GO43227 - An open-label, multicenter, Phase Ib trial evaluating the safety, pharmacokinetics, and activity of subcutaneous cevostamab (BFCR4350A) in patients with relapsed or refractory multiple myeloma (CAMMA 3)

Studio Clinico

Patologia: Mieloma

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: 1, I B

Linee di trattamento: Non applicabile

Criteri di inclusione: 

1. Age ≥18 years at time of signing Informed Consent Form
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
3. Life expectancy of at least 12 weeks
4. Participants with a diagnosis of R/R MM for which no established therapy for multiple myeloma (MM) is appropriate and available, or intolerance to those established therapies
5. Agreement to provide bone marrow biopsy and aspirate samples
6. Adverse events from prior anti-cancer therapy resolved to Grade less than or equal to (≤) 1, except any grade alopecia and peripheral sensory or motor neuropathy which must have resolved to Grade ≤ 2
7. Measurable disease defined by laboratory test results.

Criteri di esclusione: 

Current participant exclusion criteria as of 06/06/2024:
1. Prior treatment with cevostamab or another agent targeting fragment crystallizable receptor-like 5 (FcRH5)
2. Inability to comply with protocol-mandated hospitalization and activities restrictions
3. Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the last dose of cevostamab or within 3 months after the last dose of tocilizumab (if applicable)
4. Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate as anti-cancer therapy within 4 weeks prior to first study treatment, except for the use of non-myeloma therapy
5. Prior treatment with systemic checkpoint inhibitors, including, but not limited to anti-CTLA4, anti-PD-1, and anti-PD-L1 therapeutic antibodies within 12 weeks or 5 half-lives of the drug, whichever is shorter, prior to first study treatment
6. Prior treatment with allogeneic or autologous chimeric antigen receptor (CAR) T-cell therapy within 12 weeks prior to first study treatment
7. Known treatment-related, immune-mediated adverse events associated with prior checkpoint inhibitors
8. Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
9. Treatment with any chemotherapeutic agent or other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first study treatment
10. Treatment with radiotherapy within 4 weeks (systemic radiation) or 14 days (focal radiation) prior to first study treatment
11. Autologous stem cell transplant (SCT) within 100 days prior to first study treatment
12. Prior allogeneic SCT
13. Prior solid organ transplantation
14. Circulating plasma cell count exceeding 500/microlitres (µL) or 5% of the peripheral blood white cells
15. History of autoimmune disease
16. History of confirmed progressive multifocal leukoencephalopathy
17. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
18. Known history of amyloidosis (e.g., positive Congo Red stain or equivalent in tissue biopsy)
19. Participants with lesions in proximity of vital organs that may develop sudden decompensation/deterioration in the setting of a tumor flare
20. History of other malignancy within 2 years prior to screening, except those with negligible risk of metastasis or death
21. Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, neurodegenerative disease, or CNS involvement by MM
22. Significant cardiovascular disease that may limit a participant's ability to adequately respond to a CRS event
23. Symptomatic active pulmonary disease or requiring supplemental oxygen
24. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antimicrobials where the last dose of IV antimicrobial was given within 14 days prior to first study treatment
25. 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. Patients with active COVID-19 infection must have clinical recovery and two negative antigen tests at least 24 hours apart prior to first study treatment
26. Positive and quantifiable Epstein-Barr virus (EBV) PCR, or CMV PCR prior to start of study treatment
27. Known or suspected chronic active EBV infection
28. Recent major surgery within 4 weeks prior to first study treatment
29. Positive serologic or polymerase chain reaction (PCR) test results for acute or chronic Hepatitis B virus (HBV) infection
30. Acute or chronic Hepatitis C virus (HCV) infection
31. Known history of Human Immunodeficiency Virus (HIV) seropositivity
32. Administration of a live, attenuated vaccine within 4 weeks prior to first study treatment or anticipation that such a live attenuated vaccine will be required during the study
33. Treatment with systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents), with the exception of corticosteroid treatment ≤ 10 mg/day prednisone or equivalent within 2 weeks prior to first study treatment
34. History of illicit drug or alcohol abuse within 12 months prior to screening, in the investigator’s judgment
35. Any medical condition or abnormality in clinical laboratory tests that, in the investigator’s judgement, precludes the patient’s safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results.

Trattamento sperimentale: 

Cevostamab

Trattamento di controllo: 

NA

Centri partecipanti

Nord Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2023-503404-89-00

Promotore

Genentech Inc.

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile

Telefono: 00000

Email: na@na.it

Localita: na