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A Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone in Previously Untreated Subjects With Multiple Myeloma

9. september 2015 opdateret af: Celgene Corporation

A Multicenter, Randomized, Parallel-group , Double Blind, Placebo-controlled Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone as Induction Therapy for Previously Untreated Subjects With Multiple Myeloma

To compare the efficacy of combination oral thalidomide plus oral dexamethasone treatment to that of oral dexamethasone-alone treatments as induction (first-line) therapy for subjects with active multiple myeloma

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

470

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Australien
    • Queensland
      • Herston, Queensland, Australien, 4029
        • Royal Brisbane Hospital
      • Woolloongabba, Queensland, Australien, 4102
        • Haematology Princess Alexandra Hospital
    • Victoria
      • Frankston, Victoria, Australien, 3199
        • Frankston Hospital
      • Melbourne, Victoria, Australien, 3004
        • The Alfred Hospital
      • Melbourne, Victoria, Australien, 3002
        • Peter Maccallum Cancer Institute
      • Parkville, Victoria, Australien, 3050
        • Bone Marrow Transplant Service Dept of Clinical Haematology and Medical Oncology
  • Belgien
      • Brussels, Belgien, 1000
        • Institut Jules Bordet Dep't of Clinical Haematology
      • Brussels, Belgien, 1090
        • Dept. Of Haematology Academisch Ziekenhuis VUB
      • Ghent, Belgien, 900
        • University Hospital Ghent Dep't of Haematology
  • Bulgarien
      • Alexandrovska, Bulgarien
        • UMHAT Alexandrovska
      • Sofia, Bulgarien
        • Military Medical Academy
      • Sofia, Bulgarien, 1756
        • National Center of Haematology and Transfusiology
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H2Y9
        • Dalhousie University
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network Princess Margaret Hospital
    • Quebec
      • Fleurimont, Quebec, Canada, J1H 5N4
        • Centre Hopitalier Universitaire de Sherbrooke Hospital Fleurimont
      • Montreal, Quebec, Canada, PQ H2W 1S6
        • McGill University
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre University of Saskatoon
  • Den Russiske Føderation
      • Chelyabinsk, Den Russiske Føderation, 454076
        • Chelyabinsk Regional Clinical Hospital Hematology Dpt
      • Ekaterinburg, Den Russiske Føderation, 620102
        • Ekaterinburg 1st Regional Clinical Hospital Regional Hematology Centre
      • Izhevsk, Den Russiske Føderation, 426039
        • Republican Clinical Hospital #1 Hematology Dpt.
      • Moscow, Den Russiske Føderation, 105229
        • Burdenko Central Military Clinical Hospital Hematology Center
      • Moscow, Den Russiske Føderation, 125167
        • Russian Academy of Medical Sciences Scientific Center of Hematology
      • Novgorod, Den Russiske Føderation, 603126
        • Nizhny Novgorod Clinical Hospital
      • Novosibirsk, Den Russiske Føderation, 630087
        • Novosibirsk State Regional Clinical Hospital Hematology Centre
      • Samara, Den Russiske Føderation, 443095
        • Samara Regional Clinical Hospital Dep't. of Hematology and Bone Marrow Transplantation
      • Shosse, Den Russiske Føderation, 115478
        • Blokhin Cancer Research Center Dpt of Myeloproliferative Disorders Chemotherapy
      • St. Petersburg, Den Russiske Føderation, 193024
        • Research Institute of Hematology and Blood Transfusion,Clinical Department of Hematology with Bone Marrow Transplantation Unit
      • St. Petersburg, Den Russiske Føderation, 197022
        • St. Petersburg Pavlov State Medical University Bone Marrow Transplantation Clinic
      • St. Petersburg, Den Russiske Føderation, 197110
        • Clinical Hospital #31 Dpt of Bone Marrow Transplantation and Chemotherapy of Patients with Myeloproliferative Disorders
  • Det Forenede Kongerige
      • Belfast, Det Forenede Kongerige, BT9 7AB
        • Belfast City Hospital Haematology Dpt.
      • London, Det Forenede Kongerige, SE1 9RT
        • Guys Hospital
      • London, Det Forenede Kongerige, SE19RT
        • Guys Hospital
  • Forenede Stater
    • Alabama
      • Hoover, Alabama, Forenede Stater, 35216
        • Clinical Research Consultants, Inc.
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85712
        • Arizona Clinical Research Center
    • California
      • Los Angeles, California, Forenede Stater, 90095
        • UCLA School of Medicine
      • West Hollywood, California, Forenede Stater, 90069
        • James Berenson
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32224
        • Mayo Clinic
      • Melbourne, Florida, Forenede Stater, 32901-3182
        • Melbourne Internal Medicine Associates Oncology
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami
      • Miami, Florida, Forenede Stater, 33176
        • Oncology Hematology Group of South Florida
      • Miami, Florida, Forenede Stater, 33136
        • Jackson Memorial Hospital and Clinics
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami Miller School/Jackson Memorial Hospital
    • Georgia
      • Augusta, Georgia, Forenede Stater, 30912-3125
        • Medical College of Georgia
    • Illinois
      • Centralia, Illinois, Forenede Stater, 62801
        • Southern Illinois Hematology /Oncology
      • Chicago, Illinois, Forenede Stater, 60612-3824
        • Rush Cancer Institute Section of Hematology
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • University of Iowa Hospital of Clinic
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70121
        • Ocshner Clinic Foundation
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109-0922
        • University of Michigan Comprehensive Cancer Center
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic Cancer Center
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Hackensack University Hospital
    • New York
      • Syracuse, New York, Forenede Stater, 13210
        • SUNY Upstate Medical University
    • North Carolina
      • Winston-Salem, North Carolina, Forenede Stater, 27157-1023
        • Wake Forest University School of Medicine
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic- Taussig Cancer Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • University of Pittsburgh
    • South Carolina
      • West Columbia, South Carolina, Forenede Stater, 29169
        • South Carolina Oncology Group
    • Tennessee
      • Collierville, Tennessee, Forenede Stater, 38017
        • The Family Centre, PLLC
      • Knoxville, Tennessee, Forenede Stater, 37920
        • East Tennessee Oncology/Hematology Associates
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Medical College of Wisconsin
  • Irland
      • Dublin, Irland, 8
        • Hope Directorate Dep't. Haematology St. James's Hospital
    • Limerick
      • Dooradoyle, Limerick, Irland
        • MidWestern Regional Hospital Haematology Dpt.
  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center Dep't. Of Hematology
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center Hematology Institute
      • Tel Hashomer, Israel, 52621
        • Director of Hematology Division BMT and CBB The Chaim Sheba Medical Center
    • Jerusalem
      • Ein Kerem, Jerusalem, Israel, 91120
        • Hadassah University Hospital Hematology Dep't
  • Italien
      • Bari, Italien, 11
        • Universita di Bari Dipartimento di Scienze Umana Sezione de Medicina Interna e Oncologia Medica Policlinico
      • Bologna, Italien, 40138
        • Istituto di Ematologia e Oncologia Medica "L. e. A. Seragnoli"
      • Genova, Italien, 16132
        • Azienda Ospedaliera San Martino
      • Milano, Italien, 20162
        • Ospedale Niguarda CA Granda
      • Pavia, Italien, 27100
        • Policlinico San Matteo
      • Roma, Italien, 00161
        • Università La Sapienza Dipartimento di Biotecnologie Cellulari ed Ematologia
      • Udine, Italien, 33100
        • Clinica Ematologica Policlinico Universitario
  • Polen
      • Bialystok, Polen, 15-276
        • Medical Academy of Bialystok
      • Gdansk, Polen, 80-211
        • Institute of Internal Diseases University of Medicine
      • Krakow, Polen, 31-501
        • Jagiellonian University Collegium Medicum Department of Hematology
      • Lodz, Polen, 93-509
        • Medical University of Lodz
      • Lublin, Polen, 20-022
        • Private Medical Practice Centre of Clinical Laboratory of Densitometry At 'Officers of Professors'
      • Warsaw, Polen, 02-097
        • Medical University of Warsaw Dep't of Hematology, Oncology and Internal Diseases
  • Schweiz
      • Zurich, Schweiz, 8091
        • Universitätsspital Zürich
  • Spanien
      • Barcelona, Spanien, 08036
        • Hospital Clinic
      • Madrid, Spanien, 28041
        • Hospital Doce de Octubre
      • Madrid, Spanien, 28006
        • Hospital Universitario de La Princessa
      • Pamplona, Spanien, 31080
        • Clinica Universitaria de Navarra
      • Salamanca, Spanien, 37007
        • Hospital Universitario de Salamanca
      • Santander, Spanien, 39008
        • Hospital Universitario Marqués de Valdecilla
  • Tyskland
      • Dusseldorf, Tyskland
        • Universitaetsklinikum Dusseldorf Klinik fuer Haematologie
  • Ukraine
      • Cherkassy, Ukraine, 18009
        • Cherkassy Regional Oncology Center
      • Dnepropetrovsk, Ukraine, 49044
        • Dnepropetrovsk City Clinical Hospital #4 Regional Hematology Centre
      • Ivano-Frankovsk, Ukraine, 76000
        • Ivano-Frankovsk Regional Clinical Hospital - Hospital Therapy Department
      • Kharkov, Ukraine, 61070
        • Kharkov Regional Clinical Oncology Center Dep't of Oncology and Pediatric Oncology
      • Kiev, Ukraine, 03022
        • Kiev Institute of Oncology of the UAMS Systemic Malignancies Department
      • Kiev, Ukraine, 03115
        • Kiev Bone Marrow Transplantation Center Bone Marrow Transplantation Department
      • Kiev, Ukraine, 04060
        • Institute of Hematology and Transfusiology of the UAMS Department of Blood Diseases with Clinical Biochemistry Group
      • Lvov, Ukraine, 79044
        • Institute of Blood Pathology and Transfusion Medicine of the UAMS
      • Odessa, Ukraine, 65025
        • Odessa Regional Clinical Hospital Hematology Dep't
      • Zaporozhye, Ukraine, 69600
        • Zaporozhje Regional Clinical Hospital Hematology Dpt
      • Zhitomir, Ukraine, 10002
        • Zhitomir Regional Clinical Hospital Hematology Centre
  • Ungarn
      • Budapest, Ungarn
        • St. Laszlo Hoszpital
      • Gyor, Ungarn, 9002
        • Petz Aladar County Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Active Multiple Myeloma Stage II or III Durie Salmon
  • Measurable levels of myeloma paraprotein in serum (≥1.0g/dL) or urine (≥ 0.2g excreted in a 24-hour collection sample)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2
  • Women of child bearing potential must agree to abstain for heterosexual intercourse or use 2 methods of contraception, one effective (for example hormonal or tubal ligation) and one barrier (for example latex condom, diaphragm)
  • Males must agree to use barrier contraception (latex condoms) when engaging in reproductive activity

Exclusion Criteria:

  • Pregnant or lactating females
  • Peripheral neuropathy ≥ to grade 2 of the NCI CTC.
  • Prior history of malignancy unless subject has been free of disease for ≥ 3 years
  • Lab abnormality: Absolute neutrophil count (ANC) <1,000 cells/mm^3 (1.0 x 10^9/L)
  • Lab abnormality: Platelet count <50,000/mm^3 (50.0 x 10^9/L)
  • Lab abnormality: Serum creatinine >3.0 mg/dL (265 µmol/L)
  • Lab abnormality: Serum glutamic oxaloacetic transaminase (SGOT) /Aspartate aminotransferase (AST) or Serum glutamic pyruvic transaminase (SGPT)/Alanine transaminase (ALT) >3.0 x upper limit of normal (ULN)
  • Lab abnormality: Serum total bilirubin > 2.0 mg/dL (34 µmol/L)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: A (Thalidomide & Dexamethasone)
Thalidomide 50mg/day + Dexamethasone 40mg
Medicin: A (Thalidomide + Dexamethasone)
Thalidomide 50mg/day + Dexamethasone 40mg
Andre navne:
  • Thalidomid
Placebo komparator: B (Dexamethasone and placebo)
Dexamethasone and placebo
Medicin: B (Placebo + Dexamethasone)
Placebo + Dexamethasone 40mg
Andre navne:
  • Dexamethason
  • placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to tumor progression (TTP)
Tidsramme: Up to 3 years
Time to tumor progression (TTP)
Up to 3 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of patients who survived
Tidsramme: Up to 3 years
Number of patients who survived
Up to 3 years
Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone)
Tidsramme: Up to 3 years
Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone)
Up to 3 years
Myeloma response rate
Tidsramme: Up to 3 years
Myeloma response determination criteria developed by Bladé et al 1998
Up to 3 years
Number of participants with adverse events
Tidsramme: Up to 3 years
Number of participants with adverse events
Up to 3 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Celgene Corporation

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2003

Primær færdiggørelse (Faktiske)

1. april 2006

Studieafslutning (Faktiske)

1. august 2013

Datoer for studieregistrering

Først indsendt

4. april 2003

Først indsendt, der opfyldte QC-kriterier

4. april 2003

Først opslået (Skøn)

8. april 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. september 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. september 2015

Sidst verificeret

1. september 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • THAL-MM-003

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Myelomatose

Kliniske forsøg med A (Thalidomide + Dexamethasone)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Kuwait

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner