ISRCTN53331091进行中（未招募）1 期
An open-label, multicenter, phase Ib trial evaluating the safety, pharmacokinetics, and activity of cevostamab in patients with relapsed or refactory multiple myeloma (CAMMA 1)
Genentech Inc. c/o F.Hoffman-La Roche Ltd0 个研究点目标入组 120 人开始时间: 2022年5月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age >= 18 years
- •2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •3. Life expectancy of at least 12 weeks
- •4. Agreement to undergo scheduled assessments and procedures including bone marrow biopsy and aspirate samples
- •5. Resolution of adverse events from prior anti-cancer therapy to Grade <=1
- •6. Measurable disease
- •7. Adequate hepatic and hematologic function
- •8. For women of childbearing potential: agreement to remain abstinent or use contraception, during the treatment period (including treatment interruptions) and for at least 2 months after the last dose of cevostamab and at least 3 months after the last dose of tocilizumab was administered
- •9. For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm, during the treatment period, and for at least 2 months after the last dose of cevostamab or tocilizumab was administered to avoid exposing the embryo and sexual partner
- •Additional Arm A-Specific Inclusion Criteria
- •10. Diagnosis of R/R MM for which no established therapy for MM is appropriate and available, or intolerance to those established therapies
- •Additional Arm B-Specific Inclusion Criteria
- •11. For Cohort B1S: Patients with R/R MM who have received at least 2 prior lines of treatment
- •12. For Cohort B1E: Patients with R/R MM who have received at least 1 prior line of treatment
- •13. Agreement to comply with all local requirements of the pomalidomide pregnancy risk minimization plan
- •14. Agreement to avoid donating blood during the treatment period and for at least 4 weeks after the last dose of pomalidomide
- •15. For women of childbearing potential: agreement to remain abstinent or use two reliable methods of contraception starting at least 4 weeks prior to, during the treatment period, and for at least 4 weeks after the last dose of pomalidomide was administered
- •16. For men: agreement to remain abstinent or use a condom during the treatment period and for at least 4 weeks after the last dose of pomalidomide, and agreement to refrain from donating sperm during this same period
- •Additional Arm C-Specific Inclusion Criteria
- •17. For Cohort C1S: Patients with R/R MM who have received at least 2 prior lines of treatment
- •18. For Cohort C1E: Patients with R/R MM who have received at least 1 prior line of therapy
- •19. For women of childbearing potential: agreement to remain abstinent or use contraceptive methods during the treatment period and for at least 3 months after the last dose of daratumumab was administered
- •20. For men: agreement to remain abstinent or use a condom during the treatment period and for at least 3 months after the last dose of daratumumab was administered to avoid exposing the embryo, and agreement to refrain from donating sperm during this same period
排除标准
- •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 2 months after the last dose of cevostamab or within 3 months after the last dose of tocilizumab
- •4. Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate as anti-cancer therapy within 4 weeks before first study treatment
- •5. Prior treatment with systemic immunotherapeutic agents within 12 weeks or 5 half-lives of the drug before first study treatment
- •6. Prior treatment with chimeric antigen receptor T (CAR T) cell therapy within 12 weeks before first study treatment
- •7. Known treatment-related, immune-mediated adverse events associated with prior checkpoint inhibitors
- •8. Treatment with radiotherapy within 4 weeks (systemic radiation) or 14 days (focal radiation) prior to first study treatment
- •9. Treatment with any chemotherapeutic agent or other anti-cancer agent within 4 weeks or 5 half-lives of the drug before first study treatment
- •10. Autologous stem cell transplant (SCT) within 100 days prior to first study treatment
- •11. Prior allogeneic SCT
- •12. Circulating plasma cell count exceeding 500/microliter or 5% of the peripheral blood white cells
- •13. Prior solid organ transplantation
- •14. History of autoimmune disease
- •15. History of confirmed progressive multifocal leukoencephalopathy
- •16. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
- •17. Known history of amyloidosis
- •18. Lesions in proximity of vital organs that may develop sudden decompensation/deterioration in the setting of a tumor flare
- •19. History of other malignancy within 2 years prior to screening
- •20. Current or past history of central nervous system (CNS) disease
- •21. Significant cardiovascular disease
- •22. Known history of Grade >=3 cytokine release syndrome (CRS) or immune effector cell associated neurotoxicity syndrome (ICANS) with prior bispecific therapies
- •23. Symptomatic active pulmonary disease or requiring supplemental oxygen
- •24. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection
- •25. Known or suspected chronic active Epstein-Barr virus (EBV) infection
- •26. Recent major surgery within 4 weeks prior to first study treatment
- •27. Positive serologic or PCR test results for acute or chronic HBV infection
- •28. Acute or chronic hepatitis C virus (HCV) infection
- •29. Known history of HIV seropositivity
- •30. Administration of a live, attenuated vaccine within 4 weeks before first study treatment
- •31. Treatment with systemic immunosuppressive medications within 2 weeks prior to first study treatment
- •32. History of illicit drug or alcohol abuse within 12 months prior to screening
- •33. Any medical condition or abnormality in clinical laboratory tests that, in 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 the results
- •Additional Arm B-Specific Exclusion Criteria
- •34. Pregnant or breastfeeding, or intending to become pregnant 4 weeks prior to initiation of study treatment, during the study, or within 4 weeks after the last dose of pomalidomide
- •35. History of erythema multiforme, Grade >=3 rash, blistering, or severe hypersensitivity to prior treatment with immunomodulatory drugs such as th
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