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.
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.
Known or centrally determined t(11;14) positive status and/or centrally determined BCL2high status.
Refractory to or intolerant of all established MM therapies that are known to provide clinical benefit and received all standard of care (SOC) agents in previous line(s) of therapy, including a proteasome inhibitors (PI), an Immunomodulatory drugs (IMID), and an anti-CD38 monoclonal antibody.
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.
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There are 30 Locations for this study
Stanford California, 94305, United States
Miami Florida, 33136, United States
New Orleans Louisiana, 70112, United States
Bethesda Maryland, 20817, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48109, United States
Rochester Minnesota, 55905, United States
New York New York, 10065, United States
Chapel Hill North Carolina, 27514, United States
Durham North Carolina, 27710, United States
Winston-Salem North Carolina, 27157, United States
Philadelphia Pennsylvania, 19104, United States
Nashville Tennessee, 37232, United States
Liverpool New South Wales, 2170, Australia
Fitzroy Melbourne Victoria, 3065, Australia
Richmond Victoria, 3121, Australia
Heidelberg , 3084, Australia
Calgary Alberta, T2N 4, Canada
Toronto Ontario, M5G 2, Canada
Nantes Pays-de-la-Loire, 44000, France
Poitiers Poitou-Charentes, 86000, France
Heidelberg Baden-Wuerttemberg, 69120, Germany
Munich Bayern, 80336, Germany
Ramat Gan Tel-Aviv, 52656, Israel
Tel Aviv-Yafo Tel-Aviv, 64239, Israel
Jerusalem Yerushalayim, 91120, Israel
Madrid , 28027, Spain
Boras Vastra Gotalands Lan, 501 8, Sweden
Leicester England, LE1 5, United Kingdom
London London, City Of, E1 2E, United Kingdom
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