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Trial Title:
Study of Subcutaneous Versus Intravenous Administration of Bortezomib in Patients With Multiple Myeloma in China
NCT ID:
NCT01812096
Condition:
Multiple Myeloma Proved by Laboratory Tests
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Bortezomib
Conditions: Keywords:
multiple myeloma
bortezomib
Subcutaneous
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Subcutaneous bortezomib
Arm group label:
the pharmacokinetic of bortezomib
Other name:
the methods of use bortezomib
Intervention type:
Other
Intervention name:
Intravenous bortezomib
Arm group label:
Intravenous
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215006
Country:
China
Start date:
May 2014
Completion date:
June 2017
Lead sponsor:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01812096
