Study of Subcutaneous Versus Intravenous Administration of Bortezomib in Patients With Multiple Myeloma in China
This trial is active, not recruiting.
|Condition||multiple myeloma proved by laboratory tests|
|Treatments||subcutaneous bortezomib, intravenous bortezomib|
|Phase||phase 1/phase 2|
|Sponsor||The First Affiliated Hospital of Soochow University|
|Start date||May 2014|
|End date||January 2016|
|Trial size||20 participants|
|Trial identifier||NCT01812096, SZ5201|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
time frame: 6 months
time frame: two years
Male or female participants at least 18 years old.
Inclusion Criteria: - Must be Multiple Myeloma Proved by Laboratory Tests - Must have the ability to observe the efficacy and events - Patient must have the ability to understand and willingness to provide written informed consent in the study and any related procedures being performed Exclusion Criteria: - If have uncontrolled intercurrent illness including ongoing or active infection,heart failure,unstable angina pectoris,or psychiatric illness/social situations that study requirements - If have severe side-effects on bortezomib
|Official title||Prospective Comparison the Pharmacokinetics of Subcutaneous Versus Intravenous Administration of Bortezomib in Newly Diagnosed Patients of Multiple Myeloma in China.|
|Principal investigator||Fu chengcheng, PhD|
|Description||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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