An Observational Study of Chinese Multiple Myeloma Patients Treated With Velcade

Multiple Myeloma Clinical Trial

Official title:

Velcade (Bortezomib for Injection) Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675245
• Other study ID #: CR006373
• Secondary ID: 26866138MMY4031V
• Status: Completed
• Phase: Phase 4
• First received: August 27, 2012
• Last updated: June 10, 2014
• Start date: March 2006
• Est. completion date: May 2010

Study information

• Verified date: June 2014
• Source: Xian-Janssen Pharmaceutical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 532
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xian-Janssen Pharmaceutical Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Information on treatment sequence for Velcade therapy	Treatment sequence or the line of therapy will be considered on Velcade utilization.	Baseline (Day -1) to Day 21	No
Primary	Information on dosage of Velcade	Dosage of Velcade will be considered on Velcade utilization. The unit of dosage will be milligram per square meter body surface area.	Baseline to Day 21	No
Primary	Information on duration of Velcade therapy	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.	Baseline to Day 21	No
Primary	Information on patient diagnosis for Velcade therapy	Diagnosis of patients will be considered on Velcade utilization.	Baseline to Day 21	No
Primary	Number of patients with disease response or progression	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.	Up to 3 years	No
Primary	Time to response	Time to response is calculated from the start date of the cycle of Velcade therapy.	Up to 3 years	No
Primary	Duration of response	Duration of response is calculated from the date on which response is documented until PD, RCR, death, or study termination occurs.	Up to 3 years	No
Primary	Time to progression	Time to progression is calculated from the date on which response is documented until PD or RCR occurs.	Up to 3 years	No
Primary	Survival status	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.	Up to 3 years	No
Primary	Number of patients with adverse events	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.	Up to 3 years	Yes
Primary	Number of emergency room visits while using Velcade therapy	Emergency room visits will be considered as a measure of health care resource utilization associated with Velcade therapy.	Up to 3 years	No
Primary	Number of inpatient hospital stays while using Velcade therapy	Inpatient hospital stays and the reasons for hospitalization will be considered as a measure of health care resource utilization associated with Velcade therapy.	Up to 3 years	No
Primary	Number of days for each hospital stay	Days for each hospital stay will be considered as a measure of health care resource utilization associated with Velcade therapy.	Up to 3 years	No
Primary	Number of patients on whom therapeutic therapies will be conducted	Therapeutic therapies (eg: surgery) will be considered as a measure of health care resource utilization associated with Velcade therapy.	Up to 3 years	No
Primary	Number of patients on whom chest radiograph will be conducted		Up to 3 years	No
Primary	Number of patients on whom whole-body bone scan will be conducted		Up to 3 years	No
Primary	Number of patients on whom radiograph for designated area will be conducted		Up to 3 years	No
Primary	Serum immunoglobin and M-protein		Up to 3 years	No
Primary	M-protein detected by immunofixation electrophoresis		Up to 3 years	No
Primary	Urine light chain M-protein		Up to 3 years	No
Primary	Bone marrow puncture and biopsy		Up to 3 years	No
Primary	ß2-microglobulin		Up to 3 years	No
Primary	C-reactive protein		Up to 3 years	No
Primary	Lactate dehydrogenase		Up to 3 years	No
Primary	Routine blood examination		Up to 3 years	No
Primary	Liver function test		Up to 3 years	No
Primary	Renal function test		Up to 3 years	No
Primary	Serum electrolytes		Up to 3 years	No
Primary	Number of patients on concomitant medications	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.	Up to 3 years	No
Secondary	Indications for Velcade therapy	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.	Baseline (Day -1)	No
Secondary	Sociodemographics for Velcade therapy	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.	Baseline	No
Secondary	Number of chronic concomitant disease	Chronic concomitant disease will be assessed at the initiation of Velcade therapy.	Baseline	No
Secondary	Treatment history	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.	Baseline	No

External Links

•   VELCADE (Bortezomib for Injection) Observational Study