JPRN-jRCT2061200056进行中（未招募）1 期
A Phase 1/2 Multicenter, Open-label Study to Assess the Safety, Pharmacokinetics and Efficacy of CC-92480 Monotherapy and in Combination with Dexamethasone in Subjects with Relapsed and Refractory Multiple Myeloma
ishio Mitsufumi0 个研究点目标入组 6 人开始时间: 2021年2月19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
- 6
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. Subjects must have a documented diagnosis of MM and measurable disease at enrollment. Measurable disease is defined as (*NOTE: This is not applicable in the Japanese Cohort):
- •a. M-protein quantities >= 0.5 g/dL by serum protein electrophoresis (sPEP) or
- •b. >= 200 mg/24 hour urine collection by urine protein electrophoresis (uPEP) or
- •c. Serum free light chain (FLC) levels > 100 mg/L (milligrams/liter) involved light chain and an abnormal kappa/lambda ratio in subjects without measurable serum or urine M-protein or
- •d. for subjects with immunoglobulin class A (IgA), myeloma whose disease can only be reliably measured by quantitative immunoglobulin measurement, a serum IgA level >= 0.50 g/dL.
- •6. All subjects must have:
- •a. received at least 3 prior anti-myeloma regimens including an immunomodulatory agent (lenalidomide or pomalidomide), a proteasome inhibitor, a glucocorticoid and a CD38 antibody (note: induction with or without bone marrow transplant and with or without maintenance therapy is considered one regimen),
- •b. documented disease progression during or after their last myeloma therapy
- •i. subjects who had CAR-T therapy as their last myeloma therapy are eligible as long as they have documented disease progression following CAR-T therapy,
- •7. Subjects must have the following laboratory values:
- •a. Absolute neutrophil count (ANC) >= 1.25 * 10^9/L without growth factor support for >= 7 days (>= 14 days for pegfilgrastim). ANC of >= 1.00 * 10^9/L is permitted for the dose expansion cohorts (Part 2). Japanese subjects must have ANC >= 1.25 * 10^9/L without growth factor support for >= 7 days (>= 14 days for pegfilgrastim)
- •b. Hemoglobin (Hgb) >= 8 g/dL.
- •c. Platelets (plt) >= 75 * 10^9/L without transfusion for >= 7 days.
- •d. Corrected serum calcium <= 13.5 mg/dL (<= 3.4 mmol/L).
- •e. estimated glomerular filtration rate (eGFR) >- 30 mL/min calculated using the Modification of Diet in Renal Disease (MDRD) formula with BSA normalization removed
- •f. AST/SGOT and ALT/SGPT <= 3.0 * upper limit of normal (ULN).
- •g. Serum bilirubin <= 1.5 * ULN or < 3.0 mg/dL for subjects with documented Gilbert's syndrome.
- •h. Uric acid <= 7.5 mg/dL (446 micromol/L).
- •i. Prothrombin time (PT)/International normalized ratio (INR) < 1.5 * ULN and partial thromboplastin time (PTT) < 1.5 * ULN, (for subjects not receiving therapeutic anticoagulation).
- •Note: Subjects receiving therapy for a thromboembolic event that occurred >3 months prior to enrollment are eligible as long as they are on a stable regimen of anticoagulation with warfarin, low-molecular weight heparin or other approved therapeutic anticoagulation or antiplatelet regimen.
- •8. Females of childbearing potential (FCBP) must:
- •a. Have two 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 discontinuation of CC-92480. 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 b
排除标准
- •1. Subject has a 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 non-secretory multiple myeloma.
- •5. Subject has refractory primary multiple myeloma (ie, no history of at least a minor response to a prior treatment regimen). *NOTE: This is not applicable in the Japanese Cohort
- •6. Subject has plasma cell leukemia or active leptomeningeal myelomatosis.
- •7. Subject has documented, systemic light chain amyloidosis or Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome.
- •8. Subject has immunoglobulin class M (IgM) myeloma.
- •9. Part 1: Subject has a history of allogeneic bone marrow transplantation. Part 2: Subject has a history of allogeneic bone marrow transplantation within 6 months prior to first dose. Subject should not have ongoing graft-versus-host disease (GVHD) requiring systemic immunosuppression.
- •10. Subject is undergoing dialysis.
- •11. Subjects with peripheral neuropathy >= Grade 2.
- •12. Subjects with gastrointestinal disease that may significantly alter the absorption of CC-92480.
- •13. Subject has impaired cardiac function or clinically significant cardiac disease, including any of the following:
- •a. LVEF < 45% as determined by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan at Screening.
- •b. Complete left bundle branch, bifascicular block or other clinically significant abnormal electrocardiographic (ECG) finding at Screening.
- •c. A prolongation of QT interval on Screening ECG as defined by repeated
- •demonstration of a QTc interval >480 milliseconds (ms) using Fridericia's QT correction formula; a history of or current risk factors for Torsades de Pointe (eg, heart failure, hypokalemia, or a family history of Long QT Syndrome); and concurrent administration of medications that prolong the QT/QTc interval.
- •d. Congestive heart failure (New York Heart Association Class III or IV).
- •e. Myocardial infarction <=6 months prior to starting CC-92480.
- •f. Unstable or poorly controlled angina pectoris, including the Prinzmetal variant of angina pectoris.
- •14. Concurrent administration of strong CYP3A modulators; concurrent administration of proton-pump inhibitors (PPI) (eg, omeprazole, esomeprazole, lansoprazole, pantoprazole) <= 2 weeks prior to starting CC-92480.
- •15. Subjects had prior exposure to an investigational anti-myeloma agent (eg, anti-PD-1, anti-PD-L1) or approved myeloma therapies (including therapeutic monoclonal antibodies such as anti-CD38 or anti-SLAM-7) <- 5 half-lives or within 4 weeks prior to starting CC-92480, whichever is shorter. NOTE: CAR-T products (including commercial and investigational products) are not excluded.
- •16. Subject had major surgery <= 2 weeks prior to starting CC-92480. Note: Subjects must have recovered from any clinically significant effects of recent surgery.
- •17. Subject is a pregnant or nursing female, or intends to become pregnant or donate ova during participation in the study. Subject who is breastfeeding but agrees to stop breastfeeding prior to the study treatment and for at least 28 days after the last dose of CC-92480, is allowed to be enrolled.
- •18. Subject has known human im
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