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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.
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00507442
First received: July 25, 2007
Last updated: April 12, 2012
Last verified: April 2012
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: VELCADE (bortezomib)
Drug: dexamethasone
Drug: cyclophosphamide
Drug: Revlimid (lenalidomide)

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
V-DR

VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) 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

VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) 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: 100 - 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

VELCADE (bortezomib), dexamethasone, cyclophosphamide 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

Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide 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     66     33     17  
COMPLETED     26     39     18     12  
NOT COMPLETED     16     27     15     5  
Adverse Event                 8                 11                 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                 4                 2                 0  
Withdrawal by Subject                 4                 4                 2                 1  
Not Specified                 2                 5                 2                 2  



  Baseline Characteristics
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Reporting Groups
  Description
V-DR

VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) 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

VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) 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: 100 - 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

VELCADE (bortezomib), dexamethasone, cyclophosphamide 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

Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide 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.
Total Total of all reporting groups

Baseline Measures
    V-DR     VDCR     V-DC     VDC-mod     Total  
Number of Participants  
[units: participants]
 		  42     66     33     17     158  
Age  
[units: participants]
 		         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     27     42     21     11     101  
>=65 years     15     24     12     6     57  
Age  
[units: years]
Mean ± Standard Deviation 		  59.5  ± 8.76     60.9  ± 8.97     61.4  ± 8.32     59.6  ± 9.16     60.5  ± 8.75  
Gender  
[units: participants]
 		         
Female     18     28     14     10     70  
Male     24     38     19     7     88  
Region of Enrollment  
[units: participants]
 		         
United States     42     66     33     17     158  



  Outcome Measures
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1.  Primary:   Number of Patients With Combined Complete Response and Very Good Partial Response   [ Time Frame: Up to 48 weeks or until disease progression ]
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2.  Secondary:   Number of Patients With Adverse Events (AEs)   [ Time Frame: From first dose of study drug through the 30 day post-treatment AE assessment visit ]
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3.  Secondary:   Number of Patients With Overall Response   [ Time Frame: Up to 48 weeks or until disease progression ]
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4.  Secondary:   Number of Patients With Stringent Complete Response Rate   [ Time Frame: Up to 48 weeks or until disease progression ]
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5.  Secondary:   Number of Patients With Complete Response Rate + Near Complete Response Rate   [ Time Frame: Up to 48 weeks or until disease progression ]
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6.  Secondary:   Duration of Response   [ Time Frame: Up to 48 weeks or until disease progression ]
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7.  Secondary:   Time to Disease Progression   [ Time Frame: Up to 48 weeks or until disease progression ]
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8.  Secondary:   Time to Response   [ Time Frame: Up to 48 weeks or until disease response ]
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9.  Secondary:   Progression-free Survival   [ Time Frame: Up to 48 weeks or until disease progression/death ]
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10.  Secondary:   Probability of 1-year Survival   [ Time Frame: survival probability at 1 year after randomization ]
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11.  Secondary:   Overall Survival   [ Time Frame: Up to 48 weeks or until death ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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