- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00288028
Bortezomib in Treating Patients With Multiple Myeloma Who Have Undergone an Autologous Peripheral Blood Stem Cell Transplant
A Phase I Study of Bortezomib During Maintenance Phase After High Dose Melphalan and Autologous Stem Cell Transplantation in Patients With Multiple Myeloma
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bortezomib after an autologous peripheral blood stem cell transplant may stop the growth of any cancer cells that remain after transplant.
PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib in treating patients with multiple myeloma who have undergone an autologous peripheral blood stem cell transplant.
연구 개요
상세 설명
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) of bortezomib during maintenance phase after high-dose melphalan and autologous peripheral blood stem cell transplantation in patients with multiple myeloma.
- Determine the safety and tolerability of bortezomib in these patients.
Secondary
- Determine the overall response rate, complete response rate, and response duration in patients treated with bortezomib at the MTD.
OUTLINE: This is an open-label, dose-finding study.
Patients receive bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 21 or 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive de-escalating doses of bortezomib (at varying dosing schedules) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
After completion of study treatment, patients are followed at 1 year.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Michigan
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Detroit, Michigan, 미국, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
- Diagnosis of multiple myeloma
Must have completed high-dose melphalan and autologous peripheral blood stem cell transplantation
- Transplant must have been completed 30-120 days ago
- Must not be receiving maintenance therapy
- Patients must have received 200 mg/m² of melphalan intravenously as a conditioning regimen (no dose reduction allowed)
- No evidence of amyloidosis
- No available donor
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 75,000/mm^3
- Bilirubin ≤ 1.5 times upper limit of normal
- Transaminase ≤ 3 times upper limit of normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Must have a negative HIV test
- No baseline neurological disease > grade I
- No cranial nerve palsy
- No demonstrated resistance to bortezomib
- No history of allergic reactions attributed to bortezomib, boron, or mannitol
- No cardiac arrhythmia
- No unstable angina pectoris
- No symptomatic congestive heart failure
- No ongoing or active infection
- No other uncontrolled illness
- No psychiatric illness or social situations that would limit compliance with study requirements
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No other concurrent anticancer therapies or agents
- No other concurrent investigational agents
- Not receiving maintenance therapy after prior stem cell transplantation on another clinical trial
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: Bortezomib
Bortezomib is administered as a 5 second IV bolus on days 1, 4, 8,11 or 1,8 and 15 of a 21-35 days cycle (Depending on the Dosing schedule).
The dosage will be calculated based on actual weight of the patient unless the actual weight is greater than 40% above the ideal body weight.
In this instance the dosage will be based on the adjusted ideal body weight.
The Adjusted IBW (kg) = IBW + 0.25 x (actual body weight - IBW).
The dosage will be adjusted based on the safety and toxicity profile, until a MTD is determined.
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Dose of Bortezomib* Level 1: 1.3 mg/m2 on Day 1, 4, 8, 11 - Every 21 days; Level 2: 1.3 mg/m2 on Day 1, 4, 8, 11 - Every 28 days; Level 3: 1.0 mg/m2 on Day 1, 8, 15 - Every 28 days; Level 4: 1.0 mg/m2 on Day 1, 8, 15 - Every 35 days
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Maximum tolerated dose
기간: At course 8
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At course 8
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Safety and tolerability
기간: At course 8
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At course 8
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Overall response rate by Southwest Oncology Group (SWOG) criteria
기간: At day 30 following stem cell transplant and following course 4, course 8, and 1 year of study treatment
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At day 30 following stem cell transplant and following course 4, course 8, and 1 year of study treatment
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Complete response rate by SWOG criteria
기간: At day 30 following stem cell transplant and following course 4, course 8, and 1 year of study treatment
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At day 30 following stem cell transplant and following course 4, course 8, and 1 year of study treatment
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Response duration by SWOG criteria
기간: At day 30 following stem cell transplant and following course 4, course 8, and 1 year of study treatment
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At day 30 following stem cell transplant and following course 4, course 8, and 1 year of study treatment
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공동 작업자 및 조사자
수사관
- 연구 의자: Muneer H. Abidi, MD, Barbara Ann Karmanos Cancer Institute
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
- CDR0000455585
- P30CA022453 (미국 NIH 보조금/계약)
- WSU-D-2957
- WSU-0506002467
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