Under construction – not a live service
Sign in

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

Next steps

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
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (16)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Universitaetsklinikum AugsburgAugsburgGermanyCompleted
Universitaet LeipzigLeipzigGermanyCompleted
Klinikum NuernbergNurembergGermanyCompleted
Aarhus UniversitetshospitalAarhus NDenmarkCompleted
RigshospitaletCopenhagen OeDenmarkCompleted
Odense University HospitalOdense CDenmarkCompleted
Clinica Universidad de NavarraMadridSpainCompleted
Clínica Universidad de navarraPamplonaSpainCompleted
Hospital Universitario Marqués de ValdecillaSantanderSpainCompleted
Centre Hospitalier Universitaire de LilleLilleFranceCompleted
Centre Hospitalier Universitaire de NantesNantesFranceCompleted
Institut Claudius RegaudToulouseFranceCompleted
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBolognaItalyCompleted
IRCCS Istituto Nazionale Tumori Fondazione PascaleNaplesItalyCompleted
Humanitas Research HospitalRozzanoItalyCompleted
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurinItalyCompleted

Are you the coordinator? Confirm the details

This page is information, not medical advice. Discuss any trial with your doctor.