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Velcade,Thalidomide, and Dexamethasone Versus Velcade and Dexamethasone Versus Velcade, Melphalan, and Prednisone (UPFRONT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00507416
First received: July 25, 2007
Last updated: March 28, 2014
Last verified: March 2014
History of Changes
Results First Received: March 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: Bortezomib
Drug: Dexamethasone
Drug: Melphalan
Drug: Prednisone
Drug: Thalidomide

  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
Participants took part in the study at 158 investigative sites in the United States from 26 June 2007 to 28 March 2013

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with previously untreated multiple myeloma were randomized in a 1:1:1 ratio to one of three treatment groups: VD: Velcade (bortezomib) and dexamethasone; VTD: Velcade, thalidomide, and dexamethasone; VMP: Velcade, melphalan, and prednisone.

Reporting Groups
  Description
Bortezomib and Dexamethasone Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Bortezomib, Thalidomide, and Dexamethasone Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Bortezomib, Melphalan and Prednisone Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).

Participant Flow:   Overall Study
    Bortezomib and Dexamethasone     Bortezomib, Thalidomide, and Dexamethasone     Bortezomib, Melphalan and Prednisone  
STARTED     168     167     167  
Treated (Safety Population)     165     158     163  
Completed 8 Treatment Cycles     82     60     69  
COMPLETED     50 [1]   42 [1]   53 [1]
NOT COMPLETED     118     125     114  
Adverse Event                 58                 67                 65  
Protocol Violation                 1                 2                 0  
Lack ofEfficacy / Physician Decision                 7                 7                 8  
Progressive Disease                 20                 10                 13  
Patient declined further treatment                 18                 14                 11  
Other                 11                 16                 13  
Did not Receive Study Treatment                 3                 9                 4  
[1] Completed is defined as having completed 13 treatment cycles.



  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.
Intention to treat population, defined as all participants randomized

Reporting Groups
  Description
Bortezomib and Dexamethasone Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Bortezomib, Thalidomide, and Dexamethasone Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Bortezomib, Melphalan and Prednisone Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Total Total of all reporting groups

Baseline Measures
    Bortezomib and Dexamethasone     Bortezomib, Thalidomide, and Dexamethasone     Bortezomib, Melphalan and Prednisone     Total  
Number of Participants  
[units: participants]
 		  168     167     167     502  
Age  
[units: years]
Mean (Standard Deviation) 		  72.6  (9.35)     71.3  (8.73)     71.3  (8.67)     71.7  (8.92)  
Age, Customized  
[units: participants]
 		       
≥ 65 years     140     135     139     414  
≥ 75 years     84     64     62     210  
≥ 80 years     40     27     23     90  
Gender  
[units: participants]
 		       
Female     67     97     77     241  
Male     101     70     90     261  
Race/Ethnicity, Customized  
[units: participants]
 		       
White     131     124     118     373  
Black     23     31     29     83  
Native Hawaiian or Other Pacific Islander     0     0     2     2  
Asian     2     1     0     3  
American Indian or Alaskan Native     0     1     2     3  
Other     10     10     15     35  
Not Reported     2     0     1     3  
Region of Enrollment  
[units: participants]
 		       
United States     168     167     167     502  



  Outcome Measures
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1.  Primary:   Progression Free Survival (PFS)   [ Time Frame: From randomization until disease progression. Median follow-up time was 43 months. ]
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2.  Secondary:   Percentage of Participants With an Overall Response   [ Time Frame: Response assessed every other cycle for up to 13 cycles (49 weeks). ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Participants With a Complete Response   [ Time Frame: Response assessed every other cycle, for up to 13 cycles (49 weeks). ]
  Show Outcome Measure 3

4.  Secondary:   Percentage of Participants With a Complete Response or a Very Good Partial Response   [ Time Frame: Response assessed every other cycle for up to 13 cycles (49 weeks). ]
  Show Outcome Measure 4

5.  Secondary:   Duration of Response   [ Time Frame: From first documented response until disease progression. Median follow-up time was 43 months. ]
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6.  Secondary:   Overall Survival   [ Time Frame: From randomization until death. Median follow-up time was 43 months. ]
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7.  Secondary:   Time to Alternative Therapy   [ Time Frame: From randomization until alternative therapy. Median follow-up time was 43 months. ]
  Show Outcome Measure 7

8.  Secondary:   Change From Baseline in EORTC QLQ-C30 - Global Health Status   [ Time Frame: Baseline and Day 1 of Cycles 3, 5, 7, 9, 11 and 13 ]
  Show Outcome Measure 8


  Serious Adverse Events
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  Other Adverse Events
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  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 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: Medical Director
Organization: Millennium Pharmaceuticals Inc
phone: 1-800-778-2860
e-mail: clinicaltrialregistry@tpna.com


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


Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00507416     History of Changes
Other Study ID Numbers: C05009
Study First Received: July 25, 2007
Results First Received: March 28, 2014
Last Updated: March 28, 2014
Health Authority: United States: Food and Drug Administration