- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00378209
Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma
Am Open-Label Phase II Study of the Safety and Efficacy of Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma
연구 개요
상세 설명
- Participants took the study medication in the clinic on Cycle 1 day 1. Each treatment cycle lasted three weeks. They took the lenalidomide (capsules) every day for the first two weeks only (days 1-14). They took dexamethasone (tablets) on Day 1, 2, 4, 5, 8, 9, 11 and 12 and came to the outpatient treatment center for intravenous bortezomib on Day 1, 4, 8 and 11. The third week of the cycle was a rest period and the participant did not take any study medication.
- Certain tests and procedures were performed throughout each treatment cycle at definitive time periods. These tests included: medical history update, physical/neurological examination, skeletal survey (x-rays or scan), blood samples, urine samples, optional bone marrow aspiration/tissue biopsy, 12-lead ECG, and MRI/CT (if needed).
- It was expected that participants were going to complete at least 8 cycles of the study, which adds up to 168 days. If the participant completed the first 8 cycles, had stable or responding disease and had not experienced bad side effects, they were allowed to continue treatment on a maintenance schedule, detailed in the protocol, at the study doctor's discretion.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, 미국, 02114
- Massachusetts General hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Diagnosis of multiple myeloma based on standard diagnostic criteria or by the new International Myeloma Foundation 2003 Diagnostic Criteria
- Relapsed or relapsed and refractory disease after receiving between 1 and 3 prior regimens
- Negative serum or urine pregnancy test
- Age 18 years or older
- Karnofsky performance status of 60 or greater
Exclusion Criteria:
- Grade 2 or greater peripheral neuropathy within 14 days before enrollment
- Renal insufficiency (serum creatinine > 2.5 mg/dL)
- Evidence of mucosal or internal bleeding and/or platelet refractory
- ANC < 1000 cells/mm3
- Hemoglobin < 8.0 g/dL
- AST or ALT greater than or equal to 2 x ULN
- Concomitant therapy medications that include corticosteroids
- Myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Clinically relevant active infection or serious co-morbid medical conditions
- Prior malignancy (within last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or breast cancer, in situ prostate cancer
- Pregnant or breast-feeding
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Uncontrolled diabetes mellitus
- Hypersensitivity to acyclovir or similar anti-viral drug
- POEMS syndrome
- Known HIV infection
- Known active hepatitis B or C viral infection
- Known intolerance to steroid therapy
- Subjects with primary refractory disease, defined as progression during initial treatment
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: lenalidomide, dexamethasone, bortezomib combination
Participants took the study medication in the clinic on Cycle 1 day 1.
Each treatment cycle lasted three weeks.
They took the lenalidomide (capsules) every day for the first two weeks only (days 1-14).
They took the dexamethasone (tablets) on Day 1, 2, 4, 5, 8, 9, 11 and 12 and came to the outpatient treatment center for intravenous bortezomib on Day 1, 4, 8 and 11.
The third week of the cycle was a rest period and the participant did not take any study medication.
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Given intravenously on days 1,4,8 and 11 of a 21-day cycle for a minimum of 8 cycles.
Taken orally once a day for 2 weeks (days 1-14) of a 21-day cycle for a minimum of 8 cycles
Taken orally on days 1,2,4,5,8,9,11,and 12 of a 21-day cycle for a minimum of 8 cycles
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
The Proportion of Patients Alive and Without Progressive Disease (PD) for ≥6 Months
기간: 6 months after therapy
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Response assessed by the European Group for Blood and Marrow Transplant (EBMT) criteria, modified to include nCR and VGPR from the international uniform response criteria (IMWG). Progressive disease (PD) required one or more of the following: >25% increased in serum monoclonal paraprotein (must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation) >25% increased in 24-hour urinary light chain excretion (must also be an absolute increase of at least 200 mg/24 h and confirmed on a repeat investigation) >25% increased in plasma cells in a bone marrow aspirate or on trephine biopsy (must also be an absolute increase of at least 10%) Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas. Development of new bone lesions or soft tissue plasmacytomas (not including compression fracture). Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.8 mmol/L not attributable to any other cause). |
6 months after therapy
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Objective Response Rate
기간: Assessed every cycle for up to 8 cycles and best response was reported
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Response assessed by the European Group for Blood and Marrow Transplant (EBMT) criteria, modified to include nCR and VGPR from the international uniform response criteria (IMWG). Objective response was defined by the achievement of at least Partial Response (PR) or better (CR-complete response, nCR-near complete response, and VGPR-very good partial response). |
Assessed every cycle for up to 8 cycles and best response was reported
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Duration of Response
기간: Assessed at a median follow-up of 44 months
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Duration of response will be measured as the time from initiation of a response to first documentation of disease progression or death, or date last known progression-free and alive for those who have not progressed or died.
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Assessed at a median follow-up of 44 months
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Progression Free Survival
기간: aassesed at a median follow-up of 44 months
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Progression-free survival is defined as the time from registration to the disease progression or death from any cause, censored at date last known progression-free for those who have not progressed or died.
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aassesed at a median follow-up of 44 months
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Overall Survival
기간: assesed at a median follow-up of 44 months
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defined as time from treatment initiation to death, or last known to be alive for those who had not died
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assesed at a median follow-up of 44 months
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 06-147
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
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University Hospital, Montpellier종료됨제1형 당뇨병 | Basal-bolus multiple-dily 인슐린 주사 | 인슐린 펌프(CSII)프랑스
Bortezomib에 대한 임상 시험
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Sun Yat-sen UniversityFudan University; West China Hospital; Peking University Cancer Hospital & Institute; Ruijin... 그리고 다른 협력자들알려지지 않은