A Prospective, Multicenter, Non-comparative, Open-label, Phase II Study to Evaluate the Effects of the Combination of Bortezomib/Dexamethasone/Zoledronic Acid on Bone Mineral Density, Bone Metabolism, Radiographically-detected Osteolytic Bone Lesions, Skeletal-related Events and Bone Pain in Patients With Multiple Myeloma Who Have Relapsed After 1-3 Prior Lines of Therapy
Multiple Myeloma represents a malignant proliferation of plasma cells derived from a single
clone. The most common symptom in myeloma, affecting more than 70% of patients at diagnosis,
is bone pain. The pain usually involves the back and ribs, and is precipitated by movement.
Bone fractures are commonly seen in myeloma patients and may present with persistent
VELCADE (bortezomib) is a proteasome inhibitor used for the treatment of multiple myeloma.
VELCADE seems to be the first agent to combine significant anti-myeloma activity and
beneficial effects on bone remodeling. Thus, it appears to be a very promising tool for the
treatment of myeloma patients.
In this study, a regimen consisting of bortezomib/dexamethasone/zoledronic acid will be
used. The rationale for using this regimen is that:
- VELCADE (bortezomib) is indicated for the treatment of relapsed myeloma patients
participating in the study and it has also a beneficial effect on biochemical markers
of bone formation.
- In phase II studies, the addition of dexamethasone in patients with a suboptimal
response to bortezomib alone improved efficacy in relapsed or refractory multiple
myeloma patients, without increasing adverse events. Therefore, in this study, the
addition of dexamethasone aims at providing the optimal therapy for participating
- Zoledronic acid, the most potent i.v. bisphosphonate, is used because of its
established effect on reducing skeletal related events in patients with multiple
myeloma due to its inhibitory effect on osteoclastic bone resorption.
Dosages and timing of dosages are based on current recommendations and guidelines for the
treatment of myeloma patients who Have Relapsed after 1-3 Prior Lines of Therapy.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Bone Mineral Density (BMD)
At the end of cycle 4 (day 84) from the treatment initiation
Meletios- Athanasios Dimopoulos, Professor
Therapeutic Clinic Department, Faculty of Medicine. University of Athens
Greece: National Organization of Medicines