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

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ClinicalTrials.gov Identifier: NCT00507416
Recruitment Status : Completed
First Posted : July 26, 2007
Results First Posted : May 1, 2014
Last Update Posted : May 1, 2014
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: Bortezomib
Drug: Dexamethasone
Drug: Melphalan
Drug: Prednisone
Drug: Thalidomide

  Participant Flow

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

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 
Overall Participants Analyzed 
[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

1.  Primary:   Progression Free Survival (PFS)   [ Time Frame: From randomization until disease progression. Median follow-up time was 43 months. ]
  Show Outcome Measure 1

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. ]
  Show Outcome Measure 5

6.  Secondary:   Overall Survival   [ Time Frame: From randomization until death. Median follow-up time was 43 months. ]
  Show Outcome Measure 6

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


  Other Adverse Events


  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.


  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: 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
First Submitted: July 25, 2007
First Posted: July 26, 2007
Results First Submitted: March 28, 2014
Results First Posted: May 1, 2014
Last Update Posted: May 1, 2014