About the study

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.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Diagnosed with MM per International Myeloma Working Group (IMWG) criteria
2. Eastern Cooperative Oncology Group Performance Status of 0, or 1, or 2
3. Resolution of AEs from prior anti-cancer therapy to Grade <=1
4. Agreement to undergo scheduled assessments and procedures Additional Inclusion Criteria for Substudy 2:
5. Completion of planned induction therapy and achievement of at least a partial response (PR)
6. Autologous Stem Cell Transplant (SCT) within 100 days prior to first study treatment and the absence of progressive disease
7. Cytogenetic high-risk features at diagnosis
8. 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
9. Agreement to comply with all local requirements of the lenalidomide risk minimization plan, which includes the global pregnancy prevention program
10. For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception
11. 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

Exclusion criteria

1. Inability to comply with protocol-mandated hospitalization and procedures
2. History of confirmed progressive multifocal leukoencephalopathy
3. History of other malignancy within 2 years prior to screening
4. Current or past history of central nervous system (CNS) disease
5. Significant cardiovascular disease that may limit a participant's ability to adequately respond to a CRS event
6. Symptomatic active pulmonary disease or requiring supplemental oxygen
7. 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
8. Known or suspected chronic active Epstein-Barr virus (EBV) infection
9. Positive serologic or PCR test results for acute or chronic hepatitis B virus (HBV) infection
10. Acute or chronic hepatitis C virus (HCV) infection
11. Known history of HIV seropositivity
12. 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
13. 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:
14. Hypersensitivity reactions to lenalidomide or other immunomodulatory drugs
15. History of autoimmune disease
16. Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
17. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
18. Harbor lesions at proximity of vital organs that may develop sudden decompensation/deterioration in the setting of a tumor flare
19. Prior treatment with any investigational medicinal product, systemic cancer therapy, or immunotherapies in any arm of study CO43923 within 5 half-lives or 3 weeks, whichever is shorter
20. Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within the 14-day period before the first dose of the study drug (does not include pretreatment medication)
21. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antimicrobials where the last dose of IV antimicrobial was given within 14 days prior to first study treatment
22. Active symptomatic COVID-19 infection at study enrollment or requiring treatment with IV antiviral where the last dose of IV antiviral treatment was given within 14 days prior to first study treatment. Patients with active COVID-19 infection must have clinical recovery and two negative antigen tests at least 24 hours apart prior to first study treatment.
23. Positive and quantifiable EBV PCR or CMV PCR prior to first study treatment
24. History of erythema multiforme, Grade >=3 rash, or blistering following prior treatment with immunomodulatory derivatives
25. Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study treatment

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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