BP43437 Phase1B/II Study of Forimtamig treatment combination in Multiple Myeloma
Research type
Research Study
Full title
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
IRAS ID
1008275
Contact name
Micaela Rocco
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2023-503689-21
Clinicaltrials.gov Identifier
Research summary
Multiple myeloma (MM) is a hematologic disorder defined by clonal expansion of malignant plasma cells in the bone marrow and/or extramedullary sites. Due to an aging population and an increase in the global population, there is an increase in the prevalence of MM. Moreover, both the incidence of MM and mortality associated with the disease are increasing globally, with a projected increase of over 70% in each from 2018 to 2040.
Increased survival has been achieved with the introduction of proteasome inhibitors (PI) such as bortezomib, immunomodulatory drugs (IMiDs) such as lenalidomide, and monoclonal antibodies (mAbs) such as daratumumab, isatuximab and elotuzumab. Despite this progress most patients eventually relapse and the outcome for patients who have relapsed or are refractory (r/r) to a PI, an IMiD, and/or anti-CD38 mAb is quite poor, with median overall survival (OS) of approximately 1 year. Therefore, r/r MM represents an indication with a significant unmet medical need.
The aim of this study is to evaluate the safety, tolerability, clinical activity, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of SC forimtamig when administered alone or in combination with carfilzomib (K) or daratumumab (D).
These combination partners are standard of care with proven clinical benefit in monotherapy. In addition to the strong clinical rationale for the combination, there is preclinical data showing synergistic/additive anti-tumour effects for forimtamig with either daratumumab or carfilzomib, which support clinical testing of these drug classes in combination with forimtamig.
The study consists of a dose exploration phase and a dose expansion phase with 1 comparator arm and up to 6 combination arms. Approximately 36-316 patients will be recruited globally. The study will last approximately 24 months. There will be approximately 6 patients in the UK at 1 site.
The study is sponsored by F. Hoffman La Roche
Research Summary; Version 1 15/6/23REC name
Wales REC 3
REC reference
23/WA/0294
Date of REC Opinion
22 Nov 2023
REC opinion
Further Information Favourable Opinion