2023-503689-21-00CompletedPhase 1/2
A Study to Evaluate Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants with Relapsed or Refractory Multiple Myeloma
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 10 Oct 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 73 (actual)
- First submitted
- 5 Jul 2023
- Start date
- 5 Dec 2023
- Lead sponsor
- F. Hoffmann-La Roche AG
- Diseases
- Multiple myeloma
- EU CT number
- 2023-503689-21-00
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 73
- 16 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Waldenström’s macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis
- Participants with myelodysplastic syndrome
Lab values
- Plasma cell leukemia with circulating plasma cell count = 5% or >500/µL
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaetsklinikum Augsburg | Augsburg | Germany | Completed |
| Universitaet Leipzig | Leipzig | Germany | Completed |
| Klinikum Nuernberg | Nuremberg | Germany | Completed |
| Aarhus Universitetshospital | Aarhus N | Denmark | Completed |
| Rigshospitalet | Copenhagen Oe | Denmark | Completed |
| Odense University Hospital | Odense C | Denmark | Completed |
| Clinica Universidad de Navarra | Madrid | Spain | Completed |
| Clínica Universidad de navarra | Pamplona | Spain | Completed |
| Hospital Universitario Marqués de Valdecilla | Santander | Spain | Completed |
| Centre Hospitalier Universitaire de Lille | Lille | France | Completed |
| Centre Hospitalier Universitaire de Nantes | Nantes | France | Completed |
| Institut Claudius Regaud | Toulouse | France | Completed |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico | Bologna | Italy | Completed |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale | Naples | Italy | Completed |
| Humanitas Research Hospital | Rozzano | Italy | Completed |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino | Turin | Italy | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.