An observational study in Multiple Myeloma, sponsored by Xian-Janssen Pharmaceutical Ltd.. Completed. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2014-06-11.
Sponsored by Xian-Janssen Pharmaceutical Ltd. (part of Johnson & Johnson) · Observational
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.
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.
3,712 studies on the registry are indexed under Multiple Myeloma; 752 are open to participants now.
This study's enrollment of 532 is above the median of 145 across 482 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Xian-Janssen Pharmaceutical Ltd. is the lead sponsor of 36 studies on the registry; 2 are open to participants now.
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Patients diagnosed with multiple myeloma (based on standard diagnosis criteria), initiating Velcade therapy within the approved indication.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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)
Information on treatment sequence for Velcade therapy
Treatment sequence or the line of therapy will be considered on Velcade utilization.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Day 21
Information on patient diagnosis for Velcade therapy
Diagnosis of patients will be considered on Velcade utilization.
Time frame: 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.
Time frame: Up to 3 years
Time to response
Time to response is calculated from the start date of the cycle of Velcade therapy.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 3 years
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
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.
Time frame: Up to 3 years
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.
Time frame: 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.
Time frame: Baseline
Number of chronic concomitant disease
Chronic concomitant disease will be assessed at the initiation of Velcade therapy.
Time frame: 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.
Time frame: Baseline
No study locations are listed for this record.
The record gives a start of Mar 2006, a primary completion of May 2010 and a completion of May 2010. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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