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)
Key facts
- Where
- Bergamo, Meldola, Milan, Naples, Ravenna és Turin, OlaszországSee the 6 sites
- Phase
- 1/2. fázis
Where in Olaszország
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, OlaszországToborzás még nem indult
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, OlaszországToborzás még nem indult
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, OlaszországToborzás még nem indult
- IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, OlaszországToborzás még nem indult
- Azienda Unità Sanitaria Locale della RomagnaRavenna, OlaszországToborzás még nem indult
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, OlaszországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AbbVie Deutschland GmbH & Co. KG
- Trial code
- EU 2025-525105-20-00
- Record updated
- 2026. július 15.
- Original description
• 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 MMRead full original descriptionShow less
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
• 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
Inclusion: 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.
Exclusion: 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.