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Monoclonal Antibodies

Elranatamab for Multiple Myeloma (EMBRACE Trial)

Phase 2

Waitlist Available

Led By Hira Mian, MD

Research Sponsored by Ontario Clinical Oncology Group (OCOG)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2

Receipt of at least three prior classes of drugs: An immunomodulatory drug (lenalidomide or pomalidomide), a proteasome inhibitor (bortezomib, ixazomib, carfilzomib), and an anti-CD38 drug (daratumumab or isatuximab)

Must not have

History of prior treatment with a BCMA targeting agent

Amyloidosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the effectiveness and safety of elranatamab in patients with relapsed and/or refractory multiple myeloma. The study will focus on improving how well patients tolerate the

Who is the study for?

This trial is for people with multiple myeloma, a type of blood cancer, who have tried at least three different treatments without success and are not responding to their current treatment. Participants will receive the drug as outpatients and must be able to visit the clinic for doses.

What is being tested?

The study is testing elranatamab injections in an outpatient setting with intermittent dosing. The goal is to see if this approach makes the drug easier to tolerate and safer for patients who have relapsed or are resistant to other treatments.

What are the potential side effects?

While specific side effects of elranatamab aren't listed here, similar drugs can cause immune system reactions, infusion-related discomfort, fatigue, nausea, bone marrow suppression leading to low blood cell counts, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can perform daily activities with minimal assistance.

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I have been treated with drugs from three specific classes for my condition.

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I am 18 years old or older.

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My multiple myeloma worsened within 2 months after my last treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with a BCMA-targeting drug before.

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I have been diagnosed with amyloidosis.

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I have a blood condition that is not active cancer.

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I have a high number of plasma cells in my blood, indicating active plasma cell leukemia.

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I do not have any active infections like HBV, HCV, HIV, or uncontrolled infections.

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I have had a stem cell transplant within the last 3 months or I am experiencing graft versus host disease.

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I have a single plasma cell tumor.

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I am unable to sign or understand the consent form.

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I am not pregnant, breastfeeding, and can follow the birth control requirements.

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I have been diagnosed with POEMS syndrome.

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I am not allergic to elranatamab or similar drugs.

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I haven't had any cancer except for certain skin cancers or localized cancer that hasn't spread in the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hospitalization rate

Rate of grade 3+ infections

Secondary study objectives

Adverse Events

Clinical laboratory data

Duration of response.

+7 more

Other study objectives

Exploratory outcome BCMA expression (biologic tumor characteristics)

Feasibility, adherence and satisfaction of remote patient monitoring

Patient satisfaction with the use of the remote monitoring device

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Elranatamab injectionExperimental Treatment1 Intervention

The administration of two step-up elranatamab doses (12 mg and 32 mg) and full dose 76 mg. The dosing interval for the first 6 cycles (each cycle q28 days) is every week, cycles 7-12 are bi-weekly. The dosing interval will increase to q4 weeks (cycle 13+) according to IMWG dose-response criteria of \>= VGPR. Further dosing interval increase to q8weeks (cycles 19+) will be done among participants based on response criteria IMWG of \>= CR.

0 / 16Eligibility criteria met