A Study to Evaluate Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants with Relapsed or Refractory Multiple Myeloma
Key facts
- Where
- Bologna, Naples, Rozzano és Turin, OlaszországSee the 4 sites
- Phase
- 1/2. fázis
Where in Olaszország
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, OlaszországNo longer taking part
- IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, OlaszországNo longer taking part
- Humanitas Research HospitalRozzano, OlaszországNo longer taking part
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, OlaszországNo longer taking part
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
- F. Hoffmann-La Roche AG
- Trial code
- EU 2023-503689-21-00
- Record updated
- 2024. október 10.
- Original description
To evaluate the safety and tolerability of forimtamig when given alone or in combination To evaluate the preliminary anti-tumor activity of forimtamig when given alone or in combination based on objective response rate (ORR), complete response (CR)/stringent complete response (sCR) rate, rate of very good partial response (VGPR) or betterRead full original descriptionShow less
An Open-label, Randomized Phase Ib/II Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants with Relapsed or Refractory Multiple Myeloma
To evaluate the safety and tolerability of forimtamig when given alone or in combination To evaluate the preliminary anti-tumor activity of forimtamig when given alone or in combination based on objective response rate (ORR), complete response (CR)/stringent complete response (sCR) rate, rate of very good partial response (VGPR) or better
Inclusion: Agreement to provide protocol-specific bone marrow biopsy and aspirate samples; Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; Life expectancy of at least 12 weeks; Documented diagnosis of MM according to the International Myeloma Working Group (IMWG) diagnostic criteria; Evidence of progressive disease based on Investigator’s determination of response by IMWG criteria on or after last dosing regimen; Participants with r/r MM who previously received therapy, including an immunomodulatory drugs (IMiDs) and a proteasome inhibitor (PI). Both anti-CD38 naïve and anti-CD38 exposed/refractory participants are allowed.
Exclusion: Waldenström’s macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis; Participants with myelodysplastic syndrome; Plasma cell leukemia with circulating plasma cell count = 5% or >500/µL; Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the last dose of forimtamig, tocilizumab, or carfilzomib, or 102 days after the last dose of daratumumab; Participants with current amyloidosis (e.g., positive Congo Red stain or equivalent in tissue biopsy); Participants with (extramedullary) lesions in proximity of vital organs that may develop sudden decompensation/deterioration in the setting of a tumor flare. Participants may be eligible after discussion with the Medical Monitor.