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An Observational Study of Chinese Multiple Myeloma Patients Treated With Velcade

Information source: Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma

Intervention: No intervention (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Xian-Janssen Pharmaceutical Ltd.

Official(s) and/or principal investigator(s):
Xian-Janssen Pharmaceutical Ltd., China Clinical Trial, Study Director, Affiliation: Xian-Janssen Pharmaceutical Ltd.

Summary

The purpose of this study is to acquire information on the usage, effectiveness, safety, and levels of health care resource utilization associated with Velcade therapy in recurrent and refractory multiple myeloma patients who are initiating Velcade and various combination therapies within the approved indication in a naturalistic setting.

Clinical Details

Official title: Velcade (Bortezomib for Injection) Observational Study

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome:

Information on treatment sequence for Velcade therapy

Information on dosage of Velcade

Information on duration of Velcade therapy

Information on patient diagnosis for Velcade therapy

Number of patients with disease response or progression

Time to response

Duration of response

Time to progression

Survival status

Number of patients with adverse events

Number of emergency room visits while using Velcade therapy

Number of inpatient hospital stays while using Velcade therapy

Number of days for each hospital stay

Number of patients on whom therapeutic therapies will be conducted

Number of patients on whom chest radiograph will be conducted

Number of patients on whom whole-body bone scan will be conducted

Number of patients on whom radiograph for designated area will be conducted

Serum immunoglobin and M-protein

M-protein detected by immunofixation electrophoresis

Urine light chain M-protein

Bone marrow puncture and biopsy

β2-microglobulin

C-reactive protein

Lactate dehydrogenase

Routine blood examination

Liver function test

Renal function test

Serum electrolytes

Number of patients on concomitant medications

Secondary outcome:

Indications for Velcade therapy

Sociodemographics for Velcade therapy

Number of chronic concomitant disease

Treatment history

Detailed description: This is a national, multi-center (study conducted in multiple sites), non-interventional (a scientific study where one or more investigators monitor one or more patients being treated with the same medication), observational study (a scientific study to make a clear and easy understanding of the cause and effect relationship) of Chinese Multiple Myeloma patients treated with Velcade. The study consists of 3 phases, including, screening phase, treatment phase, and follow up phase. In the screening phase, data will be collected on the basis of patient's demographic status, components of disease severity assessment, and potential prognostic factors. Data on prior cancer treatments will be collected retrospectively at baseline for patients receiving cancer treatment prior to receiving Velcade. In the treatment phase, Velcade is administered intravenously for a 2-week treatment period followed by a 10-day rest period. Each treatment cycle consists of 21 days. Prospective (in which the participants are first identified and then followed forward as time passes) observational data will be collected during treatment with Velcade. In the follow up phase, patients will be followed for up to three years to document long-term survival data. For patients who reinitiate Velcade, data collection should follow Velcade treatment period documentation process. Safety evaluations will be based on the incidence, intensity, and types of adverse events. The total duration of the study is set prospectively for three years from the date of the patients' initiation of Velcade.

Eligibility

Minimum age: N/A. Maximum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Must give informed consent in agreement with local legislation

- Must not have any contraindication listed in package insert

Exclusion Criteria:

- Patients currently participating in another investigational study of Velcade or any

other medication

- Patients with severe hepatic or renal impairment

- Patients with platelet count below 25000/μl

- Patients who are considered disqualified for the study by the investigators

Locations and Contacts

Additional Information

VELCADE (Bortezomib for Injection) Observational Study

Starting date: March 2006
Last updated: June 10, 2014

Page last updated: August 23, 2015

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