ABBV-453 for Multiple Myeloma

Recruiting at 28 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: AbbVie

Must be taking: Daratumumab, Dexamethasone

Disqualifiers: Major surgery, Active infections, others

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

Compensation: Varies

Number of Visits: Unknown

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial examines a new drug, ABBV-453, to determine its safety and effectiveness for individuals with multiple myeloma, a type of bone marrow cancer that has returned or is unresponsive to treatment. Researchers will test various doses of ABBV-453, sometimes in combination with other medications like daratumumab (an antibody therapy) and dexamethasone (a corticosteroid), to identify the optimal dose. Participants will undergo regular check-ups and tests to monitor the treatment's effects and any side effects. This trial may suit adults who have tried several other treatments for multiple myeloma without success. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop your current medications. However, since the trial involves specific drug combinations, it's possible that some medications might need to be adjusted. Please consult with the trial coordinators for detailed guidance.

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

Research shows that ABBV-453 is being tested for safety in treating relapsed or refractory multiple myeloma (R/R MM), a type of blood cancer. This testing includes using ABBV-453 alone and in combination with other medications. Earlier studies have focused on identifying any unwanted effects that might occur during treatment.

For ABBV-453 on its own, studies are ongoing to assess safety and possible side effects. Researchers closely monitor the drug to ensure it is safe for participants. When ABBV-453 is combined with daratumumab and dexamethasone, researchers also examine side effects to find the optimal dose that is both effective and safe.

The trial is in its early stages, so safety remains a major focus. Early trials like this involve close monitoring, allowing for quick identification and management of any side effects. The safety information from these studies will help determine how well participants can tolerate the drug. While ABBV-453 is still under investigation, daratumumab and dexamethasone are already used treatments with well-known safety records. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ABBV-453 for multiple myeloma because it introduces a novel approach to treating this condition. Unlike most treatments that target the cancer cells directly, ABBV-453 is believed to target specific proteins involved in the growth and survival of cancer cells, offering a potentially more precise method of attack. Additionally, ABBV-453 can be used alone or in combination with established drugs like daratumumab and dexamethasone, providing flexibility in treatment plans. This versatility, combined with its unique mechanism of action, offers hope for improved outcomes in multiple myeloma patients.

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

This trial studies ABBV-453 both as a monotherapy and in combination with other drugs for relapsed/refractory multiple myeloma (R/R MM). Participants in one arm will receive ABBV-453 alone, while others will receive it with daratumumab and dexamethasone. Research suggests that ABBV-453 aims to alter disease behavior, potentially slowing cancer cell growth in the bone marrow. Previous studies on similar combinations, including daratumumab and dexamethasone, have shown promising results in reducing myeloma activity. Daratumumab, in particular, has been very successful in treating myeloma when combined with other drugs, with some patients showing significant improvement. While ABBV-453 is still under investigation, its method of targeting cancer cells offers hope for better outcomes in treating this condition. ^{1 2 3 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Adults with relapsed/refractory multiple myeloma who've tried and failed several treatments can join. They should have specific genetic markers (t(11;14) positive or BCL2 high status), not have had BCL-2 inhibitors before, and meet certain protein criteria in their blood or urine.

Inclusion Criteria

My cancer has specific genetic markers (t(11;14) or high BCL2).

All participants must have measurable disease per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment: Serum M-protein >= 0.5 g/dL (>= 5g/L), Urine M-protein >= 200 mg/24 hours, For participants without measurable serum and urine M-protein: Serum free light chain (sFLC) >= 10 mg/dL (100 mg/L), provided sFLC ratio is abnormal

I've had 3-5 prior treatments for myeloma and no other treatment options are suitable for me.

Exclusion Criteria

I finished treatment for an infection less than a week ago or have an ongoing infection.

I haven't had a serious infection needing treatment in the last week.

I haven't had major surgery in the last 4 weeks and don't plan any during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive various doses of ABBV-453 in combination with daratumumab + dexamethasone to determine the best dose of ABBV-453

Up to 45 months

Regular visits for medical assessments and blood tests

Dose Expansion and Selection

Participants receive 1 of 2 doses of ABBV-453 in combination with daratumumab + dexamethasone, or daratumumab + dexamethasone + pomalidomide

Up to 45 months

Regular visits for medical assessments and blood tests

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-453
• Daratumumab
• Dexamethasone
• Pomalidomide

Trial Overview

The trial is testing ABBV-453, alone or with other drugs (daratumumab, dexamethasone, pomalidomide), to see how it affects disease activity and safety. It includes dose-finding phases and expansion phases across global sites over about 4.5 years.

How Is the Trial Designed?

Group I: Substudy 2: Dose Escalation ABBV-453 Monotherapy Experimental Treatment 1 Intervention

Japanese participants will receive various doses of ABBV-453 as a monotherapy, to determine the best dose of ABBV-453, as part of the total 4.5 year study duration.

Group II: Substudy 1: Dose Expansion and Selection ABBV-453 Combination Experimental Treatment 3 Interventions

Participants will receive 1 of 2 doses of ABBV-453 in combination with daratumumab + dexamethasone, as part of the total 4.5 year study duration.

Group III: Substudy 1: Dose Escalation ABBV-453 Combination Experimental Treatment 3 Interventions

Participants will receive various doses of ABBV-453 in combination with daratumumab + dexamethasone, to determine the best dose of ABBV-453, as part of the total 4.5 year study duration.

Group IV: Substudy 1: Dose Expansion and Selection Control Active Control 3 Interventions

Participants will receive daratumumab, dexamethasone, and pomalidomide, as part of the total 4.5 year 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.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05308654

NCT05308654 | A Study to Assess the Adverse Events and ...

The purpose of this study is to assess the safety and toxicity of ABBV-453 in adult participants with relapsed/refractory (R/R) MM.

2.

clinicaltrials.eu

clinicaltrials.eu/trial/study-of-abbv-453-alone-or-with-drug-combination-for-adults-with-multiple-myeloma-evaluation-of-safety-and-effectiveness/

Study of ABBV-453 alone or with drug combination for ...

This study focuses on patients with Multiple Myeloma, a type of blood cancer that develops in plasma cells found in bone marrow.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06953960

NCT06953960 | A Study to Assess Adverse Events and ...

The purpose of this study is to assess the safety and change in disease activity of ABBV-453 in adult participants with relapsed/refractory (R/R) MM. Adverse ...

4.

tipranks.com

tipranks.com/news/company-announcements/abbvies-promising-study-on-abbv-453-for-multiple-myeloma-a-potential-game-changer

AbbVie's Promising Study on ABBV-453 for Multiple Myeloma

The study employs a randomized, sequential intervention model with no masking, focusing on treatment as its primary purpose. This design allows ...

5.

abbvieclinicaltrials.com

abbvieclinicaltrials.com/study/?id=M21-406

M21-406

A study to assess the adverse events and change in disease activity in adult participants with relapsed or refractory multiple myeloma receiving oral ABBV-453 ...

6.

dana-farber.org

dana-farber.org/clinical-trials/25-558

A Phase 1/2, Open-Label, Platform Study to Evaluate ...

Adverse events and change in disease activity will be assessed. ABBV-453 is an investigational drug being developed for the treatment of R/R MM. In Substudy 1 ...

7.

theglobeandmail.com

theglobeandmail.com/investing/markets/stocks/ABBV/pressreleases/34185747/abbvies-abbv-453-study-a-potential-game-changer-for-multiple-myeloma-treatment/

AbbVie's ABBV-453 Study: A Potential Game-Changer for ...

' The study aims to evaluate the safety and toxicity of ABBV-453 in adults with relapsed or refractory multiple myeloma (R/R MM), focusing on ...