Etentamig + Iberdomide for Multiple Myeloma

Recruiting at 21 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: TeneoOne Inc.

Must be taking: CELMoD agents

Must not be taking: BCMA-targeted therapy

Disqualifiers: Prior etentamig, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

135 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug combination for individuals with multiple myeloma that has returned or not responded to previous treatments. The focus is on determining safe doses of etentamig (a potential new drug) when combined with iberdomide. Participants will be assigned to groups receiving different doses to evaluate the treatment's effects on the disease and its side effects. Suitable candidates for this trial have confirmed relapsed or refractory multiple myeloma and have not previously received etentamig or similar drugs. Participants will attend regular visits for health checks and assessments throughout the study. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study doctors to understand how your current medications might interact with the trial drugs.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the combination of etentamig and iberdomide is being tested for safety in people with relapsed or refractory multiple myeloma, a type of blood cancer. Earlier studies found that etentamig, administered in gradually increasing doses, worked well for patients, and the side effects were manageable. Iberdomide has been tested in several studies and is generally well-tolerated. It has been safely combined with other treatments, such as daratumumab and dexamethasone. This background provides some reassurance about the safety of using these drugs together, but the trial primarily aims to understand their safety when used in combination. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Etentamig and Iberdomide for multiple myeloma because they offer a novel approach compared to traditional treatments like proteasome inhibitors and immunomodulatory drugs. Etentamig is unique due to its mechanism of action, which targets a specific protein involved in cancer cell growth, potentially reducing tumor size more effectively. Additionally, Iberdomide enhances the immune system's ability to fight cancer cells, which might improve patient outcomes. Together, these treatments could provide a more targeted and efficient way to manage multiple myeloma, with the potential for fewer side effects.

What evidence suggests that this trial's treatments could be effective for multiple myeloma?

In this trial, participants will receive Etentamig combined with iberdomide. Research has shown that iberdomide, when paired with drugs like daratumumab and dexamethasone, yields promising results in treating multiple myeloma, with studies finding a high overall response rate of over 90%. Etentamig, another drug tested in this trial, is a bispecific antibody that can attach to two different targets on cancer cells. Early results with similar drugs in multiple myeloma have demonstrated high response rates and manageable safety. These findings suggest that using Etentamig and iberdomide together could effectively treat multiple myeloma that has returned or is not responding to other treatments. ^{1 2 5 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Adults with relapsed or refractory multiple myeloma who have measurable disease activity and are in good physical condition (ECOG performance of 0 to 1) can join this trial. Participants must have a confirmed diagnosis after their last treatment.

Inclusion Criteria

My disease can be measured by tests as required.

I am fully active or can carry out light work.

My multiple myeloma has returned or didn't respond after my last treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Participants receive escalating doses of intravenous (IV) etentamig in combination with oral iberdomide to determine a tolerable dose

8 weeks

Regular visits at an approved institution

Phase 2 Treatment

Participants receive IV etentamig at one of two doses in combination with oral iberdomide

129 months

Regular visits at an approved institution

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Etentamig
• Iberdomide

Trial Overview The study is testing the safety and effect on disease activity of Etentamig, an investigational IV drug, combined with Iberdomide, an oral CELMoD agent. The trial has two phases: one for finding tolerable doses and another for assessing efficacy at selected doses over approximately 129 months.

How Is the Trial Designed?

Group I: Phase 2: ABBV-383 Dose Expansion Dose B Experimental Treatment 2 Interventions

In phase 2 participants will receive Etentamig at dose B in combination with iberdomide, as part of the approximately 129 month study duration.

Group II: Phase 2: ABBV-383 Dose Expansion Dose A Experimental Treatment 2 Interventions

In phase 2 participants will receive Etentamig at dose A in combination with iberdomide, as part of the approximately 129 month study duration.

Group III: Phase 1: ABBV-383 Dose Escalation Experimental Treatment 2 Interventions

In phase 1 participants will receive escalating Etentamig in combination with iberdomide, as part of the approximately 129 month study duration.

Who Is Running the Clinical Trial?

TeneoOne Inc.

Lead Sponsor

Trials

5

Recruited

860+

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06896916

NCT06896916 | Study of Intravenously (IV) Infused ... The purpose of this study is to assess the adverse events and change in disease activity of etentamig in combination with a cereblon E3 ligase modulatory drug ...

2. news.bms.com news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Announces-Phase-3-EXCALIBER-RRMM-Study-Evaluating-Iberdomide-in-Combination-with-Standard-Therapies-Demonstrated-a-Significant-Improvement-in-Minimal-Residual-Disease-Negativity-Rates-in-Relapsed-or-Refractory-Multiple-Myeloma/default.aspx

Bristol Myers Squibb Announces Phase 3 EXCALIBER ... The safety profile of iberdomide in combination with daratumumab and dexamethasone in this study is generally consistent with previous studies.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0268960X25000876

Bispecific antibodies in multiple myeloma Early results show a high response rate of 91.9 % and an manageable safety profile [68]. In transplant-eligible patients, more mature data was ...

4. hematologyadvisor.com hematologyadvisor.com/news/iberdomide-shows-promising-phase-3-results-in-r-r-multiple-myeloma/

Iberdomide Shows Promising Phase 3 Results in R/R ... Results from a planned interim analysis showed that patients treated with IberDd demonstrated a statistically significant improvement in MRD ...

5. onclive.com onclive.com/view/iberdomide-daratumumab-dexamethasone-is-effective-in-newly-diagnosed-multiple-myeloma

Iberdomide/Daratumumab/Dexamethasone Is Effective in ... The iberdomide-daratumumab-dexamethasone regimen achieved a 93.1% overall response rate in frail, transplant-ineligible multiple myeloma ...

6. onclive.com onclive.com/view/etentamig-with-step-up-dosing-shows-preliminary-efficacy-safety-in-r-r-myeloma

Etentamig With Step-Up Dosing Shows Preliminary ... The step-up dosing strategy for etentamig achieved a 69% overall response rate in relapsed/refractory multiple myeloma patients, with 56% ...

7. multiplemyelomahub.com multiplemyelomahub.com/medical-information/iberdomide-efficacy-and-safety-in-rrmm

Iberdomide – efficacy and safety in RRMM Clinical studies went on to suggest that iberdomide can improve overall responses, even in the context of relapsed and refractory disease, and ...