EUCTR2016-000860-40-GB进行中（未招募）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 Relapsed and Refractory Multiple Myeloma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 303
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must satisfy the following criteria:
- •1. Subject is =18 years of age at the time of signing the 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. Subjects must have a documented diagnosis of MM and have measurable disease as further defined in the protocol.
- •5. Subjects in Cohorts A, B, C, and E 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 Cohort F must have received at least 1 prior myeloma regimen. Subjects in Cohort D must have received at least 3 prior myeloma regimens.
- •6. All subjects must have received prior treatment with at least 2 consecutive cycles of a lenalidomide or pomalidomide-containing regimen. Subjects in Cohort D 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.
- •7. All subjects must have received prior treatment with at least 2 consecutive cycles of a proteasome inhibitor or a proteasome inhibitor-containing regimen
- •8. For Part 2 (Cohort C and Cohort D), all subjects must have received prior treatment with at least 2 consecutive cycles of a CD38 antibody or a CD38 antibody-containing regimen
- •9. All subjects must have documented disease progression on or within 60 days from the last dose of their last myeloma therapy. Subjects who had CAR T therapy as their last myeloma therapy must have documented disease progression.
- •10. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
- •11. A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months) and must:
- •a) 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.
- •b) 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 CC220, 90 days after the last dose of DARA (Cohort E) or 7 months after the last dose of BTZ (Cohort F), whichever is longer. Contraception requirements are detailed in the Protocol Appendix D.
- •12. Male subjects must:
- •a. 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 las
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/µL
- •·Part 1; platelet count <75,000/µL. For Part 2; platelet count < 75,000/µL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; otherwise platelet count < 50,000/µL (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] <45 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 Cohort E), bortezomib (for Cohort F). Subject has known or suspected hypersensitivity to the excipients contained in the formulation of CC-220, DEX, daratumumab (for Cohort E), bortezomib (for Cohort F).
- •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
- •·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 injections (eg, intra-articular injection)
- •·Systemic corticosteroids at physiologic dos
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