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Multiple MyelomaPhase 2NCT02718833

A Study of Elotuzumab With Pomalidomide, Bortezomib, and Dexamethasone in Relapsed Multiple Myeloma

A Phase 2 study testing Elotuzumab, Pomalidomide and Bortezomib in people with Multiple Myeloma, run by Massachusetts General Hospital at 6 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This research study is studying a combination of study drugs as a possible treatment for relapsed and refractory Multiple Myeloma. The interventions involved in this study are elotuzumab, pomalidomide, bortezomib, dexamethasone. 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, Pomalidomide and Bortezomib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
6 sitesUnited States
Study dates
21 Jun 2016to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • All laboratory assessments should be performed within 21 days of initiation of protocol therapy unless otherwise specified.
  • Participant has given voluntary signed written informed consent before performance of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix A).
  • Age ≥ 18 years
  • Measurable disease of multiple myeloma as defined by at least one of the following
  • Serum monoclonal protein ≥ 0.5 g/dL
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  • ≥ 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
  • Serum free light chain ≥ 100 mg/L (10 mg/dL) and abnormal serum free kappa to serum free kappa light chain ratio
  • Previously treated relapsed and refractory multiple myeloma
  • Patients must have received at least one prior therapy with at least 2 cycles of lenalidomide and at least 2 cycles of a proteasome inhibitor (either in separate regimens or within the same regimen)
  • Disease progression on or within 60 days of completion of last therapy.
  • ANC ≥ 1000/μL. G-CSF is not permitted within 14 days of screening.
  • Platelet count ≥ 50,000/µL. Platelet transfusion is not permitted within 7 days of screening.
  • Hemoglobin ≥ 8 g/dL. Red blood cell transfusions are permitted to meet eligibility criteria.
  • Calculated creatinine clearance of ≥ 30 mL/min according to Cockcroft-Gault equation
  • Patent has adequate hepatic function, as evidenced by serum bilirubin values < 2 mg/dL and serum aspartate transaminase (ALT) and/or aspartate transaminase (AST) values < 3 × the upper limit of normal (ULN) of the local laboratory reference range. Patients with elevated bilirubin due to Gilbert's syndrome may be permitted with PI approval.
  • Must be able to take acetylsalicylic acid (ASA) daily as prophylactic anticoagulation. Patients intolerant to ASA may use low molecular weight heparin or equivalent. Warfarin will be allowed provided patient is full anticoagulated, with an INR of 2-3.
  • All 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.
  • Able to swallow capsules whole (pomalidomide capsules cannot be crushed, dissolved or broken).

Who cannot join

  • Prior therapy with elotuzumab
  • Participants who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier. Patients may have received dexamethasone within 2 weeks prior to entering study.
  • Participants who are receiving any other investigational agents.
  • Concomitant high dose corticosteroids except patients may be on chronic steroids (maximum dose 10 mg/day prednisone equivalent) if they are being given for disorders other than myeloma, e.g. adrenal insufficiency, rheumatoid arthritis, etc.
  • Pregnant or lactating females
  • Prior history of malignancies, other than MM, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following:
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  • Basal or squamous cell carcinoma of the skin
  • Carcinoma in situ of the cervix
  • Ductal carcinoma in situ of the breast
  • Incidental histologic finding of prostate cancer (T1a or T1b)
  • Another malignancy undergoing active treatment with the exception of non-melanoma skin cancer or in situ cervical cancer.
  • Patients with plasma cell leukemia, POEMS syndrome, or amyloidosis are excluded from this trial.
  • HIV infection
  • Active hepatitis B infection or active hepatitis C infection. Participants who have prior hepatitis C infection but who have received an antiviral treatment and show no detectable viral RNA for 6 months are eligible.
  • Peripheral neuropathy ≥ grade 2 despite supportive therapy.
  • Hypersensitivity to thalidomide, lenalidomide, pomalidomide, bortezomib, or dexamethasone (such as Stevens-Johnson syndrome). Rash to immunomodulatory drug that can be medically managed is allowable.
  • Allogeneic stem cell transplant less than 12 months prior to initiation of study treatment and who have not discontinued immunosuppressive treatment for at least four weeks prior to initiation of study treatment and who are currently dependent on such treatment. Patients may also not have active graft v. host disease.
  • Patient has a history of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory, or inflammatory illness that could preclude study participation, pose an undue medical hazard, or interfere with the interpretation of the study results, including, but not limited to, patients with congestive heart failure (New York Heart Association [NYHA] Class 3 or 4); unstable angina; cardiac arrhythmia; recent (within the preceding 6 months) myocardial infarction or stroke; hypertension requiring > 2 medications for adequate control; diabetes mellitus with > 2 episodes of ketoacidosis in the preceding 12 months; or chronic obstructive pulmonary disease (COPD) requiring > 2 hospitalizations in the preceding 12 months.
  • Patient has any other medical, psychiatric, or social condition that would preclude participation in the study, pose an undue medical hazard, interfere with the conduct of the study, or interfere with interpretation of the study results

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Mass General/North Shore Cancer Center

    Danvers, Massachusetts, 01923

  • Newton-Wellesley Hospital

    Newton, Massachusetts, 02462

  • University of Rochester

    Rochester, New York, 14642

Other trials in United States

About this study

Official title: A Phase II Study of Elotuzumab in Combination With Pomalidomide, Bortezomib, and Dexamethasone in Relapsed and Refractory Multiple Myeloma

This research study is studying a combination of study drugs as a possible treatment for relapsed and refractory Multiple Myeloma. The interventions involved in this study are elotuzumab, pomalidomide, bortezomib, dexamethasone.

Read the detailed description

This research study is a phase II clinical trial, the investigators are studying the safety and response rate of the combinations of elotuzumab, pomalidomide, bortezomib, dexamethasone (elo-PVD).

The FDA (the U.S. Food and Drug Administration) has approved each of those drugs elotuzumab, pomalidomide, bortezomib, dexamethasone as a treatment option for Refractory or relapsed multiple myeloma.

Pomalidomide is a drug that changes that enhances or suppresses your immune systems reaction to a stimulus.This change may help the body destroy tumor cells. Bortezomib is an inhibitor that targets how cells dispose of unneeded proteins. By blocking this process, bortezomib can help destroy unwanted cells. Dexamethasone is a steroid, that helps prevent inflammation in a wide variety of organs and acts against myeloma cells. Elotuzumab is a monoclonal antibody, Elotuzumab targets a protein that is highly common on the surface of multiple myeloma cells called SLAMF7.

The combination of the drugs may provide an unique approach for treating the disease.

Being tested
Elotuzumab, Pomalidomide, Bortezomib, Dexamethasone
Keywords
Multiple Myeloma, Relapse
Medical subject headings
Multiple Myeloma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02718833
Study groupRoleWhat they receive
Elotuzumab, pomalidomide, bortezomib, dexExperimentalEach cycle is 28 days. Elotuzumab will be administered by intravenous infusion. For cycles 1-2, elotuzumab will ge given weekly. For cycles 3-8, elotuzumab will be given every other week. For cycles 9+, elotuzumab will be given on day 1. Pomalidomide will be given orally on days 1-21. Bortezomib will be given weekly subcutaneously on days 1, 8, 15. Dexamethasone will be given as a combination orally and intravenously.
Receives: Drug: Elotuzumab; Drug: Pomalidomide; Drug: Bortezomib; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate by International Myeloma Working Group criteria.

    To evaluate the objective response rate (partial response or better) of elotuzumab in combination with pomalidomide, bortezomib, and dexamethasone in patients with relapsed and refractory multiple myeloma and who have received at least two prior therapies and are relapsed and/or refractory to both lenalidomide and bortezomib.

    Measured: 2 years

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: 2 years

Secondary outcomes (1)

  1. Progression Free Survival

    To evaluate the progression free survival (PFS) of elotuzumab-PVD.

    Measured: 2 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2016 (estimated)
  2. Study start21 Jun 2016
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02718833
Sponsor's protocol ID
15-475
Status last verified
Jan 2026
First submitted
11 Mar 2016
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Yee AJ, Laubach JP, Campagnaro EL, Lipe BC, Nadeem O, Friedman RS, Cole CE, O'Donnell EK, Bianchi G, Branagan AR, Schlossman RL, Shapiro SJ, Harrington CC, Burke JN, Gammon MT, Lively KJ, Reimonn CA, Andrade DX, Redd R, Lohr JG, Anderson KC, Richardson PG, Raje NS. Elotuzumab in combination with pomalidomide, bortezomib, and dexamethasone in relapsed and refractory multiple myeloma. Blood Adv. 2025 Mar 11;9(5):1163-1170. doi: 10.1182/bloodadvances.2024014717.

    PubMed 39626297

  • Waldschmidt JM, Yee AJ, Vijaykumar T, Pinto RA, Frede J, Anand P, Bianchi G, Guo G, Potdar S, Seifer C, Nair MS, Kokkalis A, Kloeber JA, Shapiro S, Budano L, Mann M, Friedman R, Lipe B, Campagnaro E, O'Donnell EK, Zhang CZ, Laubach JP, Munshi NC, Richardson PG, Anderson KC, Raje NS, Knoechel B, Lohr JG. Cell-free DNA for the detection of emerging treatment failure in relapsed/ refractory multiple myeloma. Leukemia. 2022 Apr;36(4):1078-1087. doi: 10.1038/s41375-021-01492-y. Epub 2022 Jan 13.

    PubMed 35027656

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Elotuzumab, Pomalidomide and Bortezomib in people with Multiple Myeloma, run by Massachusetts General Hospital at 6 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 19 inclusion and 19 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 22 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 6 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?

This study is still under way. Results are not available in the source record yet.

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 by International Myeloma Working Group criteria. (time frame: 2 years). 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?

On the ClinicalTrials.gov record for NCT02718833, which also lists 2 linked publications.

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 22 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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