An Observational Study of Chinese Multiple Myeloma Patients Treated With Velcade
10 juni 2014 bijgewerkt door: Xian-Janssen Pharmaceutical Ltd.
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.
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Werkelijk)
532
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Niet ouder dan 18 jaar (Kind, Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Patients diagnosed with multiple myeloma (based on standard diagnosis criteria), initiating Velcade therapy within the approved indication.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
Velcade
Velcade, 1.3 mg/m2/dose, administered intravenously on days 1, 4, 8 and 11, for 2 weeks.
|
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)
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Information on treatment sequence for Velcade therapy
Tijdsspanne: Baseline (Day -1) to Day 21
|
Treatment sequence or the line of therapy will be considered on Velcade utilization.
|
Baseline (Day -1) to Day 21
|
|
Information on dosage of Velcade
Tijdsspanne: 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.
|
Baseline to Day 21
|
|
Information on duration of Velcade therapy
Tijdsspanne: 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.
|
Baseline to Day 21
|
|
Information on patient diagnosis for Velcade therapy
Tijdsspanne: Baseline to Day 21
|
Diagnosis of patients will be considered on Velcade utilization.
|
Baseline to Day 21
|
|
Number of patients with disease response or progression
Tijdsspanne: 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.
|
Up to 3 years
|
|
Time to response
Tijdsspanne: Up to 3 years
|
Time to response is calculated from the start date of the cycle of Velcade therapy.
|
Up to 3 years
|
|
Duration of response
Tijdsspanne: 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.
|
Up to 3 years
|
|
Time to progression
Tijdsspanne: Up to 3 years
|
Time to progression is calculated from the date on which response is documented until PD or RCR occurs.
|
Up to 3 years
|
|
Survival status
Tijdsspanne: 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.
|
Up to 3 years
|
|
Number of patients with adverse events
Tijdsspanne: 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.
|
Up to 3 years
|
|
Number of emergency room visits while using Velcade therapy
Tijdsspanne: Up to 3 years
|
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
Tijdsspanne: 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.
|
Up to 3 years
|
|
Number of days for each hospital stay
Tijdsspanne: Up to 3 years
|
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
Tijdsspanne: Up to 3 years
|
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
Tijdsspanne: Up to 3 years
|
Up to 3 years
|
|
|
Number of patients on whom whole-body bone scan will be conducted
Tijdsspanne: Up to 3 years
|
Up to 3 years
|
|
|
Number of patients on whom radiograph for designated area will be conducted
Tijdsspanne: Up to 3 years
|
Up to 3 years
|
|
|
Serum immunoglobin and M-protein
Tijdsspanne: Up to 3 years
|
Up to 3 years
|
|
|
M-protein detected by immunofixation electrophoresis
Tijdsspanne: Up to 3 years
|
Up to 3 years
|
|
|
Urine light chain M-protein
Tijdsspanne: Up to 3 years
|
Up to 3 years
|
|
|
Bone marrow puncture and biopsy
Tijdsspanne: Up to 3 years
|
Up to 3 years
|
|
|
β2-microglobulin
Tijdsspanne: Up to 3 years
|
Up to 3 years
|
|
|
C-reactive protein
Tijdsspanne: Up to 3 years
|
Up to 3 years
|
|
|
Lactate dehydrogenase
Tijdsspanne: Up to 3 years
|
Up to 3 years
|
|
|
Routine blood examination
Tijdsspanne: Up to 3 years
|
Up to 3 years
|
|
|
Liver function test
Tijdsspanne: Up to 3 years
|
Up to 3 years
|
|
|
Renal function test
Tijdsspanne: Up to 3 years
|
Up to 3 years
|
|
|
Serum electrolytes
Tijdsspanne: Up to 3 years
|
Up to 3 years
|
|
|
Number of patients on concomitant medications
Tijdsspanne: 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.
|
Up to 3 years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Indications for Velcade therapy
Tijdsspanne: Baseline (Day -1)
|
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
Tijdsspanne: Baseline
|
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
Tijdsspanne: Baseline
|
Chronic concomitant disease will be assessed at the initiation of Velcade therapy.
|
Baseline
|
|
Treatment history
Tijdsspanne: Baseline
|
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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
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Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 maart 2006
Primaire voltooiing (Werkelijk)
1 mei 2010
Studie voltooiing (Werkelijk)
1 mei 2010
Studieregistratiedata
Eerst ingediend
27 augustus 2012
Eerst ingediend dat voldeed aan de QC-criteria
27 augustus 2012
Eerst geplaatst (Schatting)
29 augustus 2012
Updates van studierecords
Laatste update geplaatst (Schatting)
11 juni 2014
Laatste update ingediend die voldeed aan QC-criteria
10 juni 2014
Laatst geverifieerd
1 juni 2014
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Hart-en vaatziekten
- Vaatziekten
- Ziekten van het immuunsysteem
- Neoplasmata per histologisch type
- Neoplasmata
- Lymfoproliferatieve aandoeningen
- Immunoproliferatieve aandoeningen
- Hematologische ziekten
- Hemorragische aandoeningen
- Hemostatische aandoeningen
- Paraproteïnemieën
- Bloed eiwit stoornissen
- Multipel myeloom
- Neoplasmata, plasmacel
Andere studie-ID-nummers
- CR006373
- 26866138MMY4031 (Andere identificatie: Xian-Janssen Pharmaceutical Ltd., China)
- VEL-CHN-MA-01 (Andere identificatie: Xian-Janssen Pharmaceutical Ltd., China)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .