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Study of Subcutaneous Versus Intravenous Administration of Bortezomib in Patients With Multiple Myeloma in China
Conditions
Multiple Myeloma Proved by Laboratory Tests
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
multiple myeloma, bortezomib, Subcutaneous
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Subcutaneous bortezomib
Type: Other
Name: Intravenous bortezomib
Type: Other
Overall Status
Recruiting
Summary
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.
Detailed 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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
- 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
Location
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Status: Recruiting
Contact: Jia Chen, Dr. - chenjiasuzhou@gmail.com
Start Date
May 2014
Completion Date
January 2016
Sponsors
The First Affiliated Hospital of Soochow University
Source
The First Affiliated Hospital of Soochow University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page