Brief Summary
CO43923 is a platform study that will evaluate the safety, efficacy, and pharmacokinetics (PK) of multiple treatment combinations, as monotherapy or in combination, in participants with multiple myeloma (MM). The study is designed with the flexibility to open new treatment substudies as new treatments become available. Information regarding the opened substudies are found below.
Intervention / Treatment
- Drug: Cevostamab
- Drug: Lenalidomide
- Drug: Tocilizumab
- Drug: Iberdomide
- Drug: Dexamethasone
Inclusion Criteria
- Diagnosed with MM per International Myeloma Working Group (IMWG) criteria
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group Performance Status of 0, or 1, or 2
- Resolution of AEs from prior anti-cancer therapy to Gradea description of how abnormal cancer cells and tissue look under a microscope when compared to healthy cells <=1
- Agreement to undergo scheduled assessments and procedures
Additional Inclusion Criteria for SS2:
- Completion of planned induction therapy and achievement of at least a partial response (PR)
- Autologous Stem Cell Transplanta procedure that involves replacing unhealthy blood-forming cells (stem cells) with healthy stem cells (SCT) within 100 days prior to first study treatment and the absence of progressive disease
- Cytogenetic high-risk features at diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results
- Treatment with any investigational medicinal products, systemic cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs therapies, immunotherapies received previously in CO43923 (any arms) within 5 half-lives or 3 weeks whichever is the shortest
- Agreement to comply with all local requirements of the lenalidomide riskthe possibility that something bad will happen minimization plan, which includes the global pregnancy prevention program
- For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception
- For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom even if they have had a prior vasectomy, and agreement to refrain from donating sperm
Additional Inclusion Criteria for SS4:
- Previously exposed to at least a PI, an IMiD, and an anti-CD38 antibodya protein made by the immune system to fight against harmful substances (antigens), such as bacteria or viruses for the treatment of R/R MM for whom no suitable SOC therapy options are available