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Autologous Transplant for Multiple Myeloma

7. November 2021 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

363

Phase

  • Phase 2
  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Minnesota
      • Minneapolis, Minnesota, Vereinigte Staaten, 55455
        • Masonic Cancer Center, University of Minnesota

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verfahren: 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.
Andere Namen:
  • Knochenmarktransplantation
Arzneimittel: Cyclophosphamide + Mesna
Cyclophosphamide: 4mg/m^2 + Mesna. Mesna is used to reduce the undesired side effects of certain chemotherapy drugs.
Andere Namen:
  • Cytoxan
Arzneimittel: Melphalan
Administered intravenously 200 mg/m^2
Andere Namen:
  • Alkeran
Biologisch: Granulocyte-colony stimulating factor
Administered intravenously 10 ug/kg/day pretransplant then 5 ug/kg/day post-transplant.
Andere Namen:
  • G-CSF

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants Achieving a Complete Response
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Patients With Extended Disease-free Survival
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 1 year
The return of disease after its apparent recovery/cessation.
1 year
Number of Participants With Disease Progression
Zeitfenster: 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
Zeitfenster: 1 year
Mean number of days among patients progressing
1 year
Time to Relapse
Zeitfenster: 1 year
Mean number of days among patients relapsing
1 year
Number of Participants With Absolute Neutrophil Recovery
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: During study
During study
Dropout Rate From Maintenance Therapy
Zeitfenster: Post transplant phase
Post transplant phase
Number of Participants With Toxicities
Zeitfenster: By first 100 days
Occurrence of toxicities by first 100 days of transplant
By first 100 days
Number of Participants With Infections
Zeitfenster: By first 100 days
Occurrence of infections in the patients by the first 100 days of transplant
By first 100 days

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Masonic Cancer Center, University of Minnesota

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

20. April 2004

Primärer Abschluss (Tatsächlich)

1. August 2020

Studienabschluss (Tatsächlich)

1. August 2020

Studienanmeldedaten

Zuerst eingereicht

13. September 2005

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. September 2005

Zuerst gepostet (Schätzen)

15. September 2005

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. November 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. November 2021

Zuletzt verifiziert

1. November 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2004LS001
  • MT2003-13 (Andere Kennung: Blood and Marrow Transplantation Program)
  • 0312M54569 (Andere Kennung: IRB, University of Minnesota)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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