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

Sponsor
Celgene Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00057564
Collaborator
(none)
470
Enrollment
99
Locations
2
Arms
126
Duration (Months)
4.7
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: A (Thalidomide + Dexamethasone)
  • Drug: B (Placebo + Dexamethasone)
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
470 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Feb 1, 2003
Actual Primary Completion Date :
Apr 1, 2006
Actual Study Completion Date :
Aug 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: A (Thalidomide & Dexamethasone)

Thalidomide 50mg/day + Dexamethasone 40mg

Drug: A (Thalidomide + Dexamethasone)
Thalidomide 50mg/day + Dexamethasone 40mg
Other Names:
  • Thalidomide

    		•
    Placebo Comparator: B (Dexamethasone and placebo)

    Dexamethasone and placebo

    Drug: B (Placebo + Dexamethasone)
    Placebo + Dexamethasone 40mg
    Other Names:
  • Dexamethasone
  • placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to tumor progression (TTP) [Up to 3 years]

      Time to tumor progression (TTP)

    Secondary Outcome Measures

    1. Number of patients who survived [Up to 3 years]

      Number of patients who survived

    2. Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone) [Up to 3 years]

      Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone)

    3. Myeloma response rate [Up to 3 years]

      Myeloma response determination criteria developed by Bladé et al 1998

    4. Number of participants with adverse events [Up to 3 years]

      Number of participants with adverse events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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/mm3 (1.0 x 109/L)

    • Lab abnormality: Platelet count <50,000/mm3 (50.0 x 109/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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Research Consultants, Inc. Hoover Alabama United States 35216
    2 Arizona Clinical Research Center Tucson Arizona United States 85712
    3 UCLA School of Medicine Los Angeles California United States 90095
    4 James Berenson West Hollywood California United States 90069
    5 Mayo Clinic Jacksonville Florida United States 32224
    6 Melbourne Internal Medicine Associates Oncology Melbourne Florida United States 32901-3182
    7 Jackson Memorial Hospital and Clinics Miami Florida United States 33136
    8 University of Miami Miller School/Jackson Memorial Hospital Miami Florida United States 33136
    9 University of Miami Miami Florida United States 33136
    10 Oncology Hematology Group of South Florida Miami Florida United States 33176
    11 Medical College of Georgia Augusta Georgia United States 30912-3125
    12 Southern Illinois Hematology /Oncology Centralia Illinois United States 62801
    13 Rush Cancer Institute Section of Hematology Chicago Illinois United States 60612-3824
    14 University of Iowa Hospital of Clinic Iowa City Iowa United States 52242
    15 Ocshner Clinic Foundation New Orleans Louisiana United States 70121
    16 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109-0922
    17 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
    18 Hackensack University Hospital Hackensack New Jersey United States 07601
    19 SUNY Upstate Medical University Syracuse New York United States 13210
    20 Wake Forest University School of Medicine Winston-Salem North Carolina United States 27157-1023
    21 Cleveland Clinic- Taussig Cancer Center Cleveland Ohio United States 44195
    22 University of Pittsburgh Pittsburgh Pennsylvania United States 15213
    23 South Carolina Oncology Group West Columbia South Carolina United States 29169
    24 The Family Centre, PLLC Collierville Tennessee United States 38017
    25 East Tennessee Oncology/Hematology Associates Knoxville Tennessee United States 37920
    26 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    27 Royal Brisbane Hospital Herston Queensland Australia 4029
    28 Haematology Princess Alexandra Hospital Woolloongabba Queensland Australia 4102
    29 Frankston Hospital Frankston Victoria Australia 3199
    30 Peter MacCallum Cancer Institute Melbourne Victoria Australia 3002
    31 The Alfred Hospital Melbourne Victoria Australia 3004
    32 Bone Marrow Transplant Service Dept of Clinical Haematology and Medical Oncology Parkville Victoria Australia 3050
    33 Institut Jules Bordet Dep't of Clinical Haematology Brussels Belgium 1000
    34 Dept. Of Haematology Academisch Ziekenhuis VUB Brussels Belgium 1090
    35 University Hospital Ghent Dep't of Haematology Ghent Belgium 900
    36 UMHAT Alexandrovska Alexandrovska Bulgaria
    37 National Center of Haematology and Transfusiology Sofia Bulgaria 1756
    38 Military Medical Academy Sofia Bulgaria
    39 Dalhousie University Halifax Nova Scotia Canada B3H2Y9
    40 Princess Margaret Hospital Toronto Ontario Canada M5G 2M9
    41 University Health Network Princess Margaret Hospital Toronto Ontario Canada M5G 2M9
    42 Centre Hopitalier Universitaire de Sherbrooke Hospital Fleurimont Fleurimont Quebec Canada J1H 5N4
    43 McGill University Montreal Quebec Canada PQ H2W 1S6
    44 Saskatoon Cancer Centre University of Saskatoon Saskatoon Saskatchewan Canada S7N 4H4
    45 Universitaetsklinikum Dusseldorf Klinik fuer Haematologie Dusseldorf Germany
    46 St. Laszlo Hoszpital Budapest Hungary
    47 Petz Aladar County Hospital Gyor Hungary 9002
    48 MidWestern Regional Hospital Haematology Dpt. Dooradoyle Limerick Ireland
    49 Hope Directorate Dep't. Haematology St. James's Hospital Dublin Ireland 8
    50 Hadassah University Hospital Hematology Dep't Ein Kerem Jerusalem Israel 91120
    51 Rambam Medical Center Dep't. Of Hematology Haifa Israel 31096
    52 Tel Aviv Sourasky Medical Center Hematology Institute Tel Aviv Israel 64239
    53 Director of Hematology Division BMT and CBB The Chaim Sheba Medical Center Tel Hashomer Israel 52621
    54 Universita di Bari Dipartimento di Scienze Umana Sezione de Medicina Interna e Oncologia Medica Policlinico Bari Italy 11
    55 Istituto di Ematologia e Oncologia Medica "L. e. A. Seragnoli" Bologna Italy 40138
    56 Azienda Ospedaliera San Martino Genova Italy 16132
    57 Ospedale Niguarda Ca Granda Milano Italy 20162
    58 Policlinico San Matteo Pavia Italy 27100
    59 Università La Sapienza Dipartimento di Biotecnologie Cellulari ed Ematologia Roma Italy 00161
    60 Clinica Ematologica Policlinico Universitario Udine Italy 33100
    61 Medical Academy of Bialystok Bialystok Poland 15-276
    62 Institute of Internal Diseases University of Medicine Gdansk Poland 80-211
    63 Jagiellonian University Collegium Medicum Department of Hematology Krakow Poland 31-501
    64 Medical University of Lodz Lodz Poland 93-509
    65 Private Medical Practice Centre of Clinical Laboratory of Densitometry At 'Officers of Professors' Lublin Poland 20-022
    66 Medical University of Warsaw Dep't of Hematology, Oncology and Internal Diseases Warsaw Poland 02-097
    67 Chelyabinsk Regional Clinical Hospital Hematology Dpt Chelyabinsk Russian Federation 454076
    68 Ekaterinburg 1st Regional Clinical Hospital Regional Hematology Centre Ekaterinburg Russian Federation 620102
    69 Republican Clinical Hospital #1 Hematology Dpt. Izhevsk Russian Federation 426039
    70 Burdenko Central Military Clinical Hospital Hematology Center Moscow Russian Federation 105229
    71 Russian Academy of Medical Sciences Scientific Center of Hematology Moscow Russian Federation 125167
    72 Nizhny Novgorod Clinical Hospital Novgorod Russian Federation 603126
    73 Novosibirsk State Regional Clinical Hospital Hematology Centre Novosibirsk Russian Federation 630087
    74 Samara Regional Clinical Hospital Dep't. of Hematology and Bone Marrow Transplantation Samara Russian Federation 443095
    75 Blokhin Cancer Research Center Dpt of Myeloproliferative Disorders Chemotherapy Shosse Russian Federation 115478
    76 Research Institute of Hematology and Blood Transfusion,Clinical Department of Hematology with Bone Marrow Transplantation Unit St. Petersburg Russian Federation 193024
    77 St. Petersburg Pavlov State Medical University Bone Marrow Transplantation Clinic St. Petersburg Russian Federation 197022
    78 Clinical Hospital #31 Dpt of Bone Marrow Transplantation and Chemotherapy of Patients with Myeloproliferative Disorders St. Petersburg Russian Federation 197110
    79 Hospital Clinic Barcelona Spain 08036
    80 Hospital Universitario de la Princessa Madrid Spain 28006
    81 Hospital Doce de Octubre Madrid Spain 28041
    82 Clinica Universitaria de Navarra Pamplona Spain 31080
    83 Hospital Universitario de Salamanca Salamanca Spain 37007
    84 Hospital Universitario Marques de Valdecilla Santander Spain 39008
    85 Universitatsspital Zurich Zurich Switzerland 8091
    86 Cherkassy Regional Oncology Center Cherkassy Ukraine 18009
    87 Dnepropetrovsk City Clinical Hospital #4 Regional Hematology Centre Dnepropetrovsk Ukraine 49044
    88 Ivano-Frankovsk Regional Clinical Hospital - Hospital Therapy Department Ivano-Frankovsk Ukraine 76000
    89 Kharkov Regional Clinical Oncology Center Dep't of Oncology and Pediatric Oncology Kharkov Ukraine 61070
    90 Kiev Institute of Oncology of the UAMS Systemic Malignancies Department Kiev Ukraine 03022
    91 Kiev Bone Marrow Transplantation Center Bone Marrow Transplantation Department Kiev Ukraine 03115
    92 Institute of Hematology and Transfusiology of the UAMS Department of Blood Diseases with Clinical Biochemistry Group Kiev Ukraine 04060
    93 Institute of Blood Pathology and Transfusion Medicine of the UAMS Lvov Ukraine 79044
    94 Odessa Regional Clinical Hospital Hematology Dep't Odessa Ukraine 65025
    95 Zaporozhje Regional Clinical Hospital Hematology Dpt Zaporozhye Ukraine 69600
    96 Zhitomir Regional Clinical Hospital Hematology Centre Zhitomir Ukraine 10002
    97 Belfast City Hospital Haematology Dpt. Belfast United Kingdom BT9 7AB
    98 Guys Hospital London United Kingdom SE1 9RT
    99 Guys Hospital London United Kingdom SE19RT

    Sponsors and Collaborators

    • Celgene Corporation

    Investigators

    • Study Director: Robert Knight, MD, Celgene Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Celgene Corporation
    ClinicalTrials.gov Identifier:
    NCT00057564
    Other Study ID Numbers:
    • THAL-MM-003
    First Posted:
    Apr 8, 2003
    Last Update Posted:
    Sep 11, 2015
    Last Verified:
    Sep 1, 2015
    Keywords provided by Celgene Corporation
    Newly Diagnosed Multiple Myeloma
    Multiple Myeloma
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell
    Thalidomide
    Dexamethasone
    Dexamethasone acetate
    BB 1101

    Study Results

    No Results Posted as of Sep 11, 2015