ACTRN12617000202369已完成2 期
A randomized phase 2 study of bortezomib, cyclophosphamide and dexamethasone induction (VCD) compared with VCD and daratumumab induction followed by daratumumab maintenance (VCDD) for the initial treatment of transplant ineligible patients with multiple myeloma.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 135
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
- Randomised controlled 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 18 years or older.
- •2. Patients must have a diagnosis of symptomatic multiple myeloma as per IMWG criteria
- •3. Measureable disease
- •4. Newly diagnosed and not considered candidate for high-dose chemotherapy with autologous stem cell transplantation
- •5. Patients must be untreated apart from a brief course of corticosteroids or radiotherapy
- •6. No contraindication to the use of any of the study drugs
- •7. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •8. Patients must meet the following clinical laboratory criteria:
- •a. ANC greater than or equal to 1.0 times 10 to the power of 9 per litre (G-CSF use is permitted)
- •b. Platelet count greater than or equal to 70 times 10 to the power of 9 per litre for subjects in whom less than 50 percent of bone marrow nucleated cells are plasma cells; otherwise platelet count greater than 50 times 10 to the power of 9 per litre
- •c. Total bilirubin less than or equal to 2 times upper limit of normal (ULN), except in subjects with Gilbert syndrome, then direct bilirubin less than or equal to 2 times ULN
- •d. ALT and AST less than or equal to 5 times ULN
- •9. Voluntary written consent
- •10. Female patients who are postmenopausal or agree to use effective contraception
- •11. Male patients who agree to use effective contraception
- •12. Study site must be able to get correlative samples to the Alfred Hospital, Melbourne, Australia, within 24 hours of collection
排除标准
- •1. Patients with Amyloid light-chain (AL) amyloidosis, monoclonal gammopathy of uncertain significance or smouldering MM.
- •2. Female patients who are lactating or have a positive serum pregnancy test during the screening period.
- •3. Patient has greater than or equal to Grade 3 peripheral neuropathy, or Grade 2 with pain on clinical examination during the screening period.
- •4. Subject has significant airways disease according to the following definitions:
- •a. Subject has known chronic obstructive pulmonary disease (COPD) with an Forced Expiratory Volume in 1 second (FEV1) less than 50 percent of predicted normal.
- •b. Subject has had known moderate or severe persistent asthma within the last 2 years, or currently has uncontrolled asthma of any classification. (Note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study).
- •5. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, New York Heart Association (NYHA) class 3 or 4 heart failure symptoms, unstable angina, or myocardial infarction within the past 6 months.
- •6. Known ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive
- •7. Active malignancy with the exception of any of the following:
- •a. Adequately treated basal cell carcinoma, squamous cell carcinoma, or in situ cervical cancer
- •b. Adequately treated Stage I cancer from which the subject is currently in remission and has been in remission for 2 years
- •c. Stage I prostate cancer that does not require treatment
- •d. Any other cancer from which the subject has been disease-free for greater than or equal to 2 years
- •8. Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol.
- •9. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
- •10. Participation in other clinical trials for the treatment of multiple myeloma, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial.
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