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Taking people in GermanyPhase 1/2

Tests surzetoclax alone or with other drugs in multiple myeloma

Tests surzetoclax, alone or combined, in adults with relapsed or hard-to-treat multiple myeloma.

Key facts

Who runs it
AbbVie
Where
Hamburg, Heidelberg, Munich, and Wuerzburg, GermanySee the 4 sitesAlso in 11 other countries, 52 sites
Registry title
A Study to Assess Adverse Events and Change in Disease Activity of Oral Surzetoclax Alone or in Combination With Subcutaneous and/or Oral Antimyeloma Agents in Adult Participants With Multiple Myeloma (MM)
Status
Recruiting
Phase
Phase 1/2
People taking part
325 people, planned
Started
23 Jul 2025
Expected to end
Dec 2030
Type of study
Interventional, 8 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Surzetoclax
  • Daratumumab
  • Dexamethasone
  • Pomalidomide
  • Etentamig
Record updated
27 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults whose multiple myeloma has come back or has stopped responding to treatment, and who are positive for t(11;14) and/or BCL2 high status.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Multiple myeloma that has come back or has not responded to treatment (relapsed or refractory), with disease that can be measured by blood or urine tests. There must be proof the disease progressed during or after the last treatment.
Earlier treatment
No earlier treatment with a BCL-2 inhibitor.
Biomarker or test result
t(11;14) positive status and/or BCL2 high status.

Main reasons for not taking part

  • Major surgery within 4 weeks before study treatment, or planned during the study
  • Recent infection needing treatment through the body that ended 14 days or less before the first dose
  • Uncontrolled active infection that affects the whole body

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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
  • Must have confirmed diagnosis of relapsed or refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen, based on the investigator's determination of the international myeloma working group (IMWG) 2016 criteria

Who cannot take part

  • Major surgery within 4 weeks of study treatment or planned during study participation
  • Recent infection requiring systemic treatment that was completed <= 14 days before first dose of study treatment and/or uncontrolled active systemic infection

Where in Germany

Also in 11 other countries, 52 sites

  • University Medical Center Hamburg-EppendorfHamburg, GermanyTaking people
  • Universitaetsklinikum Heidelberg AöRHeidelberg, GermanyTaking people
  • LMU Klinikum Muenchen AöRMunich, GermanyTaking people
  • Universitaetsklinikum Wuerzburg AöRWuerzburg, GermanyTaking people

About the trial

What the trial wants to find out

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 change in disease activity of surzetoclax in adult participants with relapsed/refractory (R/R) MM. Adverse events and change in disease activity will be assessed.

Read full original descriptionShow less

Surzetoclax is an investigational drug being developed for the treatment of R/R MM. In Substudy 1 there will be dose escalation and dose expansion phases where participants will receive various doses (escalation) or 1 of 2 doses (expansion) of surzetoclax in combination with daratumumab + dexamethasone, to determine the best dose of surzetoclax. In Substudy 2, there will be a dose escalation phase where participants will receive various doses of surzetoclax alone. In Substudy 3 there will be dose escalation and optimization phases where participants will receive various doses (escalation) or 1 of 2 doses (optimization) of of surzetoclax and etentamig to determine the best dose of surzetoclax and etentamig. Optimization will also include etentamig received alone. Approximately 325 adult participants with R/R MM will be enrolled in the study in approximately 55 sites worldwide.

In Substudy 1 escalation phase, participants will receive oral surzetoclax tablets in combination with subcutaneous (SC) daratumumab injections + oral dexamethasone tablets and in the expansion phase, will receive 1 of 2 doses oral surzetoclax tablets in combination with SC daratumumab injections + oral dexamethasone tablets or daratumumab injections + oral pomalidomide + oral dexamethasone tablets. In Substudy 2, Japanese participants will receive oral surzetoclax tablets. In Substudy 3 escalation phase, participants will receive oral surzetoclax tablets in combination with IV etentamig and in the expansion phase, will receive 1 of 2 doses of both oral surzetoclax tablets in combination with of IV etentamig, or IV etentamig alone. The total study duration is approximately 4.5 years.

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

The 8 groups in the trial

  • Substudy 1: Dose Escalation Surzetoclax CombinationTreatment being tested

    Participants will receive various doses of surzetoclax in combination with daratumumab + dexamethasone, to determine the best dose of surzetoclax, as part of the total 4.5 year study duration.

    Treatment: Surzetoclax, Daratumumab, and Dexamethasone

  • Substudy 1: Dose Optimization & Selection ABBV-453 CombinationTreatment being tested

    Participants will receive 1 of 2 doses of ABBV-453 in combination with daratumumab + dexamethasone, as part of the total 4.5 year study duration.

    Treatment: Surzetoclax, Daratumumab, and Dexamethasone

  • Substudy 1: Dose Optimization & Selection ControlExisting treatment, for comparison

    Participants will receive daratumumab, dexamethasone, and pomalidomide, as part of the total 4.5 year study duration.

    Treatment: Daratumumab, Dexamethasone, and Pomalidomide

  • Substudy 2: Dose Escalation ABBV-453 MonotherapyTreatment being tested

    Japanese participants will receive various doses of ABBV-453 as a monotherapy, to determine the best dose of ABBV-453, as part of the total 4.5 year study duration.

    Treatment: Surzetoclax

  • Substudy 3: Dose Escalation Surzetoclax + EtentamigTreatment being tested

    Participants will receive various doses of both surzetoclax and etentamig, to determine the best dose of surzetoclax and etentamig, as part of the total 4.5 year study duration.

    Treatment: Surzetoclax and Etentamig

  • Substudy 3: Dose Optimization Etentamig Dose A CombinationTreatment being tested

    Participants will receive etentamig dose A in combination with surzetoclax, as part of the total 4.5 year study duration.

    Treatment: Surzetoclax and Etentamig

  • Substudy 3: Dose Optimization Etentamig Dose B CombinationTreatment being tested

    Participants will receive etentamig dose B in combination with surzetoclax, as part of the total 4.5 year study duration.

    Treatment: Surzetoclax and Etentamig

  • Substudy 3: Dose Optimization Etentamig MonotherapyTreatment being tested

    Participants will receive etentamig, as part of the total 4.5 year study duration.

    Treatment: Surzetoclax and Etentamig

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of the BCL-2 Inhibitor Surzetoclax (ABBV-453) Given as Monotherapy or in Combination With Antimyeloma Regimens in Subjects With Multiple Myeloma
Plain-language title
Tests surzetoclax alone or with other drugs in multiple myelomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
27 October 2026