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:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00531453
First received: September 14, 2007
Last updated: January 25, 2012
Last verified: January 2012
Results First Received: April 9, 2010  
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, 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  
Number of Participants  
[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


  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.


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
No text entered.  


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:
Ludwig H; Viterbo L; Greil R; Masszi T; Spicka I; Shpilberg O; Hajek R; Dmoszynska A; Cakana A; Enny C; Feng H; van de Velde H; and Harousseau J-L. Bortezomib, Thalidomide, and Dexamethasone (VTD) Versus VTD Plus Cyclophosphamide as Induction Therapy in Previously Untreated Multiple Myeloma Patients Eligible for HDT-ASCT: A Randomized Phase 2 Trial. Blood (ASH Annual Meeting Abstracts), Nov 2009; 114: 2312.

Publications automatically indexed to this study:

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00531453     History of Changes
Other Study ID Numbers: 26866138-MMY-2043
Study First Received: September 14, 2007
Results First Received: April 9, 2010
Last Updated: January 25, 2012
Health Authority: United States: Food and Drug Administration