EUCTR2017-003838-88-ES进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, Open Label Study of Venetoclax and Dexamethasone Compared with Pomalidomide and Dexamethasone in Subjects with t(11;14)-Positive Relapsed or 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
- 244
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
- •- Subjects must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
- •- Adult male or female subjects = 18 years old.
- •- Subjects should have laboratory values meeting the following criteria within the screening period prior to the first dose of study drug:
- •Absolute neutrophil count (ANC) = 1000/µL; subject may use growth factor support to achieve ANC eligibility criteria;
- •Platelets: = 50,000/mm3. For subjects with > 50% myeloma involvement in the marrow, a platelet count of = 30,000 mm3. 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 (RBC) transfusions in accordance with institutional guidelines to meet this criteria;
- •AST and ALT = 3 × upper limit of normal (ULN);
- •Total bilirubin = 1.5 x ULN (subjects with documented Gilbert's syndrome, may have bilirubin > 1.5 × ULN);
- •Creatinine clearance = 30 mL/min, measured by 24-hour urine collection or calculated using the Cockcroft-Gault formula);
- •Serum calcium corrected for albumin = 14.0 mg/dL (= 3.5 mmol/L).
- •- Subjects should be willing or able to comply with procedures required in this protocol.
- •- Subjects should be willing and able to receive antithrombotic prophylactic treatment.
- •- Documented diagnosis of multiple myeloma based on standard IMWG criteria.
- •- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status = 2.
- •- Subject has documented disease progression on or within 60 days of completion of their last therapy.
- •- Subject has received at least 2 prior lines of therapy.
- •A line of therapy consists of at least 1 complete cycle of a single agent, a regimen consisting of a combination of several drugs, or a planned sequential therapy of various regimens.
- •- Subject must have received at least 2 consecutive cycles of lenalidomide and be refractory to lenalidomide as defined by one of the following:
- •Subject experienced PD on or within 60 days of completing treatment.
- •Subject exhibited PR or better but relapsed within 6 months after stopping treatment.
- •- Subject must have received at least 2 consecutive cycles of a proteasome inhibitor (bortezomib, carfilzomib or ixazomib).
- •- Subject has measurable disease at Screening, defined by at least 1 of the following:
- •Serum M-protein = 1.0 g/dL (= 10 g/L); OR
- •Urine M-protein = 200 mg/24 hours; OR
- •Serum immunoglobulin free light chain (FLC) = 10 mg/dL (100 mg/L), provided serum FLC ratio is abnormal
- •- Subject has MM positive for t(11;14) as determined by an analytically validated FISH assay per centralized laboratory testing.
- •- A negative serum pregnancy test for all female subjects (except those of non-childbearing potential) within 10 to 14 days prior to initiating therapy and a negative urine pregnancy test within 24 hours for all female subjects (except those of non-childbearing potential) at baseline prior
排除标准
- •- Subject has history of treatment with venetoclax or another BCL-2 inhibitor or pomalidomide.
- •- Subject has a history of other active malignancies, including myelodysplastic syndromes (MDS), within
- •the past 3 years with the following exceptions:
- •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 (PSA) levels off treatment; or
- •Previous malignancy with no current evidence of disease, and which was confined and surgically resected (or treated with other modalities) with curative intent and unlikely to impact survival during the duration of the study.
- •- Subject has evidence of ongoing graft-versus-host disease (GvHD) if prior stem cell transplant (SCT).
- •- Subject must not have received any live vaccines within 8 weeks prior to randomization
- •- Subject has had prior treatment with the following:
- •Allogeneic or syngeneic SCT within 16 weeks prior to randomization; or
- •Autologous SCT within 12 weeks prior to randomization
- •- Subject has known meningeal involvement of multiple myeloma.
- •- Subject has a history of clinically significant renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, pulmonary or hepatic disease within the last 6 months that, in the opinion of the investigator, would adversely affect participation in this study.
- •- Subject has a history of known allergies, hypersensitivities, or intolerance to any of the study drug or
- •excipients, or thalidomide derivatives.
- •- Subject has the following conditions:
- •Nonsecretory multiple myeloma;
- •Active plasma cell leukemia i.e., either 20% of peripheral white blood cells or > 2.0 × 109/L circulating plasma cells by standard differential;
- •Waldenström's macroglobulinemia;
- •Primary amyloidosis;
- •POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes);
- •Known human immunodeficiency virus (HIV) infection;
- •Active hepatitis B or C infection based on screening blood testing;
- •Significant cardiovascular disease, including uncontrolled angina, arrhythmia, recent myocardial infarction within 6 months of first dose, congestive heart failure NYHA Class = 3;
- •Major surgery within 4 weeks prior to first dose or planned during study participation;
- •Acute infections within 14 days prior to first dose requiring parenteral therapy (antibiotic, antifungal, or antiviral);
- •Uncontrolled diabetes or hypertension within 14 days prior to first dose; or
- •Peripheral neuropathy = Grade 3 or = Grade 2 with pain within 2 weeks prior to first dose.
- •- Female who is pregnant, breastfeeding, or considering becoming pregnant during the study and for at least 30 days after the last dose of study drug.
- •- Male who is considering fathering a child or donating sperm during the study and for at least 30 days after the last dose of study drug.
研究者
相似试验
进行中（未招募）
1 期
Phase 3 Study of Venetoclax and Dexamethasone Compared with Pomalidomide and Dexamethasone in Subjects with t(11;14)-Positive Relapsed or Refractory Multiple MyelomaR/R Multiple MyelomaMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-003838-88-DEAbbVie Deutschland GmbH & Co. KG244
招募中
3 期
A Phase 3, Multicenter, Randomized, Open Label Study to Compare the Efficacy and Safety of BB2121 Versus Standard Regimens in Subjects with Relapsed and Refractory Multiple Myeloma (RRMM) (KarMMa-3)Relapsed and Refractory Multiple MyelomaCancer of the bone marrow that recurs or is resistant to treatment1003522710018865NL-OMON56296Celgene Corporation16
进行中（未招募）
1 期
A study to compare the efficacy and safety of bb2121 to standard treatment in people who have Myeloma that is not responsive after treatment or who had Myeloma which has returned after a period of treatment.Multiple myeloma (MM) with at least 2 prior therapies including an immunomodulatory (IMiD) compound and a proteasome inhibitor (PI) and demonstrated disease progression on or within 60 days of completion of the last therapy.MedDRA version: 16.1Level: HLTClassification code 10028229Term: Multiple myelomasSystem Organ Class: 100000004851MedDRA version: 20.0Level: LLTClassification code 10067095Term: Multiple myeloma progressionSystem Organ Class: 100000004864EUCTR2018-001023-38-ITCelgene Corporation381
进行中（未招募）
1 期
A Phase 3, Multicenter, Randomized, Open Label Study of Venetoclax and Dexamethasone Compared with Pomalidomide and Dexamethasone in Subjects with t(11;14)-Positive Relapsed or Refractory Multiple MyelomaR/R Multiple MyelomaMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864EUCTR2017-003838-88-DKAbbVie Deutschland GmbH & Co. KG244
进行中（未招募）
1 期
A study to compare the efficacy and safety of bb2121 to standard treatment in people who have Myeloma that is not responsive after treatment or who had Myeloma which has returned after a period of treatment.EUCTR2018-001023-38-FRCelgene Corporation381