begin between Days 80 and 120 following the second ASCT:
* 10 mg/kg of elotuzumab on Days 1 and 15 for Cycles 1-6 followed by 20 mg/kg on Day 1 for Cycles 7+
* 2 mg pomalidomide daily on Days 1-21 of all cycles
* 40 mg dexamethasone on Days 1 and 15 of all cycles for Cycles 1-6 followed by 40 mg on Day 1 for Cycles 7+
* Continuation therapy may continue until relapse or progression. Receives: Drug: Elotuzumab; Drug: Pomalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free Survival (EFS) Rate
-Event-free survival (EFS) will be defined as time from ASCT to disease progression, relapse, or death, whichever occurs first. Patients who are removed from study therapy prior to any of these events occurring will be censored at the time of initiation of subsequent anti-myeloma treatment.
Measured: 1 year
Secondary outcomes (5)
Overall Response Rate (ORR)
-Overall response rate (ORR) will be defined as the proportion of evaluable patients meeting the criteria for partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR).
Measured: 1 year
Complete Response Rate (CRR)
- Complete response rate (CRR) will be defined as the proportion of evaluable patients meeting the criteria complete (CR) or stringent complete response (sCR)
- Stringent complete response (sCR) requires all of the following:
- CR as defined below
- Normal free light chain ratio (0.26-1.65)
- Absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence
- Complete response (CR) requires all of the following:
- Disappearance of monoclonal protein by both protein electrophoresis and immunofixation studies from the blood and urine
- If serum and urine monoclonal protein are unmeasurable, Normal free light chain ratio (0.26-1.65)
- <5% plasma cells in the bone marrow
- Disappearance of soft tissue plasmacytoma
- Patients who do not meet the definition of CR based solely on residual monoclonal protein on serum electrophoresis and/or immunofixation, but are MRD-negative as described above, will also be considered CR.
Measured: 1 year
Progression-free Survival (PFS)
-Progression-free survival (PFS) will be defined as time from ASCT to disease progression or relapse. Any patient who expires or withdraws prior to disease progression or relapse will be censored at last follow-up. Patients who are removed from study therapy prior to progression or relapse will be censored at the time of initiation of subsequent anti-myeloma treatment.
Measured: Up to 5 years post completion of treatment
Overall Survival (OS)
-Overall survival (OS) will be defined as time from ASCT to death due to any causes. Patients who are alive at the time of data analyses will be censored on the last known alive date. Patients who are removed from study therapy prior death will be censored at the time of initiation of subsequent anti-myeloma treatment.
Measured: Up to 5 years post completion of treatment
Toxicity of Regimen as Measured by Number of Grade 3-5 Adverse Events
-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
Measured: Up to 30 days following completion of treatment (estimated to be 106 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start22 Nov 2017
- Primary completion29 Sep 2022
- Study completion26 Sep 2027 (estimated)
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 Myeloma in RelapseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Celgene
- Responsible party
- Sponsor
- Investigators
- Ravi Vij, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030261
- Sponsor's protocol ID
- 201701084
- Other IDs
- CA204-225, PO-CL-MM-PI-008341
- Status last verified
- Dec 2025
- First submitted
- 18 Jan 2017
- Last updated
- 12 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Elotuzumab, Pomalidomide, & Dexamethasone (Elo-Pom-Dex) With Second Autologous Stem Cell Transplantation for Relapsed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03030261
- Acronym / sponsor ID
- 201701084
- Conditions
- Multiple Myeloma in Relapse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Celgene
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 29 Sep 2022 (actual)
- Study completion
- 26 Sep 2027 (estimated)
- First posted
- 24 Jan 2017 (estimated)
- Results
- Posted 15 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Based on the need to improve outcomes post second autologous stem cell transplant (ASCT) for multiple myeloma (MM) and the benefits seen of maintenance treatment following initial ASCT, the natural next step is to evaluate maintenance/continuation therapy following second ASCT.
Pomalidomide is active against MM cells refractory to both bortezomib and lenalidomide, making it an ideal choice for continuation therapy following second ASCT. Adding elotuzumab may increase efficacy and also the durability of responses which is essential to improving outcomes following second ASCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elotuzumab + Pomalidomide + Dexamethasone | Experimental | Drug: Elotuzumab, Drug: Pomalidomide, Drug: Dexamethasone* Patients will receive 2-6 cycles of salvage/induction per standard of care. After protocol version 02/13/2020, patients may have already received their induction therapy prior to enrolling in the study. * Following induction, patients will undergo standard of care ASCT melphalan conditioning (ASCT). Administration of melphalan and the second ASCT will be done as part of routine care and procedures are not dictated by this protocol. * Continuation therapy with Elo-Pom-Dex will begin between Days 80 and 120 following the second ASCT: * 10 mg/kg of elotuzumab on Days 1 and 15 for Cycles 1-6 followed by 20 mg/kg on Day 1 for Cycles 7+ * 2 mg pomalidomide daily on Days 1-21 of all cycles * 40 mg dexamethasone on Days 1 and 15 of all cycles for Cycles 1-6 followed by 40 mg on Day 1 for Cycles 7+ * Continuation therapy may continue until relapse or progression. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically confirmed diagnosis of multiple myeloma.
- Received prior autologous stem cell transplantation as first line therapy for multiple myeloma with subsequent disease relapse/progression.
- Failed 1 or 2 lines of treatment for multiple myeloma. A line of treatment includes all therapy including induction, transplant, and maintenance administered in a sequence in the absence of relapse/progression. Once relapse/progression occurs and subsequently the anti-myeloma treatment is changed, a new line of treatment has begun. Local radiation or corticosteroids will not be considered treatment for multiple myeloma.
- Received 2 to 6 cycles of induction therapy per standard of care prior to 2nd autologous stem cell transplantation
- Received standard of care melphalan conditioning for 2nd autologous stem cell transplantation, is currently Day +80 to +120 following transplant, and is responding to therapy (partial response or better as compared to pre-induction assessment.
Key exclusion criteria (11 listed)
- Refractory to elotuzumab and/or pomalidomide, defined as progressive disease or clinical relapse on therapy or within 60 days following completion of therapy. Prior exposure to elotuzumab and/or pomalidomide is allowed as long as patient is not refractory to these agents.
- More than one prior transplant prior to study entry with the exception of tandem transplantation. Tandem transplantation is defined as two autologous stem cell transplants that occur within 9 months of one another, and the patient did not have disease progression in the period between the two transplants.
- Presence of peripheral neuropathy ≥ grade 3 based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.0
- History of plasma cell leukemia or MM central nervous system (CNS) involvement.
- Receiving renal replacement therapy, hemodialysis, or peritoneal dialysis.
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: EmplicitiDuring continuation therapy, elotuzumab will be administered on a 28-day cycle as follows: on Days 1 and 15 for Cycles 1-6 and on Day 1 for Cycles 7+. For Cycles 1-6 elotuzumab will be administered intravenously at a dose of 10 mg/kg. For Cycles 7+ elotuzumab will be administered at a dose of 20 mg/kg. | Drug | Elotuzumab + Pomalidomide + Dexamethasone |
| PomalidomideAlso: PomalystDuring continuation therapy, pomalidomide will be taken by mouth daily on Days 1-21 of each 28-day cycle at a starting dose of 2 mg. During continuation, pomalidomide may be dose escalated to 4 mg at the discretion of the treating physician if the 2 mg dose is tolerated. | Drug | Elotuzumab + Pomalidomide + Dexamethasone |
| DexamethasoneAlso: DecadronDuring continuation therapy, dexamethasone will be taken by mouth at a starting dose of 40 mg. It will be given on a 28-day cycle as follows: on Days 1 and 15 for Cycles 1-6 and on Day 1 only for Cycles 7+. Sufficient quantity of drug for one cycle of therapy will be prescribed to the patient at a time. | Drug | Elotuzumab + Pomalidomide + Dexamethasone |
Primary outcome
Event-free Survival (EFS) Rate
Time frame: 1 year
-Event-free survival (EFS) will be defined as time from ASCT to disease progression, relapse, or death, whichever occurs first. Patients who are removed from study therapy prior to any of these events occurring will be censored at the time of initiation of subsequent anti-myeloma treatment.
5 secondary outcomes
Overall Response Rate (ORR)
Time frame: 1 year
Complete Response Rate (CRR)
Time frame: 1 year
Progression-free Survival (PFS)
Time frame: Up to 5 years post completion of treatment
Overall Survival (OS)
Time frame: Up to 5 years post completion of treatment
Toxicity of Regimen as Measured by Number of Grade 3-5 Adverse Events
Time frame: Up to 30 days following completion of treatment (estimated to be 106 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ravi Vij, M.D. principal investigator
Washington University School of Medicine
3 sites in 2 countries: 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 in Relapse, run by Washington University School of Medicine at 3 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 17 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. 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 15 Dec 2023). 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?
Event-free Survival (EFS) Rate (time frame: 1 year). 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 12 Jan 2026.