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A Study to Evaluate Two Different Regimens of VELCADE in Combination With Dexamethasone, Thalidomide and Cyclophosphamide (VDT vs VDTC) in Newly Diagnosed Multiple Myeloma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00531453
First Posted: September 18, 2007
Last Update Posted: January 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
Results First Submitted: April 9, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: bortezomib, dexamethasone, and thalidomide
Drug: bortezomib, dexamethasone, thalidomide, and cyclophosphamide

  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
98 patients were enrolled between October 2007 and September 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All enrolled patients received at least one dose of study drug.

Reporting Groups
  Description
Three Drug Regimen (VDT) bortezomib, dexamethasone, and thalidomide
Four Drug Regimen (VDTC) bortezomib, dexamethasone, thalidomide, and cyclophosphamide

Participant Flow:   Overall Study
    Three Drug Regimen (VDT)   Four Drug Regimen (VDTC)
STARTED   49 [1]   49 [1] 
COMPLETED   49 [2]   49 [2] 
NOT COMPLETED   0   0 
[1] 02 October 2007
[2] 10 April 2009



  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.
No text entered.

Reporting Groups
  Description
Three Drug Regimen (VDT) bortezomib, dexamethasone, and thalidomide
Four Drug Regimen (VDTC) bortezomib, dexamethasone, thalidomide, and cyclophosphamide
Total Total of all reporting groups

Baseline Measures
   Three Drug Regimen (VDT)   Four Drug Regimen (VDTC)   Total 
Overall Participants Analyzed 
[Units: Participants]
 49   49   98 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   46   44   90 
>=65 years   3   5   8 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.1  (7.04)   55.8  (8.27)   55.4  (7.65) 
Gender 
[Units: Participants]
     
Female   26   25   51 
Male   23   24   47 


  Outcome Measures
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1.  Primary:   Percent of Particpants Achieving Overall Combined Complete Response (CR) Following Induction   [ Time Frame: all data included in clinical database as of 10 April 2009 ]

2.  Secondary:   Percent of Participants Achieving Overall Combined Complete Response (CR) Following High-dose Chemotherapy (HDT)/Stem Cell Transplantation (SCT)   [ Time Frame: all data included in clinical database as of 10 April 2009 ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. Helgi van de Velde
Organization: Johnson & Johnson Pharmaceutical Research & Development
e-mail: HVDVELDE@ITS.JNJ.COM


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

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00531453     History of Changes
Other Study ID Numbers: 26866138-MMY-2043
First Submitted: September 14, 2007
First Posted: September 18, 2007
Results First Submitted: April 9, 2010
Results First Posted: June 4, 2010
Last Update Posted: January 26, 2012