Overview

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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
the pharmacokinetic and pharmacodynamic, and assessed safety and efficacy of subcutaneous administration of bortezomib
subcutaneous bortezomib the methods of use bortezomib
(Active Comparator)
the pharmacokinetic and pharmacodynamic, and assessed safety and efficacy of intravenous administration of bortezomib
intravenous bortezomib

Primary Outcomes

Measure
pharmacokinetic
time frame: 6 months

Secondary Outcomes

Measure
curative effect
time frame: two years

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by The First Affiliated Hospital of Soochow University.