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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00103506




Registration number
NCT00103506
Ethics application status
Date submitted
9/02/2005
Date registered
10/02/2005
Date last updated
19/10/2015

Titles & IDs
Public title
Study of DOXIL/CAELYX (Pegylated Liposomal Doxorubicin) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma
Scientific title
A Randomized Controlled Study of DOXIL/CAELYX (Doxorubicin HCL Liposome Injection) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma
Secondary ID [1] 0 0
DOXILMMY3001
Secondary ID [2] 0 0
CR004117
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 - Bortezomib (VELCADE)
Treatment: Drugs - Bortezomib (VELCADE)
Treatment: Drugs - Doxorubicin hydrochloride (DOXIL/CAELYX)

Active Comparator: VELCADE (bortezomib) monotherapy - Bortezomib (VELCADE) 1.3 milligram per meter square (mg/m^2) by rapid (bolus) i.v. administration given on Days 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.

Experimental: DOXIL/CAELYX in combination with VELCADE (bortezomib) - Bortezomib (VELCADE) 1.3 mg/m^2 by rapid (bolus) i.v. administration given on Days 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m2 by i.v. infusion will be given on Day 4 of every 21-day cycle after the administration of bortezomib (VELCADE) for up to 8 cycles.


Treatment: Drugs: Bortezomib (VELCADE)
1.3 mg/m^2 by rapid (bolus) i.v. administration given on Days 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.

Treatment: Drugs: Bortezomib (VELCADE)
1.3 mg/m^2 by rapid (bolus) i.v. administration given on Days 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles..

Treatment: Drugs: Doxorubicin hydrochloride (DOXIL/CAELYX)
mg/m^2 by i.v. infusion will be given on Day 4 of every 21-day cycle after the administration of bortezomib (VELCADE) for up to 8 cycles.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Progression (TTP)
Timepoint [1] 0 0
Up to 1 year and 4 months (From date of first participant randomization [20 December 2004] up to interim analysis cut-off date [28 April 2006])
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Up to 9 years and 5 months (From date of first participant randomization [20 December 2004] to cut-off date for final survival analysis (16 May 2014)
Secondary outcome [2] 0 0
Number of Participants With Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Up to 1 year and 11 months (From date of first participant randomization [20 December 2004] to cut-off date for safety update (28 November 2006)

Eligibility
Key inclusion criteria
- Patients with multiple myeloma who have received at least 1 prior therapy and who have
either responded and later had progressive disease or have progressed during their
first therapy (primary refractory) are eligible for the study

- Patients who may have received prior doxorubicin but not more than a cumulative dose
of 240 milligram per meter square (mg/m^2) doxorubicin, DOXIL, or the equivalent
amount of another anthracycline (i.e., 1 mg doxorubicin = 1 mg DOXIL/CAELYX = 1.8 mg
epirubicin = 0.3 mg mitoxantrone = 0.25 mg idarubicin)

- Must have normal cardiac function, as evidenced by a left LVEF within institutional
normal limits.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of treatment with VELCADE or progressive disease while receiving an
anthracycline-containing regimen

- No change in disease status during initial therapy

- No treatment for malignancy within past 5 yrs (other than multiple myeloma) or
progressive disease while receiving anthracycline-containing regimen

- Non-secretory disease

- Myocardial infarct within past 6 months

- No major surgery in past 30 days.

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
Open (masking not used)
Who is / are masked / blinded?



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
1/12/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2014
Sample size
Target
Accrual to date
Final
646
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Darlinghurst
Recruitment hospital [3] 0 0
- Melbourne
Recruitment hospital [4] 0 0
- Perth
Recruitment hospital [5] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Darlinghurst
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Perth
Recruitment postcode(s) [5] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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Arizona
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California
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Connecticut
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Florida
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Georgia
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Idaho
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Indiana
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Kentucky
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Louisiana
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Minnesota
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New Jersey
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North Carolina
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Argentina
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Buenos Aires
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Argentina
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Ciudad De Buenos Aires
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Argentina
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La Plata
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Argentina
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Mendoza
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Austria
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Graz
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Austria
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Innsbruck
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Austria
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Salzburg
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Austria
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Wels N/A
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Austria
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Wien
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Belgium
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Brussel
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Belgium
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Gent
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Belgium
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Leuven
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Belgium
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Mont-Godinne
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Canada
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N/a N/a
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Czech Republic
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Brno
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Czech Republic
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Olomouc
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Czech Republic
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Praha 2 N/A
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France
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Angers Cedex 1 N/A
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France
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Bobigny
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France
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Creteil N/A
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France
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Lille Cedex N/A
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France
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Nantes N/A
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France
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Pierre Benite
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France
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Toulouse
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France
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Tours
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France
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Vandoeuvre Les Nancy
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Petach Tikva
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Israel
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Ramat Gan
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Israel
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Rehovot
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Israel
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Tel Aviv
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Netherlands
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Amersfoort
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Amsterdam Zuidoost
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Amsterdam
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Delft
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Den Haag
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Groningen
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Nieuwegein
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Nijmegen
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Rotterdam
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Netherlands
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Utrecht
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Poland
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Bialystok
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Gdansk
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Lodz
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Lublin
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Warszawa
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Poland
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Wroclaw
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Portugal
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Coimbra
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Portugal
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Lisboa
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Portugal
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Porto N/A
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Russian Federation
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Arkhangelsk
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Russian Federation
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Ekaterinburg
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Russian Federation
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Izhevsk
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Russian Federation
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Moscow N/A
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Russian Federation
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Moscow
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Russian Federation
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Nizhny Novgorod
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Russian Federation
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Novosibirsk
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Russian Federation
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Obninsk
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Russian Federation
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St. Petersburg
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Singapore
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Singapore
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South Africa
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Bloemfontein N/A
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South Africa
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Cape Town
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South Africa
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Johannesburg
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South Africa
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Parktown
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South Africa
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Pretoria Gauteng
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Salamanca
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United Kingdom
State/province [90] 0 0
Bath
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United Kingdom
State/province [91] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate time to progression, overall survival, response rate
and safety for the two open-label treatment groups; DOXIL/CAELYX in combination with VELCADE
vs. VELCADE monotherapy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00103506
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC C. Clinical Trial
Address 0 0
Janssen Research & Development, LLC
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/ct2/show/NCT00103506