Clinical trial NCT01675245: An Observational Study of Chinese Multiple Myeloma Patients Treated With Velcade
Official title: Velcade (Bortezomib for Injection) Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Cancer
Velcade
Bortezomib
Chinese patients
Lead sponsor: Xian-Janssen Pharmaceutical Ltd.
Sponsor class: INDUSTRY
First posted: 2012-08-29
Enrollment: 532
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with multiple myeloma (based on standard diagnosis criteria), initiating Velcade therapy within the approved indication.

Brief 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.

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 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

Primary outcomes:
measure: Information on treatment sequence for Velcade therapy
timeFrame: Baseline (Day -1) to Day 21
measure: Information on dosage of Velcade
timeFrame: Baseline to Day 21
measure: Information on duration of Velcade therapy
timeFrame: Baseline to Day 21
measure: Information on patient diagnosis for Velcade therapy
timeFrame: Baseline to Day 21
measure: Number of patients with disease response or progression
timeFrame: Up to 3 years
measure: Time to response
timeFrame: Up to 3 years
measure: Duration of response
timeFrame: Up to 3 years
measure: Time to progression
timeFrame: Up to 3 years
measure: Survival status
timeFrame: Up to 3 years
measure: Number of patients with adverse events
timeFrame: Up to 3 years
measure: Number of emergency room visits while using Velcade therapy
timeFrame: Up to 3 years
measure: Number of inpatient hospital stays while using Velcade therapy
timeFrame: Up to 3 years
measure: Number of days for each hospital stay
timeFrame: Up to 3 years
measure: Number of patients on whom therapeutic therapies will be conducted
timeFrame: Up to 3 years
measure: Number of patients on whom chest radiograph will be conducted
timeFrame: Up to 3 years
measure: Number of patients on whom whole-body bone scan will be conducted
timeFrame: Up to 3 years
measure: Number of patients on whom radiograph for designated area will be conducted
timeFrame: Up to 3 years
measure: Serum immunoglobin and M-protein
timeFrame: Up to 3 years
measure: M-protein detected by immunofixation electrophoresis
timeFrame: Up to 3 years
measure: Urine light chain M-protein
timeFrame: Up to 3 years
measure: Bone marrow puncture and biopsy
timeFrame: Up to 3 years
measure: β2-microglobulin
timeFrame: Up to 3 years
measure: C-reactive protein
timeFrame: Up to 3 years
measure: Lactate dehydrogenase
timeFrame: Up to 3 years
measure: Routine blood examination
timeFrame: Up to 3 years
measure: Liver function test
timeFrame: Up to 3 years
measure: Renal function test
timeFrame: Up to 3 years
measure: Serum electrolytes
timeFrame: Up to 3 years
measure: Number of patients on concomitant medications
timeFrame: Up to 3 years
Secondary outcomes:
measure: Indications for Velcade therapy
timeFrame: Baseline (Day -1)
measure: Sociodemographics for Velcade therapy
timeFrame: Baseline
measure: Number of chronic concomitant disease
timeFrame: Baseline
measure: Treatment history
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Xian-Janssen Pharmaceutical Ltd.
name: Xian-Janssen Pharmaceutical Ltd., China Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.