ABBV-453 for Multiple Myeloma

Recruiting at 40 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Must not be taking: Venetoclax, BCL-2 inhibitors

Disqualifiers: ECG abnormalities, others

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

Compensation: Varies

Number of Visits: Unknown

34 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effects of ABBV-453, a new treatment for multiple myeloma (MM), a cancer affecting plasma cells in the bone marrow. Initially, the trial will determine the optimal dose of ABBV-453 alone, then test it in combination with other drugs such as dexamethasone, daratumumab, and lenalidomide. The trial seeks individuals with MM that has recurred or is unresponsive to other treatments, and who have already tried multiple therapies without success. Participants must be able to visit a hospital or clinic regularly for check-ups and tests. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants in Part 2, Arm 1 must be refractory to or intolerant of all established multiple myeloma therapies, which might imply stopping those treatments. It's best to discuss your specific medications with the trial team.

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

Research shows that ABBV-453 remains in the early stages of testing for safety in humans. In previous studies, researchers closely monitored for any unwanted side effects and changes in disease activity, assessing how well participants tolerated the drug and identifying any negative reactions.

In this trial, ABBV-453 is administered alone and in combination with other drugs like daratumumab, lenalidomide, and dexamethasone. These additional drugs have been used previously for multiple myeloma and are known to be safe. For instance, combining daratumumab with lenalidomide and dexamethasone has yielded good results, but it is crucial to evaluate how ABBV-453 interacts with them.

As ABBV-453 is in an early phase of trials, safety data continues to be collected. The trial aims to determine the optimal dose, with participants closely monitored for any side effects and changes in their condition. Participation involves regular clinic visits and frequent health checks to ensure safety. ^{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 represents a novel approach in the treatment landscape. Unlike standard treatments like bortezomib or lenalidomide, ABBV-453 is being tested in combination regimens that target multiple pathways simultaneously. This includes pairing with daratumumab, which is known for targeting CD38 on myeloma cells, and dexamethasone, a steroid that helps reduce inflammation. ABBV-453's unique combination strategies aim to enhance treatment efficacy and potentially overcome resistance seen in current therapies. By exploring these innovative combinations, researchers hope to offer more effective options for patients with relapsed or refractory multiple myeloma.

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

Research has shown that ABBV-453 is a new drug being tested for treating multiple myeloma that has returned or is not responding to treatment. Early studies are examining its safety and effectiveness in reducing the disease. In this trial, participants in different arms will receive ABBV-453 combined with other drugs. For example, one arm will receive ABBV-453 with daratumumab and dexamethasone, while another arm will include lenalidomide in the combination. Previous studies showed that daratumumab had a 92% overall response rate (ORR), and adding lenalidomide increased the ORR to 95%, with many patients experiencing significant improvement or complete remission. These results suggest that ABBV-453, especially when used with other treatments, could be promising for patients with multiple myeloma. ^{1 3 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, meet specific lab criteria, and are in good enough health to participate. Those in earlier parts of the trial must have tried all other beneficial treatments without success. Later parts require having had 1-3 prior therapies but no previous treatment with certain inhibitors.

Inclusion Criteria

You have a disease that can be measured according to the study's guidelines.

I have been diagnosed with multiple myeloma according to IMWG standards.

My cancer has a specific genetic feature (t(11;14) positive or BCL2high).

Exclusion Criteria

I have been treated with venetoclax or a BCL-2 inhibitor before.

You have important abnormalities in your heart's electrical activity, as described in the study guidelines.

I have previously been treated with daratumumab or another anti-CD38 therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Monotherapy Dose Escalation

Participants receive escalating doses of ABBV-453 to determine the maximum tolerated dose

28-day cycles

Regular visits at approved institutions

Treatment - Part 2 Arm 1

Participants receive continuous doses of ABBV-453 with dexamethasone in 28-day cycles

Up to 12 months

Regular visits at approved institutions

Treatment - Part 2 Arm 2

Participants receive ABBV-453 with daratumumab and dexamethasone in 28-day cycles

Up to 12 months

Regular visits at approved institutions

Treatment - Part 2 Arm 3

Participants receive ABBV-453 with daratumumab, lenalidomide, and dexamethasone in 28-day cycles

Up to 12 months

Regular visits at approved institutions

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 36 months

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-453

Trial Overview The safety and effectiveness of ABBV-453 tablets for Multiple Myeloma are being tested. Participants will receive different combinations of ABBV-453 with dexamethasone, daratumumab, and lenalidomide across various groups to find the best dose and assess changes in their condition.

How Is the Trial Designed?

Group I: Part 2: Arm 3 Experimental Treatment 4 Interventions

Participants will receive continuous doses of ABBV-453 in combination with daratumumab, lenalidomide, and dexamethasone in 28-day cycles.

Group II: Part 2: Arm 2 Experimental Treatment 3 Interventions

Participants will receive continuous doses of ABBV-453 in combination with daratumumab and dexamethasone in 28-day cycles.

Group III: Part 2: Arm 1 Experimental Treatment 2 Interventions

Participants will receive continuous doses of ABBV-453 in combination with dexamethasone in 28-day cycles.

Group IV: Part 1: Monotherapy Dose Escalation Experimental Treatment 1 Intervention

Participants with relapsed or refractory (R/R) multiple myeloma (MM) will receive escalating doses of ABBV-453, until the maximum tolerated dose (MTD) is determined.

Group V: Japan Cohort Experimental Treatment 1 Intervention

Participants with R/R MM will receive escalating doses of ABBV-453, until the MTD is determined.

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.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 ...

3. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M25-275

A Study to Assess Adverse Events and Change in Disease ... A Study to Assess Adverse Events and Change in Disease Activity of Oral ABBV-453 Alone or in Combination With Subcutaneous and/or Oral Antimyeloma Agents in ...

4. 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.

5. 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 ...

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

M21-406 The purpose of this study is to assess the safety and toxicity of ABBV-453 in adult participants with relapsed/refractory (R/R) MM. Adverse events and change ...

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-04694

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