A Phase II trial of bortezomib and dexamethasone in renally-impaired patients with untreated multiple myeloma.

Prof. Andrew Spencer0 个研究点目标入组 28 人开始时间: 2011年6月14日最近更新: 2020年1月13日

试验速览

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•Renal impairment, secondary to MM, defined as a calculated estimated GFR <50ml/min,
•- Able to provide written informed consent prior to the start of study-related procedures,
•- Subject is, in the investigator's opinion, willing and able to comply with protocol requirements,
•- If female, the subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control from signing of informed consent form through to the final visit/early termination visit.
•- If male, the subject agrees to use an acceptable barrier method for contraception from signing of the informed consent through to the final visit/early termination visit.
•- The patient meets the following pre-treatment laboratory criteria at and within 21 days before baseline:
•*Platelet count >50x109/L, with or without transfusion support;
•*Haemoglobin >7.0g/dL, with or without transfusion support;
•*Absolute neutrophil count (ANC)>/=2.0x109/L;
•*Serum calcium <4.5mmol/L (<14mg/dL);
•*Aspartate Transaminase (AST) <2.5x the upper limit of normal;
•*Alanine transaminase (ALT): <2.5x the upper limit of normal;
•*Total bilirubin: <1.5x the upper limit of normal (exceptions will be made for patients diagnosed with Gilbert Syndrome);
•*ECOG status 0-3.

•- Use of investigational agents within 28 days of study entry;
•- Inadequate hepatic function;
•- Severe co-morbidity or othe likely difficulty in completing the study;
•- History of allergic reaction attributable to compounds containing boron or mannitol;
•- Peripheral neuropathy or neuropathic pain Grade 2-4 defined by NCI CTCAE version 3;
•- Uncontrolled or severe cardiovascular disease, including M1 within 6 months of enrolment, New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis;
•- Subject has history of hypotension or has decreasing blood pressure (sitting systrolic blood pressure - Subject has an active uncontrolled systemic infection requiring treatment;
•- If female, the subject is pregnant or breastfeeding. Confirmation that the subject is not pregnant must be established by a negative serum beta-HCG pregnancy test during screening. Pregnancy test is not required for post-menopausal or surgically steralised women;
•- Anyy condition, that, in the opinion of the investigator, would compromise the well-being of the subject or the study.

发起方

Prof. Andrew Spencer