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 therapyInformation 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 therapySociodemographics 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
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