Study of Subcutaneous Versus Intravenous Administration of Bortezomib in Patients With Multiple Myeloma in China

Phase 1

• Conditions: Multiple Myeloma Proved by Laboratory Tests

• Registration Number: NCT01812096
• Lead Sponsor: The First Affiliated Hospital of Soochow University

Brief 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.

Study Timeline

• Study First Submitted: 2013-03-13
• Study First Submitted QC: 2013-03-13
• Study First Posted: 2013-03-15
• Study Start: 2014-05
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-17
• Last Update Posted: 2015-08-18
• Primary Completion: 2016-01
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
pharmacokinetic	6 months

Secondary Outcome Measures

Name	Time	Method
curative effect	two years

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China