EUCTR2018-004767-31-IT进行中（未招募）1 期
A Phase 1/2, Multicenter, Open-label, Study to Determine the Recommended Dose and Regimen, and Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination with Standard Treatments in Subjects with Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM) -
CELGENE CORPORATIO0 个研究点目标入组 238 人开始时间: 2021年1月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 238
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
- •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. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
- •5. Females of childbearing potential (FCBP) must:
- •a. Have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy. 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 reliable forms of contraception as defined in the Pregnancy Prevention Plan (PPP)without interruption, 28 days prior to starting CC-92480, during the study treatment (including during dose interruptions), and for 28 days after the last dose of CC-92480 or 90 days after the last dose of BTZ (for Cohorts A, D and G) or DARA (for Cohorts B and E) or 6 months after the last dose of CFZ (for Cohorts C and F), whichever is later.
- •Note: A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point and, 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.
- •6. Male subjects must:
- •a. Practice true abstinence* (which must be reviewed on a monthly basis) or agree to use of a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study (even during dose interruptions) and for at least 3 months following study treatment discontinuation, even if he has undergone a successful vasectomy.
- •* True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and coitus interruptus (withdrawal) are not acceptable methods of contraception.
- •7. Males must agree to refrain from donating sperm or semen while on study treatment, and for at least 3 months following last dose of study treatment. Females must refrain from egg cell (ova) donation while on study treatment, and for 28 days after the last dose of CC-92480.
- •8. All subjects must agree to refrain from donating blood while on study treatment and for 28 days after the last dose of study treatment.
- •9. All male and female subjects must follow all requirements defined in the Pregnancy Prevention Plan for Subjects in Clinical Trials.
- •Please refer to protocol for additional inclusion criteria for subjects in Cohorts A, B, C, D, E and F and for subjects in Cohort G.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 143
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 95
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 any of the following laboratory abnormalities:
- •a. Absolute neutrophil count (ANC) < 1,000/µL (for Phase 1 without growth factor support for = 7 days [= 14 days for pegfilgrastim])
- •b. Platelet count: < 75,000/µL (it is not permissible to transfuse a subject to reach this level)
- •c. Hemoglobin < 8 g/dL (< 4.9 mmol/L)
- •d. Creatinine clearance (CrCl) < 45 mL/min (<30 mL/min for Cohort G)
- •e. Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L)
- •f. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 x ULN
- •g. Serum total bilirubin > 1.5 x ULN or > 3.0 mg/dL for subjects with documented Gilbert's syndrome
- •h. Prothrombin time (PT)/international normalized ration (INR) > 1.5 x ULN or partial thromboplastin time (PTT) > 1.5 x ULN, (for subjects not receiving therapeutic anticoagulation).
- •5. Subject has peripheral neuropathy = Grade 2
- •6. Subject with gastrointestinal disease that may significantly alter the absorption of CC-92480.
- •7. Subject has 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 non-invasive 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 histologic finding of prostate cancer or prostate cancer that is curative
- •8. Subject has plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or clinically significant amyloidosis.
- •9. Subject with known central nervous system (CNS) involvement with myeloma.
- •10. Subject has received immunosuppressive medication within the last 14 days of initiating study treatment. Please refer to protocol for exceptions to this criterion.
- •Please refer to protocol for exclusion criteria 11-19 and for additional exclusion criteria for subjects in Cohorts A, B, C, D, E and F and for subjects in Cohort G.
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