Mobilization of Stem Cells With Plerixafor, Chemotherapy and G-CSF in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients
Treatment With Plerixafor in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients to Increase the Number of Peripheral Blood Stem Cells When Given With A Mobilizing Regimen of Chemotherapy and G-CSF
調査の概要
詳細な説明
An open label, multi-center, phase 2 study was conducted in patients with MM or NHL who were to be treated with peripheral blood stem cells (PBSC) autologous transplantation. The only change to the standard of care was the addition of plerixafor to a mobilization regimen of chemotherapy and G-CSF. Patients were first given a mobilizing regimen of chemotherapy as per local practice guidelines and G-CSF (at customary doses) and apheresis was performed. After the first apheresis, plerixafor was given at 10PM, 10-11 hours before the second apheresis the next day or in the morning of the second day, 6 hours before the second apheresis. The change in the patient's peripheral CD34+ cell count between the plerixafor dose and the start of apheresis was measured. The apheresis yields on Day 1 and Day 2 were compared.
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
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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California
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Duarte、California、アメリカ
- City of Hope National Medical Center
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Indiana
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Beech Grove、Indiana、アメリカ
- Indiana Blood and Marrow Transplantation
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New York
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Rochester、New York、アメリカ
- University of Rochester Medical Center
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Oregon
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Portland、Oregon、アメリカ
- Oregon Health and Science University
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Washington
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Seattle、Washington、アメリカ
- Fred Hutchinson Cancer Research Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria (Abbreviated List):
- MM in first partial response/complete response, first relapse, or second partial/complete response
- NHL in first or second partial or complete remission
- NHL patients who do not have bone marrow involvement and < 10% for follicular involvement
- MM patients who have stable disease with < 40% bone marrow involvement
- No more than three prior regimens of chemotherapy (thalidomide and Decadron are not considered chemotherapy)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- White blood cell count (WBC) >3.0 x 10^9/L
- Absolute neutrophil count >1.5 x 10^9/L
- Platelet count >100 x 10^9/L
Exclusion Criteria (Abbreviated List):
- Brain metastases or carcinomatous meningitis
- Hypercalcaemia [>1 mg/dl above the upper limit of normal (ULN)]
- Cardiovascular disease that includes proven or predisposition to ventricular arrhythmias
- Acute Infection
研究計画
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：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
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：Plerixafor PM
Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days. Called 'Cohort A' in protocol, study report and publications. |
G-CSF and plerixafor were administered as described in the treatment arms.
他の名前：
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実験的：Plerixafor AM
Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days. Called 'Cohort B' in protocol, study report and publications. |
G-CSF and plerixafor were administered as described in the treatment arms.
他の名前：
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実験的：Low CD34+ Count/ Plerixafor PM
Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days. Called 'Cohort C' in protocol, study report and publications. |
G-CSF and plerixafor were administered as described in the treatment arms.
他の名前：
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実験的：Plerixafor After Chemo
This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms. Called 'Investigational Cohort' in protocol, study report and publications. |
G-CSF and plerixafor were administered as described in the treatment arms.
他の名前：
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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 |
|---|---|---|
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Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant
時間枠：13 months
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Safety assessment was based on the incidence of adverse event reports.
Participant count of AEs (Adverse Events) by severity and by relationship to study drug.
AEs were reported regardless of relationship to study treatment.
The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment.
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13 months
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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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参加者が12日目までに多形核白血球（PMN）生着を達成したが、21日目までに末梢血幹細胞（PBSC）移植後までに達成した移植の数
時間枠：2ヶ月
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参加者は、現地の標準的なケアに従って、多形核白血球 (PMN) の生着を監視されました。
生着の目標は PBSC 移植後 12 日であり、生着に 21 日以上かかる移植はありませんでした。
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2ヶ月
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Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL
時間枠：Days 4-5 (first dose of plerixafor to apheresis)
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The fold increase was measured by fluorescence activated cell sorting (FACS) analysis and was expressed as a ratio.
Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).
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Days 4-5 (first dose of plerixafor to apheresis)
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協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
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。
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