A Phase 2 Study of Velcade™ in Subjects With Relapsed or Refractory Follicular B-Cell Lymphoma
This is a prospective, randomized, sequential, international, multicentric, 2-arm,
non-comparative, open-label, 2-stage clinical study to determine disease response rates
therapy of Velcade™ in subjects who have relapsed or refractory follicular B-cell lymphoma
Qualitative comparisons of the 2 treatment arms based on safety, efficacy and dosing
convenience will be made in order to recommend a dose schedule for further clinical study.
It is anticipated that approximatively 120 subjects will be enrolled to achieve the required
110 evaluable subjects, 55 in each treatment arm. Patients who receive any amount of
Velcade™ are evaluable. Subjects not evaluable for response will be replaced.
A central randomization will be used in this study. Subjects will be randomized and
stratified with factors for prior therapies (1 or 2 versus > 2) and time to progression
(TPP) for the last given anti-neoplastic therapy (≤ 12 months versus > 12 months).
The eligible subjects will be randomized to either Treatment Arm A or Treatment Arm B in a
- Subjects randomized to Treatment Arm A will receive 1.5 mg/m² Velcade™ administered
biweekly on Days 1, 4, 8, and 11 of a 21-day cycle. Patients will receive 8 cycles. The
dose of Velcade™ received in schedule A will be 48 mg/m² over 24 weeks.
- Subjects randomized to Treatment Arm B will receive 1.6 mg/m² Velcade™ administered
weekly on Days 1, 8, 15, and 22 of a 35-day cycle. Patients will receive 6 cycles. The
dose of Velcade™ received in schedule B will be 38.4 mg/m² over 30 weeks.
Two additional cycles may be administered if the patient shows improvement to PR after 8 or
6 cycles for arm A or B, respectively.
Study drug dose and schedule reduction for toxicity will be allowed during the study.
A two stage interim analysis will be conducted in each treatment arm to determine whether
either of the 2 treatments lacks sufficient efficacy.
The final analysis will be conducted when all subjects have had the opportunity to complete
the 30 day post-treatment evaluation visit. All data from all visits up until this point
will be used in the final analysis, including data from any follow-up visits that have
Patients will be recruited approximately over 2 years and followed until all data are
available for final analysis.
The total duration of the study is expected to be 5 years.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the response rate to Velcade™ as a single agent
End of treatment
Bertrand Coiffier, MD
Hospices Civils de Lyon, Lyon, France
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)