A Study Evaluating the Safety and Efficacy of Multiple Treatment Combinations in Participants With Multiple Myeloma

• Status: Not yet recruiting
• Trial end date: 2026-07-30
• Target enrollment: 0
• Participant gender: All

Summary

CO43923 is a platform study that will evaluate the safety, efficacy, and pharmacokinetics (PK) of multiple treatment combinations in subsets of patients with multiple myeloma (MM). The study is designed with the flexibility to open new treatment substudies as new treatments become available. Information regarding the substudy opened is found below.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Lenalidomide

Criteria

Inclusion Criteria:

• Diagnosed with MM per International Myeloma Working Group (IMWG) criteria

• Eastern Cooperative Oncology Group Performance Status of 0, or 1, or 2

• Resolution of AEs from prior anti-cancer therapy to Grade <=1

• Agreement to undergo scheduled assessments and procedures

Additional Inclusion Criteria for Substudy 2:

• Completion of planned induction therapy and achievement of at least a partial response (PR)

• Autologous Stem Cell Transplant (ASCT) within 100 days prior to first study treatment and the absence of progressive disease

• Cytogenetic high-risk features at diagnosis

• Treatment with any investigational medicinal products, systemic cancer 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 risk minimization plan, which includes the global pregnancy prevention program

• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception

• For men: 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

Exclusion Criteria:

• Inability to comply with protocol-mandated hospitalization and procedures

• History of confirmed progressive multifocal leukoencephalopathy

• History of other malignancy within 2 years prior to screening

• Current or past history of central nervous system (CNS) disease

• Significant cardiovascular disease that may limit a participant's ability to adequately respond to a CRS event

• Symptomatic active pulmonary disease or requiring supplemental oxygen

• Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment, or any major episode of infection requiring treatment with IV antibiotics where the last dose of IV antibiotics was given within 14 days prior to first study treatment

• Known or suspected chronic active Epstein-Barr virus (EBV) infection

• Positive serologic or PCR test results for acute or chronic hepatitis B virus (HBV) infection

• Acute or chronic hepatitis C virus (HCV) infection

• Known history of HIV seropositivity

• Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation that such a live, attenuated vaccine will be required during the study

• Any medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results

Additional Exclusion Criteria for Substudy 2:

• Severe hypersensitivity reactions to lenalidomide

• History of autoimmune disease

• Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)

• History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)

• Harbor lesions at proximity of vital organs that may develop sudden decompensation/deterioration in the setting of a tumor flare

• Chronic treatment with more than 10 milligrams (mg)/day of corticosteroids. The maximal authorized dose of corticosteroids in the study is 10 mg/day when not used to treat an AE or as a premedication for cevostamab dosing

• History of erythema multiforme, Grade >=3 rash, or blistering following prior treatment with immunomodulatory derivatives

• Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study treatment