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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00057564
• Other study ID #: THAL-MM-003
• Status: Completed
• Phase: Phase 3
• First received: April 4, 2003
• Last updated: September 9, 2015
• Start date: February 2003
• Est. completion date: August 2013

Study information

• Verified date: September 2015
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 470
• Est. completion date: August 2013
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• A (Thalidomide + Dexamethasone)
Thalidomide 50mg/day + Dexamethasone 40mg
• B (Placebo + Dexamethasone)
Placebo + Dexamethasone 40mg

Locations

Country	Name	City	State
Australia	Frankston Hospital	Frankston	Victoria
Australia	Royal Brisbane Hospital	Herston	Queensland
Australia	Peter MacCallum Cancer Institute	Melbourne	Victoria
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Bone Marrow Transplant Service Dept of Clinical Haematology and Medical Oncology	Parkville	Victoria
Australia	Haematology Princess Alexandra Hospital	Woolloongabba	Queensland
Belgium	Dept. Of Haematology Academisch Ziekenhuis VUB	Brussels
Belgium	Institut Jules Bordet Dep't of Clinical Haematology	Brussels
Belgium	University Hospital Ghent Dep't of Haematology	Ghent
Bulgaria	UMHAT Alexandrovska	Alexandrovska
Bulgaria	Military Medical Academy	Sofia
Bulgaria	National Center of Haematology and Transfusiology	Sofia
Canada	Centre Hopitalier Universitaire de Sherbrooke Hospital Fleurimont	Fleurimont	Quebec
Canada	Dalhousie University	Halifax	Nova Scotia
Canada	McGill University	Montreal	Quebec
Canada	Saskatoon Cancer Centre University of Saskatoon	Saskatoon	Saskatchewan
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	University Health Network Princess Margaret Hospital	Toronto	Ontario
Germany	Universitaetsklinikum Dusseldorf Klinik fuer Haematologie	Dusseldorf
Hungary	St. Laszlo Hoszpital	Budapest
Hungary	Petz Aladar County Hospital	Gyor
Ireland	MidWestern Regional Hospital Haematology Dpt.	Dooradoyle	Limerick
Ireland	Hope Directorate Dep't. Haematology St. James's Hospital	Dublin
Israel	Hadassah University Hospital Hematology Dep't	Ein Kerem	Jerusalem
Israel	Rambam Medical Center Dep't. Of Hematology	Haifa
Israel	Tel Aviv Sourasky Medical Center Hematology Institute	Tel Aviv
Israel	Director of Hematology Division BMT and CBB The Chaim Sheba Medical Center	Tel Hashomer
Italy	Universita di Bari Dipartimento di Scienze Umana Sezione de Medicina Interna e Oncologia Medica Policlinico	Bari
Italy	Istituto di Ematologia e Oncologia Medica "L. e. A. Seragnoli"	Bologna
Italy	Azienda Ospedaliera San Martino	Genova
Italy	Ospedale Niguarda Ca Granda	Milano
Italy	Policlinico San Matteo	Pavia
Italy	Università La Sapienza Dipartimento di Biotecnologie Cellulari ed Ematologia	Roma
Italy	Clinica Ematologica Policlinico Universitario	Udine
Poland	Medical Academy of Bialystok	Bialystok
Poland	Institute of Internal Diseases University of Medicine	Gdansk
Poland	Jagiellonian University Collegium Medicum Department of Hematology	Krakow
Poland	Medical University of Lodz	Lodz
Poland	Private Medical Practice Centre of Clinical Laboratory of Densitometry At 'Officers of Professors'	Lublin
Poland	Medical University of Warsaw Dep't of Hematology, Oncology and Internal Diseases	Warsaw
Russian Federation	Chelyabinsk Regional Clinical Hospital Hematology Dpt	Chelyabinsk
Russian Federation	Ekaterinburg 1st Regional Clinical Hospital Regional Hematology Centre	Ekaterinburg
Russian Federation	Republican Clinical Hospital #1 Hematology Dpt.	Izhevsk
Russian Federation	Burdenko Central Military Clinical Hospital Hematology Center	Moscow
Russian Federation	Russian Academy of Medical Sciences Scientific Center of Hematology	Moscow
Russian Federation	Nizhny Novgorod Clinical Hospital	Novgorod
Russian Federation	Novosibirsk State Regional Clinical Hospital Hematology Centre	Novosibirsk
Russian Federation	Samara Regional Clinical Hospital Dep't. of Hematology and Bone Marrow Transplantation	Samara
Russian Federation	Blokhin Cancer Research Center Dpt of Myeloproliferative Disorders Chemotherapy	Shosse
Russian Federation	Clinical Hospital #31 Dpt of Bone Marrow Transplantation and Chemotherapy of Patients with Myeloproliferative Disorders	St. Petersburg
Russian Federation	Research Institute of Hematology and Blood Transfusion,Clinical Department of Hematology with Bone Marrow Transplantation Unit	St. Petersburg
Russian Federation	St. Petersburg Pavlov State Medical University Bone Marrow Transplantation Clinic	St. Petersburg
Spain	Hospital Clinic	Barcelona
Spain	Hospital Doce de Octubre	Madrid
Spain	Hospital Universitario de la Princessa	Madrid
Spain	Clinica Universitaria de Navarra	Pamplona
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Universitario Marques de Valdecilla	Santander
Switzerland	Universitatsspital Zurich	Zurich
Ukraine	Cherkassy Regional Oncology Center	Cherkassy
Ukraine	Dnepropetrovsk City Clinical Hospital #4 Regional Hematology Centre	Dnepropetrovsk
Ukraine	Ivano-Frankovsk Regional Clinical Hospital - Hospital Therapy Department	Ivano-Frankovsk
Ukraine	Kharkov Regional Clinical Oncology Center Dep't of Oncology and Pediatric Oncology	Kharkov
Ukraine	Institute of Hematology and Transfusiology of the UAMS Department of Blood Diseases with Clinical Biochemistry Group	Kiev
Ukraine	Kiev Bone Marrow Transplantation Center Bone Marrow Transplantation Department	Kiev
Ukraine	Kiev Institute of Oncology of the UAMS Systemic Malignancies Department	Kiev
Ukraine	Institute of Blood Pathology and Transfusion Medicine of the UAMS	Lvov
Ukraine	Odessa Regional Clinical Hospital Hematology Dep't	Odessa
Ukraine	Zaporozhje Regional Clinical Hospital Hematology Dpt	Zaporozhye
Ukraine	Zhitomir Regional Clinical Hospital Hematology Centre	Zhitomir
United Kingdom	Belfast City Hospital Haematology Dpt.	Belfast
United Kingdom	Guys Hospital	London
United Kingdom	Guys Hospital	London
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Medical College of Georgia	Augusta	Georgia
United States	Southern Illinois Hematology /Oncology	Centralia	Illinois
United States	Rush Cancer Institute Section of Hematology	Chicago	Illinois
United States	Cleveland Clinic- Taussig Cancer Center	Cleveland	Ohio
United States	The Family Centre, PLLC	Collierville	Tennessee
United States	Hackensack University Hospital	Hackensack	New Jersey
United States	Clinical Research Consultants, Inc.	Hoover	Alabama
United States	University of Iowa Hospital of Clinic	Iowa City	Iowa
United States	Mayo Clinic	Jacksonville	Florida
United States	East Tennessee Oncology/Hematology Associates	Knoxville	Tennessee
United States	UCLA School of Medicine	Los Angeles	California
United States	Melbourne Internal Medicine Associates Oncology	Melbourne	Florida
United States	Jackson Memorial Hospital and Clinics	Miami	Florida
United States	Oncology Hematology Group of South Florida	Miami	Florida
United States	University of Miami	Miami	Florida
United States	University of Miami Miller School/Jackson Memorial Hospital	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Ocshner Clinic Foundation	New Orleans	Louisiana
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Arizona Clinical Research Center	Tucson	Arizona
United States	South Carolina Oncology Group	West Columbia	South Carolina
United States	James Berenson	West Hollywood	California
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Celgene Corporation

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Bulgaria,  Canada,  Germany,  Hungary,  Ireland,  Israel,  Italy,  Poland,  Russian Federation,  Spain,  Switzerland,  Ukraine,  United Kingdom, 

References & Publications (1)

Rajkumar SV, Rosiñol L, Hussein M, Catalano J, Jedrzejczak W, Lucy L, Olesnyckyj M, Yu Z, Knight R, Zeldis JB, Bladé J. Multicenter, randomized, double-blind, placebo-controlled study of thalidomide plus dexamethasone compared with dexamethasone as initia — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to tumor progression (TTP)	Time to tumor progression (TTP)	Up to 3 years	No
Secondary	Number of patients who survived	Number of patients who survived	Up to 3 years	Yes
Secondary	Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone)	Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone)	Up to 3 years	No
Secondary	Myeloma response rate	Myeloma response determination criteria developed by Bladé et al 1998	Up to 3 years	No
Secondary	Number of participants with adverse events	Number of participants with adverse events	Up to 3 years	Yes