Study of DOXIL/CAELYX (Pegylated Liposomal Doxorubicin) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00103506
First received: February 9, 2005
Last updated: September 28, 2015
Last verified: September 2015
Results First Received: May 8, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: Bortezomib (VELCADE)
Drug: Doxorubicin hydrochloride (DOXIL/CAELYX)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Velcade (Bortezomib) Monotherapy Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
Doxil/Caelyx Plus Velcade (Bortezomib) Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.

Participant Flow:   Overall Study
    Velcade (Bortezomib) Monotherapy     Doxil/Caelyx Plus Velcade (Bortezomib)  
STARTED     322     324  
COMPLETED     0     0  
NOT COMPLETED     322     324  
Study closed by sponsor                 34                 37  
Death                 257                 253  
Lost to Follow-up                 13                 13  
Withdrawal by Subject                 18                 21  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Velcade (Bortezomib) Monotherapy Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
Doxil/Caelyx Plus Velcade (Bortezomib) Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
Total Total of all reporting groups

Baseline Measures
    Velcade (Bortezomib) Monotherapy     Doxil/Caelyx Plus Velcade (Bortezomib)     Total  
Number of Participants  
[units: participants]
  322     324     646  
Age  
[units: years]
Mean (Standard Deviation)
  61.5  (9.56)     61.4  (9.61)     61.4  (9.58)  
Gender  
[units: participants]
     
Female     148     135     283  
Male     174     189     363  
Region of Enrollment  
[units: participants]
     
ARGENTINA     6     9     15  
AUSTRALIA     31     31     62  
AUSTRIA     12     6     18  
BELGIUM-LUXEMBURG     6     14     20  
CANADA     20     23     43  
CZECH REPUBLIC     14     22     36  
FRANCE     21     28     49  
GREAT BRITAIN     8     7     15  
ISRAEL     25     21     46  
ITALY     17     11     28  
NETHERLANDS     29     32     61  
POLAND     35     17     52  
PORTUGAL     6     14     20  
RUSSIA     38     34     72  
SINGAPORE     3     2     5  
SOUTH AFRICA     13     15     28  
SPAIN     20     15     35  
UNITED STATES OF AMERICA     18     23     41  



  Outcome Measures
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1.  Primary:   Time to Progression (TTP)   [ Time Frame: 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]) ]

2.  Secondary:   Overall Survival   [ Time Frame: 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) ]

3.  Secondary:   Number of Participants With Serious Adverse Events (SAEs)   [ Time Frame: 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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study stopped in terms of primary endpoint based on its results at planned interim analysis (28 Apr 2006). However, Long-term follow-up for survival continued until 16 May 2014.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Project Physician
Organization: Janssen R&D UK
e-mail: ClinicalTrialDisclosure@its.jnj.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00103506     History of Changes
Other Study ID Numbers: CR004117
DOXILMMY3001 ( Other Identifier: Janssen Research & Development, LLC )
2004-001842-34 ( EudraCT Number )
Study First Received: February 9, 2005
Results First Received: May 8, 2015
Last Updated: September 28, 2015
Health Authority: United States: Food and Drug Administration
Great Britain: Medicines and Healthcare Products Regulatory Agency
Great Britain: Research Ethics Committee