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

  • STATUS
    Recruiting
  • End date
    Jun 9, 2026
  • participants needed
    21
  • sponsor
    AbbVie
Updated on 3 June 2022

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.

Details
Condition Relapsed/Refractory Multiple Myeloma
Treatment ABBV-453
Clinical Study IdentifierNCT05308654
SponsorAbbVie
Last Modified on3 June 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note