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

Last updated: June 3, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Multiple Myeloma

Platelet Disorders

Leukemia

Treatment

Forimtamig

Carfilzomib

Daratumumab

Clinical Study ID

NCT06055075
BP43437
2023-503689-21-00
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 byIMWG criteria on or after last dosing regimen

  • Measurable disease

  • AEs from prior anti-cancer therapy resolved to Grade ≤ 1,

  • Adequate organ functions

Exclusion

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 4weeks 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 studytreatment

  • 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-relatedtoxicity

  • Participants with known liver cirrhosis

  • Participants eligible for allogeneic stem cell transplantation (SCT) or autologousSCT at the time of enrollment for Study BP43437 are excluded

Study Design

Total Participants: 19
Treatment Group(s): 3
Primary Treatment: Forimtamig
Phase: 1/2
Study Start date:
December 12, 2023
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Princess Alexandra Hospital Woolloongabba

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Americas Centro de Oncologia Integrado

    Rio de Janeiro, RJ 22793-080
    Brazil

    Site Not Available

  • Instituto D'Or Pesquisa e Ensino

    Sao Paulo, SP 04502-001
    Brazil

    Site Not Available

  • Hamilton Health Sciences

    Hamilton, Ontario L8V 5C2
    Canada

    Site Not Available

  • Aarhus Universitetshospital Skejby; Blodsygdomme - Klinisk Forsknings Enhed

    Aarhus N, 8200
    Denmark

    Site Not Available

  • Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT

    København Ø, 2100
    Denmark

    Site Not Available

  • Odense Universitetshospital; Hæmatologisk Afdeling

    Odense C, 5000
    Denmark

    Site Not Available

  • CHRU Lille - Hôpital Claude Huriez; Service des Maladies du Sang

    Lille, 59037
    France

    Site Not Available

  • CHU NANTES - Hôtel Dieu; Service d'Hematologie Clinique

    Nantes, 44093
    France

    Site Not Available

  • Universitätsklinikum Augsburg; II. Med. Klinik

    Augsburg, 86156
    Germany

    Site Not Available

  • Universitätsklinikum Leipzig - Klinik und Poliklinik für Hämatologie; Zelltherapie & Hämostaseologie

    Leipzig, 04103
    Germany

    Site Not Available

  • Klinikum Nürnberg Nord; Klinik für Innere Medizin 5, Schwerpunkt Onkologie / Hämatologie

    Nürnberg, 90419
    Germany

    Site Not Available

  • IRCCS Istituto Nazionale dei Tumori di Napoli - Pascale Ematologia Oncologica

    Napoli, Campania 80131
    Italy

    Site Not Available

  • Policlinico S.Orsola-Malpighi;Istituto di Ematologia "Seragnoli"

    Bologna, Emilia-Romagna 40138
    Italy

    Site Not Available

  • Istituto Clinico Humanitas

    Rozzano, Lombardia 20089
    Italy

    Site Not Available

  • Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia

    Rozzano, Lombardia 20089
    Italy

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Seoul St Mary's Hospital

    Seoul, 06591
    Korea, Republic of

    Site Not Available

  • New Zealand Clinical Research - Auckland

    Auckland, 1010
    New Zealand

    Site Not Available

  • Hospital Universitario Marques de Valdecilla; Servicio de Hematologia

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Clinica Universitaria de Navarra

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Clinica Universitaria de Navarra; Servicio de Hematologia

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Clinica Universidad de Navarra Madrid; Servicio de Hematología

    Madrid, 28027
    Spain

    Site Not Available

  • City of Hope - Lennar Foundation Cancer Center

    Irvine, California 92618
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

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