- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01675245
An Observational Study of Chinese Multiple Myeloma Patients Treated With Velcade
10 juni 2014 uppdaterad av: 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
532
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
Inte äldre än 18 år (Barn, Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Patients diagnosed with multiple myeloma (based on standard diagnosis criteria), initiating Velcade therapy within the approved indication.
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Information on treatment sequence for Velcade therapy
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Up to 3 years
|
Up to 3 years
|
|
|
Number of patients on whom whole-body bone scan will be conducted
Tidsram: Up to 3 years
|
Up to 3 years
|
|
|
Number of patients on whom radiograph for designated area will be conducted
Tidsram: Up to 3 years
|
Up to 3 years
|
|
|
Serum immunoglobin and M-protein
Tidsram: Up to 3 years
|
Up to 3 years
|
|
|
M-protein detected by immunofixation electrophoresis
Tidsram: Up to 3 years
|
Up to 3 years
|
|
|
Urine light chain M-protein
Tidsram: Up to 3 years
|
Up to 3 years
|
|
|
Bone marrow puncture and biopsy
Tidsram: Up to 3 years
|
Up to 3 years
|
|
|
β2-microglobulin
Tidsram: Up to 3 years
|
Up to 3 years
|
|
|
C-reactive protein
Tidsram: Up to 3 years
|
Up to 3 years
|
|
|
Lactate dehydrogenase
Tidsram: Up to 3 years
|
Up to 3 years
|
|
|
Routine blood examination
Tidsram: Up to 3 years
|
Up to 3 years
|
|
|
Liver function test
Tidsram: Up to 3 years
|
Up to 3 years
|
|
|
Renal function test
Tidsram: Up to 3 years
|
Up to 3 years
|
|
|
Serum electrolytes
Tidsram: Up to 3 years
|
Up to 3 years
|
|
|
Number of patients on concomitant medications
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Indications for Velcade therapy
Tidsram: 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
Tidsram: 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
Tidsram: Baseline
|
Chronic concomitant disease will be assessed at the initiation of Velcade therapy.
|
Baseline
|
|
Treatment history
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
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Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2006
Primärt slutförande (Faktisk)
1 maj 2010
Avslutad studie (Faktisk)
1 maj 2010
Studieregistreringsdatum
Först inskickad
27 augusti 2012
Först inskickad som uppfyllde QC-kriterierna
27 augusti 2012
Första postat (Uppskatta)
29 augusti 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
11 juni 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 juni 2014
Senast verifierad
1 juni 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Hjärt-kärlsjukdomar
- Kärlsjukdomar
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Lymfoproliferativa störningar
- Immunproliferativa störningar
- Hematologiska sjukdomar
- Hemorragiska störningar
- Hemostatiska störningar
- Paraproteinemier
- Blodproteinstörningar
- Multipelt myelom
- Neoplasmer, Plasmacell
Andra studie-ID-nummer
- CR006373
- 26866138MMY4031 (Annan identifierare: Xian-Janssen Pharmaceutical Ltd., China)
- VEL-CHN-MA-01 (Annan identifierare: Xian-Janssen Pharmaceutical Ltd., China)
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