An Observational Study of Chinese Multiple Myeloma Patients Treated With Velcade
2014년 6월 10일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
관찰
등록 (실제)
532
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이하 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Patients diagnosed with multiple myeloma (based on standard diagnosis criteria), initiating Velcade therapy within the approved indication.
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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)
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Information on treatment sequence for Velcade therapy
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Up to 3 years
|
Up to 3 years
|
|
|
Number of patients on whom whole-body bone scan will be conducted
기간: Up to 3 years
|
Up to 3 years
|
|
|
Number of patients on whom radiograph for designated area will be conducted
기간: Up to 3 years
|
Up to 3 years
|
|
|
Serum immunoglobin and M-protein
기간: Up to 3 years
|
Up to 3 years
|
|
|
M-protein detected by immunofixation electrophoresis
기간: Up to 3 years
|
Up to 3 years
|
|
|
Urine light chain M-protein
기간: Up to 3 years
|
Up to 3 years
|
|
|
Bone marrow puncture and biopsy
기간: Up to 3 years
|
Up to 3 years
|
|
|
β2-microglobulin
기간: Up to 3 years
|
Up to 3 years
|
|
|
C-reactive protein
기간: Up to 3 years
|
Up to 3 years
|
|
|
Lactate dehydrogenase
기간: Up to 3 years
|
Up to 3 years
|
|
|
Routine blood examination
기간: Up to 3 years
|
Up to 3 years
|
|
|
Liver function test
기간: Up to 3 years
|
Up to 3 years
|
|
|
Renal function test
기간: Up to 3 years
|
Up to 3 years
|
|
|
Serum electrolytes
기간: Up to 3 years
|
Up to 3 years
|
|
|
Number of patients on concomitant medications
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Indications for Velcade therapy
기간: 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
기간: 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
기간: Baseline
|
Chronic concomitant disease will be assessed at the initiation of Velcade therapy.
|
Baseline
|
|
Treatment history
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2006년 3월 1일
기본 완료 (실제)
2010년 5월 1일
연구 완료 (실제)
2010년 5월 1일
연구 등록 날짜
최초 제출
2012년 8월 27일
QC 기준을 충족하는 최초 제출
2012년 8월 27일
처음 게시됨 (추정)
2012년 8월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 6월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 6월 10일
마지막으로 확인됨
2014년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CR006373
- 26866138MMY4031 (기타 식별자: Xian-Janssen Pharmaceutical Ltd., China)
- VEL-CHN-MA-01 (기타 식별자: Xian-Janssen Pharmaceutical Ltd., China)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
다발성 골수종에 대한 임상 시험
-
Sanko University완전한MULTİPLE SCLEROSİS | BALANCE | 유효성 | 신뢰도터키 (Türkiye)
-
University Hospital, Montpellier종료됨제1형 당뇨병 | Basal-bolus multiple-dily 인슐린 주사 | 인슐린 펌프(CSII)프랑스
No intervention에 대한 임상 시험
-
Shanghai Yueyang Integrated Medicine Hospital아직 모집하지 않음
-
Second Affiliated Hospital, School of Medicine,...모집하지 않고 적극적으로
-
Guangzhou Women and Children's Medical Center아직 모집하지 않음NEC - 괴사성 장염
-
Monash UniversityThe Alfred; Melbourne Sexual Health Centre모병매독중국, 호주, 남아프리카, 영국
-
IRCCS San Raffaele모집하지 않고 적극적으로