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RecruitingLast updated: 14 May 2024

This study is assessing how safe and effective a new targeted therapy (called ABBV-453) is in people with relapsed or refractory multiple myelomaFirst-in-Human Study of the BCL-2 Inhibitor ABBV-453 in Biomarker-Selected Subjects With Relapsed or Refractory Multiple Myeloma

Clinical summary


Eligible participants will receive escalating doses of ABBV-453 (a BCL2 inhibitor) which will be administered via oral tablet once daily.


This trial is treating patients with relapsed or refractory multiple myeloma


Blood Cancers Haematological





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Trial Identifiers

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Trial sponsor


Scientific Title

First-in-Human Study of the BCL-2 Inhibitor ABBV-453 in Biomarker-Selected Subjects With Relapsed or Refractory Multiple Myeloma



  • 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.


  • 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.


  • You have had treatment, but your cancer has come back.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.


  • You have certain types of non-cancer medical conditions.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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Victorian Cancer Registry Victorian Government

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