EUCTR2019-004340-30-HU进行中（未招募）1 期
A Phase 2, Open-Label, Multi-Center Study of Venetoclax in Combination with Carfilzomib and Dexamethasone in Subjects with 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
- 120
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. Eastern Cooperative Oncology Group (ECOG) performance score of = 2.
- •2. Subject has documented RRMM on or after any regimen or is refractory to the most recent line of therapy.
- •- Relapsed myeloma is defined as previously treated myeloma that progresses and requires initiation of salvage therapy, but does not meet criteria for refractory myeloma.
- •- Refractory myeloma is defined as disease that is nonresponsive (failure to achieve minimal response or development of progressive disease [PD]) while on primary or salvage therapy, or progresses within 60 days of last therapy.
- •- For Part 4, subjects must meet the above criteria and also be positive for translocation t(11;14) as determined by an analytically validated Fluorescent In Situ Hybridization (FISH) assay per central laboratory testing.
- •3. Subject has received prior treatment with at least one prior line of therapy for MM.
- •- Parts 1, 2, 3: Subject has received prior treatment with one to three prior lines of therapy.
- •- Part 4: Subject has received prior treatment with at least one prior line of therapy.
- •- A line of therapy consists of = 1 complete cycle of a single agent, a regimen consisting of a combination of several drugs, or a planned sequential therapy of various regimens.
- •4. Subject has measurable disease at Screening, defined as at least one of the following:
- •- Serum M-protein = 0.5 g/dL (= 5 g/L), OR
- •- Urine M-protein = 200 mg/24 hours, OR
- •- Serum free light chain (FLC) = 10 mg/dL, provided serum FLC ratio is abnormal.
- •5. Subject must meet the following laboratory parameters within 2 weeks prior to first dose, per laboratory reference range:
- •- Absolute neutrophil count (ANC) = 1000/µL; subject may use growth factor support to achieve ANC eligibility criteria.
- •- Platelet count:
- •o = 50,000/mm3 for subject with = 50% myeloma involvement in the bone marrow;
- •o = 30,000/mm3 for subject with > 50% myeloma involvement in the bone marrow;
- •o Subject 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 × ULN; subject with documented Gilbert's syndrome may have bilirubin > 1.5 × ULN with the approval of the Primary Therapeutic Area Medical Director.
- •- Creatinine clearance = 30 mL/min, measured by 24-hour urine collection or calculated using the Cockcroft-Gault formula.
- •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 48
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 72
排除标准
- •1. Subject has any of the following conditions:
- •- Non-secretory or oligo-secretory MM
- •- 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)
- •- Active hepatitis B or C infection based on screening blood testing
- •- Significant cardiovascular disease, including uncontrolled angina, hypertension, arrhythmia, recent myocardial infarction within 6 months of first dose, congestive heart failure New York Heart Association (NYHA) Class = 3, and/or left ventricular ejection fraction = 40% as assessed by multiple gated acquisition scan (MUGA) or ECHO.
- •- Major surgery within 4 weeks prior to first dose
- •- Acute infections requiring antibiotic, antifungal, or antiviral therapy within 14 days prior to first dose.
- •- Peripheral neuropathy = Grade 3 or = Grade 2 with pain within 2 weeks prior to first dose
- •- Uncontrolled diabetes or uncontrolled hypertension within 14 days prior to first dose
- •- Any other medical condition that, in the opinion of the Investigator, would adversely affect the subject's participation in the study.
- •2. Subject has a history of other active malignancies, including myelodysplastic syndrome (MDS), within the past 3 years prior to study entry, 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,
- •- 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.
- •3. If subject had a prior allogeneic stem cell transplant (SCT), subject has evidence of ongoing graft-versus-host disease (GvHD).
- •4. Subject has had prior treatment with carfilzomib or has a hypersensitivity or allergy to captisol (a cyclodextrin derivative used to solubilize carfilzomib) or dexamethasone.
- •5. Subject is refractory to any BCL-2 family inhibitor.
- •6. Subject has been treated or received any of the following:
- •- Allogeneic or syngeneic SCT within 6 months prior to first dose.
- •- Autologous SCT within 12 weeks prior to first dose.
- •- Immunization with live vaccine within 8 weeks prior to first dose.
- •- Monoclonal antibodies within 6 weeks prior to first dose.
- •- Any anti-myeloma therapy (other than monoclonal antibodies), including chemotherapy, radiotherapy, biological, immunotherapy or an investigational therapy, including targeted small molecule agents within 5 half-lives (or 14 days if half-life is unknown) prior to first dose.
- •- Corticosteroid therapy at a dose equivalent to = 4 mg/day of dexamethasone within 3 weeks prior to first dose.
- •- A strong or moderate CYP3A inhibitor or inducer within 1 week prior to first dose.
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