An Observational Study of Chinese Multiple Myeloma Patients Treated With Velcade
Velcade (Bortezomib for Injection) Observational Study
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Numero di gruppi/coorti
Coorti e interventi
Gruppo / CoorteGruppo / Coorte |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
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Velcade
Velcade, 1.3 mg/m2/dose, administered intravenously on days 1, 4, 8 and 11, for 2 weeks.
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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)
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Information on treatment sequence for Velcade therapy
Lasso di tempo: Baseline (Day -1) to Day 21
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Treatment sequence or the line of therapy will be considered on Velcade utilization.
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Baseline (Day -1) to Day 21
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Information on dosage of Velcade
Lasso di tempo: Baseline to Day 21
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Dosage of Velcade will be considered on Velcade utilization.
The unit of dosage will be milligram per square meter body surface area.
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Baseline to Day 21
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Information on duration of Velcade therapy
Lasso di tempo: Baseline to Day 21
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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.
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Baseline to Day 21
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Information on patient diagnosis for Velcade therapy
Lasso di tempo: Baseline to Day 21
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Diagnosis of patients will be considered on Velcade utilization.
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Baseline to Day 21
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Number of patients with disease response or progression
Lasso di tempo: Up to 3 years
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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.
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Up to 3 years
|
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Time to response
Lasso di tempo: Up to 3 years
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Time to response is calculated from the start date of the cycle of Velcade therapy.
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Up to 3 years
|
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Duration of response
Lasso di tempo: Up to 3 years
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Duration of response is calculated from the date on which response is documented until PD, RCR, death, or study termination occurs.
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Up to 3 years
|
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Time to progression
Lasso di tempo: Up to 3 years
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Time to progression is calculated from the date on which response is documented until PD or RCR occurs.
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Up to 3 years
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Survival status
Lasso di tempo: Up to 3 years
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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.
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Up to 3 years
|
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Number of patients with adverse events
Lasso di tempo: Up to 3 years
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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.
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Up to 3 years
|
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Number of emergency room visits while using Velcade therapy
Lasso di tempo: Up to 3 years
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Emergency room visits will be considered as a measure of health care resource utilization associated with Velcade therapy.
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Up to 3 years
|
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Number of inpatient hospital stays while using Velcade therapy
Lasso di tempo: Up to 3 years
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Inpatient hospital stays and the reasons for hospitalization will be considered as a measure of health care resource utilization associated with Velcade therapy.
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Up to 3 years
|
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Number of days for each hospital stay
Lasso di tempo: Up to 3 years
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Days for each hospital stay will be considered as a measure of health care resource utilization associated with Velcade therapy.
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Up to 3 years
|
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Number of patients on whom therapeutic therapies will be conducted
Lasso di tempo: Up to 3 years
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Therapeutic therapies (eg: surgery) will be considered as a measure of health care resource utilization associated with Velcade therapy.
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Up to 3 years
|
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Number of patients on whom chest radiograph will be conducted
Lasso di tempo: Up to 3 years
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Up to 3 years
|
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Number of patients on whom whole-body bone scan will be conducted
Lasso di tempo: Up to 3 years
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Up to 3 years
|
|
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Number of patients on whom radiograph for designated area will be conducted
Lasso di tempo: Up to 3 years
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Up to 3 years
|
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Serum immunoglobin and M-protein
Lasso di tempo: Up to 3 years
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Up to 3 years
|
|
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M-protein detected by immunofixation electrophoresis
Lasso di tempo: Up to 3 years
|
Up to 3 years
|
|
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Urine light chain M-protein
Lasso di tempo: Up to 3 years
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Up to 3 years
|
|
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Bone marrow puncture and biopsy
Lasso di tempo: Up to 3 years
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Up to 3 years
|
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β2-microglobulin
Lasso di tempo: Up to 3 years
|
Up to 3 years
|
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C-reactive protein
Lasso di tempo: Up to 3 years
|
Up to 3 years
|
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Lactate dehydrogenase
Lasso di tempo: Up to 3 years
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Up to 3 years
|
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Routine blood examination
Lasso di tempo: Up to 3 years
|
Up to 3 years
|
|
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Liver function test
Lasso di tempo: Up to 3 years
|
Up to 3 years
|
|
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Renal function test
Lasso di tempo: Up to 3 years
|
Up to 3 years
|
|
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Serum electrolytes
Lasso di tempo: Up to 3 years
|
Up to 3 years
|
|
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Number of patients on concomitant medications
Lasso di tempo: 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.
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Up to 3 years
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Indications for Velcade therapy
Lasso di tempo: Baseline (Day -1)
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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.
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Baseline (Day -1)
|
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Sociodemographics for Velcade therapy
Lasso di tempo: Baseline
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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.
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Baseline
|
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Number of chronic concomitant disease
Lasso di tempo: Baseline
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Chronic concomitant disease will be assessed at the initiation of Velcade therapy.
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Baseline
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Treatment history
Lasso di tempo: Baseline
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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.
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Baseline
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Collaboratori e investigatori
Sponsor
Sponsor
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Effettivo)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattia cardiovascolare
- Malattie vascolari
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Neoplasie
- Malattie linfoproliferative
- Disturbi immunoproliferativi
- Malattie ematologiche
- Disturbi emorragici
- Disturbi emostatici
- Paraproteinemie
- Disturbi delle proteine del sangue
- Mieloma multiplo
- Neoplasie, plasmacellule
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- CR006373
- 26866138MMY4031 (Altro identificatore: Xian-Janssen Pharmaceutical Ltd., China)
- VEL-CHN-MA-01 (Altro identificatore: Xian-Janssen Pharmaceutical Ltd., China)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .