- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00602706
Samarium Sm 153 Lexidronam Pentasodium and High-Dose Melphalan in Treating Patients With Multiple Myeloma Undergoing Stem Cell Transplant
A Phase I/II Dose Escalation Study Assessing the Toxicity and Efficacy of 153-Samarium-EDTMP in Place of TBI in the Conditioning Regimen for PBSCT for Patients With Multiple Myeloma
RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing. Samarium Sm 153 lexidronam pentasodium contains a radioactive substance that kill cancer cells. Peripheral blood stem cell transplant using stem cells from the patient may be able to replace immune cells that were destroyed by chemotherapy and radioactive drugs used to kill cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of samarium Sm 153 lexidronam pentasodium when given together with high-dose melphalan in treating patients with multiple myeloma undergoing stem cell transplant.
연구 개요
상태
상세 설명
OBJECTIVES:
- To find the maximum tolerated dose of samarium Sm 153 lexidronam pentasodium when given with fixed high-dose melphalan as a conditioning regimen for autologous peripheral blood stem cell transplantation in patients with multiple myeloma. (Phase I)
- To assess the response rates of this regimen in these patients. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of samarium Sm 153 lexidronam pentasodium followed by a phase II study.
- Phase I: Patients receive samarium Sm 153 lexidronam pentasodium IV once between days -14 and -10. Patients also receive melphalan IV on day -1. Patients undergo peripheral blood stem cell transplantation on day 0. Patients receive sargramostim (GM-CSF) subcutaneously once daily beginning on day 6 and continuing until blood counts recover.
- Phase II: Patients receive samarium Sm 153 lexidronam pentasodium at the MTD determined in phase I .
Blood samples are collected periodically to determine clearance of samarium Sm 153 lexidronam pentasodium and bone marrow dosimetry.
연구 유형
등록 (예상)
단계
- 2 단계
- 1단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
- Diagnosis of multiple myeloma requiring treatment
- Must have at least 2 x 10^6 CD34+ cells collected for peripheral blood stem cell transplantation
PATIENT CHARACTERISTICS:
Inclusion criteria:
- ECOG performance status (PS) 0-2 (ECOG PS > 2 allowed if secondary to neuropathy or acute bone event)
- Direct bilirubin ≤ 2.0 mg/dL
- Alkaline phosphatase ≤ 750 μ/L
- Creatinine ≤ 3.0 mg/dL
- Ejection fraction ≥ 45%
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception for 6 months after the completion of study therapy
Exclusion criteria:
- DLCO < 50%
- FVC < 50%
- FEV_1 < 50%
- Active malignancy with the exception of nonmelanoma skin cancer
- Uncontrolled infection
- NYHA class III-IV cardiac disease
PRIOR CONCURRENT THERAPY:
- May or may not have received prior chemotherapy
At least 3 weeks since prior chemotherapy
- Cyclophosphamide pulsing for stem cell collection allowed
- At least 4 weeks since prior biologic therapy
- At least 2 weeks since prior bisphosphonates and bisphosphonates maybe resumed 1 month post-study treatment
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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Number of toxicity incidents (Phase I)
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Proportion of successes (Phase II)
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2차 결과 측정
결과 측정 |
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Number of responses (Phase I)
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전체 생존(제2상)
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무진행 생존(제2상)
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Time to progression (Phase II)
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Progressive disease variables
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공동 작업자 및 조사자
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
- CDR0000582552
- P30CA015083 (미국 NIH 보조금/계약)
- MC9981 (기타 식별자: Mayo Clinic Cancer Center)
- 1046-99 (기타 식별자: Mayo Clinic IRB)
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말초혈액 줄기세포 이식에 대한 임상 시험
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Navy General Hospital, BeijingXijing Hospital; Peking Union Medical College Hospital; Chinese PLA General Hospital; Peking...알려지지 않은관상동맥 질환