Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
Inclusion Criteria:
- Documented diagnosis of MM based on standard International Myeloma Working Group
(IMWG) criteria
- Evidence of progressive disease based on investigators determination of response by
IMWG criteria on or after their last dosing regimen
- Prior BCMA ADC or CAR-T Cohort: participants who have received a BCMA-targeted CAR-T
or ADC therapy and are triple-class relapsed or refractory
- Prior BCMA Bispecific Cohort: participants who have received a BCMA-targeting
T-cell-dependent bispecific (TDB) antibody and are triple-class relapsed or refractory
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy is at least 12 weeks
- Agreement to protocol-specified assessments, including bone marrow biopsy and aspirate
samples as detailed in the protocol
- Resolution of AEs from prior anti-cancer therapy to Grade =< 1
- 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
- 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:
- Inability to comply with protocol-mandated hospitalization
- 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)
- Prior treatment with cevostamab or another agent with the same target
- Prior BCMA ADC or CAR-T Cohort: prior treatment with any T cell dependent bi-specific
antibody (TDB) antibody including non BCMA targeting TDB
- 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
- Prior treatment with systemic immunotherapeutic agents
- Prior treatment with CAR-T cell therapy within 12 weeks before first cevostamab
infusion
- Known treatment-related, immune-mediated adverse events associated with prior
checkpoint inhibitors
- 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
- Autologous stem cell transplantation (SCT) within 100 days prior to first study
treatment
- Prior allogeneic SCT
- Circulating plasma cell count exceeding 500/ microliter (µL) or 5% of the peripheral
blood white cells
- Prior solid organ transplantation
- History of autoimmune disease
- History of confirmed progressive multifocal leukoencephalopathy
- History of severe allergic or anaphylactic reactions to mAb therapy
- Known history of amyloidosis
- Lesions in proximity of vital organs that may develop sudden
decompensation/deterioration in the setting of a tumor flare
- 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
- Current or past history of central nervous system (CNS) disease, such as stroke,
epilepsy, CNS vasculitis, neurodegenerative disease, or CNS involvement by MM
- Significant cardiovascular disease that may limit a potential participant's ability to
adequately respond to a cytokine release syndrome (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
(intravenous) antimicrobials where the last dose of IV antimicrobial was given within
14 days prior to first study treatment
- 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
- Positive and quantifiable Epstein-Barr virus (EBV) polymerase chain reaction (PCR) or
cytomegalovirus (CMV) PCR prior to first study treatment
- Known or suspected chronic active EBV infection
- Known history of Grade >=3 CRS or immune effector cell-associated neurotoxicity
syndrome (ICANS) with prior bispecific therapies
- Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation
syndrome (MAS)
- Recent major surgery within 4 weeks prior to first study treatment
- 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 human immunodeficiency virus (HIV) seropositivity
- 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
- 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
- History of illicit drug or alcohol abuse within 12 months prior to screening, in the
investigator's judgment
- 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
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 2/6/2024. Questions regarding updates should be directed to the study team contact.