A Multicenter, Open-label, Phase 1b Study of Carfilzomib, Cyclophosphamide and Dexamethasone in Newly Diagnosed Multiple Myeloma Subjects (CHAMPION 2)
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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California
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Encinitas、California、アメリカ
- California Cancer Associates For Research and Excellence
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West Hollywood、California、アメリカ
- James R. Berenson, MD
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Whittier、California、アメリカ
- The Oncology Institute of Hope and Innovation
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Indiana
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Lafayette、Indiana、アメリカ
- Horizon Oncology Research
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Maryland
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Bethesda、Maryland、アメリカ
- Center for Cancer and Blood Disorders
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New York
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New York、New York、アメリカ
- Clinical Research Alliance
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Tennessee
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Nashville、Tennessee、アメリカ
- Tennessee Oncology
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Texas
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Austin、Texas、アメリカ
- Texas Oncology
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Virginia
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Norfolk、Virginia、アメリカ
- Virginia Oncology Associates
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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:
- Newly diagnosed multiple myeloma
Measurable disease, as defined by 1 or more of the following
- Serum M-protein ≥ 0.5 g/dL, or
- Urine M-protein ≥ 200 mg/24 hours, or
- In subjects without detectable serum or urine M-protein, serum free light chain (SFLC) > 100 mg/L (involved light chain) and an abnormal kappa lambda ( κ/λ) ratio
- Males and females ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate hepatic function
- Left ventricular ejection fraction (LVEF) ≥ 40%
- Absolute neutrophil count (ANC) ≥ 1.0 × 10^9/L
- Platelet count ≥ 50 × 10^9/L
- Calculated or measured creatinine clearance (CrCl) of ≥ 15 mL/min
Exclusion Criteria:
- Planned autologous hematopoietic stem cell transplantation (HSCT) for the initial therapy of newly diagnosed multiple myeloma
- Multiple myeloma of immunoglobulin M (IgM) subtype
- Prior systemic treatment for multiple myeloma
- Glucocorticoid therapy within 14 days prior to enrollment that equals or exceeds the equivalent of dexamethasone 160 mg
- Known amyloidosis
- Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 6 months prior to enrollment.
- Known human immunodeficiency virus (HIV) seropositive, hepatitis C infection, and/or hepatitis B (subjects with hepatitis B surface antigen [SAg] or core antibody receiving and responding to antiviral therapy directed at hepatitis B are allowed)
- Significant neuropathy (Grades ≥ 2) within 14 days prior to enrollment
- Any other clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
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:なし
- 介入モデル:単一グループの割り当て
- 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:Carfilzomib, Cyclophosphamide and Dexamethasone (CCd)
Participants received carfilzomib, cyclophosphamide and dexamethasone for up to eight 28-day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
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Carfilzomib administered as a 30-minute intravenous (IV) infusion on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle.
On Days 1 and 2 of Cycle 1, all participants received carfilzomib at 20 mg/m².
他の名前:
Cyclophosphamide administered orally (PO) at the dose of 300 mg/m² on Days 1, 8, and 15 of each 28-day cycle.
Dexamethasone administered PO or IV at 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle.
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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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Number of Participants With Dose-limiting Toxicities (DLTs)
時間枠:First cycle treatment over 28-days
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The MTD is defined as the highest carfilzomib dose at which fewer than 33% of participants experience a treatment-related dose-limiting toxicity (DLT) during the first 28-day cycle. The number of participants who experienced a DLT is reported. Dose-limiting toxicities are defined as any of the following carfilzomib-related adverse events: Nonhematologic:
Hematologic:
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First cycle treatment over 28-days
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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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Overall Response Rate (ORR)
時間枠:Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.
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Participants were evaluated for disease response and progression by the investigator according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC).
Disease response and progression assessments included serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), serum immunofixation, serum free light chain (SFLC), bone marrow sample (including fluorescent in situ hybridization [FISH]), plasmacytoma evaluation, and skeletal survey.
Overall response rate is defined as the percentage of participants with a best response of stringent complete response, complete response, very good partial response (VGPR), or partial response.
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Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.
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Time To Response (TTR)
時間枠:Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.
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Time to response is defined as months from treatment start to first documentation of response of partial response or better.
Summary of time to response includes confirmed responders of PR or better only.
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Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.
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Number of Participants With Adverse Events
時間枠:From first dose of study drug until 30 days after last dose; median duration of treatment was 31 weeks.
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Adverse events (AEs) were graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 and using the following scale: Grade 1 = Mild, Grade 3 = Moderate; Grade 3 = Severe, Grade 4 = Life-threatening; Grade 5 = Fatal. |
From first dose of study drug until 30 days after last dose; median duration of treatment was 31 weeks.
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協力者と研究者
スポンサー
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 (実際)
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 2012-003
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。
Carfilzomibの臨床試験
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Amgen完了肝障害 | 固形腫瘍 | 血液悪性腫瘍イギリス, オランダ, アメリカ, フランス
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Amgen完了多発性骨髄腫カナダ, デンマーク, フィンランド, フランス, イタリア, スペイン, スウェーデン, イギリス, チェコ, ポーランド, アメリカ, ベルギー, ハンガリー, ニュージーランド, オーストラリア, ドイツ, 日本, ギリシャ, ノルウェー, ルーマニア
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University of Alabama at BirminghamJanssen Scientific Affairs, LLC; Amgen完了
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AmgenInnovative Therapies For Children with Cancer Consortium; Therapeutic Advances in Childhood...積極的、募集していない急性リンパ芽球性白血病(ALL)スペイン, イギリス, アメリカ, 大韓民国, チェコ, フランス, ロシア連邦, サウジアラビア, タイ, カナダ, イタリア, シンガポール, 七面鳥, 台湾, ポルトガル, ポーランド, ルーマニア, ブラジル, オーストラリア, ギリシャ, アルゼンチン, メキシコ, オーストリア, チリ, オランダ, ノルウェー, コロンビア, スウェーデン, ブルガリア, デンマーク, 香港, イスラエル, 南アフリカ