An Observational Study of Chinese Multiple Myeloma Patients Treated With Velcade

Velcade (Bortezomib for Injection) Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: No intervention

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.

• Study Type: Observational
• Enrollment (Actual): 532

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with multiple myeloma (based on standard diagnosis criteria), initiating Velcade therapy within the approved indication.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Velcade; Velcade, 1.3 mg/m2/dose, administered intravenously on days 1, 4, 8 and 11, for 2 weeks.	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Information on patient diagnosis for Velcade therapy	Diagnosis of patients will be considered on Velcade utilization.	Baseline to Day 21
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
Time to response	Time to response is calculated from the start date of the cycle of Velcade therapy.	Up to 3 years
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
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
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
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
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
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
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
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
Number of patients on whom chest radiograph will be conducted		Up to 3 years
Number of patients on whom whole-body bone scan will be conducted		Up to 3 years
Number of patients on whom radiograph for designated area will be conducted		Up to 3 years
Serum immunoglobin and M-protein		Up to 3 years
M-protein detected by immunofixation electrophoresis		Up to 3 years
Urine light chain M-protein		Up to 3 years
Bone marrow puncture and biopsy		Up to 3 years
β2-microglobulin		Up to 3 years
C-reactive protein		Up to 3 years
Lactate dehydrogenase		Up to 3 years
Routine blood examination		Up to 3 years
Liver function test		Up to 3 years
Renal function test		Up to 3 years
Serum electrolytes		Up to 3 years
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
Number of chronic concomitant disease	Chronic concomitant disease will be assessed at the initiation of Velcade therapy.	Baseline
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

Collaborators and Investigators

• Sponsor: Xian-Janssen Pharmaceutical Ltd.

Publications and helpful links

General Publications

• Lin M, Hou J, Chen W, Huang X, Liu Z, Zhou Y, Li Y, Zhao T, Wang L, Wu KW, Shen Z. Improved response rates with bortezomib in relapsed or refractory multiple myeloma: an observational study in Chinese patients. Adv Ther. 2014 Oct;31(10):1082-94. doi: 10.1007/s12325-014-0159-z. Epub 2014 Oct 21.

Helpful Links

• VELCADE (Bortezomib for Injection) Observational Study

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: August 27, 2012
• First Submitted That Met QC Criteria: August 27, 2012
• First Posted (Estimate): August 29, 2012

Study Record Updates

• Last Update Posted (Estimate): June 11, 2014
• Last Update Submitted That Met QC Criteria: June 10, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Cancer; Multiple Myeloma; Bortezomib; Velcade; Chinese patients
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: CR006373; 26866138MMY4031 (Other Identifier: Xian-Janssen Pharmaceutical Ltd., China); VEL-CHN-MA-01 (Other Identifier: Xian-Janssen Pharmaceutical Ltd., China)