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Autologous Transplant for Multiple Myeloma

2021年11月7日 更新者：Masonic Cancer Center, University of Minnesota

Autologous Transplantation for Multiple Myeloma

This is a study of a regimen of melphalan and autologous stem cells for patients with multiple myeloma. We hypothesize that this particular regimen will improve the survival of these patients.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

Before starting treatment in this study, the bone marrow transplant (BMT) doctor will check the subject's general health. Subjects will have the following tests and evaluations to find out if they can participate:--Medical history and physical examination, including height and weight.--Blood tests (approximately 4 - 5 tablespoons) --Urine tests--Chest x-ray--Electrocardiogram (ECG or EKG)--Heart Scan (MUGA)--Pulmonary Function Test (PFT)--Bone marrow biopsies and aspirates. --If Female subjects of child-bearing age will have a serum pregnancy test performed. After eligible patients have been completely staged and exercised consent, they may undergo one cycle of chemotherapy (cyclophosphamide and Mesna) and growth factor (G-CSF) to effect cytoreduction and mobilization of PBSC for collection. All patients will receive high-dose melphalan followed by an autologous stem cell transplant (SCT). Blood tests will be performed frequently to evaluate the subject's response to treatment and possible side effects of treatment. If necessary, platelet and red cell transfusions will be given to maintain adequate levels and antibiotics will be given to treat or prevent infection. Subjects may also require intravenous nutritional support and pain medications during or after transplantation. The study coordinators will collect health information over three years. They will collect information every week for 100 days, then at 6 months, 1 year, 2 years, and 3 years.

研究の種類

介入

入学 (実際)

363

段階

  • フェーズ2
  • 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

  • アメリカ
    • Minnesota
      • Minneapolis、Minnesota、アメリカ、55455
        • Masonic Cancer Center, University of Minnesota

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:

  • Patients meeting the Durie and Salmon criteria for initial diagnosis of multiple myeloma, requiring therapy and meeting one of the following:

    • After initial therapy in either first complete or partial remission or no objective response
    • After achieving initial response and later disease progression, patient will be eligible after subsequent therapy upon achievement of either complete or partial response
  • Is not eligible or has refused any protocols of higher priority
  • 18 - 75 years of age

  • Adequate organ function defined as:

    • Hematologic: hemoglobin ≥ 8 gm/dl (untransfused), white blood cells (WBC) ≥ 3000/μl, absolute neutrophil count (ANC) ≥ 1500/μl, platelets ≥ 100,000/μl (untransfused)
    • Cardiac: no active ischemia, left ventricular ejection fraction > 45% by MUGA scan
    • Hepatic: bilirubin < 2.0 mg/dl, ALT < 3x the upper limit of normal
    • Pulmonary: FEV1-Forced Expiratory Volume in One Second AND Forced vital capacity (FVC) >50% predicted and Carbon Monoxide Diffusing Capacity (DLCO) (corrected) > 50% predicted
    • Performance status: Karnofsky performance of > 80%.
  • Free of active uncontrolled infection at the time of study entry.
  • At time of study enrollment > 4 weeks from prior myelosuppressive chemotherapy; and > 6 weeks from prior nitrosoureas.
  • Patients must exercise informed voluntary consent and sign a consent form approved by the University of Minnesota IRB: Human Subjects Committee.

Exclusion Criteria:

  • Patients will be ineligible if they have advanced myeloma refractory and unresponsive to salvage chemotherapy regimens.
  • Female patients who are pregnant (positive b-HCG) or breastfeeding will be excluded from study entry. In addition fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment, particularly after thalidomide will also be excluded from study entry.

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：Chemotherapy and Transplant Treatment
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m^2). Post-transplant maintenance therapy is then prescribed if appropriate.
手順：Stem Cell Transplant
As part of the stem cell transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover.
他の名前：
  • 骨髄移植
薬：Cyclophosphamide + Mesna
Cyclophosphamide: 4mg/m^2 + Mesna. Mesna is used to reduce the undesired side effects of certain chemotherapy drugs.
他の名前：
  • シトキサン
薬：Melphalan
Administered intravenously 200 mg/m^2
他の名前：
  • アルケラン
生物学的：Granulocyte-colony stimulating factor
Administered intravenously 10 ug/kg/day pretransplant then 5 ug/kg/day post-transplant.
他の名前：
  • G-CSF

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
Number of Participants Achieving a Complete Response
時間枠：100 Days post transplant

Myeloma Response Definitions - Using International Uniform Response Criteria:

Stringent Complete Response (sCR)requires, plus CR:

  • Normal free light chain ratio
  • Absence of clonal cells in bone marrow

Complete Response (CR):

  • Absence of the original monoclonal paraprotein
  • <5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy
  • No increase in size or number of lytic bone lesions
  • Disappearance of soft tissue plasmacytomas.
100 Days post transplant
Number of Participants Achieving a Complete Response
時間枠：6 months post transplant

Myeloma Response Definitions - Using International Uniform Response Criteria:

Stringent Complete Response (sCR)requires, plus CR:

  • Normal free light chain ratio
  • Absence of clonal cells in bone marrow

Complete Response (CR):

  • Absence of the original monoclonal paraprotein
  • <5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy
  • No increase in size or number of lytic bone lesions
  • Disappearance of soft tissue plasmacytomas.
6 months post transplant
Number of Participants Achieving a Complete Response
時間枠：12 months post transplant

Myeloma Response Definitions - Using International Uniform Response Criteria:

Stringent Complete Response (sCR)requires, plus CR:

  • Normal free light chain ratio
  • Absence of clonal cells in bone marrow

Complete Response (CR):

  • Absence of the original monoclonal paraprotein
  • <5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy
  • No increase in size or number of lytic bone lesions
  • Disappearance of soft tissue plasmacytomas.
12 months post transplant

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of Patients With Extended Disease-free Survival
時間枠：36 Months
Extended disease free survival will be defined as percentage of patients surviving more than 36 months without relapse or disease progression.
36 Months
Number of Participants With Overall Survival
時間枠：1 year
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.
1 year
Number of Participants With Overall Survival
時間枠：2 years
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.
2 years
Number of Participants With Overall Survival
時間枠：3 years
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.
3 years
Count of Participants Experiencing Transplant Related Mortality
時間枠：1 year
In the field of transplantation, toxicity is high and all deaths without previous relapse or progression are usually considered as related to transplantation.
1 year
Number of Participants Experiencing Incidence of Relapse
時間枠：1 year
The return of disease after its apparent recovery/cessation.
1 year
Number of Participants With Disease Progression
時間枠：1 year

Myeloma Response Definitions - Using International Uniform Response Criteria:

Progressive Disease (PD)

For patients not in CR or sCR, progressive disease requires one or more of the following:

  • >25% increase in the level of the serum monoclonal paraprotein, which must also be an absolute increase of at least 0.5 g/dL.
  • >25% increase in 24-hour urine protein electrophoresis, which must also be an absolute increase of at least 200 mg/24 hours.
  • Absolute increase in the difference between involved and uninvolved FLC levels (absolute increase must be >10 mg/dl), only in patients without measurable paraprotein in the serum and urine.
  • >25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%.
  • Definite increase in the size of existing bone lesions or soft tissue plasmacytomas.
1 year
Time to Progression
時間枠：1 year
Mean number of days among patients progressing
1 year
Time to Relapse
時間枠：1 year
Mean number of days among patients relapsing
1 year
Number of Participants With Absolute Neutrophil Recovery
時間枠：Day 42
Hematologic recovery is defined by absolute neutrophil count (ANC) >2500/μl and platelets > 100,000/μl
Day 42
Time to Attainment of CR
時間枠：12 months post transplant

Mean (STD) among patients achieving complete remission (CR)

Myeloma Response Definitions - Using International Uniform Response Criteria:

Complete Response (CR):

  • Absence of the original monoclonal paraprotein
  • <5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy
  • No increase in size or number of lytic bone lesions
  • Disappearance of soft tissue plasmacytomas
12 months post transplant
Time to Attainment of CR+PR
時間枠：12 months post transplant

Mean (STD) among patients achieving complete remission (CR) and partial remission (PR)

Myeloma Response Definitions - Using International Uniform Response Criteria:

Complete Response (CR):

  • Absence of the original monoclonal paraprotein
  • <5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy
  • No increase in size or number of lytic bone lesions
  • Disappearance of soft tissue plasmacytomas.

Partial Response (PR):

  • Greater than or equal to 50% reduction in the level of the serum monoclonal paraprotein and/or reduction in 24 hour urinary monoclonal paraprotein either by greater than or equal to 90% or to <200 mg/24 hours in light chain disease.
  • If the only measurable non-bone marrow parameter is FLC, greater than or equal to 50% reduction in the difference between involved and uninvolved FLC levels or a 50% decrease in level
12 months post transplant
Duration of Maintenance Treatment
時間枠：During study
During study
Dropout Rate From Maintenance Therapy
時間枠：Post transplant phase
Post transplant phase
Number of Participants With Toxicities
時間枠：By first 100 days
Occurrence of toxicities by first 100 days of transplant
By first 100 days
Number of Participants With Infections
時間枠：By first 100 days
Occurrence of infections in the patients by the first 100 days of transplant
By first 100 days

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

Masonic Cancer Center, University of Minnesota

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 (実際)

2004年4月20日

一次修了 (実際)

2020年8月1日

研究の完了 (実際)

2020年8月1日

試験登録日

最初に提出

2005年9月13日

QC基準を満たした最初の提出物

2005年9月13日

最初の投稿 (見積もり)

2005年9月15日

学習記録の更新

投稿された最後の更新 (実際)

2021年11月9日

QC基準を満たした最後の更新が送信されました

2021年11月7日

最終確認日

2021年11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

  • 2004LS001
  • MT2003-13 (その他の識別子：Blood and Marrow Transplantation Program)
  • 0312M54569 (その他の識別子：IRB, University of Minnesota)

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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