Multiple Myeloma Clinical Trial

A Study Evaluating the Efficacy and Safety of Cevostamab in Prior B Cell Maturation Antigen (BCMA)-Exposed Participants With Relapsed/Refractory Multiple Myeloma

Summary

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

View Eligibility Criteria

Eligibility Criteria

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 refractory
Prior BCMA Bispecific Cohort: participants who have received a BCMA-targeting T-cell-dependent bispecific (TDB) antibody and are triple-class 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 2 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 cevostamab or 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 3 months after the final dose of cevostamab or tocilizumab
Prior treatment with cevostamab or another agent with the same target
Prior BCMA ADC or CAR-T Cohort: prior treatment with any TDB antibody
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, including but not limited to, cytokine therapy and anti- Cytotoxic T lymphocyte-associated antigen-4 (CTLA-4), anti- Programmed cell death protein 1 (PD-1), and anti- Programmed death-ligand 1 (PD-L1) therapeutic antibodies within 12 weeks or 5 half-lives of the drug, whichever is shorter, before first study treatment
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) antibiotics or antivirals for coronavirus disease 2019 (COVID-19) where the last dose of treatment was given within 14 days prior to first study treatment
Known or suspected chronic active Epstein-Barr virus (EBV) infection
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 polymerase chain reaction (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

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

140

Study ID:

NCT05535244

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

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There are 4 Locations for this study

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Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Tennessee Onc., PLLC - SCRI
Nashville Tennessee, 37203, United States
Methodist Hospital
San Antonio Texas, 78229, United States
UZ Leuven Gasthuisberg
Leuven , 3000, Belgium

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

140

Study ID:

NCT05535244

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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