- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01060202
Quality of Life of Non-transplant Candidate Multiple Myeloma Patients Treated With Early Bortezomib
16 juli 2013 uppdaterad av: Janssen Korea, Ltd., Korea
A Prospective, Open-label, Multicenter Observational Study to Evaluate the QoL of Non-transplant Candidate Multiple Myeloma Patients Treated With Early Bortezomib
This study will observe the degree of the quality of life in non-transplant candidate patients with multiple myeloma before and after bortezomib administration by using EORTC-QLQ C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30) and EQ-5D (EuroQol-5 Dimensions).
Both tools are validated research instruments used to measure the quality of life in cancer patients and consequently will provide fundamental data regarding the quality of life in patients with multiple myeloma by analyzing factors that affect the quality of life.
Studieöversikt
Detaljerad beskrivning
Multiple myeloma (MM) is a plasma cell malignancy with progression marked by symptoms and signs of lowered resistance to infection, skeletal destruction, renal failure, and anemia.
It is incurable and follows a relapsing course, with a median survival of approximately 4-5 years.
The various therapies associated with disease control, are often associated with significant side effects, and ultimately, patients relapse.
Therefore, assessment of health-related quality of life (HRQL) represents an important tool for evaluating the value of effective therapies when weighed against the potential toxic effects of treatment from the patient's perspective.
Patients diagnosed with MM suffer from pain, fatigue, reduced physical and role functioning, and reduced overall HRQL compared with an age- and gender-matched population.
These symptoms can improve with successful treatment with either cytotoxic therapy or supportive care.
Many clinical studies for the treatment of multiple myeloma have been conducted in Korea, but none of them have evaluated the improvement in the quality of life in patients with multiple myeloma.
Most study variables used to evaluate the quality of life of patients with multiple myeloma are subjective and limited.
This study will observe the degree of the quality of life of patients in the early status of multiple myeloma before and after bortezomib administration by using EORTC-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30) and EQ-5D (EuroQol-5 Dimensions), validated research instruments used to measure the quality of life in cancer patients and consequently will provide fundamental data regarding the quality of life in patients with multiple myeloma.
Observational Study - No investigational drug administered.
Studietyp
Observationell
Inskrivning (Faktisk)
60
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
20 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Non-transplant candidate patients who are newly prescribed bortezomib injection as a secondary agent for the treatment of multiple myeloma, those of whom can understand and fill out questionnaire, and agree to provide information will be included.
Beskrivning
Inclusion Criteria:
- Symptomatic multiple myeloma patient
- ECOG score less than 3
- Patient is not a candidate for stem cell transplantation
- Previous treatment duration is less than 6 months
- Previous treatment response is less than partial response (PR)
- Willing and able to complete the questionnaire
- Patients (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion Criteria:
- Known hypersensitivity to bortezomib
- Acute severe infection requiring antibiotics therapy
- Pre-existing peripheral neuropathy greater than or equal to grade 2
- Uncontrolled or severe cardiovascular disease
- Pregnancy or breastfeeding
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 |
|---|---|
|
Bortezomib
|
This is an observational study.
Patients receiving bortezomib injection intravenously (into a vein) 1.3 mg/m2 twice a week for 21 days will be observed.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
The change in the quality of life as measured by EORTC QLQ-C30 and EQ-5D before and after the administration of bortezomib
Tidsram: On day 1 at the first cycle, 12 weeks, 24 weeks
|
On day 1 at the first cycle, 12 weeks, 24 weeks
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Relationship between the primary outcome and the complete remission (CR) rate
Tidsram: 12 weeks and 24 weeks
|
12 weeks and 24 weeks
|
|
Relationship between the primary outcome and overall response
Tidsram: 12 weeks and 24 weeks
|
12 weeks and 24 weeks
|
|
Relationship between the primary outcome and the time to response
Tidsram: 12 weeks and 24 weeks
|
12 weeks and 24 weeks
|
|
Relationship between the primary outcome and the survival
Tidsram: 12 weeks and 24 weeks
|
12 weeks and 24 weeks
|
|
Adverse events
Tidsram: every 3 week cycle
|
every 3 week cycle
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
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 november 2009
Primärt slutförande (Faktisk)
1 juli 2011
Avslutad studie (Faktisk)
1 juli 2011
Studieregistreringsdatum
Först inskickad
29 januari 2010
Först inskickad som uppfyllde QC-kriterierna
29 januari 2010
Första postat (Uppskatta)
2 februari 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
17 juli 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 juli 2013
Senast verifierad
1 juli 2013
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
- CR016750
- BOR-KOR-5022 (Annan identifierare: Janssen Korea, Ltd., Korea)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .