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Taking peoplePhase 1/2

Surzetoclax alone or with other medicines for adults with multiple myeloma

Tests surzetoclax, alone or combined, in adults with multiple myeloma.

Key facts

Who runs it
AbbVie Deutschland GmbH & Co. KG
Where
Bergamo, Meldola, Milan, Naples, Ravenna, and Turin, ItalySee the 6 sitesAlso in 8 other countries, 27 sites
Trial code
Registry title
A Study to Assess Adverse Events and Change in Disease Activity of Oral Surzetoclax (ABBV-453) 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
88 people, planned
Started
20 Aug 2026
Expected to end
14 Jan 2031
Type of study
Interventional
Record updated
15 July 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 came back or did not respond to earlier treatment, and who have a certain marker in their cancer cells.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Multiple myeloma that came back or did not respond to treatment (relapsed or refractory), with signs of progression during or after the last treatment.
Earlier treatment
Cannot have had etentamig or any BCMA bispecific treatment before. A stem cell transplant must not be recent (see exclusions).
Biomarker or test result
Centrally tested t(11;14) positive and/or BCL2high status.

Main reasons for not taking part

  • Earlier treatment with etentamig or any BCMA bispecific
  • Autologous stem cell transplant within 12 weeks
  • Allogeneic stem cell transplant within 6 months, or graft versus host disease symptoms after one
  • Serious kidney, nerve, mental health, hormone, metabolic, immune, lung or liver disease in the last 6 months that the investigator thinks would harm the person in the study

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • Participants must have confirmed diagnosis of R/R MM with documented evidence of progression during or after the subject's last treatment regimen based on the investigator's determination of the IMWG 2016 criteria
  • ECOG performance status 0 or 1
  • Centrally determined t(11;14) positive status and/or centrally determined BCL2high status

Who cannot take part

  • Participant who has received prior etentamig treatment or prior treatment with any BCMA bispecific
  • Participant who has received an autologous stem cell transplant within 12 weeks, or an allogeneic SCT within ≤ 6 months of the first dose of study treatment. Participant who received an allogenic SCT should not have any symptoms of acute or chronic graft versus host disease
  • Participant who has history of clinically significant renal, neurologic, psychiatric, endocrine, metabolic, immunologic, pulmonary, or hepatic disease within the last 6 months that, in investigator's opinion, would adversely affect the participant in the study

Where in Italy

Also in 8 other countries, 27 sites

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, ItalyNot yet recruiting
  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, ItalyNot yet recruiting
  • Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyNot yet recruiting
  • IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, ItalyNot yet recruiting
  • Azienda Unità Sanitaria Locale della RomagnaRavenna, ItalyNot yet recruiting
  • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyNot yet recruiting

About the trial

What the trial wants to find out

• To characterize the safety, toxicity, and tolerability of surzetoclax in combination with etentamig in biomarker-selected subjects with relapsed or refractory (R/R) Multiple Myeloma (MM) • To determine the recommended doses of surzetoclax and etentamig when given in combination in biomarker-selected subjects with R/R MM

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

Print a page for my doctor

Data and sources

Registry record
Listed 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
Surzetoclax alone or with other medicines for adults with 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 9 November 2026.
Record updated
15 July 2026