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A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma

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Titre complet:
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
Stade ou Condition:
Relapsed or Refractory Multiple Myeloma
Phase d'étude:
Phase 1/Phase 2
Résumé:
The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of forimtamig when administered alone or in combination with carfilzomib or daratumumab or other combination partners in participants with relapsed or refractory multiple myeloma (r/r MM). The study consists of two phases: a dose exploration phase and a dose-expansion phase.
Description détaillée:
Non disponible
Traitements:
Drug : Forimtamig

Forimtamig will be administered SC at different doses during dose exploration phase. Forimtamig will be administered at a fixed dose determined during dose exploration phase in dose expansion phase.

Drug : Carfilzomib

Carfilzomib will be administered via IV infusion in combination with forimtamig.

Drug : Daratumumab

Daratumumab will be administered via SC injection in combination with forimtamig.

Groupes d'étude:
Experimental : Dose Exploration Phase: Forimtamig (Dose 1) + Carfilzomib
Participants will receive Dose 1 of forimtamig, subcutaneous (SC) injection in combination with carfilzomib, intravenous (IV) infusion until disease progression.
Experimental : Dose Exploration Phase: Forimtamig (Dose 2) + Carfilzomib
Participants will receive Dose 2 of forimtamig, SC injection in combination with carfilzomib, IV infusion until disease progression.
Experimental : Dose Exploration Phase: Forimtamig (Dose 3) + Carfilzomib
Participants will receive Dose 3 of forimtamig, SC injection in combination with carfilzomib, IV infusion until disease progression.
Experimental : Dose Exploration Phase: Forimtamig (Dose 1) + Daratumumab
Participants will receive Dose 1 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression.
Experimental : Dose Exploration Phase: Forimtamig (Dose 2) + Daratumumab
Participants will receive Dose 2 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression.
Experimental : Dose Exploration Phase: Forimtamig (Dose 3) + Daratumumab
Participants will receive Dose 3 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression.
Experimental : Dose Expansion Phase: Forimtamig
Participants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase until disease progression or completion of 12 months of treatment, whichever occurs first.
Experimental : Dose Expansion Phase: Forimtamig + Carfilzomib
Participants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase in combination with carfilzomib, IV infusion until disease progression.
Experimental : Dose Expansion Phase: Forimtamig + Daratumumab
Participants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase in combination with daratumumab, SC injection until disease progression.
Type d'étude:
Interventional
Protocole de l'étude:
Allocation: Randomized
Intervention Model: Sequential Assignment
Primary Purpose: Treatment
Masking: None (Open Label)
Statut du recrutement:
En cours
Critères d'admissibilités:
Inclusion Criteria:
  • 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 IMWG diagnostic criteria
  • Evidence of progressive disease based on Investigator's determination of response by IMWG criteria on or after last dosing regimen
  • Measurable disease
  • AEs from prior anti-cancer therapy resolved to Grade ≤ 1,
  • Adequate organ functions
Exclusion Criteria:
  • Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the last dose of study drug
  • Plasma cell leukemia with circulating plasma cell count ≥ 5% or >500/microliter (µL)
  • Participants with known amyloidosis
  • Participants with myelodysplastic syndrome
  • Prior treatment with monoclonal antibody (mAb) and antibody-drug conjugate within 4 weeks or 5 half-lives of the drug, whichever is shorter
  • Prior anti-cancer therapy (chemotherapy, small molecule/tyrosine kinase inhibitors, radiotherapy) within 14 days prior to first forimtamig administration
  • Prior solid organ transplantation
  • Active auto-immune disease or flare within 6 months prior to start of study treatment
  • Known or suspected chronic active Epstein-Barr virus (EBV) infection
  • Hepatitis B virus (HBV) infection
  • Acute or chronic hepatitis C virus (HCV) infection
  • Known history of HIV seropositivity
  • Live vaccine(s) within one month prior to start of the treatment
  • Participants not fully vaccinated for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as per local recommendations
  • Previous refractoriness to carfilzomib
  • Participants who discontinued prior carfilzomib treatment due to treatment-related toxicity
  • Participants with known liver cirrhosis
  • Participants eligible for allogeneic stem cell transplantation (SCT) or autologous SCT at the time of enrollment for Study BP43437 are excluded
Lieux / Centres:

Hamilton Health Sciences, Hamilton, Ontario – En cours

Contacts:
Name: Reference Study ID Number: BP43437 https://forpatients.roche.com/
Phone: 888-662-6728 (U.S. Only)
Email: [email protected]
Publications:
???
Date d’affichage:
2023-09-26
Date de début:
December 12, 2023
Dernière mise à jour:
2024-04-12
Nombre d'inscriptions anticipées:
316
Date de fin prévue:
2027-06-10
Date de fin prévue de l'étude primaire:
2027-06-10
Condition:
Relapsed or Refractory Multiple Myeloma
Genre:
All
Âge:
18 Years-N/A
Accepte des bénévoles en santé:
No
Pays participants:
Australia
Canada
Denmark
France
Italy
Korea, Republic of
New Zealand
Spain
Numéro d’identification:
NCT06055075
Autres numéros d'identification de l'étude:
BP43437
Comité de suivi des données:
Non disponible
Produit réglementé par la FDA (É-U):
Yes
IPD Sharing Statement :
???
Responsables de l’étude:
Sponsor
Commanditaires de l’étude:
lead_sponsor
Hoffmann-La Roche
Industry
Collaborators:
???
Chercheurs:
Clinical Trials Hoffmann-La Roche
Protocol Registration and Results System:
???
Date de vérification:
2024-04-01