ACTRN12621001458820尚未招募1 期
Phase I Clinical Trial to Determine Dosing Schedule of Hydroxychloroquine in Participants with Multiple Myeloma and Partial Response or Less to Carfilzomib
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 36
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
- 19 Years 至 o limit（—）
- 性别
- All
入选标准
- •Written informed consent given by the participant or next of kin, legal guardian or appointed public guardian
- •Males and females aged greater than 18
- •Disease status: Progressive multiple myeloma according to the IMWG Criteria for Response Assessment after at least one prior line of therapy and satisfies the PBS criteria for Carfilzomib treatment
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- •Left ventricular ejection fraction greater than or equal to 40%, assessed by echocardiogram or multi-gated acquisition scan
- •Absolute neutrophil count greater than or equal to 1 x 109/L within 21 days prior to Cycle 1 Day 1
- •Haemoglobin greater than or equal to 80 g/L within 21 days prior to Cycle 1 Day 1
- •Platelet count greater than or equal to 50 x 109/L (or greater than or equal to 30 x 109/L if myeloma involvement in the bone marrow is greater than 50%), within 21 days prior to Cycle 1 day 1
- •Calculated or measured creatinine clearance of greater than or equal to 15 mL/min within 21 days prior to Cycle 1 Day 1
- •Adequate hepatic function within 21 days prior to Cycle 1 Day 1, with bilirubin < 1.5 times the upper limit of normal, and aspartate aminotransferase and alanine aminotransferase < 3 times the upper limit of normal.
- •Female patients of child-bearing potential must have a negative serum pregnancy test within 21 days prior to Cycle 1 Day 1 and agree to use an effective method of contraception during the study and for 3 months following the last dose of drug
- •oPostmenopausal females (> 45 years old and without menses for > 1 year) and surgically sterilised females are exempt from any pregnancy test.
- •Male patients must agree to use an effective method of contraception during the study and for 3 months following the last dose of drug
排除标准
- •Written informed consent not obtained
- •ECOG performance status greater than or equal to 2
- •Known hypersensitivity to 4-aminoquinoline compounds or Hydroxychloroquine
- •Known hypersensitivity to sulfobutyl betadex sodium (a cyclodextrin used to solubilise Carfilzomib)
- •G6PD deficiency
- •Pre-existing maculopathy of the eye
- •Currently on a clinical trial for any other anti-cancer drug or anti-myeloma chemotherapy
- •Has active congestive heart failure (New York Heart Association Functional Classification of Heart Failure Class III to IV, symptomatic ischaemia or conduction abnormalities uncontrolled by conventional intervention
- •Has had myocardial infarction within 4 months prior to Cycle 1 Day 1
- •Prolonged QT interval on electrocardiogram
- •Pre-existing proarrhythmic conditions (e.g., bradycardia < 50 bpm)
- •Any history of ventricular dysrhythmia
- •Uncorrected hypokalaemia and/or hypomagnesaemia
- •Uncontrolled hypertension (greater than or equal to 140/90 mmHg within 21 days prior to Cycle 1 Day 1)
- •Platelet count < 50 x 109/L and neutrophil count < 0.5 x 109/L (except in patients with cytopenia thought to be attributed to multiple myeloma)
- •Currently pregnant or lactating
- •POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes)
- •Waldenstrom macroglobulinemia
- •Second malignancy within the past 3 years except the following:
- •oAdequately treated basal cell or squamous cell skin cancer
- •oCarcinoma in situ of the cervix
- •oProstate cancer with Gleason score < 6 and stable prostate-specific antigen over 12 months
- •oBreast carcinoma in situ with full surgical resection
- •oTreated medullary or papillary thyroid cancer
- •Has myelodysplastic syndrome
- •Chemotherapy with approved or investigational anticancer therapeutics within 7 days prior to screening bone marrow biopsy
- •Glucocorticoid therapy (prednisolone > 30 mg/day or equivalent) within 7 days prior to screening bone marrow biopsy
- •Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to screening bone marrow biopsy and Cycle 1 Day 1 (i.e., prior radiation must have been to < 30% of bone marrow)
- •Immunotherapy within 21 days prior to screening bone marrow biopsy and Cycle 1 Day 1
- •Major surgery (excluding kyphoplasty) within 14 days prior to screening bone marrow biopsy and Cycle 1 Day 1
- •Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents within 7 days prior to screening bone marrow biopsy and Cycle 1 Day 1
- •Known HIV seropositive, hepatitis C infection (except for patients who have had hepatitis C treatment and have cleared blood hepatitis C viral RNA) and/or hepatitis B (except for patients with hepatitis B surface antigen or core antibody receiving and responding to antiviral therapy directed at hepatitis B)
- •Known cirrhosis
- •Ongoing graft-vs-host disease
- •Taking any prohibited concomitant medication that cannot be stopped for the duration of the study
- •Any other clinically significant medical condition or psychiatric condition (in the investigator’s opinion) that may interfere with protocol adherence or a patient’s ability to give or withdraw informed consent
- •Any other diseases, clinical features and laboratory abnormalities that contraindicates the use of investigational drug and /or renders the participant at high risk of complications.
研究者
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