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

Phase 1

• Conditions: Multiple Myeloma Proved by Laboratory Tests
• Interventions: Other: Subcutaneous bortezomib; Other: Intravenous bortezomib

• 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

Arm && Interventions

Group	Intervention	Description
the pharmacokinetic of bortezomib	Subcutaneous bortezomib	the pharmacokinetic and pharmacodynamic, and assessed safety and efficacy of subcutaneous administration of bortezomib
Intravenous	Intravenous bortezomib	the pharmacokinetic and pharmacodynamic, and assessed safety and efficacy of intravenous administration of bortezomib

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