Etentamig for Multiple Myeloma

Recruiting at 18 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: AbbVie

Disqualifiers: CNS involvement, Active infection, others

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

Compensation: Varies

Number of Visits: Unknown

440 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, Etentamig, to determine its safety and effectiveness for people with multiple myeloma, a blood cancer that affects the bones and can cause pain and weakness. The study consists of several parts, where participants receive different doses of Etentamig, sometimes combined with other medications, to identify the best combination. Suitable candidates for this trial have been diagnosed with multiple myeloma that is either new or has not responded well to other treatments. Participants must visit the hospital or clinic regularly for check-ups and tests. As a Phase 1/Phase 2 trial, this research aims to understand how Etentamig works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking treatment development.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop your current medications. However, since the study involves new drug combinations, it's possible that changes to your medication may be required. Please consult with the trial coordinators for specific guidance.

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

Research has shown that etentamig has a manageable safety profile for patients with relapsed or refractory multiple myeloma. In earlier studies, etentamig was linked to a low rate of serious infections, indicating a positive safety sign. Patients have generally tolerated etentamig well, with manageable side effects. While some side effects might occur, they are not severe for most people. However, individual experiences can differ, so participants should discuss potential risks and side effects with their healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Etentamig for treating multiple myeloma because it offers a novel approach compared to standard treatments like bortezomib, lenalidomide, and dexamethasone. Unlike these treatments, Etentamig potentially targets the disease through a unique mechanism that may enhance its ability to combat cancer cells. Additionally, its use in combination with other drugs like carfilzomib and daratumumab could lead to improved outcomes by attacking the cancer through multiple pathways. This innovative strategy has the potential to overcome resistance seen with current therapies, providing new hope for patients battling this challenging disease.

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

Research has shown that etentamig may help treat relapsed or refractory multiple myeloma (MM). In studies, etentamig reduced cancer signs in nearly 7 out of 10 patients whose MM had returned or did not respond to previous treatments. This trial will administer different doses and combinations of etentamig across various treatment arms. The treatment effects persisted over time, and most patients tolerated it well. These findings suggest that etentamig could be a useful option for managing MM, especially for those with limited alternatives. ^{1 3 6 7 8}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for adults with multiple myeloma, a type of blood cancer. Participants can be newly diagnosed or have relapsed/refractory MM and must be able to perform daily activities with minimal assistance (ECOG performance ≤1).

Inclusion Criteria

I am fully active and can carry on all my pre-disease activities without restriction.

I have been diagnosed with multiple myeloma, either new or relapsed/refractory.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of etentamig alone or in combination with other drugs

8 weeks

Regular visits at hospital or clinic

Dose Expansion

Participants receive etentamig at established dose levels alone or in combination with other drugs

52 weeks

Regular visits at hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Carfilzomib
• Daratumumab
• Dexamethasone
• Etentamig
• Lenalidomide

Trial Overview The study tests Etentamig alone or combined with other drugs (Daratumumab, Lenalidomide, Dexamethasone, Carfilzomib) in various phases to assess its safety and effectiveness against MM. It involves regular hospital visits for IV infusions and monitoring.

How Is the Trial Designed?

Group I: Substudy 4: Etentamig Dose Expansion Dose Level 2 Experimental Treatment 2 Interventions

Participants will receive dose level 2 of etentamig in combination with R, as part of the approximately 130 month study duration.

Group II: Substudy 4: Etentamig Dose Expansion Dose Level 1 Experimental Treatment 2 Interventions

Participants will receive dose level 1 of etentamig in combination with R, as part of the approximately 130 month study duration.

Group III: Substudy 4: Etentamig Dose Escalation Experimental Treatment 2 Interventions

Participants will receive escalating etentamig in combination with R, as part of the approximately 130 month study duration.

Group IV: Substudy 3: Etentamig Dose Expansion Dose Level 2 Experimental Treatment 3 Interventions

Participants will receive dose level 2 of etentamig in combination with Kd, as part of the approximately 130 month study duration.

Group V: Substudy 3: Etentamig Dose Expansion Dose Level 1 Experimental Treatment 3 Interventions

Participants will receive dose level 1 of etentamig in combination with Kd, as part of the approximately 130 month study duration.

Group VI: Substudy 3: Etentamig Dose Escalation Experimental Treatment 3 Interventions

Participants will receive escalating etentamig in combination with carfilzomib, and dexamethasone (Kd), as part of the approximately 130 month study duration.

Group VII: Substudy 3: Comparator Experimental Treatment 3 Interventions

Participants will receive daratumumab, carfilzomib, and dexamethasone (DKd), as part of the approximately 130 month study duration.

Group VIII: Substudy 2: Etentamig Dose Expansion Dose Level 2 Experimental Treatment 1 Intervention

Participants will receive dose level 2 of etentamig, as part of the approximately 130 month study duration.

Group IX: Substudy 2: Etentamig Dose Expansion Dose Level 1 Experimental Treatment 1 Intervention

Participants will receive dose level 1 of etentamig, as part of the approximately 130 month study duration.

Group X: Substudy 2: Etentamig Dose Escalation Experimental Treatment 1 Intervention

Participants will receive escalating etentamig, as part of the approximately 130 month study duration.

Group XI: Substudy 2: Comparator Experimental Treatment 1 Intervention

Participants will receive lenalidomide (R), as part of the approximately 130 month study duration.

Group XII: Substudy 1: Etentamig Dose Expansion Dose Level 2 Experimental Treatment 3 Interventions

Participants will receive dose level 2 of etentamig in combination with DR, as part of the approximately 130 month study duration.

Group XIII: Substudy 1: Etentamig Dose Expansion Dose Level 1 Experimental Treatment 3 Interventions

Participants will receive dose level 1 of etentamig in combination with DR, as part of the approximately 130 month study duration.

Group XIV: Substudy 1: Etentamig Dose Escalation Experimental Treatment 3 Interventions

Participants will receive escalating etentamig in combination with daratumumab, and lenalidomide (DR), as part of the approximately 130 month study duration.

Group XV: Substudy 1: Comparator Experimental Treatment 3 Interventions

Participants will receive daratumumab, lenalidomide, and dexamethasone (DRd), as part of the approximately 130 month study duration.

Who Is Running the Clinical Trial?

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. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.7527

Long-term efficacy and safety of etentamig, a B-cell ... Tumor response was assessed per IMWG 2016 criteria. Results: Of 146 pts with RRMM who received etenta, 87 (60%) were male, median age (range) ...

2. 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% ...

3. cancernetwork.com cancernetwork.com/view/etentamig-displays-durable-responses-tolerability-in-r-r-multiple-myeloma

Etentamig Displays Durable Responses, Tolerability in R/R ... Efficacy data revealed that the objective response rate (ORR) was 66% among efficacy-evaluable patients with relapsed/refractory multiple ...

4. myeloma.org myeloma.org/sparkcures/trial/1360/NCT05650632

Etentamig Preliminary efficacy data show early and high response rates, consistent with outcomes from other ABBV-383 studies.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06892522

NCT06892522 | A Study to Assess Change in Disease ... A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Multiple Myeloma Receiving Etentamig (ABBV-383) as an ...

6. myeloma.org myeloma.org/sparkcures/trial/1245

Etentamig As of May 15, 2024, 74 pts were enrolled and treated across 3 dose levels of ABBV-383 plus Dd. Median age was 69 years (range 39–89) and 45 (61%) pts were male.

7. pharmacytimes.com pharmacytimes.com/view/etentamig-shows-manageable-safety-and-low-severe-infection-risk-in-rrmm

Etentamig Shows Manageable Safety and Low Severe ... Etentamig shows a manageable safety profile with low incidence of severe infections in patients with relapsed/refractory multiple myeloma. The ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05259839

NCT05259839 | A Study to Assess Adverse Events and ... The purpose of this study is to assess the safety and toxicity of etentamig (ABBV-383) when co-administered with pomalidomide-dexamethasone (Pd), lenalidomide- ...