Status:
COMPLETED
A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Relapsed or Refractory Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2025
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT06055075
Start Date
December 12 2023
End Date
July 8 2025
Last Update
July 14 2025
Active Locations (7)
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1
Princess Alexandra Hospital Woolloongabba
Woolloongabba, Queensland, Australia, 4102
2
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
3
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
4
Istituto Clinico Humanitas
Rozzano, Lombardy, Italy, 20089