Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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.
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.
Total Total of all reporting groups

Baseline Measures
   Velcade (Bortezomib) Monotherapy   Doxil/Caelyx Plus Velcade (Bortezomib)   Total 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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
  Hide Limitations and Caveats

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
  Hide More Information

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