Phase
Condition
Multiple Myeloma
Platelet Disorders
Leukemia
Treatment
Forimtamig
Carfilzomib
Daratumumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Princess Alexandra Hospital Woolloongabba
Woolloongabba, Queensland 4102
AustraliaSite Not Available
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology
Woolloongabba, Queensland 4102
AustraliaSite Not Available
Royal Adelaide Hospital
Adelaide, South Australia 5000
AustraliaSite Not Available
Americas Centro de Oncologia Integrado
Rio de Janeiro, RJ 22793-080
BrazilSite Not Available
Instituto D'Or Pesquisa e Ensino
Sao Paulo, SP 04502-001
BrazilSite Not Available
Hamilton Health Sciences
Hamilton, Ontario L8V 5C2
CanadaSite Not Available
Aarhus Universitetshospital Skejby; Blodsygdomme - Klinisk Forsknings Enhed
Aarhus N, 8200
DenmarkSite Not Available
Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT
København Ø, 2100
DenmarkSite Not Available
Odense Universitetshospital; Hæmatologisk Afdeling
Odense C, 5000
DenmarkSite Not Available
CHRU Lille - Hôpital Claude Huriez; Service des Maladies du Sang
Lille, 59037
FranceSite Not Available
CHU NANTES - Hôtel Dieu; Service d'Hematologie Clinique
Nantes, 44093
FranceSite Not Available
Universitätsklinikum Augsburg; II. Med. Klinik
Augsburg, 86156
GermanySite Not Available
Universitätsklinikum Leipzig - Klinik und Poliklinik für Hämatologie; Zelltherapie & Hämostaseologie
Leipzig, 04103
GermanySite Not Available
Klinikum Nürnberg Nord; Klinik für Innere Medizin 5, Schwerpunkt Onkologie / Hämatologie
Nürnberg, 90419
GermanySite Not Available
IRCCS Istituto Nazionale dei Tumori di Napoli - Pascale Ematologia Oncologica
Napoli, Campania 80131
ItalySite Not Available
Policlinico S.Orsola-Malpighi;Istituto di Ematologia "Seragnoli"
Bologna, Emilia-Romagna 40138
ItalySite Not Available
Istituto Clinico Humanitas
Rozzano, Lombardia 20089
ItalySite Not Available
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
Rozzano, Lombardia 20089
ItalySite Not Available
Samsung Medical Center
Seoul, 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Seoul St Mary's Hospital
Seoul, 06591
Korea, Republic ofSite Not Available
New Zealand Clinical Research - Auckland
Auckland, 1010
New ZealandSite Not Available
Hospital Universitario Marques de Valdecilla; Servicio de Hematologia
Santander, Cantabria 39008
SpainSite Not Available
Clinica Universitaria de Navarra
Pamplona, Navarra 31008
SpainSite Not Available
Clinica Universitaria de Navarra; Servicio de Hematologia
Pamplona, Navarra 31008
SpainSite Not Available
Clinica Universidad de Navarra Madrid; Servicio de Hematología
Madrid, 28027
SpainSite Not Available
City of Hope - Lennar Foundation Cancer Center
Irvine, California 92618
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
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