Mezigdomide + Elranatamab for Multiple Myeloma

Recruiting at 25 trial locations

Overseen By BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Celgene

Must not be taking: Mezigdomide, TCE, BCMA-targeting

Disqualifiers: Prior mezigdomide, TCE, BCMA, others

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

Compensation: Varies

Number of Visits: Unknown

62 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks to determine the safety and effectiveness of combining two drugs, mezigdomide and elranatamab, for treating multiple myeloma, a type of blood cancer that has returned or not responded to previous treatments. The study aims to identify the optimal dose of these drugs when used together. It is open to individuals with relapsed or hard-to-treat multiple myeloma who have already tried between one and four different treatments. As a Phase 1/Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in multiple myeloma 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 trial coordinators or your doctor.

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

Research has shown that mezigdomide, when used with other treatments, generally has a manageable safety profile. Specifically, when combined with new drugs like TAZ or BMS-986158, it was well-tolerated and showed promising results. This suggests that mezigdomide might be safe for patients with multiple myeloma, although some side effects could still occur.

For elranatamab, studies have identified common side effects, such as infections, a temporary immune response called cytokine release syndrome, and anemia, which is a low red blood cell count. However, these side effects were usually manageable. The treatment worked quickly and effectively, providing deep and rapid responses in patients.

Both treatments remain under study, so further information will enhance understanding of their safety. Prospective trial participants should discuss any concerns with a healthcare professional. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Mezigdomide and Elranatamab for treating multiple myeloma because they offer new mechanisms of action. Unlike current treatments like proteasome inhibitors and immunomodulatory drugs, Mezigdomide is a novel cereblon modulator that enhances the immune system's ability to fight cancer cells. Elranatamab, on the other hand, is a bispecific antibody that targets BCMA, a protein often found on myeloma cells, and CD3 on T-cells, directing the immune system to attack the cancer cells directly. These innovative approaches could potentially lead to more effective treatments with different side effect profiles for patients with multiple myeloma.

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

Research has shown that mezigdomide may effectively treat multiple myeloma. In one study, 41% of patients responded positively, with benefits lasting about 7.6 months. Another study found a higher response rate of 60% at a specific dose. Research indicates that elranatamab can help patients live longer, with an average of 17.2 months before the disease worsens. This trial studies the combined potential of mezigdomide and elranatamab in managing relapsed and refractory multiple myeloma. ^{2 3 4 5 6}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for people with multiple myeloma that has come back or didn't respond to treatment. Participants should meet specific health criteria not detailed here.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

Adherence to contraception requirements

I am over 18 and have had 2-4 (Phase 1) or 1-3 (Phase 2) treatments for my relapsed multiple myeloma.

Exclusion Criteria

I have previously been treated with mezigdomide.

I have previously been treated with T cell engaging therapies.

Other protocol-defined Inclusion/Exclusion criteria apply

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Participants receive mezigdomide in combination with elranatamab to determine the recommended dose and schedule

8-12 weeks

Phase 2 Treatment

Participants continue treatment to evaluate safety and preliminary efficacy

12-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term Follow-up

Participants are monitored for long-term outcomes, including survival and disease progression

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone
• Elranatamab
• Mezigdomide

Trial Overview The study tests the safety and initial effectiveness of combining two drugs, Mezigdomide and Elranatamab, along with Dexamethasone in a recommended dose for relapsed/refractory multiple myeloma.

How Is the Trial Designed?

Group I: Phase 2 Experimental Treatment 3 Interventions

Group II: Phase 1 Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

Celgene

Lead Sponsor

Trials

649

Recruited

130,000+

Top Products

>- **Revlimid (lenalidomide)**: Multiple myeloma, myelodysplastic syndromes, and mantle cell lymphoma treatment. - **Pomalyst (pomalidomide)**: Relapsed/refractory multiple myeloma treatment. - **Otezla (apremilast)**: Psoriatic arthritis treatment. - **Thalomid (thalidomide)**: Erythema nodosum leprosum and multiple myeloma treatment.

Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40713551/

Comparison of outcomes with elranatamab and real world ... This study provides recent real world evidence of poor outcomes in TCE RRMM in the UK. PFS was longer among patients who received ...

2. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-14624-9

Comparison of outcomes with elranatamab and real world ... Clinical outcomes in the ECA were poor (median PFS 3.71 months [95% confidence interval (CI) 2.73–4.73], median OS 11.00 months [8.02–18.10]).

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.7549

A US subgroup analysis from MagnetisMM-3. Median (95% CI) PFS was 27.3 mo (4.3–NE). Median (95% CI) OS was NR (14.9–NE); the probability of survival at 30 mo (95% CI) was 55.8% (40.1- ...

4. nature.com nature.com/articles/s41591-023-02528-9

Elranatamab in relapsed or refractory multiple myeloma Primary and secondary efficacy endpoints. After a median follow-up of 14.7 months (range: 0.2–25.1 months), the primary endpoint was met with ...

5. pfizer.com pfizer.com/news/press-release/press-release-detail/elrexfiotm-shows-median-overall-survival-more-two-years

ELREXFIO™ Shows Median Overall Survival of More Than ... Patients in MagnetisMM-3 demonstrated a median overall survival (OS) of 24.6 months, with median progression-free survival (PFS) of 17.2 months.

6. ashpublications.org ashpublications.org/blood/article/146/16/1929/546367/Safety-and-efficacy-of-elranatamab-in-patients

Safety and efficacy of elranatamab in patients with relapsed ... Elranatamab elicits deep and rapid heme responses in patients with relapsed AL amyloidosis, including minimal residual disease negativity.