Effects of bortezomib on bone turnover during treatment of relapsed multiple myeloma: a pilot study of quantitative in-vivo monitoring. - Bone turnover in multiple myeloma.

Vrije Universiteit Medisch Centrum0 个研究点目标入组 25 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•Inclusion criteria
•* Patients with relapsed or progressive multiple myeloma who did not receive treatment with bortezomib before, and requiring treatment
•* At least one manifest osteolytic lesion
•* Age 18-75
•* Not on active treatment with dexamethasone in the last 4 weeks, or requiring immediate treatment with dexamethasone
•* Patients on bisphosphonate treatment are allowed if bisphosphonates were started * 3 months before registration
•* WHO performance 0-2 (Appendix A)

•* Polyneuropathy * grade 2
•* Severe cardiac dysfunction (NYHA classification II-IV, appendix B)
•* Severe pulmonary dysfunction
•* Significant hepatic dysfunction (total bilirubin * 30 umol/l or transaminases * 3 times normal level), unless related to myeloma
•* Creatinine clearance <30 ml/min
•* Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months)
•* History of hypotension or decreased blood pressure (sitting systolic blood pressure [SBP] £100 mmHg and/or sitting diastolic blood pressure [DBP] £60 mmHg)
•* Patients with active, uncontrolled infections
•* Pre-treatment with proteasome inhibitors
•* Current treatment with dexamethasone or proteasome inhibitors
•* Patients requiring urgent start of bisphosphonates (e.g. uncontrolled hypercalcemia)
•* Have received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment
•* Contraindications for Magnetic Resonance Imaging ,

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