Phase I: Melphalan, Bendamustine and Carfilzomib for Autologous Transplant in Multiple Myeloma
A Phase I Study of Melphalan, Bendamustine, and Carfilzomib for Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma
調査の概要
状態
条件
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
-
-
Michigan
-
Grand Rapids、Michigan、アメリカ、49503
- Spectrum Health
-
-
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:
- Diagnosis of multiple myeloma
- At least 2 x 106 CD34+ cells/kg have been collected from the patient and cryopreserved for ASCT
- Greater than 18 years
- Karnofsky score greater than 70%
- No evidence of progressive bacterial, viral, or fungal infection
- Absolute neutrophil count above 1000
- Platelet count above 50,000
- Hemoglobin above 8 g/dL
- Creatinine clearance greater than 50 mL/min
- Total bilirubin, ALT, and AST less than 2 x the upper limit of normal
- Alkaline phosphatase less than or equal to 250 IU/L
- Left Ventricular Ejection Fraction (LVEF) greater than or equal to 45%
- Adjusted Carbon Monoxide Diffusing Capacity (DLCO) greater than or equal to 60%
- Negative HIV serology
- Recovered from toxicity of previous chemotherapy (excludes grade 1 neurotoxicity and hematological toxicity)
- Patients with a pre-transplant disease status consistent with a very good partial response (VGPR), partial response (PR), stable disease (SD), progressive disease (PD), or relapse from complete remission (CR).
Exclusion Criteria:
- Patients who are refractory to carfilzomib. Refractory is defined as disease progression while on carfilzomib therapy after receiving at least two cycles of treatment.
- Patients with a complete response (CR) (including near CR and stringent CR) to conventional induction therapy and proceeding to transplantation.
- Pregnant or nursing females or women of reproductive capability who are unwilling to use effective contraception. A woman of reproductive capability is one who has not undergone a hysterectomy (removal of the womb), has not had both ovaries removed, or has not been post-menopausal (stopped menstrual periods) for more than 24 months in a row.
- Male subjects who refuse to practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse. This must be done even if they are surgically sterilized (ie, post-vasectomy).
- Patient with Grade 2 peripheral neuropathy
- Inability to provide informed consent
- Patient had myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Prior to study entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant.
- Known allergies to any of the components of the investigational treatment regimen or required ancillary treatments.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Diagnosed or treated for another malignancy within 3 years of enrollment (with the exception of non-melanoma skin cancer).
- Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial.
- Prisoner
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 |
---|---|
アクティブコンパレータ:Cohort 1: Carfilzomib 15 mg/m2
Carfilzomib 15 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes.
|
Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 15 mg/m2 on day -2, -1, + 5 and +6
他の名前:
|
アクティブコンパレータ:Cohort 2: Carfilzomib 20 mg/m2
Carfilzomib 20 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes.
|
Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 20 mg/m2 on day -2, -1, + 5 and +6
他の名前:
|
アクティブコンパレータ:Cohort 2b: Carfilzomib 20 mg/m2
Carfilzomib 20 mg/m2 on days -2, -1 and +5 IV over 10 minutes.
|
Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 20 mg/m2 on day -2, -1 and + 5
他の名前:
|
アクティブコンパレータ:Cohort 3: Carfilzomib 27mgm2
Carfilzomib 27 mg/m2 on days -2, -1 and +5 IV over 10 minutes.
|
Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 27 mg/m2 on day -2, -1 and + 5
他の名前:
|
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 |
---|---|---|
Dose Limiting Toxicity
時間枠:Assessed daily (while inpatient) through clinical and laboratory examinations up to 90 days.
|
An absence of neutrophil engraftment by Day +22, absence of platelet engraftment by Day +35, and any grade 4 GI toxicity or any >/= grade 3 non-hematologic toxicity as defined by the common toxicity criteria, which is deemed by the DSMB as probably related to the study protocol.
|
Assessed daily (while inpatient) through clinical and laboratory examinations up to 90 days.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Engraftment
時間枠:Assessed daily (while inpatient) through clinical and laboratory examinations up to 90 days.
|
Engraftment of Neutrophils: ANC recovery is defined as an absolute neutrophil count (ANC) of ≥ 0.5 x 109/L for three consecutive laboratory values obtained on different days. The day used as neutrophil engraftment is the date of the first of three laboratory values. Engraftment of Platelets: Platelet engraftment is defined as a platelet count ≥ 20 x 109/L for 3 consecutive measurements obtained on different days. The patient must not have received a platelet infusion for seven consecutive days prior to the first day being considered. The day used as platelet engraftment is the date of the first of three laboratory values. Graft Failure: Graft failure includes failure to achieve neutrophil engraftment by day 22. |
Assessed daily (while inpatient) through clinical and laboratory examinations up to 90 days.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Response Rate
時間枠:Disease assessment at day +100, +180, and +365 (+/- 7 days).
|
Find the response rate of the combination of melphalan, bendamustine, and carfilzomib as a conditioning regimen in patients with multiple myeloma undergoing autologous transplantation.
|
Disease assessment at day +100, +180, and +365 (+/- 7 days).
|
協力者と研究者
捜査官
- 主任研究者:Muneer H Abidi, MD、Spectrum Health Hospitals
研究記録日
主要日程の研究
研究開始 (実際)
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
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。
Cohort 1: Carfilzomib 15 mg/m2の臨床試験
-
University of Alabama at BirminghamSanofi; Astellas Pharma Inc引きこもった
-
Pfizer完了
-
Italian Sarcoma GroupFrench Sarcoma Group; Grupo Espanol de Investigacion en Sarcomas積極的、募集していない
-
Bay Area Gynecology Oncologyわからない