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Fractionated Stem Cell Infusions in Myeloma Patients Undergoing Autologous Stem Cell Transplant

2016年4月28日 更新者：Memorial Sloan Kettering Cancer Center

Pilot Trial of Fractionated Stem Cell Infusions in Myeloma Patients Undergoing Autologous Stem Cell Transplant

Multiple myeloma is difficult to treat with only anti-cancer medicine (called chemotherapy) or radiation alone. Sometimes higher doses of chemotherapy are used but when used can also lower blood counts. Using own cells (special cells called stem cells) to help increase the blood counts after high doses of chemotherapy is called autologous stem cell transplantation (ASCT).

Using own stem cells to restore blood counts and other advances in supportive measures (antibiotics and growth factors that increase blood counts) has improved the safety of ASCT. However, blood counts still decrease for a period of days after high doses of chemotherapy. During that time, patients are at greater risk for infections. Studies have shown that the faster the blood counts recover after ASCT, the less at risk there is for developing unwanted side effects after ASCT.

Typically during an ASCT, a patient's stem cells are given back to them all at once on a single day. In this study, the investigators plan to see what happens when smaller amounts of own stem cells are given back to the patient over multiple days. The investigators want to find out what effects good and/or bad this will have on the patient and there multiple myeloma. Some studies have shown that giving back stem cells over a period of days helps to increase bone marrow activity and decrease the time it takes for blood counts to recover after ASCT. It is our hope that this new approach may lower a patient's risk of side effects and infections, decrease the number of blood transfusions that a patient needs during this process, reduce the time a patient has to spend in the hospital, and lower overall treatment costs.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

26

段階

  • 適用できない

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

  • アメリカ
    • New York
      • New York、New York、アメリカ、10065
        • Memorial Sloan-Kettering Cancer Center

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～75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:

  • Age ≥18 and < than or = to 75
  • Histologic and serologic findings, reviewed at MSKCC, confirming the diagnosis of multiple myeloma. Standard diagnostic criteria for multiple myeloma will be used, as per the International Myeloma Foundation consensus guidelines (Durie et al, 2003) .

  • Patients must have symptomatic multiple myeloma who have responded to prior induction or salvage chemotherapy (i.e. chemosensitive disease):

    • Patients who are receiving high-dose melphalan and ASCT as part of their initial therapy require at least minor response to their last line of therapy to document chemosensitive disease (Anderson et al. 2008)
    • Patients who are receiving high-dose melphalan and ASCT as part of salvage therapy require at least a minor response to their last line of therapy to document chemosensitive disease (Anderson et al. 2008).

    • There is no limit on the number of prior regimens received by the patient.

      • Patients must have at least 7 x 10^6 (+/- 0.5 x 10^6) CD34+ stem cells/kg frozen if he/she is being treated as part of a salvage (second) transplant strategy; patients must have 10 x 10^6 (+/- 0.5 x 10^6) CD34+ stem cells/kg frozen if ASCT is being performed as part of initial therapy.
      • Adequate organ function is required, defined as follows:
    • Serum bilirubin ≤ 2.0 mg/dl
    • AST, ALT and alkaline phosphatase < 3 times the upper limit of laboratory normal

    • Creatinine clearance > or = to 40 ml/min (24 hour urine collection or calculated*)

      *To be calculated by the Cockroft-Gault method: (140-Age) x Mass (kg) x [0.85 if female] (72 x Creatinine (mg/dL)

    • LVEF > or = to 45% by MUGA or rest ECHO
    • Diffusing capacity > or = to 45% (adjusted for hemoglobin) predicted by pulmonary function testing
  • Performance status KPS > or = to 70%.

Exclusion Criteria:

  • Unstable angina or myocardial infarction within 4 months of initiating therapy on trial, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker
  • Pregnant or lactating females
  • Nonhematologic malignancy within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas
  • Contraindication to melphalan or any of the required supportive treatments, including hypersensitivity to G-CSF or pegfilgrastim
  • Any other medical condition or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial

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：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
実験的：Fractionated Stem Cell Infusions
A single arm, open-label, single institution pilot trial is planned. Patients with chemosensitive MM and at least 7 x 10^6 CD34+ stem cells/kg (+/- 0.5 x 10^6 CD34+ stem cells/kg)available for use will be enrolled following initial induction or salvage therapy.
手順：Fractionated Stem Cell Infusions
Following enrollment patients will be treated with melphalan intravenously (IV) through a central venous catheter (CVC) over 30 minutes at 200mg/m2 or 140mg/m2 (if creatinine clearance is < or = to 50 and/or age > 70 years) on day -2. Following 24 hours of rest, the first dose of CD34+ stem cell will be administered on day 0 (2.5-5 x 106 CD 34+ stem cells/kg)+/- 0.5 x 106 CD34+ stem cells/kg), followed by 3 additional doses of CD 34+ stem cells (1.5-2.5 x 106 CD 34+ stem cells/kg)+/- 0.5 x 106 CD34+ stem cells/kg) on days +2, +4, and +6. Pegfilgrastim 6μg will be administered on day +1. Filgrastim 5μg/kg will be 12-24 hours after the 2nd-4th stem cell infusions. There will be a +/- 1 day window for the Day +2, +4, and +6 infusions to accommodate infusions that occur over the weekend or on holidays.
他の名前：
  • Patients will receive standard supportive care measures (including
  • antimicrobial prophylaxis, red blood cell and platelet transfusions and
  • treatment for neutropenic fever) as per institutional practices. Neutrophil
  • engraftment is defined as absolute neutrophil count (ANC) > or = to 500 x 10^6/L for 2
  • consecutive 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
engraftment kinetics
時間枠：2 years
as measured by duration of neutropenia in patients with MM undergoing high-dose melphalan followed by fractionated CD34+ stem cell infusions.
2 years

二次結果の測定

結果測定
メジャーの説明
時間枠
safety and toxicity profile
時間枠：2 years
of high-dose melphalan therapy followed by multiple doses of CD34+ stem cell rescue in patients with MM. Whenever possible, the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 should be used to describe the event and for assessing the severity of AEs.
2 years
neutrophil and platelet recovery rates.
時間枠：2 years
Duration of neutropenia will be defined as the number of days ANC< 500x106/L. Time until platelet recovery (defined as platelets>=30x109/L), the number of units of red blood cells and platelets.
2 years
incidence of infection
時間枠：3 months post-SCT
The incidence of infection by three months after re-infusion will be calculated.
3 months post-SCT
red cell and platelet transfusion requirements
時間枠：2 years
will be evaluated using the Spearman rank correlation coefficient
2 years
duration of hospital admission
時間枠：2 years
length of hospital stay in days will be summarized using descriptive statistics.
2 years
To assess symptom burden
時間枠：2 years
using the MSK Modified M.D. Anderson Symptom Inventory (MDASI).
2 years
Multiple Myeloma response rates
時間枠：at 3 months
at 3 months post-transplant according to standard response criteria. Response rates will be evaluated based on International Myeloma Working Group Uniform Response Criteria at 3 months following ASCT.
at 3 months
correlation between engraftment kinetics and symptom burden
時間枠：2 years
in patients with MM who receive high-dose melphalan and fractionated CD34+ stem cell infusions
2 years
the number of CD34+ cells/Kg present
時間枠：2 years
at the time of infusion. The difference between the number of CD34+ cells/kg given at each stem cell infusion time point and the number of CD34+ cells/kg before cryopreservation will be calculated as both a simple difference and percentage change.
2 years
To correlate the number CD34+ cells/Kg given
時間枠：2 years
at the time of transplant with engraftment kinetics. The difference between the number of CD34+ cells/kg given at each stem cell infusion time point and the number of CD34+ cells/kg before cryopreservation will be calculated as both a simple difference and percentage change.
2 years

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。

スポンサー

Memorial Sloan Kettering Cancer Center

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。

便利なリンク

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

2011年8月1日

一次修了 (実際)

2016年4月1日

研究の完了 (実際)

2016年4月1日

試験登録日

最初に提出

2011年8月11日

QC基準を満たした最初の提出物

2011年8月11日

最初の投稿 (見積もり)

2011年8月12日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年4月29日

QC基準を満たした最後の更新が送信されました

2016年4月28日

最終確認日

2016年4月1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

  • 11-105

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