- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01524445
Retrospective Survey of Re-treatment With Bortezomib
2012년 6월 11일 업데이트: Janssen Pharmaceutica N.V., Belgium
Retrospective Evaluation of Re-Treatment With Bortezomib in Subjects With First Relapse After Bortezomib First-Line Therapy
The purpose of this retrospective study is to collect information about patients who received bortezomib as their first chemotherapy and who responded well to it, but who relapsed afterwards and were treated again with bortezomib a second time after a treatment-free period of at least 6 months.
During this non-interventional study (this means that no drug is being tested in this study) the safety and effectiveness (whether it works or not) of bortezomib re-treatment will be evaluated in patients with multiple myeloma.
Only data already mentioned in your clinical file will be collected.
About 100 adult patients will take part in the study
연구 개요
상세 설명
This is an international, multicenter, non-interventional, retrospective study to evaluate the efficacy and safety of bortezomib in 100 adult patients diagnosed with multiple myeloma (MM) who responded to bortezomib as first-line treatment, experienced partial response or better, presented with relapsed disease, and were re-treated (second-line) with bortezomib (for at least 3 cycles) after a treatment-free interruption of at least 6 months.
As this is a non-interventional study, no changes to the current treatment that the patient receives will be required, and no additional treatment will be provided by the company.
The decision of the patients to take part in this study will not have any impact on the care they receive.
All the appropriate treatment-related decisions will have been made by the treating physician(s), and only data available from clinical practice will be collected.
Retrospective data will be collected at a single time point for each patient (the data collection visit).
Each investigator should collect data from patients fulfilling all inclusion and exclusion criteria.
After receiving the signed informed consent form (ICF) from the patient (if required by local regulations), the investigator will start documenting the retrospective data for each patient using electronic data capture (eDC).
After confirmation of the patient's eligibility, the patient's last visit, patient characteristics, predefined risk factors (if available), MM-related data, and first- and second-line bortezomib-related data will be documented in the Case Report Form (CRF).
The patient's status after re-treatment with bortezomib, medical resource utilization data, as well as (serious) adverse drug reactions ([S]ADRs) will be collected.
No blood, urine, or other biological samples will be taken, and no additional investigations will be performed.
the current therapy of the patient will be maintained with no changes
연구 유형
관찰
등록 (실제)
35
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Alexandroupoli, 그리스
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Athens, 그리스
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Athens Attica, 그리스
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Patra, 그리스
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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 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Clinic; Hospital
설명
Inclusion Criteria:
- Has a current diagnosis/was diagnosed with MM or secretory MM
- Was previously treated with bortezomib-containing chemotherapy
- Responded to bortezomib as first-line treatment
- Has been re-treated with bortezomib (at least 3 cycles) due to relapse of the disease (following the first bortezomib treatment), after a treatment-free interruption of at least 6 months
- Completed bortezomib re-treatment at least 2 months ago Exclusion Criteria:
- Was a pregnant or breastfeeding woman while receiving either first-line or second-line treatment with Velcade
Has received bortezomib-containing chemotherapy for the first time following a first relapse or later
- Has participated in a clinical trial in which bortezomib was used as second-line treatment following a relapse after response to Velcade as first-line chemotherapy, and the study data are not publicly available at the time of inclusion in the current study
- Has received bortezomib as first-line therapy and was re-treated with bortezomib after first relapse in the VISTA clinical trial
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 |
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bortezomib retreatment
bortezomib retreatment due to relapse Patients who received bortezomib-containing chemotherapy as first-line treatment for MM experienced partial response or better and were re-treated (second-line) with bortezomib (for at least 3 cycles) due to a relapse of the disease after a treatment free interruption of at least 6 months
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Patients who received bortezomib-containing chemotherapy as first-line treatment for MM, experienced partial response or better, and were re-treated (second-line) with bortezomib (for at least 3 cycles) due to a relapse of the disease after a treatment free interruption of at least 6 months
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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overall response after retreatment
기간: Day 1
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overall response after retreatment will be assessed from initial diagnosis to the time of data collection
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Day 1
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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number of medical care encounters
기간: Day 1
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number of medical care encounters are collected retrospectively from initial diagnosis to the time of data collection
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Day 1
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duration of medical care encounters
기간: Day 1
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duration of medical care encounters are collected retrospectively from initial diagnosis to the time of data collection
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Day 1
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duration of hospitalization
기간: Day 1
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duration of hospitalizations are collected retrospectively from initial diagnosis to the time of data collection
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Day 1
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number and character of diagnostic and therapeutic tests and procedures
기간: Day 1
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number and character of diagnostic and therapeutic tests and procedures are collected retrospectively from initial diagnosis to the time of data collection
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Day 1
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outpatient medical encounters and treatments
기간: Day 1
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outpatient medical encounters and treatments are collected retrospectively from initial diagnosis to the time of data collection
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Day 1
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safety and tolerability
기간: Day 1
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safety and tolerability will be evaluated based on the collection of serious and non serious adverse drug reactions from initial diagnosis to the time of data collection
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Day 1
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 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
2011년 3월 1일
연구 완료 (실제)
2011년 10월 1일
연구 등록 날짜
최초 제출
2011년 6월 16일
QC 기준을 충족하는 최초 제출
2012년 2월 1일
처음 게시됨 (추정)
2012년 2월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2012년 6월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2012년 6월 11일
마지막으로 확인됨
2012년 6월 1일
추가 정보
이 연구와 관련된 용어
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. .
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