Relapsed or Refractory Multiple Myeloma
Conditions
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 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.
Interventions
DRUGForimtamig
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.
DRUGCarfilzomib
Carfilzomib will be administered via IV infusion in combination with forimtamig.
DRUGDaratumumab
Daratumumab will be administered via SC injection in combination with forimtamig.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Adverse Events (AEs) | Up to approximately 24 months |
| Objective Response Rate (ORR) as Determined by the Investigator per International Myeloma Working Group (IMWG) Criteria | Up to approximately 24 months |
| Complete Response (CR)/Stringent Complete Response (sCR) Rate as Determined by the Investigator per IMWG Criteria | Up to approximately 24 months |
| Rate of Very Good Partial Response (VGPR) or Better as Determined by the Investigator per IMWG Criteria | Up to approximately 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) as Determined by the Investigator per IMWG Criteria | Up to approximately 24 months |
| Progression-Free Survival (PFS) as Determined by the Investigator per IMWG Criteria | Up to approximately 24 months |
| Percentage of Participants with Anti-Drug Antibodies (ADAs) to Forimtamig | Up to approximately 24 months |
| Serum Concentration of Forimtamig | Up to approximately 24 months |
| Duration of Response (DoR) for Participants who Achieve a Partial Response (PR) or Better as Determined by the Investigator per IMWG Criteria | Up to approximately 24 months |
| Time to First Response as Determined by the Investigator per IMWG Criteria | Up to approximately 24 months |
| Time to Best Response as Determined by the Investigator per IMWG Criteria | Up to approximately 24 months |
Countries
Australia, Canada, Italy, New Zealand, South Korea, Spain
Outcome results
None listed