EUCTR2018-003287-31-ES进行中（未招募）1 期
A Phase 2, Multicenter, Single Arm, Open Label Study of Venetoclax Plus Lenalidomide and Dexamethasone for the Treatment of Newly Diagnosed t(11;14)-Positive Multiple Myeloma in Subjects Who Are Ineligible for High-Dose Therapy
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
- 40
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
入选标准
- •- Subject must have documented, confirmed active MM with = 10% clonal bone marrow plasma cells or biopsy-proven bone or extramedullary plasmacytoma and any one or more of the following myeloma-defining events:
- •Evidence of end organ damage attributed to the underlying plasma cell proliferative disorder and satisfying at least one of the CRAB criteria:
- •1. Hypercalcemia (serum calcium > 0.25 mmol/L [> 1 mg/dL] higher than the upper limit of normal (ULN) or > 2.75 mmol/L [> 11 mg/dL]);
- •2. Renal insufficiency (creatinine clearance [CrCL] < 40 mL/min or serum creatinine > 177 µmol/L [> 2 mg/dL]);
- •3. Anemia (hemoglobin > 20 g/L below the lower limit of normal or hemoglobin < 100 g/L);
- •4. Bone lesions (one or more osteolytic lesions on skeletal radiography, computed tomography [CT], or positive emission tomography [PET]-CT).
- •Or Any one or more of the following biomarkers of malignancy:
- •1. = 60% clonal bone marrow plasma cells;
- •2. Involved:uninvolved serum free light chain ratio = 100;
- •3. > 1 focal lesions on magnetic resonance imaging (MRI; each focal lesion must be 5 mm or more in size).
- •- Subject must have measurable disease defined by at least one of the following criteria:
- •Serum M-protein = 1.0 g/dL (immunoglobulin [Ig]G myeloma) or = 0.5 g/dL (IgA, IgM, IgD, or IgE myeloma);
- •Urine M-protein = 200 mg/24 hours;
- •Serum free light chain (FLC) = 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal.
- •- Subject is newly diagnosed and not considered a candidate for high-dose therapy and hematopoietic stem cell transplantation (HSCT) due to:
- •Age = 65 years;
- •Or age less than (<) 65 years with presence of comorbid condition(s) likely to have a negative impact on tolerability of high dose chemotherapy with hematopoietic stem cell transplantation. Sponsor review and approval of participants below 65 years of age is required.
- •- Subject must have MM positive for the t(11;14) translocation, as determined by an analytically validated fluorescence in situ hybridization (FISH) assay per central laboratory testing of a bone marrow aspirate sample (enrollment with local t(11;14)-positive FISH results will be considered at the discretion of the therapeutic area medical director or scientific director).
- •- Subject must have Eastern Cooperative Oncology Group performance status = 2.
- •- Subject must have laboratory values meeting the following criteria within the screening period before the first dose of study drug:
- •Absolute neutrophil count (ANC) = 1000/µL; subject may use growth factor support to achieve ANC eligibility criteria;
- •Platelets: = 75,000/mm3. For subjects with > 50% myeloma involvement in the marrow, a platelet count of = 50,000 mm3 is allowed. Subjects may not have received a platelet transfusion within 72 hours prior to the platelet count used
- •for eligibility;
- •Hemoglobin = 8.0 g/dL; subject may receive red blood cell transfusions in accordance with institutional guidelines to meet this criteria;
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3 × upper limit of normal (ULN);
- •Total bilirubin = 1
排除标准
- •The subject is not naïve to treatment with venetoclax or another BCL-2 inhibitor
- •The subject has been treated or received any of the following:
- •o Prior or current systemic therapy or HSCT for MM
- •o Radiation therapy within 2 weeks of dosing
- •o Plasmapheresis within 4 weeks of dosing
- •o Immunization with live vaccine within 8 weeks of dosing
- •The subject has a history of other active malignancies, including myelodysplastic syndromes (MDS) within the past three years except adequately treated in situ carcinoma of the cervix, uteri or the breast; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; Prostate cancer Gleason grade 6 or lower AND with stable prostate specific antigen levels off treatment; previous malignancy with no evidence of disease confined and surgically resected (or treated with other modalities) with curative intent and unlikely to impact survival during the duration of the study.
- •The subject has known allergies, hypersensitivities, or intolerance to any of the study drug or excipients.
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