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Phase 1/2 Study of VELCADE® in Combination With Other Drugs to Treat Previously Untreated Multiple Myeloma Patients (EVOLUTION)
This study has been completed.
Study NCT00507442   Information provided by Millennium Pharmaceuticals, Inc.

First Received on July 25, 2007.   Last Updated on November 28, 2011   History of Changes
Results First Received: November 28, 2011  
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 + lenalidomide
Drug: bortezomib + dexamethasone + cyclophosphamide + lenalidomide
Drug: bortezomib + dexamethasone + cyclophosphamide
Drug: Bortezomib + Dexamethasone + 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
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
V-DR

Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.

Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.

Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
VDCR

Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.

Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.

Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.

Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
V-DC

Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.

Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.

Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
VDC-mod

Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.

Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.

Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.

Participant Flow:   Overall Study
    V-DR     VDCR     V-DC     VDC-mod  
STARTED     42     48     33     17  
COMPLETED     26     26     18     12  
NOT COMPLETED     16     22     15     5  
Adverse Event                 8                 10                 4                 1  
Protocol Violation                 0                 1                 0                 0  
Lost to Follow-up                 0                 0                 1                 0  
Physician Decision                 0                 2                 4                 1  
Progressive Disease                 2                 3                 2                 0  
Withdrawal by Subject                 4                 3                 2                 1  
Other                 2                 3                 2                 2  



  Baseline Characteristics
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Reporting Groups
  Description
V-DR

Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.

Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.

Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
VDCR

Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.

Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.

Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.

Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
V-DC

Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.

Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.

Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
VDC-mod

Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.

Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.

Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.

Baseline Measures
    V-DR     VDCR     V-DC     VDC-mod     Total  
Number of Participants  
[units: participants]
 		  42     48     33     17     140  
Age  
[units: participants]
 		         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     27     30     21     11     89  
>=65 years     15     18     12     6     51  
Age  
[units: years]
Mean ± Standard Deviation 		  59.5  ± 8.76     60.8  ± 8.94     61.4  ± 8.32     59.6  ± 9.16     60.4  ± 8.71  
Gender  
[units: participants]
 		         
Female     18     19     14     10     61  
Male     24     29     19     7     79  
Region of Enrollment  
[units: participants]
 		         
United States     42     48     33     17     140  



  Outcome Measures

1.  Primary:   Combined Complete Response and Very Good Partial Response.   [ Time Frame: End of treatment period ]
  Show Outcome Measure 1

2.  Secondary:   Evaluate the Safety and Tolerability of the Combination Therapy   [ Time Frame: 48 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Overall Response   [ Time Frame: 48 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Stringent Complete Response Rate   [ Time Frame: 48 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Complete Response Rate + Near Complete Response Rate   [ Time Frame: 48 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Duration of Response   [ Time Frame: time from date of first documented confirmed response to date of first documented progressive disease ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Time to Disease Progression   [ Time Frame: time from date of randomization to date of first documented progressive disease ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Time to Response   [ Time Frame: time from date of randomization to the date of the first documentation of a confirmed response ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Progression-free Survival   [ Time Frame: time from the date of randomization to the date of the first documented progressive disease or death. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   1-year Survival   [ Time Frame: survival probability at 1 year after randomization ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Overall Survival   [ Time Frame: time from the date of randomization to the date of death ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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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.


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: Dixie-Lee Esseltine, MD
Organization: Millennium Pharmaceuticals, Inc
phone: (617) 679-7000


No publications provided


Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00507442     History of Changes
Other Study ID Numbers: C05008
Study First Received: July 25, 2007
Results First Received: November 28, 2011
Last Updated: November 28, 2011
Health Authority: United States: Food and Drug Administration





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