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
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
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.
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.
Multiple Myeloma,
Phase I
Phase I
Adults
Mol. targeted/Immunotherapy/Biologics
ABBV-453
Baljevic, Muhamed
International
Vanderbilt University
01-03-2023
Treatment
VICCHEMP2230
NCT05308654
Eligibility
19 Years
BOTH
NO
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status
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.
Eastern Cooperative Oncology Group (ECOG) performance status
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.
