Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients
2014년 2월 10일 업데이트: Genzyme, a Sanofi Company
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of AMD3100 Plus G-CSF Versus G-CSF Plus Placebo to Mobilize and Collect ≥ 6*10^6 CD34+ Cells/kg in Multiple Myeloma Patients for Autologous Transplantation
The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and granulocyte colony-stimulating factor (G-CSF, generic name of filgrastim) is better than G-CSF alone to mobilize and collect the optimal number of stem cells in multiple myeloma patients for autologous transplantation.
연구 개요
상태
완전한
정황
상세 설명
A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Currently filgrastim (G-CSF), a colony stimulating factor, is used to cause the growth and mobilization of stem cells from bone marrow to peripheral blood, which can then be collected from the peripheral blood by a process called apheresis. Plerixafor aids in the release of the stem cells from the bone marrow into the peripheral blood, possibly allowing for a more rapid collection of a larger number of stem cells from the peripheral blood. Larger stem cell doses for transplantation correlate to faster recovery times after high dose chemotherapy followed with stem cell transplantation. This study is intended to determine whether the combination of plerixafor with filgrastim (G-CSF)is better than filgrastim (G-CSF) alone in helping multiple myeloma patients collect at least 6 million stem cells in two or less apheresis sessions.
This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.
연구 유형
중재적
등록 (실제)
302
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Heidelberg, 독일, 69120
- Universitätsklinikum Heidelberg,
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Arizona
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Phoenix, Arizona, 미국, 85006
- City of Hope Samaritan Bone Marrow Transplant Program
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Arkansas
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Little Rock, Arkansas, 미국, 72205
- Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences
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California
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Duarte, California, 미국, 91010
- City of Hope National Medical Center
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Los Angeles, California, 미국, 90048
- Cedars-Sinai
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Los Angeles, California, 미국, 90095
- University of California
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Colorado
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Denver, Colorado, 미국, 80218
- Rocky Mountain Cancer Center
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Connecticut
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New Haven, Connecticut, 미국, 06520
- Yale University School of Medicine
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Florida
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Gainesville, Florida, 미국, 32611
- University of Florida
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Tampa, Florida, 미국, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Atlanta, Georgia, 미국, 30322
- Emory University
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Illinois
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Maywood, Illinois, 미국, 60153
- Loyola University Medical Center
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Indiana
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Beech Grove, Indiana, 미국, 46107
- Indiana Blood and Marrow Transplantation Center
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Iowa
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Iowa City, Iowa, 미국, 52242
- University of Iowa Hosptials and Clinics
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Minnesota
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Minneapolis, Minnesota, 미국, 55455
- Fairview-University Medical Center, University of Minnesota
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic
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Missouri
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Kansas City, Missouri, 미국, 64111
- Kansas City Cancer Center
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Saint Louis, Missouri, 미국, 63110
- Washington University School of Medicine, Division of Bone Marrow Transplantation and Leukemia
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New Jersey
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Hackensack, New Jersey, 미국, 07601
- The Cancer Center at Hackensack University Medical Center
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New York
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Buffalo, New York, 미국, 14263
- Roswell Park Cancer Institute
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New York, New York, 미국, 10011
- St. Vincent's Comprehensive Cancer Center
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New York, New York, 미국, 10065
- Memorial Sloan Kettering
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New York, New York, 미국, 10032
- New York Hospital
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Rochester, New York, 미국, 14642
- University of Rochester Medical Center
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North Carolina
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Durham, North Carolina, 미국, 27705
- Duke University Medical Center
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Ohio
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Cleveland, Ohio, 미국, 44106
- Case Western Reserve University
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Cleveland, Ohio, 미국, 44195
- Cleveland Clinic Foundation
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Columbus, Ohio, 미국, 43210
- Ohio State University
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Oregon
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Portland, Oregon, 미국, 97239
- Oregon Health & Science University
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- Hospital of the University of Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19107
- Thomas Jefferson University
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Texas
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Houston, Texas, 미국, 77030
- The University of Texas MD Anderson Cancer Center
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Lackland AFB, Texas, 미국, 78236
- Wilford Hall Medical Center
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San Antonio, Texas, 미국, 78229
- Texas Transplant Institute
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San Antonio, Texas, 미국, 78229
- University of Texas Health Science Center
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Utah
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Salt Lake City, Utah, 미국, 84132
- Utah Blood and Marrow Transplant Program, University of Utah
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Virginia
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Richmond, Virginia, 미국, 23298
- Virginia Commonwealth University
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Washington
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Seattle, Washington, 미국, 98109
- Fred Hutchinson Cancer Research Center
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British Columbia
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Vancouver, British Columbia, 캐나다, V5Z 1M9
- Vancouver General Hospital
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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 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Diagnosis of multiple myeloma in first or second complete or partial remission
- >= 4 weeks since last cycle of chemotherapy (thalidomide, dexamethasone, and Velcade were not considered prior chemotherapy for the purpose of this study)
- Recovered from all acute toxic effects of prior chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- White Blood Cell count (WBC) > 2.5*10^9/L
- Absolute polymorphonuclear leukocytes (PMN) count > 1.5*10^9/L
- Platelet (PLT) > 100*10^9/L
- Serum creatinine <=2.2 mg/dL
- Cardiac and pulmonary status sufficient to undergo apheresis and transplantation
- Negative for HIV
Exclusion Criteria):
- Failed previous stem cell collection
- Previous stem cell transplantation
- Brain metastases or myelomatous meningitis
- Radiation to ≥ 50% of the pelvis
- Abnormal electrocardiogram (ECG) with rhythm disturbance (ventricular arrhythmias) or other conduction abnormality
- Received bone-seeking radionuclides (e.g. holmium)
- A residual acute medical condition resulting from prior chemotherapy
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: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: G-CSF 플러스 플레릭사포
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Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection.
On the evening of Day 4, participants received plerixafor (240 µg/kg), administered by SC injection.
On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx.
10 to 11 hours after the dose of plerixafor (within 60 minutes of G-CSF administration).
Participants continued to receive an evening dose of plerixafor followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
다른 이름들:
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위약 비교기: G-CSF 플러스 위약
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Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection.
On the evening of Day 4, participants received placebo, administered by SC injection.
On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx.
10 to 11 hours after the dose of placebo (within 60 minutes of G-CSF administration).
Participants continued to receive an evening dose of placebo followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 2 or Fewer Days of Apheresis.
기간: up to Day 6
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Proportion of participants achieving a target of ≥ 6*10^6 CD34+ cells/kg in 2 or fewer days of apheresis.
Central lab data were taken from Days 5 to 6 of the Treatment/Apheresis period.
Each participant's value was calculated as the sum of all daily values collected over the 2 apheresis days.
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up to Day 6
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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부작용이 있는 참가자 수
기간: 38일까지
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치료 응급 부작용(AE)이 있는 참가자 수.
치료 긴급 AE에 대한 기간은 1일(G-CSF 동원 시작)부터 화학요법 시작 전날(약 38일 후)까지로 정의됩니다.
AE는 연구 치료와의 관계와 상관없이 보고되었습니다.
연구자는 세계보건기구(WHO) 부작용 등급 척도를 사용하여 각 AE를 등급화했습니다.
3등급의 AE는 심각한 것으로 간주되었고 4등급은 생명을 위협하는 것으로 간주되었습니다.
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38일까지
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Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.
기간: up to Day 8
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Proportion of participants achieving a target of ≥ 6*10^6 CD34+ cells/kg in 4 or fewer days of apheresis.
Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period.
Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.
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up to Day 8
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Proportion of Participants Achieving a Target of ≥ 2*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.
기간: up to Day 8
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Proportion of participants achieving a target of ≥ 2*10^6 CD34+ cells/kg in 4 or fewer days of apheresis.
Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period.
Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.
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up to Day 8
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Median Number of Days to ≥6*10^6 CD34+ Cells/kg
기간: up to Day 8
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The Kaplan Meier estimate of median number of days (number of days at which 50% of participants have experienced the event, accounting for censored values) in each treatment arm to collect an optimum number of cells (≥6*10^6 CD34+ cells/kg) for transplantation.
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up to Day 8
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Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment
기간: Up to Month 13
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The Kaplan Meier estimate of median number of days to PMN engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint.
Engraftment was defined as PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day.
Time to engraftment corresponded to the first day that the criteria were met and was evaluated up to 12 months post transplant.
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Up to Month 13
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Median Number of Days to Platelet (PLT) Engraftment
기간: Up to Month 13
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The Kaplan Meier estimate of median number of days to PLT engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint.
Engraftment was defined as ≥ 20*10^9/L without transfusion for the preceding 7 days.
Time to engraftment corresponded to the first day that the criteria were met and was evaluated up to 12 months post transplant.
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Up to Month 13
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Graft Durability at 100 Days Post Transplantation
기간: approximately Day 138
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The proportion of participants maintaining a durable graft at 100 days post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.
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approximately Day 138
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Graft Durability at 6 Months Post Transplantation
기간: approximately Month 7
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The proportion of participants maintaining a durable graft at 6 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.
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approximately Month 7
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Graft Durability at 12 Months Post Transplantation
기간: approximately Month 13
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The proportion of participants maintaining a durable graft at 12 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.
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approximately Month 13
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
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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
2005년 1월 1일
기본 완료 (실제)
2006년 10월 1일
연구 완료 (실제)
2008년 1월 1일
연구 등록 날짜
최초 제출
2005년 2월 11일
QC 기준을 충족하는 최초 제출
2005년 2월 11일
처음 게시됨 (추정)
2005년 2월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 3월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 2월 10일
마지막으로 확인됨
2014년 2월 1일
추가 정보
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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Sanko University완전한MULTİPLE SCLEROSİS | BALANCE | 유효성 | 신뢰도터키 (Türkiye)
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University Hospital, Montpellier종료됨제1형 당뇨병 | Basal-bolus multiple-dily 인슐린 주사 | 인슐린 펌프(CSII)프랑스
Granulocyte colony-stimulating factor plus plerixafor에 대한 임상 시험
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Fudan University모병
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TECAM GroupHospital General Universitario Gregorio Marañon알려지지 않은
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University of Maryland, BaltimoreHematologics, Inc모병
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Washington University School of Medicine완전한
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National Institute of Allergy and Infectious Diseases...Immune Tolerance Network (ITN)완전한
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Hospital Infantil Universitario Niño Jesús, Madrid...Universitat Autonoma de Barcelona; Instituto de Investigación Sanitaria de la Fundación... 그리고 다른 협력자들완전한