Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients
2014年2月10日 更新者：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.
調査の概要
状態
完了
条件
詳細な説明
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.
研究の種類
介入
入学 (実際)
302
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Arizona
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Phoenix、Arizona、アメリカ、85006
- City of Hope Samaritan Bone Marrow Transplant Program
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Arkansas
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Little Rock、Arkansas、アメリカ、72205
- Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences
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California
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Duarte、California、アメリカ、91010
- City of Hope National Medical Center
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Los Angeles、California、アメリカ、90048
- Cedars-Sinai
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Los Angeles、California、アメリカ、90095
- University of California
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Colorado
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Denver、Colorado、アメリカ、80218
- Rocky Mountain Cancer Center
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Connecticut
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New Haven、Connecticut、アメリカ、06520
- Yale University School of Medicine
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Florida
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Gainesville、Florida、アメリカ、32611
- University of Florida
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Tampa、Florida、アメリカ、33612
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Atlanta、Georgia、アメリカ、30322
- Emory University
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Illinois
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Maywood、Illinois、アメリカ、60153
- Loyola University Medical Center
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Indiana
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Beech Grove、Indiana、アメリカ、46107
- Indiana Blood and Marrow Transplantation Center
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Iowa
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Iowa City、Iowa、アメリカ、52242
- University of Iowa Hosptials and Clinics
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Minnesota
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Minneapolis、Minnesota、アメリカ、55455
- Fairview-University Medical Center, University of Minnesota
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Rochester、Minnesota、アメリカ、55905
- Mayo Clinic
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Missouri
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Kansas City、Missouri、アメリカ、64111
- Kansas City Cancer Center
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Saint Louis、Missouri、アメリカ、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、アメリカ、07601
- The Cancer Center at Hackensack University Medical Center
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New York
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Buffalo、New York、アメリカ、14263
- Roswell Park Cancer Institute
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New York、New York、アメリカ、10011
- St. Vincent's Comprehensive Cancer Center
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New York、New York、アメリカ、10065
- Memorial Sloan Kettering
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New York、New York、アメリカ、10032
- New York Hospital
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Rochester、New York、アメリカ、14642
- University of Rochester Medical Center
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North Carolina
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Durham、North Carolina、アメリカ、27705
- Duke University Medical Center
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Ohio
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Cleveland、Ohio、アメリカ、44106
- Case Western Reserve University
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Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic Foundation
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Columbus、Ohio、アメリカ、43210
- Ohio State University
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Oregon
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Portland、Oregon、アメリカ、97239
- Oregon Health & Science University
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Hospital of the University of Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19107
- Thomas Jefferson University
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Texas
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Houston、Texas、アメリカ、77030
- The University of Texas MD Anderson Cancer Center
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Lackland AFB、Texas、アメリカ、78236
- Wilford Hall Medical Center
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San Antonio、Texas、アメリカ、78229
- Texas Transplant Institute
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San Antonio、Texas、アメリカ、78229
- University of Texas Health Science Center
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Utah
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Salt Lake City、Utah、アメリカ、84132
- Utah Blood and Marrow Transplant Program, University of Utah
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Virginia
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Richmond、Virginia、アメリカ、23298
- Virginia Commonwealth University
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Washington
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Seattle、Washington、アメリカ、98109
- Fred Hutchinson Cancer Research Center
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British Columbia
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Vancouver、British Columbia、カナダ、V5Z 1M9
- Vancouver General Hospital
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Heidelberg、ドイツ、69120
- Universitätsklinikum Heidelberg,
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～78年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：G-CSF とプレリキサホル
|
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.
他の名前：
|
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プラセボコンパレーター：G-CSF プラス プラセボ
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 2 or Fewer Days of Apheresis.
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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有害事象のある参加者の数
時間枠：38日目まで
|
治療緊急有害事象（AE）のある参加者の数。
治療緊急AEの時間枠は、1日目（G-CSF動員の開始）から化学療法開始前日（約38日後）までと定義されます。
試験治療との関係に関係なく、有害事象が報告されました。
治験責任医師は、世界保健機関 (WHO) の有害事象評価尺度を使用して各 AE を評価しました。
グレード 3 の AE は重度と見なされ、グレード 4 は生命を脅かすと見なされました。
|
38日目まで
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Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.
時間枠：up to Day 8
|
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.
時間枠：up to Day 8
|
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
時間枠：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
時間枠：Up to Month 13
|
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
時間枠：Up to Month 13
|
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
時間枠：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
時間枠：approximately Month 7
|
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.
|
approximately Month 7
|
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Graft Durability at 12 Months Post Transplantation
時間枠：approximately Month 13
|
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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2005年1月1日
一次修了 (実際)
2006年10月1日
研究の完了 (実際)
2008年1月1日
試験登録日
最初に提出
2005年2月11日
QC基準を満たした最初の提出物
2005年2月11日
最初の投稿 (見積もり)
2005年2月14日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年3月13日
QC基準を満たした最後の更新が送信されました
2014年2月10日
最終確認日
2014年2月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。