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RecruitingLast updated: 30 September 2025

A study recruiting people with multiple myeloma to evaluate a targeted drug called ABBV-453 when given alone and in combination with other treatmentsA Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of the BCL-2 Inhibitor ABBV-453 Given as Monotherapy or in Combination With Antimyeloma Regimens in Subjects With Multiple Myeloma

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Clinical summary

Summary

Multiple myeloma (MM) is a plasma cell disease characterised by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety and change in disease activity of a drug called ABBV-453 in adults with relapsed/refractory (R/R) MM.

ABBV-453 is an investigational drug being developed for the treatment of R/RMM.

In Substudy 1, there will be a dose escalation phase where participants will receive various doses of ABBV-453 in combination with daratumumab + dexamethasone, to determine the best dose of ABBV-453.

This will be followed by a dose expanion and selection phase where participants will receive 1 of 2 doses of ABBV-453 in combination with daratumumab + dexamethasone, or daratumumab + dexamethasone + pomalidomide (only during the expansion phase).

In Substudy 2, there will be a dose escalation phase where participants will receive various doses of ABBV-453 alone. 

There may be a 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. The effect of the treatment will be frequently checked by medical assessments, blood tests, and side effects.

Conditions

This trial is treating people with relapsed or refractory multiple myeloma

Eligibility

Inclusion

  • Documented diagnosis of multiple myeloma (MM) based on standard international myeloma working group (IMWG) diagnostic criteria.

  • All participants must have measurable disease per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment:

    • Serum M-protein >= 0.5 g/dL (>= 5g/L); OR
    • Urine M-protein >= 200 mg/24 hours; OR
    • For participants without measurable serum and urine M-protein: Serum free light chain (sFLC) ≥ 10 mg/dL (100 mg/L), provided sFLC ratio is abnormal.
  • B-cell lymphoma (BCL)-2 inhibitor treatment naïve.
  • t(11;14) positive status and/or BCL2 high status.

  • Substudy 1 Dose Escalation Cohorts and Substudy 2:

    -- Must be triple class exposed (PI, IMiD and anti-CD38) and have received 3 to 5 lines of prior antimyeloma therapy, and who have no other appropriate treatment options as deemed by the investigator.

  • Substudy 1 Dose Expansion Cohorts:

    • Must be double class exposed (PI, IMiD) and have received 1 to 3 lines of prior antimyeloma therapy.

Exclusion

  • Major surgery within 4 weeks of study treatment or planned during study participation.
  • Active infections: no recent infection requiring systemic treatment that was completed <= 7 days before first dose of study treatment and/or uncontrolled systemic infection.
  • Recent infection requiring systemic treatment that was completed <= 7 days before first dose of study treatment and/or uncontrolled active systemic infection.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

AbbVie

Scientific Title

A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of the BCL-2 Inhibitor ABBV-453 Given as Monotherapy or in Combination With Antimyeloma Regimens in Subjects With Multiple Myeloma

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