JPRN-jRCT2080224873已完成1 期
A Phase 1b/2a Multicenter, Open-label, Dose-escalation Study to Determine the Maximum Tolerated Dose, Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CC-220 as Monotherapy and in Combination with Other Treatments in Subjects with Multiple Myeloma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
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
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Subject is >=18 years of age at the time of signing the informed consent form (ICF).
- •2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
- •3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- •4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
- •5. A female of childbearing potential (FCBP) is a female who:
- •-Have two negative pregnancy tests as verified by the Investigator prior to starting study treatment. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact.
- •-Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with two forms of contraception: one highly effective, and one additional effective (barrier) measure of contraception without interruption 28 days prior to starting investigational product, during the study treatment (including dose interruptions), and for at least 28 days after the last dose of CC-220, 90 days after the last dose of DARA (for Cohorts K), or 7 months after last dose of BTZ (for Cohorts J1), whichever is longer.
- •6. Male subjects must:
- •-Practice true abstinence (which must be reviewed on a monthly basis and source documented) or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 90 days following the last dose of study treatment, or 4 months after the last dose of BTZ (for Cohorts J1), whichever is longer, even if he has undergone a successful vasectomy.
- •7. Males must agree to refrain from donating sperm while on study treatment, during dose interruptions and for at least 90 days following last dose of study treatment.
- •8. All subjects must agree to refrain from donating blood while on study treatment, during dose interruptions and for at least 28 days following the last dose of study treatment.
- •9. All male and female subjects must follow all requirements defined in the Pregnancy Prevention Program.
- •[Cohort H1/H2]
- •10. All subjects must have a documented diagnosis of MM and have measurable disease defined as:
- •a. M-protein (serum and/or urine protein electrophoresis (sPEP or uPEP)): sPEP >= 0.5 g/dL or uPEP >= 200 mg/24 hours and/or
- •b. Light chain MM without measurable disease in the serum or urine: serum immunoglobulin free light chain >= 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio
- •11. Subjects in Cohorts H1 must have received at least 2 prior myeloma regimens (note: induction with or without bone marrow transplant and with or without maintenance therapy is considered one regimen). Subjects in Cohorts H2 must have received at least 3 prior myeloma regimens.
- •12. Subjects must have received prior treatment with at least 2 consecutive cycles of a lenalidomide or pomalidomide-containing regimen. Subjects in Cohorts H2 must have received prior treatment with at least 2 consecutive cycles of a lenalidomide-containing regimen and at least 2 consecutive cycles of a pomalidomide-containing regimen
- •13. Subjects must have received prior treatment with at least 2 consecutive cycles of a proteasome inhibitor or a proteasome inhibitor-containing regimen.
排除标准
- •1. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
- •2. Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
- •3. Subject has any condition that confounds the ability to interpret data from the study
- •4. Subject has nonsecretory or oligosecretory multiple myeloma
- •5. Subjects with Plasma Cell leukemia or amyloidosis
- •6. Any of the following laboratory abnormalities
- •-Absolute neutrophil count (ANC) < 1,000/microL
- •-Platelet count < 75,000/microL for Part 1. For Part 2; platelet count < 75,000/microL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; otherwise platelet count < 50,000/microL (transfusions are not permitted to achieve minimum platelet counts)
- •-Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L)
- •-Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) or serum glutamic pyruvic transaminase (SGPT)/alanine aminotransferase (ALT) >= 2.0 x upper limit of normal (ULN)
- •-Serum total bilirubin and alkaline phosphatase >1.5 x ULN
- •-Subjects with serious renal impairment (creatinine clearance [CrCl] < 30 mL/min) or requiring dialysis would be excluded
- •7. Subjects with peripheral neuropathy >= Grade 2
- •8. Subjects with gastrointestinal disease that may significantly alter the absorption of CC-220
- •9. Subjects with a prior history of malignancies, other than MM, unless the subject has been free of the disease for >= 5 years with the exception of the following noninvasive malignancies:
- •-Basal cell carcinoma of the skin
- •-Squamous cell carcinoma of the skin
- •-Carcinoma in situ of the cervix
- •-Carcinoma in situ of the breast
- •-Incidental histological findings of prostate cancer such as T1a or T1b using the Tumor/Node/Metastasis (TNM) classification of malignant tumors or prostate cancer that is curative
- •10. Subject has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, pomalidomide, DEX, daratumumab (for Cohorts K), or bortezomib (for Cohorts J1). Subject has known or suspected hypersensitivity to the excipients contained in the formulation of CC-220, DEX, daratumumab (for Cohorts K), or bortezomib (for Cohorts J1).
- •11. Contraindications to the other treatment regimens, as per local prescribing information
- •12. Subject has received any of the following within the last 14 days of initiating IP:
- •-Plasmapheresis
- •-Major surgery (as defined by the Investigator)
- •-Radiation therapy other than local therapy for MM associated bone lesions
- •-Use of any systemic myeloma drug therapy
- •13. Subject has been treated with an investigational agent (ie, an agent not commercially available) within 28 days or 5 half-lives (whichever is longer) of initiating IP. Not applicable for subjects who had CAR T as last prior regimen.
- •14. Subject has any one of the following:
- •-Clinically significant abnormal electrocardiogram (ECG) finding at Screening.
- •-Congestive heart failure (New York Heart Association Class III or IV)
- •-Myocardial infarction within 12 months prior to starting IP
- •-Unstable or poorly controlled angina pectoris, including the Prinzmetal variant of angina pectoris
- •15. Subject has current or prior use of immunosuppressive medication within 14 days prior to the first dose of IP. The following are exceptions to this criterion:
- •-Intranasal, inhaled, topical or local steroid injection
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