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

Information source: Celgene Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma

Intervention: A (Thalidomide + Dexamethasone) (Drug); B (Placebo + Dexamethasone) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Celgene Corporation

Official(s) and/or principal investigator(s):
Robert Knight, MD, Study Director, Affiliation: Celgene Corporation

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Time to tumor progression (TTP)

Secondary outcome:

Number of patients who survived

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

Myeloma response rate

Number of participants with adverse events

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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)

Locations and Contacts

Dept. Of Haematology Academisch Ziekenhuis VUB, Brussels 1090, Belgium

Institut Jules Bordet Dep't of Clinical Haematology, Brussels 1000, Belgium

University Hospital Ghent Dep't of Haematology, Ghent 900, Belgium

UMHAT Alexandrovska, Alexandrovska, Bulgaria

Military Medical Academy, Sofia, Bulgaria

National Center of Haematology and Transfusiology, Sofia 1756, Bulgaria

Universitaetsklinikum Dusseldorf Klinik fuer Haematologie, Dusseldorf, Germany

St. Laszlo Hoszpital, Budapest, Hungary

Petz Aladar County Hospital, Gyor 9002, Hungary

Hope Directorate Dep't. Haematology St. James's Hospital, Dublin 8, Ireland

Rambam Medical Center Dep't. Of Hematology, Haifa 31096, Israel

Tel Aviv Sourasky Medical Center Hematology Institute, Tel Aviv 64239, Israel

Director of Hematology Division BMT and CBB The Chaim Sheba Medical Center, Tel Hashomer 52621, Israel

Universita di Bari Dipartimento di Scienze Umana Sezione de Medicina Interna e Oncologia Medica Policlinico, Bari 11, Italy

Istituto di Ematologia e Oncologia Medica "L. e. A. Seragnoli", Bologna 40138, Italy

Azienda Ospedaliera San Martino, Genova 16132, Italy

Ospedale Niguarda Ca Granda, Milano 20162, Italy

Policlinico San Matteo, Pavia 27100, Italy

Università La Sapienza Dipartimento di Biotecnologie Cellulari ed Ematologia, Roma 00161, Italy

Clinica Ematologica Policlinico Universitario, Udine 33100, Italy

Medical Academy of Bialystok, Bialystok 15-276, Poland

Institute of Internal Diseases University of Medicine, Gdansk 80-211, Poland

Jagiellonian University Collegium Medicum Department of Hematology, Krakow 31-501, Poland

Medical University of Lodz, Lodz 93-509, Poland

Private Medical Practice Centre of Clinical Laboratory of Densitometry At 'Officers of Professors', Lublin 20-022, Poland

Medical University of Warsaw Dep't of Hematology, Oncology and Internal Diseases, Warsaw 02-097, Poland

Chelyabinsk Regional Clinical Hospital Hematology Dpt, Chelyabinsk 454076, Russian Federation

Ekaterinburg 1st Regional Clinical Hospital Regional Hematology Centre, Ekaterinburg 620102, Russian Federation

Republican Clinical Hospital #1 Hematology Dpt., Izhevsk 426039, Russian Federation

Burdenko Central Military Clinical Hospital Hematology Center, Moscow 105229, Russian Federation

Russian Academy of Medical Sciences Scientific Center of Hematology, Moscow 125167, Russian Federation

Nizhny Novgorod Clinical Hospital, Novgorod 603126, Russian Federation

Novosibirsk State Regional Clinical Hospital Hematology Centre, Novosibirsk 630087, Russian Federation

Samara Regional Clinical Hospital Dep't. of Hematology and Bone Marrow Transplantation, Samara 443095, Russian Federation

Blokhin Cancer Research Center Dpt of Myeloproliferative Disorders Chemotherapy, Shosse 115478, Russian Federation

Clinical Hospital #31 Dpt of Bone Marrow Transplantation and Chemotherapy of Patients with Myeloproliferative Disorders, St. Petersburg 197110, Russian Federation

Research Institute of Hematology and Blood Transfusion,Clinical Department of Hematology with Bone Marrow Transplantation Unit, St. Petersburg 193024, Russian Federation

St. Petersburg Pavlov State Medical University Bone Marrow Transplantation Clinic, St. Petersburg 197022, Russian Federation

Hospital Clinic, Barcelona 08036, Spain

Hospital Doce de Octubre, Madrid 28041, Spain

Hospital Universitario de la Princessa, Madrid 28006, Spain

Clinica Universitaria de Navarra, Pamplona 31080, Spain

Hospital Universitario de Salamanca, Salamanca 37007, Spain

Hospital Universitario Marques de Valdecilla, Santander 39008, Spain

Universitatsspital Zurich, Zurich 8091, Switzerland

Cherkassy Regional Oncology Center, Cherkassy 18009, Ukraine

Dnepropetrovsk City Clinical Hospital #4 Regional Hematology Centre, Dnepropetrovsk 49044, Ukraine

Ivano-Frankovsk Regional Clinical Hospital - Hospital Therapy Department, Ivano-Frankovsk 76000, Ukraine

Kharkov Regional Clinical Oncology Center Dep't of Oncology and Pediatric Oncology, Kharkov 61070, Ukraine

Institute of Hematology and Transfusiology of the UAMS Department of Blood Diseases with Clinical Biochemistry Group, Kiev 04060, Ukraine

Kiev Bone Marrow Transplantation Center Bone Marrow Transplantation Department, Kiev 03115, Ukraine

Kiev Institute of Oncology of the UAMS Systemic Malignancies Department, Kiev 03022, Ukraine

Institute of Blood Pathology and Transfusion Medicine of the UAMS, Lvov 79044, Ukraine

Odessa Regional Clinical Hospital Hematology Dep't, Odessa 65025, Ukraine

Zaporozhje Regional Clinical Hospital Hematology Dpt, Zaporozhye 69600, Ukraine

Zhitomir Regional Clinical Hospital Hematology Centre, Zhitomir 10002, Ukraine

Belfast City Hospital Haematology Dpt., Belfast BT9 7AB, United Kingdom

Guys Hospital, London SE1 9RT, United Kingdom

Guys Hospital, London SE19RT, United Kingdom

Clinical Research Consultants, Inc., Hoover, Alabama 35216, United States

Arizona Clinical Research Center, Tucson, Arizona 85712, United States

UCLA School of Medicine, Los Angeles, California 90095, United States

James Berenson, West Hollywood, California 90069, United States

Mayo Clinic, Jacksonville, Florida 32224, United States

Melbourne Internal Medicine Associates Oncology, Melbourne, Florida 32901-3182, United States

Jackson Memorial Hospital and Clinics, Miami, Florida 33136, United States

Oncology Hematology Group of South Florida, Miami, Florida 33176, United States

University of Miami, Miami, Florida 33136, United States

University of Miami Miller School/Jackson Memorial Hospital, Miami, Florida 33136, United States

Medical College of Georgia, Augusta, Georgia 30912-3125, United States

Southern Illinois Hematology /Oncology, Centralia, Illinois 62801, United States

Rush Cancer Institute Section of Hematology, Chicago, Illinois 60612-3824, United States

University of Iowa Hospital of Clinic, Iowa City, Iowa 52242, United States

Hadassah University Hospital Hematology Dep't, Ein Kerem, Jerusalem 91120, Israel

MidWestern Regional Hospital Haematology Dpt., Dooradoyle, Limerick, Ireland

Ocshner Clinic Foundation, New Orleans, Louisiana 70121, United States

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan 48109-0922, United States

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States

Hackensack University Hospital, Hackensack, New Jersey 07601, United States

SUNY Upstate Medical University, Syracuse, New York 13210, United States

Wake Forest University School of Medicine, Winston-Salem, North Carolina 27157-1023, United States

Dalhousie University, Halifax, Nova Scotia B3H2Y9, Canada

Cleveland Clinic- Taussig Cancer Center, Cleveland, Ohio 44195, United States

Princess Margaret Hospital, Toronto, Ontario M5G 2M9, Canada

University Health Network Princess Margaret Hospital, Toronto, Ontario M5G 2M9, Canada

University of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States

Centre Hopitalier Universitaire de Sherbrooke Hospital Fleurimont, Fleurimont, Quebec J1H 5N4, Canada

McGill University, Montreal, Quebec PQ H2W 1S6, Canada

Royal Brisbane Hospital, Herston, Queensland 4029, Australia

Haematology Princess Alexandra Hospital, Woolloongabba, Queensland 4102, Australia

Saskatoon Cancer Centre University of Saskatoon, Saskatoon, Saskatchewan S7N 4H4, Canada

South Carolina Oncology Group, West Columbia, South Carolina 29169, United States

The Family Centre, PLLC, Collierville, Tennessee 38017, United States

East Tennessee Oncology/Hematology Associates, Knoxville, Tennessee 37920, United States

Frankston Hospital, Frankston, Victoria 3199, Australia

Peter MacCallum Cancer Institute, Melbourne, Victoria 3002, Australia

The Alfred Hospital, Melbourne, Victoria 3004, Australia

Bone Marrow Transplant Service Dept of Clinical Haematology and Medical Oncology, Parkville, Victoria 3050, Australia

Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States

Additional Information

Starting date: February 2003
Last updated: March 9, 2015

Page last updated: August 23, 2015

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