An Observational Study of Chinese Multiple Myeloma Patients Treated With Velcade

Overview

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 Title of Study: “Velcade (Bortezomib for Injection) Observational Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2010

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.

Interventions

  • Drug: 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)

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Information on treatment sequence for Velcade therapy
    • Time Frame: Baseline (Day -1) to Day 21
    • Treatment sequence or the line of therapy will be considered on Velcade utilization.
  • Information on dosage of Velcade
    • Time Frame: Baseline to Day 21
    • Dosage of Velcade will be considered on Velcade utilization. The unit of dosage will be milligram per square meter body surface area.
  • Information on duration of Velcade therapy
    • Time Frame: Baseline to Day 21
    • Duration of Velcade therapy will be measured on Velcade utilization. The unit of duration will be number of days or the length of the course of therapy.
  • Information on patient diagnosis for Velcade therapy
    • Time Frame: Baseline to Day 21
    • Diagnosis of patients will be considered on Velcade utilization.
  • Number of patients with disease response or progression
    • Time Frame: Up to 3 years
    • Complete response (CR), near complete response (complete response with positive immunofixation; nCR), partial response (PR), minimal response (MR), stable disease (SD), progressive disease (PD), or relapse from CR (RCR); the methods and criteria used to evaluate the responses will be chosen by the physician and recorded.
  • Time to response
    • Time Frame: Up to 3 years
    • Time to response is calculated from the start date of the cycle of Velcade therapy.
  • Duration of response
    • Time Frame: Up to 3 years
    • Duration of response is calculated from the date on which response is documented until PD, RCR, death, or study termination occurs.
  • Time to progression
    • Time Frame: Up to 3 years
    • Time to progression is calculated from the date on which response is documented until PD or RCR occurs.
  • Survival status
    • Time Frame: Up to 3 years
    • Survival status is calculated from the start of Velcade therapy until death; to be monitored, to the extent possible, beyond the end of Velcade therapy, up to the end of the study period.
  • Number of patients with adverse events
    • Time Frame: Up to 3 years
    • Safety criteria will be considered for new skeletal events (fractures, radiotherapy of bone, operation on the bone, spinal cord compression), infection and haematological toxicity (with greater than or equal to grade 3 using WHO Common Toxicity Criteria [WHO CTC]), and any neurotoxic events by WHO CTC.
  • Number of emergency room visits while using Velcade therapy
    • Time Frame: Up to 3 years
    • Emergency room visits will be considered as a measure of health care resource utilization associated with Velcade therapy.
  • Number of inpatient hospital stays while using Velcade therapy
    • Time Frame: Up to 3 years
    • Inpatient hospital stays and the reasons for hospitalization will be considered as a measure of health care resource utilization associated with Velcade therapy.
  • Number of days for each hospital stay
    • Time Frame: Up to 3 years
    • Days for each hospital stay will be considered as a measure of health care resource utilization associated with Velcade therapy.
  • Number of patients on whom therapeutic therapies will be conducted
    • Time Frame: Up to 3 years
    • Therapeutic therapies (eg: surgery) will be considered as a measure of health care resource utilization associated with Velcade therapy.
  • Number of patients on whom chest radiograph will be conducted
    • Time Frame: Up to 3 years
  • Number of patients on whom whole-body bone scan will be conducted
    • Time Frame: Up to 3 years
  • Number of patients on whom radiograph for designated area will be conducted
    • Time Frame: Up to 3 years
  • Serum immunoglobin and M-protein
    • Time Frame: Up to 3 years
  • M-protein detected by immunofixation electrophoresis
    • Time Frame: Up to 3 years
  • Urine light chain M-protein
    • Time Frame: Up to 3 years
  • Bone marrow puncture and biopsy
    • Time Frame: Up to 3 years
  • β2-microglobulin
    • Time Frame: Up to 3 years
  • C-reactive protein
    • Time Frame: Up to 3 years
  • Lactate dehydrogenase
    • Time Frame: Up to 3 years
  • Routine blood examination
    • Time Frame: Up to 3 years
  • Liver function test
    • Time Frame: Up to 3 years
  • Renal function test
    • Time Frame: Up to 3 years
  • Serum electrolytes
    • Time Frame: Up to 3 years
  • Number of patients on concomitant medications
    • Time Frame: Up to 3 years
    • Concomitant medications will be considered as a measure of health care resource utilization associated with Velcade therapy. Concomitant medications include over-the-counter as well as prescription medications, start and stop dates, dosages, and indication. The compliance of concomitant medications will be evaluated by the percentage of patient reported dose over prescribed dose.

Secondary Measures

  • Indications for Velcade therapy
    • Time Frame: Baseline (Day -1)
    • Multiple myeloma patients who receive two or more prior treatments and demonstrate disease progression on the most recent treatment will be indicated for Velcade therapy.
  • Sociodemographics for Velcade therapy
    • Time Frame: Baseline
    • Sociodemographics of patients will be assessed, at the initiation of Velcade therapy, such as: gender, date of birth, height, weight, highest degree, and career information.
  • Number of chronic concomitant disease
    • Time Frame: Baseline
    • Chronic concomitant disease will be assessed at the initiation of Velcade therapy.
  • Treatment history
    • Time Frame: Baseline
    • Treatment history will be assessed at the initiation of Velcade therapy. Treatment history includes: confirmation date of diagnosis of multiple myeloma patients or other patients receiving Velcade therapy; names of diseases for patient receiving Velcade therapy; prior treatments for multiple myeloma; outcomes of prior treatments for multiple myeloma.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Xian-Janssen Pharmaceutical Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Xian-Janssen Pharmaceutical Ltd., China Clinical Trial, Study Director, Xian-Janssen Pharmaceutical Ltd.

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