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Study Combining Bortezomib With High Dose Melphalan to Treat Multiple Myeloma (Mel-Vel)

2022년 7월 15일 업데이트: Hackensack Meridian Health

A Phase I/II Study of Escalating Doses of Bortezomib in Conjunction With High Dose Melphalan as a Conditioning Regimen for Autologous Peripheral Blood Stem Cell Transplantation in Patients With Multiple Myeloma

The purpose of this study is to determine the tolerance and potential efficacy of combining dose intense melphalan with escalating doses of bortezomib in patients with multiple myeloma undergoing autologous stem cell transplantation.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

Multiple myeloma is the second most common hematological malignancy that has affected approximately 40,000 Americans.Conventional chemotherapy has achieved limited control of this disease but studies have reported improved response rates for patients who are treated with dose-intense therapy and autologous hematopoietic stem cell transplantation. This Phase I/II study will investigate the potential of combination therapy of dose-intense melphalan with escalating doses of bortezomib.

연구 유형

중재적

등록 (실제)

32

단계

  • 2 단계
  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • New Jersey
      • Hackensack, New Jersey, 미국, 07601
        • Hackensack University Medical Center

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 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. A confirmed diagnosis of multiple myeloma

  2. Show progression of disease after a previous cycle of dose-intense melphalan, or less than 25% decrease in paraprotein measured at 8 weeks after a prior cycle of dose-intense melphalan

    • May have received intervening therapies for disease progression after dose-intense melphalan and enrollment in this protocol
  3. Age:18yrs-76yrs at time of melphalan administration
  4. Gender: There is no gender restriction

  5. Availability of >2x10^6 autologous peripheral blood CD34+ cells/kg or a syngeneic donor meeting eligibility criteria for syngeneic donation

    • Syngeneic transplantation is preferred
    • For patients enrolled in the phase I part of this study, >1x10^6 autologous or syngeneic peripheral blood CD34+ cells/kg remaining in storage as "backup" in case of engraftment failure
  6. Recovery from complications of salvage therapy, if administered -

Exclusion Criteria:

  1. Diagnosis other than multiple myeloma
  2. Chemotherapy or radiotherapy within 28 days of initiating treatment in this study
  3. Prior dose-intense therapy within 56 days of initiating treatment in this study
  4. Uncontrolled bacterial,viral,fungal or parasitic infections
  5. Uncontrolled CNS metastases
  6. Known amyloid deposition in heart

  7. Organ dysfunction

    • LVEF<40% or cardiac failure not responsive to therapy
    • FVC,FEV1,or DLCO<50% of predicted and/or receiving supplementary continuous oxygen
    • Evidence of hepatic synthetic dysfunction, or total bilirubin>2x or AST>3x ULN
    • Measured creatinine clearance <20ml/min
    • Sensory peripheral neuropathy grade 4
  8. Karnofsky score<70% unless a result of bone disease directly caused by myeloma
  9. Life expectancy limited by another co-morbid illness
  10. History of another malignancy in remission <2yrs (other than basal cell carcinoma)
  11. Pregnant (women)or unwilling to use acceptable birth control methods (men or women) for twelve months after treatment
  12. Documented hypersensitivity to melphalan or bortezomib or any components of the formulation
  13. Patients unable or unwilling to provide consent

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 순차적 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Phase I Cohort - Bortezomib 1 mg/m2
Bortezomib at 1 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.
의약품: Bortezomib 1 mg/m2
  • Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line
  • Bortezomib will be administered any time on day -4 and 24 hrs after the start of the melphalan infusion on day -1
  • Dosing will be based on actual body weight Patient weight must be measured within seven days of the start of the treatment regimen
다른 이름들:
  • 벨케이드
의약품: Melphalan
  • Melphalan is administered by rapid intravenous infusion via a central or peripheral vein over one hour
  • Melphalan will be dissolved with 10 ml of diluent to a concentration of 5 mg/mL which is then immediately diluted in 0.9% normal saline to a concentration NOT exceeding 0.45 mg/mL prior to administration
  • The final dilution of melphalan is physically and chemically stable for 60 minutes and therefore will be administered within that time period
  • Melphalan will be given as a single dose (not split over 2 or more days)
  • Dosing will be based body surface area calculated using actual body weight
다른 이름들:
  • 알케란
실험적: Phase I Cohort - Bortezomib 1.3 mg/m2
Bortezomib at 1.3 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.
의약품: Melphalan
  • Melphalan is administered by rapid intravenous infusion via a central or peripheral vein over one hour
  • Melphalan will be dissolved with 10 ml of diluent to a concentration of 5 mg/mL which is then immediately diluted in 0.9% normal saline to a concentration NOT exceeding 0.45 mg/mL prior to administration
  • The final dilution of melphalan is physically and chemically stable for 60 minutes and therefore will be administered within that time period
  • Melphalan will be given as a single dose (not split over 2 or more days)
  • Dosing will be based body surface area calculated using actual body weight
다른 이름들:
  • 알케란
의약품: Bortezomib 1.3 mg/m2
  • Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line
  • Bortezomib will be administered any time on day -4 and 24 hrs after the start of the melphalan infusion on day -1
  • Dosing will be based on actual body weight Patient weight must be measured within seven days of the start of the treatment regimen
다른 이름들:
  • 벨케이드
실험적: Phase I Cohort - Bortezomib 1.6 mg/m2
Bortezomib at 1.6 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.
의약품: Melphalan
  • Melphalan is administered by rapid intravenous infusion via a central or peripheral vein over one hour
  • Melphalan will be dissolved with 10 ml of diluent to a concentration of 5 mg/mL which is then immediately diluted in 0.9% normal saline to a concentration NOT exceeding 0.45 mg/mL prior to administration
  • The final dilution of melphalan is physically and chemically stable for 60 minutes and therefore will be administered within that time period
  • Melphalan will be given as a single dose (not split over 2 or more days)
  • Dosing will be based body surface area calculated using actual body weight
다른 이름들:
  • 알케란
의약품: Bortezomib 1.6 mg/m2
  • Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line
  • Bortezomib will be administered any time on day -4 and 24 hrs after the start of the melphalan infusion on day -1
  • Dosing will be based on actual body weight Patient weight must be measured within seven days of the start of the treatment regimen
다른 이름들:
  • 벨케이드
실험적: Phase II Cohort
Bortezomib at 1.6 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.
의약품: Melphalan
  • Melphalan is administered by rapid intravenous infusion via a central or peripheral vein over one hour
  • Melphalan will be dissolved with 10 ml of diluent to a concentration of 5 mg/mL which is then immediately diluted in 0.9% normal saline to a concentration NOT exceeding 0.45 mg/mL prior to administration
  • The final dilution of melphalan is physically and chemically stable for 60 minutes and therefore will be administered within that time period
  • Melphalan will be given as a single dose (not split over 2 or more days)
  • Dosing will be based body surface area calculated using actual body weight
다른 이름들:
  • 알케란
의약품: Bortezomib 1.6 mg/m2
  • Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line
  • Bortezomib will be administered any time on day -4 and 24 hrs after the start of the melphalan infusion on day -1
  • Dosing will be based on actual body weight Patient weight must be measured within seven days of the start of the treatment regimen
다른 이름들:
  • 벨케이드

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
The Maximum Tolerated Dose of Bortezomib (MTD)
기간: During dosing of Bortezomib on Day -4 to Day -1 of ASCT
The Maximum Tolerated Dose of Bortezomib (MTD) Will be Defined as the Dose Level Prior to That Resulting in Two Out of Six Patients Experiencing a DLT
During dosing of Bortezomib on Day -4 to Day -1 of ASCT

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hackensack Meridian Health

수사관

  • 수석 연구원: Scott D Rowley, MD, Director-Blood and Marrow Transplantation Program

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

2007년 1월 1일

기본 완료 (실제)

2013년 12월 1일

연구 완료 (실제)

2013년 12월 1일

연구 등록 날짜

최초 제출

2008년 10월 31일

QC 기준을 충족하는 최초 제출

2008년 11월 3일

처음 게시됨 (추정)

2008년 11월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 8월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 7월 15일

마지막으로 확인됨

2022년 7월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 06.05.109B

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

Bortezomib 1 mg/m2에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

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정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
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