Multiple MyelomaNCT01675245
An Observational Study of Chinese Multiple Myeloma Patients Treated With Velcade
An observational study of Multiple Myeloma, run by Xian-Janssen Pharmaceutical Ltd..
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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Multiple Myeloma
- Type of treatment
- Injection or infusion
- How many people
- 532 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients diagnosed with multiple myeloma (based on standard diagnosis criteria), initiating Velcade therapy within the approved indication.
Who may be able to join
- Must give informed consent in agreement with local legislation
- Must not have any contraindication listed in package insert
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- No intervention
- Keywords
- Multiple Myeloma, Cancer, Velcade, Bortezomib, Chinese patients
- Medical subject headings
- Multiple Myeloma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Velcade | Velcade, 1.3 mg/m2/dose, administered intravenously on days 1, 4, 8 and 11, for 2 weeks. Receives: Drug: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Information on treatment sequence for Velcade therapy
Treatment sequence or the line of therapy will be considered on Velcade utilization.
Measured: 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.
Measured: 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.
Measured: Baseline to Day 21
Information on patient diagnosis for Velcade therapy
Diagnosis of patients will be considered on Velcade utilization.
Measured: 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.
Measured: Up to 3 years
Time to response
Time to response is calculated from the start date of the cycle of Velcade therapy.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 3 years
Number of patients on whom chest radiograph will be conducted
Measured: Up to 3 years
Number of patients on whom whole-body bone scan will be conducted
Measured: Up to 3 years
Number of patients on whom radiograph for designated area will be conducted
Measured: Up to 3 years
Serum immunoglobin and M-protein
Measured: Up to 3 years
M-protein detected by immunofixation electrophoresis
Measured: Up to 3 years
Urine light chain M-protein
Measured: Up to 3 years
Bone marrow puncture and biopsy
Measured: Up to 3 years
β2-microglobulin
Measured: Up to 3 years
C-reactive protein
Measured: Up to 3 years
Lactate dehydrogenase
Measured: Up to 3 years
Routine blood examination
Measured: Up to 3 years
Liver function test
Measured: Up to 3 years
Renal function test
Measured: Up to 3 years
Serum electrolytes
Measured: 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.
Measured: Up to 3 years
Secondary outcomes (4)
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.
Measured: 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.
Measured: Baseline
Number of chronic concomitant disease
Chronic concomitant disease will be assessed at the initiation of Velcade therapy.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study startMar 2006
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 532 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xian-Janssen Pharmaceutical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xian-Janssen Pharmaceutical Ltd., China Clinical Trial, Study director, Xian-Janssen Pharmaceutical Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675245
- Sponsor's protocol ID
- CR006373
- Other IDs
- 26866138MMY4031, VEL-CHN-MA-01
- Status last verified
- Jun 2014
- First submitted
- 27 Aug 2012
- Last updated
- 11 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 25331616
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Velcade (Bortezomib for Injection) Observational Study
- ClinicalTrials.gov ID
- NCT01675245
- Acronym / sponsor ID
- CR006373
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Cancer, Velcade, Bortezomib, Chinese patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 532 participants (actual)
- Lead sponsor
- Xian-Janssen Pharmaceutical Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 29 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Velcade | – | Drug: No interventionVelcade, 1.3 mg/m2/dose, administered intravenously on days 1, 4, 8 and 11, for 2 weeks. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients diagnosed with multiple myeloma (based on standard diagnosis criteria), initiating Velcade therapy within the approved indication.
Key inclusion criteria (2 listed)
- Must give informed consent in agreement with local legislation
- Must not have any contraindication listed in package insert
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis 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) | Drug | Velcade |
Primary outcome
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.
4 secondary outcomes
Indications for Velcade therapy
Time frame: Baseline (Day -1)
Sociodemographics for Velcade therapy
Time frame: Baseline
Number of chronic concomitant disease
Time frame: Baseline
Treatment history
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2014.
- Derived from this study: PubMed 25331616Lin 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.
- VELCADE (Bortezomib for Injection) Observational StudyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xian-Janssen Pharmaceutical Ltd., China Clinical Trial study director
Xian-Janssen Pharmaceutical Ltd.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Xian-Janssen Pharmaceutical Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Information on treatment sequence for Velcade therapy (time frame: Baseline (Day -1) to Day 21). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01675245, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2014.