Unknown

The Evaluation of VELCADE®
Employed as Retreatment for
Efficacy, Safety, and Tolerability
Protocol C05004
Trial Objective
EVEREST is a phase IV, open-label study
assessing the efficacy, safety, and tolerability
of retreatment with VELCADE® (bortezomib)
for Injection in multiple myeloma patients.

EVEREST A phase IV trial with VELCADE® (bortezomib) for Injection
The Evaluation of VELCADE® (bortezomib) for Injection Employed as
Retreatment for Efficacy, Safety, and Tolerability
Trial Summary
Patient does not have peripheral neuropathy of
grade 2 with pain or greater intensity.1
Study patients will receive the standard regimen of
VELCADE. Within each 3-week treatment cycle, the
Patient does not have poorly controlled hyper-
patient will receive VELCADE 1.3 mg/m2/dose as a
tension, diabetes mellitus, or other serious
bolus intravenous (IV) injection twice weekly (days 1,
medical or psychiatric illness that could
4, 8, and 11) followed by a 10-day rest period (days
potentially interfere with the completion of
12 21). The next treatment cycle would begin on
treatment according to this protocol.
day 22. The best response based on M-protein will
How to enroll in the EVEREST study
be used to assess clinical activity. Patients will be
assessed for safety by recording all grades of neu-
Complete and return the attached Site Feasibility
ropathy, grades 3 and 4, and serious adverse events
Questionnaire. Millennium Clinical Operations will
(SAEs). Recruitment of 100150 patients anticipated
contact your site to further assess your interest after
in the next 2 years.
reviewing the questionnaire.
If approved to participate, you will be sent a protocol
Which patients are eligible to participate?
and startup package.
Multiple myeloma patients who have previously
received 1.0 or 1.3 mg/m2/dose of VELCADE
You will be responsible for notifying Millennium
and discontinued following at least a partial
Clinical Operations when an appropriate patient is
response ( 50% decrease in myeloma protein)
available for screening. At that time, a contract and
which lasted 6 months.
forms for institutional review board (IRB) submission
will be mailed to your site. Once a contract is in place
At least 4 months have elapsed since the
and IRB approval has been provided to Millennium,
patient's last dose of VELCADE, and the patient
patients can be consented.
has not received other treatment (chemotherapy,
radiotherapy, or antibody/immunotherapy)
Upon IRB submission, Millennium Clinical Operations
for multiple myeloma.
will schedule a teleconference to present an overview
of the study design and procedures.
Patient has met the criteria for disease progression.
Patient has the following laboratory values within
For more information:
14 days of baseline (day 1 of cycle 1, before
Contact Millennium Clinical Operations with ques-
study drug administration):
tions about the study or participation:
·
Platelet count 25 x 109/L without
Mollie Baird
transfusion support within 7 days
Clinical Research Specialist
before the test
Tel: 617.444.2315
·
Hemoglobin 7.5 g/dL without transfusion
Email: Mollie.Baird@mpi.com
support within 7 days before the test
·
Absolute neutrophil count (ANC) 0.75 x
Reference: 1. National Cancer Institute Cancer Therapy Evaluation Program.
Common Toxicity Criteria, Version 2.0, June 1, 1999.
109/L without the use of growth factors
·
Calculated or measured creatinine clearance
20 mL/min

EVEREST Site Feasibility Questionnaire Please complete and return this questionnaire by fax to
perforation
Mollie Baird, Clinical Trials Department, Millennium Pharmaceuticals, 617.374.7625 within five business days.
This phase IV trial will begin enrollment in January 2005.
INVESTIGATOR(S)/SITE INFORMATION
Institution/Name of Practice: ______________________________________________________________________________
Principal Investigator: _________________________________________ Title: ______________________________________
Specialty: __________________________________________________________________________________________
Address: ______________________________________________________________________________________________
City: _____________________________________________________ State: __________
Zip:
____________________
Tel: __________________________ Fax: _________________________ Email: ___________________________________
Additional Investigators' Names:___________________________________________________________________________
______________________________________________________________________________________________________
ABOUT YOUR PRACTICE/GROUP
How many patients with multiple myeloma have been treated with VELCADE® (bortezomib) for Injection in your
practice/group in the past 12 months? _________
How many physicians are in your practice/group? _________
RESEARCH STAFF AND SITE ASSESSMENT
What type of dedicated staff do you have to assist in the conduct of clinical trials?
Study coordinator
Data manager
Study nurse
Nurse (other)
Co-investigator
Lab personnel
Pharmacist
Other: _________________________________________________
None
INVESTIGATOR RESEARCH EXPERIENCE
1. Are you part of any oncology network? Yes
No
If yes, please specify._________________________________________________________________________________
2. Have you been involved in similar studies within the last 3 years? Yes
No (If no, please proceed to question 5.)
3. In which studies were you involved? ____________________________________________________________________
___________________________________________________________________________________________________
4. How many patients from your center were entered in these trials? _____________________
5. How many studies in multiple myeloma are currently being conducted at your site (or will be open by early 2005)?
___________________
6. When does recruitment end for these studies? _______________________________
ETHICS COMMITTEE
1. Are you able to use a central IRB/IEC? Yes
No
If no, what is the average time from IRB/IEC meeting to have approval documentation in hand?______________ (days)
2. Are there any other committees involved in the protocol review process? Yes
No
If yes, please indicate names of committees:_____________________________________________________________
Please add any further comments below (e.g., reasons that would delay your start of the study):
______________________________________________________________________________________________________
______________________________________________________________________________________________________
______________________________________________________________________________________________________
_______________________________________________ _________________________________________ ____________
(Please Print) Name of Person Completing the Form
Signature
Date
Thank you for your assistance and your timely return of this questionnaire!