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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
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United States of America
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Arizona
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California
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Florida
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Illinois
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Iowa
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Louisiana
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Michigan
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Minnesota
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New Jersey
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New York
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North Carolina
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Ohio
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Pennsylvania
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Tennessee
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Wisconsin
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Brussels
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Ghent
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Alexandrovska
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Sofia
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Nova Scotia
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Samara
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Shosse
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Pamplona
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Santander
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Switzerland
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Zurich
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Cherkassy
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Dnepropetrovsk
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Kharkov
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Kiev
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Lvov
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Odessa
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Zaporozhye
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Zhitomir
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United Kingdom
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Belfast
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United Kingdom
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London

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

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT00057564
Trial related presentations / publications
Rajkumar SV, Rosinol L, Hussein M, Catalano J, Jedrzejczak W, Lucy L, Olesnyckyj M, Yu Z, Knight R, Zeldis JB, Blade J. Multicenter, randomized, double-blind, placebo-controlled study of thalidomide plus dexamethasone compared with dexamethasone as initial therapy for newly diagnosed multiple myeloma. J Clin Oncol. 2008 May 1;26(13):2171-7. doi: 10.1200/JCO.2007.14.1853. Epub 2008 Mar 24.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00057564