NCT01812096

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2013

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

August 18, 2015

Status Verified

August 1, 2015

Enrollment Period

1.7 years

First QC Date

March 13, 2013

Last Update Submit

August 17, 2015

Conditions

Multiple Myeloma Proved by Laboratory Tests

Keywords

multiple myelomabortezomibSubcutaneous

Outcome Measures

Primary Outcomes (1)

  • pharmacokinetic

    6 months

Secondary Outcomes (1)

  • curative effect

    two years

Study Arms (2)

the pharmacokinetic of bortezomib

EXPERIMENTAL

the pharmacokinetic and pharmacodynamic, and assessed safety and efficacy of subcutaneous administration of bortezomib

Other: Subcutaneous bortezomib

Intravenous

ACTIVE COMPARATOR

the pharmacokinetic and pharmacodynamic, and assessed safety and efficacy of intravenous administration of bortezomib

Other: Intravenous bortezomib

Interventions

Subcutaneous bortezomibOTHER
Also known as: the methods of use bortezomib
the pharmacokinetic of bortezomib
Intravenous bortezomibOTHER
Intravenous

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Fu chengcheng, PhD

    First Affiliated Hospital,Soochow University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2013

First Posted

March 15, 2013

Study Start

May 1, 2014

Primary Completion

January 1, 2016

Study Completion

June 1, 2017

Last Updated

August 18, 2015

Record last verified: 2015-08

Locations

CN(1)