A Study Evaluating the Efficacy and Safety of Cevostamab in Prior B Cell Maturation Antigen (BCMA)-Exposed Participants With Relapsed/Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma
- Registration Number
- NCT05535244
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria:<br><br> - Documented diagnosis of MM based on standard International Myeloma Working Group<br> (IMWG) criteria<br><br> - Evidence of progressive disease based on investigators determination of response by<br> IMWG criteria on or after their last dosing regimen<br><br> - Prior BCMA ADC or CAR-T Cohort: participants who have received a BCMA-targeted CAR-T<br> or ADC therapy and are triple-class relapsed or refractory<br><br> - Prior BCMA Bispecific Cohort: participants who have received a BCMA-targeting<br> T-cell-dependent bispecific (TDB) antibody and are triple-class relapsed or<br> refractory<br><br> - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1<br><br> - Life expectancy is at least 12 weeks<br><br> - Agreement to protocol-specified assessments, including bone marrow biopsy and<br> aspirate samples as detailed in the protocol<br><br> - Resolution of AEs from prior anti-cancer therapy to Grade =< 1<br><br> - For female participants of childbearing potential: agreement to remain abstinent<br> (refrain from heterosexual intercourse) or use contraception during the treatment<br> period and for at least 5 months after the final dose of cevostamab and for 3 months<br> after the last dose of tocilizumab was administered<br><br> - For male participants: agreement to remain abstinent (refrain from heterosexual<br> intercourse) or use a condom, and agree to refrain from donating sperm during the<br> treatment period and for at least 2 months after the final dose of tocilizumab (if<br> applicable) to avoid exposing the embryo<br><br>Exclusion Criteria:<br><br> - Inability to comply with protocol-mandated hospitalization<br><br> - Pregnancy or breastfeeding, or intention of becoming pregnant during the study or<br> within 5 months after the final dose of cevostamab or tocilizumab or within 3 months<br> after the last dose of tocilizumab (if applicable)<br><br> - Prior treatment with cevostamab or another agent with the same target<br><br> - Prior BCMA ADC or CAR-T Cohort: prior treatment with any T cell dependent<br> bi-specific antibody (TDB) antibody including non BCMA targeting TDB<br><br> - Prior use of any monoclonal antibody (mAb), radioimmunoconjugate, or ADC as<br> anti-cancer therapy within 4 weeks before first study treatment, except for the use<br> of non-myeloma therapy<br><br> - Prior treatment with systemic immunotherapeutic agents<br><br> - Prior treatment with CAR-T cell therapy within 12 weeks before first cevostamab<br> infusion<br><br> - Known treatment-related, immune-mediated adverse events associated with prior<br> checkpoint inhibitors<br><br> - Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other<br> anti-cancer agent within 4 weeks or 5 half-lives of the drug, whichever is shorter,<br> prior to first study treatment<br><br> - Autologous stem cell transplantation (SCT) within 100 days prior to first study<br> treatment<br><br> - Prior allogeneic SCT<br><br> - Circulating plasma cell count exceeding 500/ microliter (µL) or 5% of the peripheral<br> blood white cells<br><br> - Prior solid organ transplantation<br><br> - History of autoimmune disease<br><br> - History of confirmed progressive multifocal leukoencephalopathy<br><br> - History of severe allergic or anaphylactic reactions to mAb therapy<br><br> - Known history of amyloidosis<br><br> - Lesions in proximity of vital organs that may develop sudden<br> decompensation/deterioration in the setting of a tumor flare<br><br> - History of other malignancy within 2 years prior to screening, except those with<br> negligible risk of metastasis or death, such as ductal carcinoma in situ not<br> requiring chemotherapy, appropriately treated carcinoma in situ of the cervix,<br> non-melanoma skin carcinoma, low-grade, localized prostate cancer not requiring<br> treatment or appropriately treated Stage I uterine cancer<br><br> - Current or past history of central nervous system (CNS) disease, such as stroke,<br> epilepsy, CNS vasculitis, neurodegenerative disease, or CNS involvement by MM<br><br> - Significant cardiovascular disease that may limit a potential participant's ability<br> to adequately respond to a cytokine release syndrome (CRS) event<br><br> - Symptomatic active pulmonary disease or requiring supplemental oxygen<br><br> - Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection<br> at study enrollment, or any major episode of infection requiring treatment with IV<br> (intravenous) antimicrobials where the last dose of IV antimicrobial was given<br> within 14 days prior to first study treatment<br><br> - Active symptomatic COVID-19 infection at study enrollment or requiring treatment<br> with IV antiviral where the last dose of IV antiviral treatment was given within 14<br> days prior to first study treatment. Participants with active COVID-19 infection<br> must have clinical recovery and two negative antigen tests at least 24 hours apart<br> prior to first study treatment<br><br> - Positive and quantifiable Epstein-Barr virus (EBV) polymerase chain reaction (PCR)<br> or cytomegalovirus (CMV) PCR prior to first study treatment<br><br> - Known or suspected chronic active EBV infection<br><br> - Known history of Grade >=3 CRS or immune effector cell-associated neurotoxicity<br> syndrome (ICANS) with prior bispecific therapies<br><br> - Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation<br> syndrome (MAS)<br><br> - Recent major surgery within 4 weeks prior to first study treatment<br><br> - Positive serologic or PCR test results for acute or chronic hepatitis B virus (HBV)<br> infection<br><br> - Acute or chronic hepatitis C virus (HCV) infection<br><br> - Known history of human immunodeficiency virus (HIV) seropositivity<br><br> - Administration of a live, attenuated vaccine within 4 weeks before first study<br> treatment or anticipation that such a live attenuated vaccine will be required<br> during the study<br><br> - Treatment with systemic immunosuppressive medications, with the exception of<br> corticosteroid treatment <= 10 mg/day prednisone or equivalent, within 2 weeks prior<br> to first study treatment<br><br> - History of illicit drug or alcohol abuse within 12 months prior to screening, in the<br> investigator's judgment<br><br> - Any medical condition or abnormality in clinical laboratory tests that, in the<br> investigator's judgment, precludes the participant's safe participation in and<br> completion of the study, or which could affect compliance with the protocol or<br> interpretation of results
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) as Determined by the Investigator;Percentage of Participants with Adverse Events
- Secondary Outcome Measures
Name Time Method