Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00057564




Registration number
NCT00057564
Ethics application status
Date submitted
4/04/2003
Date registered
8/04/2003
Date last updated
11/09/2015

Titles & IDs
Public title
A Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone in Previously Untreated Subjects With Multiple Myeloma
Scientific 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
Secondary ID [1] 0 0
THAL-MM-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - A (Thalidomide + Dexamethasone)
Treatment: Drugs - B (Placebo + Dexamethasone)

Experimental: A (Thalidomide & Dexamethasone) - Thalidomide 50mg/day + Dexamethasone 40mg

Placebo comparator: B (Dexamethasone and placebo) - Dexamethasone and placebo


Treatment: Drugs: A (Thalidomide + Dexamethasone)
Thalidomide 50mg/day + Dexamethasone 40mg

Treatment: Drugs: B (Placebo + Dexamethasone)
Placebo + Dexamethasone 40mg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to tumor progression (TTP)
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [1] 0 0
Number of patients who survived
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [2] 0 0
Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone)
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [3] 0 0
Myeloma response rate
Timepoint [3] 0 0
Up to 3 years
Secondary outcome [4] 0 0
Number of participants with adverse events
Timepoint [4] 0 0
Up to 3 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2013
Sample size
Target
Accrual to date
Final
470
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Royal Brisbane Hospital - Herston
Recruitment hospital [2] 0 0
Haematology Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 0 0
Frankston Hospital - Frankston
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Institute - Melbourne
Recruitment hospital [5] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [6] 0 0
Bone Marrow Transplant Service Dept of Clinical Haematology and Medical Oncology - Parkville
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
3002 - Melbourne
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
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Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Wisconsin
Country [19] 0 0
Belgium
State/province [19] 0 0
Brussels
Country [20] 0 0
Belgium
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Ghent
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Bulgaria
State/province [21] 0 0
Alexandrovska
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Sofia
Country [23] 0 0
Canada
State/province [23] 0 0
Nova Scotia
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
Canada
State/province [25] 0 0
Quebec
Country [26] 0 0
Canada
State/province [26] 0 0
Saskatchewan
Country [27] 0 0
Germany
State/province [27] 0 0
Dusseldorf
Country [28] 0 0
Hungary
State/province [28] 0 0
Budapest
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Hungary
State/province [29] 0 0
Gyor
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Ireland
State/province [30] 0 0
Limerick
Country [31] 0 0
Ireland
State/province [31] 0 0
Dublin
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Israel
State/province [32] 0 0
Jerusalem
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Israel
State/province [33] 0 0
Haifa
Country [34] 0 0
Israel
State/province [34] 0 0
Tel Aviv
Country [35] 0 0
Israel
State/province [35] 0 0
Tel Hashomer
Country [36] 0 0
Italy
State/province [36] 0 0
Bari
Country [37] 0 0
Italy
State/province [37] 0 0
Bologna
Country [38] 0 0
Italy
State/province [38] 0 0
Genova
Country [39] 0 0
Italy
State/province [39] 0 0
Milano
Country [40] 0 0
Italy
State/province [40] 0 0
Pavia
Country [41] 0 0
Italy
State/province [41] 0 0
Roma
Country [42] 0 0
Italy
State/province [42] 0 0
Udine
Country [43] 0 0
Poland
State/province [43] 0 0
Bialystok
Country [44] 0 0
Poland
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Gdansk
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Lublin
Country [48] 0 0
Poland
State/province [48] 0 0
Warsaw
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Chelyabinsk
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Russian Federation
State/province [50] 0 0
Ekaterinburg
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Russian Federation
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Izhevsk
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Russian Federation
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Moscow
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Russian Federation
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Novgorod
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Russian Federation
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Novosibirsk
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Russian Federation
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Samara
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Russian Federation
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Shosse
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Russian Federation
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St. Petersburg
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Spain
State/province [58] 0 0
Barcelona
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Spain
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Madrid
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Spain
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Pamplona
Country [61] 0 0
Spain
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Salamanca
Country [62] 0 0
Spain
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Santander
Country [63] 0 0
Switzerland
State/province [63] 0 0
Zurich
Country [64] 0 0
Ukraine
State/province [64] 0 0
Cherkassy
Country [65] 0 0
Ukraine
State/province [65] 0 0
Dnepropetrovsk
Country [66] 0 0
Ukraine
State/province [66] 0 0
Ivano-Frankovsk
Country [67] 0 0
Ukraine
State/province [67] 0 0
Kharkov
Country [68] 0 0
Ukraine
State/province [68] 0 0
Kiev
Country [69] 0 0
Ukraine
State/province [69] 0 0
Lvov
Country [70] 0 0
Ukraine
State/province [70] 0 0
Odessa
Country [71] 0 0
Ukraine
State/province [71] 0 0
Zaporozhye
Country [72] 0 0
Ukraine
State/province [72] 0 0
Zhitomir
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Belfast
Country [74] 0 0
United Kingdom
State/province [74] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Knight, MD
Address 0 0
Celgene Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Rajkumar SV, Rosinol L, Hussein M, Catalano J, Jed... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT00057564