Phase 1 Myeloma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been formally diagnosed with multiple myeloma (MM) according to recognised international diagnostic standards
• People whose multiple myeloma has shown signs of getting worse based on their doctor's assessment after their most recent treatment
• People whose multiple myeloma has either returned after treatment (relapsed) or stopped responding to treatment (refractory)
• People who are generally able to carry out daily activities with little or no limitation (rated 0 or 1 on a standard medical performance scale)
• People with a life expectancy of at least 12 weeks
• People who agree to undergo all required assessments during the trial, including bone marrow biopsy and sample collection as outlined in the study plan
• People whose side effects from previous cancer treatments have largely resolved to a mild level or better
• Female participants of childbearing potential who agree to either abstain from heterosexual intercourse or use contraception throughout treatment and for at least 5 months after the last dose of cevostamab, and for 3 months after the last dose of tocilizumab
• Male participants who agree to either abstain from heterosexual intercourse or use a condom, and to avoid donating sperm, throughout treatment and for at least 2 months after the last dose of tocilizumab (if applicable)

Who may not be able to join:

• People who are unable to comply with the required hospital stays specified in the study protocol
• People who are pregnant, breastfeeding, or planning to become pregnant during the study or within 5 months after the final dose of cevostamab, or within 3 months after the last dose of tocilizumab (if applicable)
• People who have previously been treated with cevostamab or another treatment that works on the same biological target
• People who have received certain types of cancer treatment (monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate therapy) within 4 weeks before the start of the study, unless used for a condition other than myeloma
• People who have previously received systemic immune-based cancer therapies, including cytokine therapy or certain checkpoint inhibitor treatments (such as anti-CTLA-4, anti-PD-1, or anti-PD-L1)
• People who have received CAR-T cell therapy within 12 weeks before the first planned study treatment
• People who experienced known immune-related side effects from previous checkpoint inhibitor treatments
• People who have received radiotherapy, chemotherapy, or any other anti-cancer treatment within 4 weeks (or within 5 half-lives of that drug, whichever is shorter) before the first study treatment
• People who have had an autologous stem cell transplant within 100 days before the first study treatment
• People who have ever had an allogeneic (donor) stem cell transplant
• People who have ever had a solid organ transplant
• People with a history of autoimmune disease
• People with a history of a confirmed brain condition called progressive multifocal leukoencephalopathy
• People who have had severe allergic or anaphylactic reactions to monoclonal antibody treatments in the past
• People with a known history of amyloidosis (a condition involving abnormal protein deposits in organs)
• People who have tumour lesions located near vital organs that could suddenly worsen if the tumour responds to treatment (confirm with trial site)
• People with a history of another cancer within the past 2 years, with some exceptions for certain low-risk or early-stage cancers (confirm with trial site for specific exceptions)
• People with a current or past history of conditions affecting the central nervous system, such as stroke, epilepsy, CNS vasculitis, neurodegenerative disease, or myeloma affecting the brain or spinal cord
• People with significant heart disease that may affect the ability to safely manage a potential side effect called cytokine release syndrome
• People with active lung disease causing symptoms, or those who require supplemental oxygen
• People with a known active infection (bacterial, viral, fungal, or other) at the time of enrolment, or who have recently required intravenous (IV) antibiotics with the last IV dose given within 14 days before the first study treatment
• People with an active symptomatic COVID-19 infection at enrolment, or who required IV antiviral treatment with the last dose given within 14 days before the first study treatment
• People with detectable levels of Epstein-Barr virus (EBV) or cytomegalovirus (CMV) on blood testing before the first study treatment
• People with a known or suspected ongoing active EBV infection
• People with a known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS) — serious inflammatory conditions (confirm with trial site)
• People who have previously experienced a severe (Grade 3 or higher) cytokine release syndrome or a serious nervous system reaction (ICANS) from prior bispecific antibody therapies
• People who have had major surgery within 4 weeks before the first study treatment
• People with a current or past hepatitis B virus infection detected by blood or PCR testing
• People with a current or past hepatitis C virus infection
• People with a known history of HIV
• People who have received a live or live-attenuated vaccine within 4 weeks before the first study treatment, or who are expected to need one during the study
• People who have been taking systemic immune-suppressing medications within 2 weeks before the first study treatment, except for low-dose corticosteroids (equivalent to 10 mg/day of prednisone or less)
• People with a history of illicit drug or alcohol misuse within the 12 months before screening, as assessed by the investigator
• People with any other medical condition or abnormal laboratory results that, in the investigator's judgement, would make participation unsafe or affect the reliability of study results

Important: Always verify eligibility with the trial site directly before applying.