An Observational Study of Chinese Multiple Myeloma Patients Treated With Velcade

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

532 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-03-31

Study Completion Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Multiple Myeloma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Velcade

Velcade, 1.3 mg/m2/dose, administered intravenously on days 1, 4, 8 and 11, for 2 weeks.

No intervention

Intervention Type DRUG

This is an observational study. Velcade will be administered as per the recommended regimen. (Velcade, 1.3 mg/m2/dose, administered intravenously on days 1, 4, 8 and 11, for 2 weeks)

Interventions

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No intervention

This is an observational study. Velcade will be administered as per the recommended regimen. (Velcade, 1.3 mg/m2/dose, administered intravenously on days 1, 4, 8 and 11, for 2 weeks)

Intervention Type DRUG

Eligibility Criteria

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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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No