ACTRN12618001085268已完成2 期
An exploratory study of Venetoclax in combination with Bortezomib-Cyclophosphamide-Dexamethasone (VCD) induction therapy in newly diagnosed transplant eligible (NDTE MM) multiple myeloma with proteomic correlative studies
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Male or female patients aged 18 years or older.
- •2.Patient has newly diagnosed treatment naïve MM as per the IMWG criteria and is planned to proceed to high-dose chemotherapy conditioned ASCT as part of first-line treatment.
- •3.Treatment naïve apart from a limited exposure to corticosteroids and/or radiotherapy for urgent symptom control.
- •4.No contraindication to the use of any of the study drugs.
- •5.Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- •6.Subject has measurable disease at screening, defined as at least one of the following:
- •- Serum M-protein >= 5 g/L, OR
- •- Urine M-protein >= 200 mg in 24-hours, OR
- •- Serum immunoglobulin free light chain (FLC) >= 100 mg/L provided serum FLC ratio abnormal.
- •7.Subject must meet the following laboratory parameters, per laboratory reference range:
- •- Absolute neutrophil count (ANC) >= 1 x 10^9/L within 2 weeks prior to starting induction. Subjects may use growth factor support to achieve ANC eligibility criteria.
- •- Platelet count >= 50 x 109/L, within 2 weeks prior to starting induction. For subjects with > 50% myeloma involvement in the bone marrow, a platelet count of >= 30 x10^9/L within 2 weeks prior to starting induction is allowed. Subjects cannot receive a platelet transfusion within 72 hours prior to the platelet count used for eligibility.
- •- Haemoglobin >= 80 g/L, within 2 weeks prior to starting induction. Subjects may receive RBC transfusions in accordance with institutional guidelines to meet this criterion.
- •- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) <= 3 × upper limit of normal range (ULN).
- •- Total bilirubin <= 1.5 x ULN (unless bilirubin rise is due to Gilbert syndrome or of non-hepatic origin).
- •- CrCl >= 30 mL/minute (min), measured by 24-hour urine collection or calculated using Cockcroft-Gault formula:
- •CrCl = ((140 – age in years) × weight in kg × 0.85 if female) / (72 × serum creatinine in mg/dL)
- •8.Subject must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC) prior to the initiation of any screening or study-specific procedures.
- •9.If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation at least 3 months before study participation, bilateral oophorectomy and/or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and 90 days after last dose of study drug.
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 comprised of plasma cells or > 2.0 × 109/L) circulating plasma cells by standard differential.
- •- Waldenström's macroglobulinemia.
- •- Amyloidosis.
- •- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
- •- Subject is known to be positive for Human Immunodeficiency Virus (HIV)
- •- Significant cardiovascular disease, including uncontrolled angina, severe or uncontrolled arrhythmia, recent myocardial infarction within 6 months of induction, or congestive heart failure New York Heart Association (NYHA) Class >= 3.
- •- Major surgery within 4 weeks prior to starting induction.
- •- Uncontrolled and/or active systemic infections (viral, bacterial or fungal).
- •- Chronic hepatitis B (HBV) or hepatitis C (HCV) requiring treatment.
- •- Peripheral neuropathy >= Grade 3 or >= Grade 2 with pain within 2 weeks prior to starting induction.
- •- Uncontrolled diabetes or uncontrolled hypertension within 14 days prior to starting induction.
- •- 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.Subject has a hypersensitivity or allergy to any of the components of study therapy including Venetoclax, Bortezomib, boron, mannitol, or Dexamethasone.
- •4.Subject has received any prior anti-MM with the exception of Dexamethasone (total dose not exceeding 160mg) or localized radiotherapy for the emergency management of newly diagnosed MM.
- •5.Subject has received a strong or moderate CYP3A inhibitor or inducer within 1 week prior to commencing study treatment.
- •6.Administration or consumption of grapefruit or grapefruit products, Seville oranges (including marmalade containing Seville orange) or star fruit within 3 days prior to the first dose of study drug.
研究者
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