Emapalumab for Multiple Myeloma

Not yet recruiting at 2 trial locations
OB
GG
Overseen ByGabrielle Gargano, BS, CCRC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether emapalumab, an immunotherapy drug, can prevent serious side effects like cytokine release syndrome (CRS) and neurotoxicity in patients with blood cancers such as lymphoma or multiple myeloma who receive bispecific antibody therapy. The goal is to determine if emapalumab effectively and safely reduces these risks. It suits individuals with relapsed or hard-to-treat large B-cell lymphoma or multiple myeloma who have tried other treatments and are scheduled for bispecific antibody therapy. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants, providing an opportunity to contribute to significant findings.

Do I need to stop my current medications for the trial?

The trial requires a break from certain medications before starting the bispecific antibody therapy. You need to wait at least 2 weeks or 5 half-lives (whichever is shorter) after your last systemic therapy, except for immune checkpoint therapy, which requires a longer break. Steroids need a 7-day break.

Is there any evidence suggesting that emapalumab is likely to be safe for humans?

Research has shown that emapalumab has been used safely in other conditions. One study found that serious side effects occurred in 53% of patients, with infections and stomach bleeding being common issues. However, other research has not identified any new safety concerns. The FDA has already approved emapalumab for treating macrophage activation syndrome, indicating it has passed rigorous safety tests. Although serious side effects have been reported, its approval for other uses may provide some reassurance about its safety.12345

Why do researchers think this study treatment might be promising for multiple myeloma?

Emapalumab is unique because it targets the immune protein interferon gamma (IFN-γ), which plays a role in inflammation and immune response. Unlike current treatments for multiple myeloma, which often include therapies like proteasome inhibitors and immunomodulatory drugs, Emapalumab offers a novel approach by specifically inhibiting IFN-γ. Researchers are excited about Emapalumab because this targeted action could potentially reduce inflammation and improve outcomes for patients, offering a new line of attack against the disease.

What evidence suggests that emapalumab might be an effective treatment for preventing CRS and ICANS in patients with hematologic malignancies?

Research has shown that emapalumab may help treat immune system issues. In studies on primary hemophagocytic lymphohistiocytosis (HLH), emapalumab helped 63% of patients improve, indicating its potential effectiveness in managing immune problems. Specifically, in severe cases of cytokine release syndrome (CRS), emapalumab improved patient health quickly, within 12 hours. This trial will investigate emapalumab as a prophylactic treatment to potentially prevent CRS and nerve damage in patients receiving certain treatments for blood cancers, such as multiple myeloma.16789

Who Is on the Research Team?

OB

Oscar B. Lahoud, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults with certain types of lymphoma or multiple myeloma who are about to start bispecific antibody therapy. Participants must have had previous treatments, be in generally good physical condition, and meet blood count requirements. There are specific timing rules about when past therapies must have ended before joining.

Inclusion Criteria

I have stopped previous treatments at least 2 weeks ago or as required before starting this therapy.
I have been diagnosed with diffuse large B-cell lymphoma.
I have primary mediastinal large B-cell lymphoma.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive prophylactic Emapalumab prior to bispecific antibody therapy to prevent CRS and ICANS

4 weeks
Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Emapalumab

Trial Overview

The study tests if emapalumab can help prevent serious immune reactions (CRS and ICANS) in people receiving bispecific antibody treatment for blood cancers like lymphoma or multiple myeloma. Emapalumab is given before the main cancer therapy as a preventive measure.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Prophylactic EmapalumabExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Citations

Emapalumab use in malignancy-associated hemophagocytic ...

At the end of the study, 4 of 17 patients were alive (overall survival: 23.5%), and the 12-month survival probability was 22.1% from initiation of emapalumab- ...

Results from pivotal phase 2/3 study of emapalumab in ... - Sobi

The results with emapalumab in primary HLH published in the New England Journal of Medicine highlight the overall response rate of 63 percent in ...

Emapalumab for Multiple Myeloma · Info for Participants

The purpose of this study is to evaluate emapalumab as a prophylactic therapy in preventing cytokine release syndrome (CRS) and immune effector ...

Emapalumab for severe cytokine release syndrome in solid ...

Within 12 hours after the first dose of emapalumab, there was a dramatic improvement in hemodynamic status and the patient was weaned off all four vasopressors.

761107Orig1s000 - accessdata.fda.gov

supports that efficacy results can be attributed to emapalumab therapy. Concomitant dexamethasone therapy is consistent with the standard ...

Safety Data | Gamifant® (emapalumab-lzsg) For HCPs

Serious adverse reactions were reported in 53% of patients. The most common serious adverse reactions (≥3%) included infections, gastrointestinal hemorrhage ...

Emapalumab in Children with Primary Hemophagocytic ...

At the last observation, 74% of the previously treated patients and 71% of the patients who received emapalumab were alive. Emapalumab was not ...

Results from pivotal phase 2/3 study of emapalumab in ... - Sobi

The results with emapalumab in primary HLH published in the New England Journal of Medicine highlight the overall response rate of 63 percent in ...

Efficacy and Safety of Emapalumab in Children and Adults ...

No new safety concerns were identified. 6 serious adverse drug reactions were reported in 4 pts and 14 infusion-related reactions occurred in 8 ...