Suspended

MMProspective Comparison the Pharmacokinetics of Subcutaneous Versus Intravenous Administration of Bortezomib in Newly Diagnosed Patients of Multiple Myeloma in China.

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What is being tested

Subcutaneous bortezomib

+ Intravenous bortezomib

Other
Who is being recruted

Blood Protein Disorders+12

+ Cardiovascular Diseases

+ Hematologic Diseases

Over 18 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: May 2014
See protocol details

Summary

Principal SponsorThe First Affiliated Hospital of Soochow University
Last updated: August 18, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2014

Actual date on which the first participant was enrolled.

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.

NCT01812096
Principal SponsorThe First Affiliated Hospital of Soochow University
Last updated: August 18, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Protein DisordersCardiovascular DiseasesHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersImmune System DiseasesImmunoproliferative DisordersLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeParaproteinemiasVascular DiseasesHemostatic DisordersNeoplasms, Plasma CellMultiple Myeloma

Criteria

3 inclusion criteria required to participate
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
2 exclusion criteria prevent from participating
If have severe side-effects on bortezomib
If have uncontrolled intercurrent illness including ongoing or active infection,heart failure,unstable angina pectoris,or psychiatric illness/social situations that study requirements

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

The First Affiliated Hospital of Soochow University

Suzhou, ChinaOpen The First Affiliated Hospital of Soochow University in Google Maps
SuspendedOne Study Center