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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
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
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
Argentina
State/province [18] 0 0
Buenos Aires
Country [19] 0 0
Argentina
State/province [19] 0 0
Ciudad De Buenos Aires
Country [20] 0 0
Argentina
State/province [20] 0 0
La Plata
Country [21] 0 0
Argentina
State/province [21] 0 0
Mendoza
Country [22] 0 0
Austria
State/province [22] 0 0
Graz
Country [23] 0 0
Austria
State/province [23] 0 0
Innsbruck
Country [24] 0 0
Austria
State/province [24] 0 0
Salzburg
Country [25] 0 0
Austria
State/province [25] 0 0
Wels N/A
Country [26] 0 0
Austria
State/province [26] 0 0
Wien
Country [27] 0 0
Belgium
State/province [27] 0 0
Brussel
Country [28] 0 0
Belgium
State/province [28] 0 0
Gent
Country [29] 0 0
Belgium
State/province [29] 0 0
Leuven
Country [30] 0 0
Belgium
State/province [30] 0 0
Mont-Godinne
Country [31] 0 0
Canada
State/province [31] 0 0
British Columbia
Country [32] 0 0
Canada
State/province [32] 0 0
Ontario
Country [33] 0 0
Canada
State/province [33] 0 0
Quebec
Country [34] 0 0
Canada
State/province [34] 0 0
N/a N/a
Country [35] 0 0
Czech Republic
State/province [35] 0 0
Brno
Country [36] 0 0
Czech Republic
State/province [36] 0 0
Olomouc
Country [37] 0 0
Czech Republic
State/province [37] 0 0
Praha 2 N/A
Country [38] 0 0
France
State/province [38] 0 0
Angers Cedex 1 N/A
Country [39] 0 0
France
State/province [39] 0 0
Bobigny
Country [40] 0 0
France
State/province [40] 0 0
Creteil N/A
Country [41] 0 0
France
State/province [41] 0 0
Lille Cedex N/A
Country [42] 0 0
France
State/province [42] 0 0
Nantes N/A
Country [43] 0 0
France
State/province [43] 0 0
Pierre Benite
Country [44] 0 0
France
State/province [44] 0 0
Toulouse
Country [45] 0 0
France
State/province [45] 0 0
Tours
Country [46] 0 0
France
State/province [46] 0 0
Vandoeuvre Les Nancy
Country [47] 0 0
Israel
State/province [47] 0 0
Haifa
Country [48] 0 0
Israel
State/province [48] 0 0
Jerusalem
Country [49] 0 0
Israel
State/province [49] 0 0
Petach Tikva
Country [50] 0 0
Israel
State/province [50] 0 0
Ramat Gan
Country [51] 0 0
Israel
State/province [51] 0 0
Rehovot
Country [52] 0 0
Israel
State/province [52] 0 0
Tel Aviv
Country [53] 0 0
Netherlands
State/province [53] 0 0
Amersfoort
Country [54] 0 0
Netherlands
State/province [54] 0 0
Amsterdam Zuidoost
Country [55] 0 0
Netherlands
State/province [55] 0 0
Amsterdam
Country [56] 0 0
Netherlands
State/province [56] 0 0
Delft
Country [57] 0 0
Netherlands
State/province [57] 0 0
Den Haag
Country [58] 0 0
Netherlands
State/province [58] 0 0
Groningen
Country [59] 0 0
Netherlands
State/province [59] 0 0
Nieuwegein
Country [60] 0 0
Netherlands
State/province [60] 0 0
Nijmegen
Country [61] 0 0
Netherlands
State/province [61] 0 0
Rotterdam
Country [62] 0 0
Netherlands
State/province [62] 0 0
Utrecht
Country [63] 0 0
Poland
State/province [63] 0 0
Bialystok
Country [64] 0 0
Poland
State/province [64] 0 0
Gdansk
Country [65] 0 0
Poland
State/province [65] 0 0
Lodz
Country [66] 0 0
Poland
State/province [66] 0 0
Lublin
Country [67] 0 0
Poland
State/province [67] 0 0
Warszawa
Country [68] 0 0
Poland
State/province [68] 0 0
Wroclaw
Country [69] 0 0
Portugal
State/province [69] 0 0
Coimbra
Country [70] 0 0
Portugal
State/province [70] 0 0
Lisboa
Country [71] 0 0
Portugal
State/province [71] 0 0
Porto N/A
Country [72] 0 0
Russian Federation
State/province [72] 0 0
Arkhangelsk
Country [73] 0 0
Russian Federation
State/province [73] 0 0
Ekaterinburg
Country [74] 0 0
Russian Federation
State/province [74] 0 0
Izhevsk
Country [75] 0 0
Russian Federation
State/province [75] 0 0
Moscow N/A
Country [76] 0 0
Russian Federation
State/province [76] 0 0
Moscow
Country [77] 0 0
Russian Federation
State/province [77] 0 0
Nizhny Novgorod
Country [78] 0 0
Russian Federation
State/province [78] 0 0
Novosibirsk
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Obninsk
Country [80] 0 0
Russian Federation
State/province [80] 0 0
St. Petersburg
Country [81] 0 0
Singapore
State/province [81] 0 0
Singapore
Country [82] 0 0
South Africa
State/province [82] 0 0
Bloemfontein N/A
Country [83] 0 0
South Africa
State/province [83] 0 0
Cape Town
Country [84] 0 0
South Africa
State/province [84] 0 0
Johannesburg
Country [85] 0 0
South Africa
State/province [85] 0 0
Parktown
Country [86] 0 0
South Africa
State/province [86] 0 0
Pretoria Gauteng
Country [87] 0 0
Spain
State/province [87] 0 0
Barcelona
Country [88] 0 0
Spain
State/province [88] 0 0
Madrid
Country [89] 0 0
Spain
State/province [89] 0 0
Salamanca
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Bath
Country [91] 0 0
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
Trial website
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

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

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00103506