Multiple Myeloma Clinical Trial

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

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. This study will include a dose escalation phase to determine the best dose of ABBV-453. Approximately 21 adult participants with R/R MM will be enrolled in the study in approximately 12 sites worldwide.

Participants will receive oral ABBV-453 tablets once daily (QD) 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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

360

Study ID:

NCT05308654

Recruitment Status:

Recruiting

Sponsor:

AbbVie

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There are 20 Locations for this study

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Stanford University School of Med /ID# 242809
Stanford California, 94305, United States
Sylvester Comprehensive Cancer Center /ID# 243417
Miami Florida, 33136, United States
Tulane University /ID# 244854
New Orleans Louisiana, 70112, United States
American Oncology Partners of Maryland, PA /ID# 244858
Bethesda Maryland, 20817, United States
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 242754
Ann Arbor Michigan, 48109, United States
Mayo Clinic - Rochester /ID# 242844
Rochester Minnesota, 55905, United States
Memorial Sloan Kettering Cancer Center /ID# 243503
New York New York, 10065, United States
Univ NC Chapel Hill /ID# 243420
Chapel Hill North Carolina, 27514, United States
Duke Univ Med Ctr /ID# 242808
Durham North Carolina, 27710, United States
Wake Forest Baptist Health /ID# 244252
Winston-Salem North Carolina, 27157, United States
Penn Presbyterian Medical Center /ID# 242842
Philadelphia Pennsylvania, 19104, United States
Vanderbilt Ingram Cancer Center /ID# 242810
Nashville Tennessee, 37232, United States
Liverpool Hospital /ID# 244826
Liverpool New South Wales, 2170, Australia
St Vincent's Hospital Melbourne /ID# 244827
Fitzroy Melbourne Victoria, 3065, Australia
St. Vincent's Private Hospital Melbourne /ID# 262631
Fitzroy Victoria, 3065, Australia
Austin Health and Ludwig Institute for Cancer Research /ID# 248311
Heidelberg Victoria, 3084, Australia
Epworth Healthcare /ID# 248705
Richmond Victoria, 3121, Australia
The Chaim Sheba Medical Center /ID# 250482
Ramat Gan Tel-Aviv, 52656, Israel
Tel Aviv Sourasky Medical Center /ID# 250483
Tel Aviv Tel-Aviv, 64239, Israel
Hadassah Medical Center-Hebrew University /ID# 250484
Jerusalem Yerushalayim, 91120, Israel
Barts Health NHS Trust /ID# 248972
London London, City Of, E1 2E, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

360

Study ID:

NCT05308654

Recruitment Status:

Recruiting

Sponsor:


AbbVie

How clear is this clinincal trial information?

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