Status:

UNKNOWN

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

Lead Sponsor:

The First Affiliated Hospital of Soochow University

Conditions:

Multiple Myeloma Proved by Laboratory Tests

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

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 vers...

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),...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2017

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT01812096

Start Date

May 1 2014

End Date

June 1 2017

Last Update

August 18 2015

Active Locations (1)

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Page 1 of 1 (1 locations)

1

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215006