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Elotuzumab + Iberdomide + Dexamethasone for Multiple Myeloma

Phase 1 & 2

Recruiting

Research Sponsored by Omar Nadeem, MD

Eligibility Criteria Checklist

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

Must have

ECOG performance status ≤2 (Karnofsky ≥60%)

Patient who has been treated with at least 4 prior lines of anti-myeloma treatment including immunomodulating agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody

Must not have

Requirement for corticosteroids exceeding specified amounts

Female patients who are pregnant or lactating

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test if the combination of Elotuzumab and Iberdomide can effectively treat relapsed and refractory multiple myeloma after prior treatment with Idecabtagene

Who is the study for?

This trial is for individuals with relapsed and refractory multiple myeloma who have previously undergone Idecabtagene Vicleucel therapy. Participants should meet specific health criteria to be eligible.

What is being tested?

The study tests the effectiveness of combining Elotuzumab (monoclonal antibody) and Iberdomide (cereblon E3 ligase modulator) with Dexamethasone (steroid) in patients post-Ide-cel treatment for multiple myeloma.

What are the potential side effects?

Potential side effects may include immune system reactions, infusion-related responses, fatigue, increased risk of infections, and possible steroid-related issues such as mood swings or elevated blood sugar.

Eligibility Criteria

Inclusion Criteria

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

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I can care for myself but may not be able to do active work.

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I've had 4 or more treatments for myeloma, including specific types of therapy.

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I received ide-cel treatment, responded well, and it's been less than 90 days since my infusion.

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I am 18 years old or older.

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I agree to use contraception as required.

Exclusion Criteria

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

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I take more than the specified amount of corticosteroids.

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I am not pregnant or breastfeeding.

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I have been diagnosed with POEMS syndrome.

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I have previously been treated with Iberdomide.

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My cancer has spread to my brain or spinal cord.

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I do not have symptoms of amyloidosis or plasma cell leukemia.

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I cannot tolerate blood clot prevention treatments.

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I am experiencing graft versus host disease following a stem cell transplant.

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I have heart problems that are not well-controlled.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum Tolerated Dose (MTD) [Phase I]

Number of Participants Experiencing Dose Limiting Toxicity (DLT) [Phase I]

Progression-free Survival Rate at 12 months (rPFS12)

Secondary study objectives

Duration of Complete Response (DOCR)

Duration of Response (DOR)

Extramedullary disease (EMD) response rate

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 2: Dose ExpansionExperimental Treatment3 Interventions

Participants will be enrolled and will complete study procedures as follows: * Baseline visit * Cycle 1 through Cycle 2: * Days 1 through 21 of 28 Day Cycle: Predetermined dose of Iberdomide 1x daily. * Days 1, 8, 15, and 22 of 28 Day Cycle: Predetermined dose of Dexamethasone 1x daily. * Days 1, 8, 15, and 22 of 23 Day Cycle: Predetermined dose of Elotuzumab 1x daily. * Cycle 3 through End of Treatment: * Days 1 through 21 of 28 Day Cycle: Predetermined dose of Iberdomide 1x daily. * Day 1 of 28 Day Cycle: Predetermined dose of Dexamethasone 1x daily. * Days 1, 8, 15, and 22 of 23 Day Cycle: Predetermined dose of Elotuzumab 1x daily. * End of Treatment visit * 14 Day Follow Up Visit: to be in-clinic after end of treatment visit. * Follow Up: Every 28 days for up to 2 years

Group II: Phase 1: Dose EscalationExperimental Treatment3 Interventions

Participants will be enrolled in a standard 3+3 dose escalation design to find the Maximum Tolerated Dose (MTD) of Iberdomide, starting at Dose Level 0 and increasing to Dose Level 1 * Baseline visit * Cycle 1 through Cycle 2: * Days 1 through 21 of 28 Day Cycle: Predetermined dose of Iberdomide 1x daily * Days 1, 8, 15, and 22 of 28 Day Cycle: Predetermined dose of Dexamethasone 1x daily * Days 1, 8, 15, and 22 of 28 Day Cycle: Predetermined dose of Elotuzumab 1x daily * Cycle 3 through End of Treatment: * Days 1 through 21 of 28 Day Cycle: Predetermined dose of Iberdomide 1x daily * Day 1 of 28 Day Cycle: Predetermined dose of Dexamethasone 1x daily * Day 1 of 28 Day Cycle: Predetermined dose of Elotuzumab 1x daily * End of Treatment visit * 14 Day Follow Up Visit: to be in-clinic after end of treatment visit * Follow Up: Every 28 days for up to 2 years * Dose expansion will proceed according to dose-limiting toxicity (DLT) guidelines per the protocol

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

Elotuzumab

2016

Completed Phase 3

~950