An open label, multicentre, phase I/II dose escalation trial of carfilzomib in combination with doxorubicin and dexamethasone (CAD) therapy in transplant eligible relapsed myeloma patients

niversity of Leeds (UK)0 个研究点目标入组 48 人开始时间: 2011年5月12日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Able to give informed consent and willing to follow study protocol
•2. Aged over 18 years, either sex
•3. Patients with relapsed myeloma requiring therapy
•4. Transplant eligible
•5. Adequate renal function (creatinine clearance greater than or equal to 30 ml/min) within 14 days prior to study entry
•6. Adequate liver function (alanine aminotransferase [ALT]/aspartate aminotransferase [AST] less than 3 x upper limit of normal [ULN]) within 14 days prior to study entry
•7. Adequate bone marrow reserve (haemoglobin [Hb] greater than 8.0 g/dL, absolute neutrophil count [ANC] greater than 1.0 x 10^9/L, platelets [Plts] greater than 75 x 10^9/L) within 14 days prior to study entry
•8. Female subjects of child-bearing potential must have a negative pregnancy test within 24 hours prior to starting therapy and agree to use dual methods of contraception for the duration of the study. Male subjects must agree to use a barrier method of contraception for the duration of the study if sexually active with a female of child-bearing potential.

•1. Unable to tolerate an aggressive fluid hydration regimen (e.g. due to pre-existing pulmonary, cardiac or renal impairment)
•2. Received an investigational medicinal product at any dose within 28 days of study entry (registration)
•3. Concurrent or previous malignancies (less than 12 months post end of treatment) at other sites, with the exception of appropriately treated localised epithelial skin or cervical cancer. Patients with histories (greater than or equal to 12 months) of other tumours may be entered.
•4. Seropositive for human immunodeficiency [HIV], or active hepatitis A, B or C infection
•5. Any history of hypersensitivity to any of the study medications or excipients
•6. Patients with active uncontrolled infections
•7. Patients with peripheral neuropathy Common Toxicity Criteria (CTC) grade 3 or higher within 14 days prior to study entry
•8. Poorly controlled or serious medical or psychiatric illness that, in the Investigator's opinion, is likely to interfere with participation and/or compliance in this clinical study
•9. Pregnant or breast feeding

发起方

niversity of Leeds (UK)