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Multiple MyelomaPhase 2NCT03227432

An Exploratory Study to Evaluate the Combination of Elotuzumab and Nivolumab With and Without Pomalidomide in Relapsed Refractory Multiple Myeloma

A Phase 2 study testing Dexamethasone, Pomalidomide and Elotuzumab in people with Multiple Myeloma, run by Dana-Farber Cancer Institute at 3 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This research study is studying a combination of targeted therapies as a possible treatment for multiple myeloma (MM). The drugs involved in this study are: Elotuzumab Nivolumab Pomalidomide 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?
Dexamethasone, Pomalidomide and Elotuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
3 sitesUnited States
Study dates
Dec 2018to 31 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Male or female patient ≥ age 18 years
  • Patient is able to understand and has given voluntary written informed consent before performance of any study-related procedures not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care
  • Patient has been previously diagnosed with MM based on standard International Myeloma Working Group (IMWG) criteria and currently requires treatment.
  • Patient must have received at least two previous lines of therapy for multiple myeloma including lenalidomide or thalidomide and a proteasome inhibitor (bortezomib, carfilzomib or ixazomib).
  • Patient must have demonstrated disease progression on or within 60 days of completion of the last therapy. Patient has measurable disease defined as at least one of the following:
  • Serum M protein ≥ 0.5 g/dL (≥5 g/L)
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  • Urine M protein ≥200 mg/24 hours
  • Serum free light chain (FLC) assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65)
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Appendix A)
  • Negative serum or urine pregnancy test for women of child-bearing potential
  • Screening Laboratory parameters:
  • Absolute neutrophil count (ANC) ≥ 1,000 cells/dL (1.0 x 109/L). Granulocyte colony-stimulating factor (GCSF) is not permitted during screening to meet eligibility criteria and within 14 days of initiation of therapy
  • Platelet count ≥ 75,000 cells/dL (75 x 109/L) Platelet transfusion is not permitted during screening to meet eligibility criteria and within 14 days of initiation of therapy
  • Hemoglobin ≥ 8.0 g/dl ( red blood cell (RBC) transfusions are permitted during the screening period)
  • Total Bilirubin ≤ 1.5 X upper limit of normal (ULN) (Patients with known Gilbert Syndrome are allowed to have total bilirubin < 3.0 mg/dL)
  • Aspartate transaminase (AST, or SGOT) and alanine transaminase (ALT, or SGPT) ≤ 3.0x ULN
  • Estimated creatinine clearance by Cockcroft-Gault formula ≥ 40 mL/min
  • Serum creatinine < 1.5 X ULN. (Appendix C)

Who cannot join

  • Diagnosed or treated for another malignancy within 3 years prior to enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low risk prostate cancer after curative therapy.
  • Prior therapy with pomalidomide
  • Prior treatment with monoclonal antibodies including elotuzumab
  • Prior therapy with anti-programmed death 1 (PD-1) or programmed death-ligand 1 (PD-L1) agents.
  • Received any investigational drug within 14 days or 5 half-lives of the investigational drug, whichever is longer.
  • Prior anti-cancer therapy within 14 days.
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  • Patient has any Grade 3 or > unresolved adverse reaction from previous treatment. Previous allogeneic stem cell transplantation with active graft-versus-host disease (GVHD) or being under immunosuppressive therapy in the last 2 months prior to inclusion in the trial.
  • Autologous stem cell transplant if < 12 weeks from enrollment.
  • Daily requirement for oral corticosteroids (equivalent to > 10 mg/day prednisone daily) Inhaled or topical corticosteroids are allowed.
  • Patient is human immunodeficiency virus (HIV) positive,.
  • Patient is Hepatitis B Surface antigen-positive.
  • Patient has active hepatitis C infection.
  • Patient has an autoimmune disease. (Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger).
  • Any clinically significant, uncontrolled medical conditions that, in the treating Investigator's opinion, would impose excessive risk to the patient or may interfere with compliance or interpretation of the study results. Uncontrolled intercurrent illness may include, but is not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations as determined by treating investigator that would limit compliance with study requirements.
  • History of erythema multiforme or severe hypersensitivity to prior IMiD's®
  • Inability to tolerate thromboprophylaxis
  • Known severe intolerance to prior steroid therapy (Grade 3 or above adverse event which was unresponsive to a dose reduction)

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02115

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

Other trials in United States

About this study

This research study is studying a combination of targeted therapies as a possible treatment for multiple myeloma (MM).

The drugs involved in this study are:

  • Elotuzumab
  • Nivolumab
  • Pomalidomide
  • Dexamethasone
Read the detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug combination to learn whether the combination works in treating a specific disease. "Investigational" means that the drug combination is being studied.

This study has two parts. Each part tests a different combination of drugs.

  • In Part 1 participants will be given elotuzumab and nivolumab.
  • In Part 2 participants will be given elotuzumab, nivolumab, pomalidomide, and dexamethasone.

Each of these drugs works in a different way to help the body fight multiple myeloma. The drugs are being tested in different combinations to see if they are more effective when taken together.

Elotuzumab is an antibody, that stimulates the immune system to fight your disease. The FDA (the U.S. Food and Drug Administration) has approved elotuzumab in combination with lenalidomide as a treatment option for this disease.

In this research study, the participant will receive pomalidomide which is an immunomodulatory drug. This means that pomalidomide modulates the immune system to help fight the disease. The FDA has approved pomalidomide as a treatment option for this disease after receiving two other therapies.

Dexamethasone, also FDA approved, is a type of steroid and is usually combined with other chemotherapy for the treatment of blood cancers, such as myeloma and leukemias.

The FDA has not approved nivolumab for this specific disease but it has been approved for other uses, specifically lung cancer. Nivolumab works by blocking an inhibitory signal within immune cells, potentially allowing the immune system to fight the cancer.

In this research study the investigators are looking to see if the combination of elotuzumab, nivolumab, pomalidomide, and dexamethasone is effective in fighting the cancer.

Being tested
Dexamethasone, Pomalidomide, Elotuzumab, Nivolumab
Keywords
Multiple Myeloma
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 Maxidex

    Dexamethasone, a corticosteroid, is similar to a natural hormone produced by adrenal glands. It relieves inflammation.

  • PomalidomideDrug

    Also called Pomalyst

    Pomalidomide which is an immunomodulatory drug. This means that pomalidomide modulates the immune system to help fight diseases.

  • ElotuzumabDrug

    Also called Empliciti

    Elotuzumab is an antibody, that stimulates the immune system to fight diseases

  • NivolumabDrug

    Also called Opdivo

    Nivolumab works by blocking an inhibitory signal within immune cells, potentially allowing the immune system to fight the cancer

Study groups in NCT03227432
Study groupRoleWhat they receive
Nivolumab + ElotuzumabExperimental* 22 patients will be entered, If > 4 patients achieve at least a partial response (PR) within 4 cycles an additional 18 patients will be treated. * Nivolumab will be administered intravenously twice per cycle for cycle 1-4 * Nivolumab will be administered intravenously once per cycle for cycle 5 * Elotuzumab will be administered intravenously 4 times per cycle for cycle 1-2 * Elotuzumab will be administered intravenously twice per cycle for cycle 3-4 * Elotuzumab will be administered intravenously once per cycle for cycle 5
Receives: Drug: Elotuzumab; Drug: Nivolumab
Nivolumab+Elotuzumab+Pomalidomide+DexamethasoneExperimental* Nivolumab will be administered intravenously twice per cycle for cycle 1-4 * Nivolumab will be administered intravenously once per cycle for cycle 5 * Elotuzumab will be administered intravenously 4 times per cycle for cycle 1-2 * Elotuzumab will be administered intravenously twice per cycle for cycle 3-4 * Elotuzumab will be administered intravenously once per cycle for cycle 5 * Pomalidomide will be administered for 21 days per cycle * Dexamethasone will be administered weekly
Receives: Drug: Dexamethasone; Drug: Pomalidomide; Drug: Elotuzumab; Drug: Nivolumab

What is being measured

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

  1. Response Rate

    Measured: 2 years

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

    Measured: 6 months

Secondary outcomes (6)

  1. The Rate of Clinical Benefit Response (CBR)

    Measured: 2 years

  2. Time to Response

    Measured: 2 years

  3. Duration of Response

    Measured: 2 years

  4. Progression Free Survival

    Measured: 2 years

  5. Overall Survival

    Measured: 2 years

  6. Time to Treatment Failure

    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 Jul 2017
  2. Study startDec 2018 (estimated)
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Why it stopped: Withdrawn before enrollment due to issues around the FDA hold on PD-1/PD-L1 drugs in combination with IMIDs.

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03227432
Sponsor's protocol ID
16-645
Status last verified
Aug 2018
First submitted
7 Jul 2017
Last updated
14 Aug 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dexamethasone, Pomalidomide and Elotuzumab in people with Multiple Myeloma, run by Dana-Farber Cancer Institute at 3 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 18 inclusion and 17 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: withdrawn, as of the sponsor's last update on 14 Aug 2018. 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. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Response Rate (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 NCT03227432.

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 Aug 2018.

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