Multiple Myeloma Proved by Laboratory Tests Clinical Trial
Official title:
Prospective Comparison the Pharmacokinetics of Subcutaneous Versus Intravenous Administration of Bortezomib in Newly Diagnosed Patients of Multiple Myeloma in China.
Intravenous injection is the standard administration route of bortezomib; however, subcutaneous administration is an important alternative. We want to compared the pharmacokinetic of subcutaneous versus intravenous bortezomib at the approved 1•3 mg/m2 dose and twice per week,on days1, 4, 8 and 11 of 21-day cycles, schedule in newly diagnosed patients of multiple myeloma.
The new diagnosed multiple myeloma patients are randomized to receive bortezomib by standard
intravenous bolus (n=10) or subcutaneous injection (n=10) at the recommended dose and
schedule (1.3 mg/m2), days 1, 4, 8, 11;eight 21-day cycles).
Patients discontinued treatment due to progressive disease, insufficient efficacy,
unacceptable toxicity, or serious protocol violation. Dose modifications are specified for
unexpected pharmacokinetic observations or toxicity. Bortezomib-related neuropathic pain
and/or peripheral sensory neuropathy were managed using established dose-modification
guidelines.
Blood samples for pharmacokinetic/pharmacodynamic analysis are collected on days 1 and 11,
cycle 1:before bortezomib administration, and at 2, 5, 15, 30, and 60 min, and 2, 4, 6, 10,
24, 32, 48, and 72 hours post-dosing. Pharmacodynamic analyses were performed using a
whole-blood 20S proteasome specific activity inhibition assay.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment