ABBV-453 for Multiple Myeloma

Recruiting at 39 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

Trial Summary

What is the purpose of this trial?

This trial tests ABBV-453, a new drug for adults with multiple myeloma that has come back or didn't respond to other treatments. The drug aims to stop cancer cell growth and is tested alone or with other medications to find the best treatment combination.

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.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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