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

Soochow University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Multiple Myeloma Proved by Laboratory Tests

Treatments: Other: Subcutaneous bortezomib; Other: Intravenous bortezomib

Study type: Interventional

Funder types: Other

Identifiers

NCT01812096

SZ5201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

the pharmacokinetic of bortezomib

Experimental group

Description:

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

Treatment:

Other: Subcutaneous bortezomib

Intravenous

Active Comparator group

Description:

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

Treatment:

Other: Intravenous bortezomib