About the study

This study will evaluate the efficacy, safety, and pharmacokinetics of cevostamab in participants with refractory multiple myeloma (R/R MM) via intravenous (IV) infusion.

Who can take part?

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

Inclusion criteria

1. Documented diagnosis of MM based on standard International Myeloma Working Group (IMWG) criteria
2. Evidence of progressive disease based on investigators determination of response by IMWG criteria on or after their last dosing regimen
3. Prior BCMA ADC or CAR-T Cohort: participants who have received a BCMA-targeted CAR-T or ADC therapy and are triple-class refractory
4. Prior BCMA Bispecific Cohort: participants who have received a BCMA-targeting T-cell-dependent bispecific (TDB) antibody and are triple-class refractory
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
6. Life expectancy is at least 12 weeks
7. Agreement to protocol-specified assessments, including bone marrow biopsy and aspirate samples as detailed in the protocol
8. Resolution of AEs from prior anti-cancer therapy to Grade =< 1
9. For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for at least 5 months after the final dose of cevostamab and for 3 months after the last dose of tocilizumab was administered
10. For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for at least 2 months after the final dose of tocilizumab (if applicable) to avoid exposing the embryo

Exclusion criteria

1. Inability to comply with protocol-mandated hospitalization
2. Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 5 months after the final dose of cevostamab or tocilizumab or within 3 months after the last dose of tocilizumab (if applicable)
3. Prior treatment with cevostamab or another agent with the same target
4. Prior BCMA ADC or CAR-T Cohort: prior treatment with any T cell dependent bi-specific antibody (TDB) antibody including non BCMA targeting TDB
5. Prior use of any monoclonal antibody (mAb), radioimmunoconjugate, or ADC as anti-cancer therapy within 4 weeks before first study treatment, except for the use of non-myeloma therapy
6. Prior treatment with systemic immunotherapeutic agents
7. Prior treatment with CAR-T cell therapy within 12 weeks before first cevostamab infusion
8. Known treatment-related, immune-mediated adverse events associated with prior checkpoint inhibitors
9. Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other anti-cancer agent within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first study treatment
10. Autologous stem cell transplantation (SCT) within 100 days prior to first study treatment
11. Prior allogeneic SCT
12. Circulating plasma cell count exceeding 500/ microliter (µL) or 5% of the peripheral blood white cells
13. Prior solid organ transplantation
14. History of autoimmune disease
15. History of confirmed progressive multifocal leukoencephalopathy
16. History of severe allergic or anaphylactic reactions to mAb therapy
17. Known history of amyloidosis
18. Lesions in proximity of vital organs that may develop sudden decompensation/deterioration in the setting of a tumor flare
19. History of other malignancy within 2 years prior to screening, except those with negligible risk of metastasis or death, such as ductal carcinoma in situ not requiring chemotherapy, appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, low-grade, localized prostate cancer not requiring treatment or appropriately treated Stage I uterine cancer
20. Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, neurodegenerative disease, or CNS involvement by MM
21. Significant cardiovascular disease that may limit a potential participant's ability to adequately respond to a cytokine release syndrome (CRS) event
22. Symptomatic active pulmonary disease or requiring supplemental oxygen
23. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment, or any major episode of infection requiring treatment with IV (intravenous) antimicrobials where the last dose of IV antimicrobial was given within 14 days prior to first study treatment
24. 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. Participants with active COVID-19 infection must have clinical recovery and two negative antigen tests at least 24 hours apart prior to first study treatment
25. Positive and quantifiable Epstein-Barr virus (EBV) polymerase chain reaction (PCR) or cytomegalovirus (CMV) PCR prior to first study treatment
26. Known or suspected chronic active EBV infection
27. Known history of Grade >=3 CRS or immune effector cell-associated neurotoxicity syndrome (ICANS) with prior bispecific therapies
28. Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
29. Recent major surgery within 4 weeks prior to first study treatment
30. Positive serologic or PCR test results for acute or chronic hepatitis B virus (HBV) infection
31. Acute or chronic hepatitis C virus (HCV) infection
32. Known history of human immunodeficiency virus (HIV) seropositivity
33. Administration of a live, attenuated vaccine within 4 weeks before first study treatment or anticipation that such a live attenuated vaccine will be required during the study
34. Treatment with systemic immunosuppressive medications, with the exception of corticosteroid treatment <= 10 mg/day prednisone or equivalent, within 2 weeks prior to first study treatment
35. History of illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment
36. 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

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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