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S0232 Dexamethasone With or Without Lenalidomide in Treating Patients With Previously Untreated Stage I, Stage II, or Stage III Multiple Myeloma

5. März 2015 aktualisiert von: Southwest Oncology Group

Phase III Trial Comparing Dexamethasone (DEX) to the Combination of DEX + CC-5013 in Patients With Previously Untreated Multiple Myeloma

RATIONALE: Drugs used in chemotherapy such as dexamethasone use different ways to stop cancer cells from dividing so they stop growing or die. Lenalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor. It is not yet known whether dexamethasone is more effective with or without lenalidomide in treating multiple myeloma.

PURPOSE: This randomized phase III trial is studying dexamethasone and lenalidomide to see how well they work compared to dexamethasone alone in treating patients with previously untreated stage I, stage II, or stage III multiple myeloma.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

OBJECTIVES:

  • Compare the progression-free survival of patients with previously untreated stage I, II, or III multiple myeloma treated with dexamethasone with or without lenalidomide.
  • Compare the overall response rate in patients treated with these regimens.
  • Compare the major response rate (indicated by greater than 75% decrease in M-protein) in patients treated with these regimens.
  • Compare the overall survival and time to best response in patients treated with these regimens.
  • Compare the toxicity profile of these regimens, including thrombotic complications, in these patients.
  • Compare the effect of these regimens on gene expression and proteomic analysis in these patients.

OUTLINE: This is a randomized, double-blind, crossover, multicenter study. Patients are stratified according to disease stage by the International Staging System (I vs II vs III) and Zubrod performance status (0-1 vs 2-3). Patients are randomized to 1 of 2 treatment arms.

Arm I

  • Induction therapy: Patients receive oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
  • Maintenance therapy: Patients receive oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Arm II

  • Induction therapy: Patients receive DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction.

Patients with responding or stable disease proceed to maintenance therapy. Patients with disease progression during induction therapy cross over and receive unblinded treatment with DM and lenalidomide as in arm I induction. Patients with responding or stable disease after unblinded induction therapy receive unblinded maintenance therapy with DM and lenalidomide as in arm I maintenance.

  • Maintenance therapy: Patients receive oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.

Patients with disease progression during maintenance therapy cross over and receive unblinded treatment with DM and lenalidomide as in arm I induction. Patients with responding or stable disease after unblinded induction therapy proceed to unblinded maintenance therapy with DM and lenalidomide as in arm I maintenance.

Patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 500 patients (250 per treatment arm) will be accrued for this study within 4 years.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

198

Phase

  • 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
    • Michigan
      • Royal Oak, Michigan, Vereinigte Staaten, 48073
        • William Beaumont Hospital - Royal Oak Campus
    • Utah
      • Salt Lake City, Utah, Vereinigte Staaten, 84106
        • Utah Cancer Specialists at UCS Cancer Center

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 und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

DISEASE CHARACTERISTICS:

  • Previously untreated multiple myeloma

    • Stage I, II, or III disease by the International Staging System

  • Measurable M-protein as defined by 1 of the following:

    • Serum M-protein at least 1.0 g/dL by serum protein electrophoresis or immunoelectrophoresis
    • Urinary M-protein excretion at least 200 mg/24 hours
  • No nonsecretory multiple myeloma
  • Not planning to undergo future autologous stem cell transplantation

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-3* NOTE: *Zubrod 3 allowed only if multiple myeloma is the central cause of disability

Life expectancy

  • Not specified

Hematopoietic

  • Platelet count at least 80,000/mm^3*
  • Absolute neutrophil count at least 1,000/mm^3*
  • Hemoglobin at least 9 g/dL* (epoetin alfa or transfusion allowed) NOTE: *Unless due to greater than 50% marrow involvement by myeloma on biopsy

Hepatic

  • AST/ALT no greater than 3 times upper limit of normal* NOTE: *Values outside of this range are allowed at the investigator's discretion

Renal

  • Creatinine no greater than 2.5 mg/dL* NOTE: *Values outside of this range are allowed at the investigator's discretion

Cardiovascular

  • No New York Heart Association class III or IV heart failure
  • No myocardial infarction within the past 6 months
  • No poorly controlled hypertension

Other

  • Not pregnant or nursing
  • Negative pregnancy test

  • Fertile patients must use effective contraception for 4 weeks before, during, and for 4 weeks after study treatment

    • Female patients must use 2 reliable forms of contraception simultaneously
    • Male patients must use effective barrier contraception
  • No uncontrolled active infection requiring IV antibiotics
  • No poorly controlled diabetes mellitus that would preclude ability to take oral glucocorticoids
  • No other serious medical condition that would preclude study participation
  • No psychiatric illness that would preclude study participation
  • No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • Must be able to take aspirin by mouth at a dose of 325 mg per day or enoxaparin subcutaneously at a dose of 40 mg per day as a form of thrombotic prophylaxis, except if already on therapeutic anticoagulant medication

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior interferon or thalidomide

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Prior high-dose dexamethasone allowed provided duration of administration was no more than 4 days

Radiotherapy

  • Prior localized radiotherapy allowed provided it was not to the sole site of evaluable disease

Surgery

  • Not specified

Other

  • No prior treatment for clinically significant ventricular cardiac arrhythmias
  • Concurrent bisphosphonates allowed

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Arm I
Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arzneimittel: Dexamethason
Mündlich gegeben
Arzneimittel: Lenalidomid
Mündlich gegeben
Aktiver Komparator: Arm II
Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
Arzneimittel: Dexamethason
Mündlich gegeben
Sonstiges: Placebo
Mündlich gegeben

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Progression-Free Survival
Zeitfenster: From date of initial registration to date of progression/relapse of disease or death from any cause, whichever came first, up to 5 years

Progression is defined as a > 25% increase from baseline in myeloma protein production or other signs of disease progression such as hypercalcemia, etc.

In patients with a confirmed Partial Remission, Remission, or Complete Remission, relapse is defined as the first occurrence of any of the following: 1) a myeloma protein increase by than 100% from the lowest level recorded on study, provided the absolute magnitude of this increase is at least 1g/dL for a serum monoclonal protein or at least 500 mg/24 hrs of urine M-protein; 2) a myeloma protein increase above the response criteria for Partial Remission, with the same requirements for the absolute magnitude of the protein increase; 3)reappearance of any myeloma peak that had disappeared while on protocol treatment, provided it meets the same requirements listed above; 4) increase in the size and number of lytic bone lesions recognized on radiographs.
From date of initial registration to date of progression/relapse of disease or death from any cause, whichever came first, up to 5 years

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Toxicity
Zeitfenster: From time of initiating study treatment until discontinuation of study treatment or of open-label REVLIMID + LOW DOSE DEX, whichever comes last, up to 5 years
Compare the toxicity profile of these regimens, including thrombotic complications, in these patients, based on CTCAE v. 3.0.
From time of initiating study treatment until discontinuation of study treatment or of open-label REVLIMID + LOW DOSE DEX, whichever comes last, up to 5 years

Mitarbeiter und Ermittler

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

Sponsor

Southwest Oncology Group

Mitarbeiter

National Cancer Institute (NCI)

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

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

1. November 2004

Primärer Abschluss (Tatsächlich)

1. Oktober 2008

Studienabschluss (Tatsächlich)

1. Mai 2012

Studienanmeldedaten

Zuerst eingereicht

8. Juli 2003

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Juli 2003

Zuerst gepostet (Schätzen)

9. Juli 2003

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

25. März 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. März 2015

Zuletzt verifiziert

1. März 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • S0232 (Andere Kennung: SWOG)
  • U10CA032102 (US NIH Stipendium/Vertrag)

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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