An Observational Study of Chinese Multiple Myeloma Patients Treated With Velcade

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Multiple Myeloma

Treatments: Drug: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT01675245

26866138MMY4031 (Other Identifier)

VEL-CHN-MA-01 (Other Identifier)

CR006373

Details and patient eligibility

About

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.

Full 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.

Enrollment: 532 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

532 participants in 1 patient group

Velcade

Description:

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

Treatment:

Drug: No intervention