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 Tablets

NCT05308654 · tracked via the Priya Life Science UK tracker

Sponsor

AbbVie

Phase

Phase 1

Started

2022-05-17

Last updated

2025-08-14

Condition(s) studied

Relapsed/Refractory Multiple Myeloma

Investigational drug(s) / intervention(s)

ABBV-453DexamethasoneDaratumumabLenalidomide

ABBV-453: Oral; Tablet

Dexamethasone: Oral Tablet

Daratumumab: Subcutaneous Injection

Lenalidomide: Oral Capsule

Study summary

Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. 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 in disease activity will be assessed.

ABBV-453 is an investigational drug being developed for the treatment of R/R MM. Part 1 will be a monotherapy dose escalation phase to determine the best dose of ABBV-453. In Part 2, participants are placed in 1 of 3 groups called treatment arms. Each group receives a different treatment. Approximately 28 to 48 adult participants in Part 1 and 150 to 312 adult participants in Part 2 with R/R MM will be enrolled in the study in approximately 70 sites worldwide.

In Part 1 and the Japan Cohort, Participants will receive oral ABBV-453 tablets once daily (QD) in 28-day cycles. In Part 2, Arm 1, participants will receive continuous doses of oral ABBV-453 tablets QD in combination with oral dexamethasone tablets once weekly in 28-day cycles. In Part 2, Arm 2, participants will receive continuous doses of oral ABBV-453 tablets QD in combination with subcutaneous injections of daratumumab every 1 to 4 weeks and oral dexamethasone tablets once weekly in, 28-day cycles. In Part 2, Arm 3, participants will receive continuous doses of oral ABBV-453 tablets QD in combination with subcutaneous injections of daratumumab every 1 to 4 weeks, oral lenalidomide capsules QD on Days 1-21, and oral dexamethasone tablets once weekly, in 28-day cycles.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, and side effects.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status \<= 1. * Laboratory values meeting the criteria outlined in the protocol. * Documented diagnosis of multiple myeloma (MM) based on standard International Myeloma Working Group (IMWG) criteria. * Has measurable disease at screening as defined in the protocol. * Locally documented or centrally determined t(11;14) positive status and/or centrally determined BCL2high status. Note: If local testing for t(11;14) is discordant with central testing for t(11;14) status, a detailed review of central and local results for t(11;14) status is required to ensure the participants' safety. * Part 1 and Part 2, Arm 1 Only: Refractory to or intolerant of all established MM therapies that are known to provide clinical benefit and are triple class exposed to a proteasome inhibitors (PI), an Immunomodulatory drugs (IMID), and an anti-CD38 monoclonal antibody in previous line(s) of therapy. * Part 2, Arms 2 and 3 Only: Received 1 to 3 prior lines of therapy, including a PI or an IMiD. * Part 1 only: Permitted to be venetoclax or BCL-2 inhibitor exposed in previous lines of therapy. * Life expectancy \>= 12 weeks. Exclusion Criteria: * Clinically relevant or significant Electrocardiogram (ECG) abnormalities as outlined in the protocol. * Part 2 only: Previous treatment with venetoclax or BCL-2 inhibitor. * Part 2, Arms 2 and 3 only: Prior daratumumab or other anti-CD38 therapy exposure that meets any of the criteria outlined in the protocol.

Primary outcome measure(s)

Overall Response Rate (ORR) per International Myeloma Working Group (IMWG) Criteria — Up to Approximately 12 Months
ORR is defined as the percentage of participants with a confirmed best overall response (BOR) of partial response (PR) + very good partial response (VGPR) + complete response (CR) + stringent complete response (sCR) as assessed by investigators per adapted IMWG criteria for relapsed or refractory (R/R) multiple myeloma (MM).

Trial sites (21)

Facility	City	Region
Stanford University School of Med /ID# 242809	Stanford	California
Sylvester Comprehensive Cancer Center /ID# 243417	Miami	Florida
Tulane University School of Medicine /ID# 244854	New Orleans	Louisiana
American Oncology Partners of Maryland /ID# 244858	Bethesda	Maryland
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 242754	Ann Arbor	Michigan
Mayo Clinic - Rochester /ID# 242844	Rochester	Minnesota
Memorial Sloan Kettering Cancer Center /ID# 243503	New York	New York
Atrium Health Levine Cancer Institute /ID# 243420	Charlotte	North Carolina
Duke Univ Med Ctr /ID# 242808	Durham	North Carolina
Wake Forest Baptist Health /ID# 244252	Winston-Salem	North Carolina
University of Pennsylvania /ID# 242842	Philadelphia	Pennsylvania
Vanderbilt Ingram Cancer Center /ID# 242810	Nashville	Tennessee
Liverpool Hospital /ID# 244826	Liverpool	New South Wales
St. Vincent's Private Hospital Melbourne /ID# 262631	Fitzroy	Victoria
St Vincent's Hospital Melbourne /ID# 244827	Fitzroy Melbourne	Victoria
Austin Health and Ludwig Institute for Cancer Research /ID# 248311	Heidelberg	Victoria
Epworth Healthcare /ID# 248705	Richmond	Victoria
Hadassah Medical Center-Hebrew University /ID# 250484	Jerusalem	Jerusalem
The Chaim Sheba Medical Center /ID# 250482	Ramat Gan	Tel Aviv
Tel Aviv Sourasky Medical Center /ID# 250483	Tel Aviv	Tel Aviv
Barts Health NHS Trust /ID# 248972	London	London, City of

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05308654 on ClinicalTrials.gov ↗ ← All trials in the UK