Effect of Velcade on Myeloma related Bone Disease (protocol 2.0)

• Research type

  Research Study

• Full title

  A Phase 2, Multicentre, Randomised, Open-Label, Parallel Group Study to Evaluate the Effect of VELCADE® on Myeloma related Bone Disease

• Contact name

  John Andrew Snowden

• Sponsor organisation

  Janssen-Cilag International N.V.

• Eudract number

  2008-004264-39

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Over 85,000 patients all over the world with multiple myeloma and other types of cancer have been treated with VELCADE©. In this study, patients with multiple myeloma will be treated with the experimental drug VELCADE© (bortezomib) after having received first line treatment for this type of cancer with stem cell transplantation and high dose chemotherapy. The purpose of this research study is to evaluate the safety and effectiveness of VELCADE© consolidation therapy in addition to standard medical care in the prevention of bone related diseases. Approximately 80% of subjects with multiple myeloma may experience myeloma bone disease, which is the result of increased destruction of bone that cannot be compensated for by new bone formation. VELCADE© has been shown to promote bone formation and inhibit the bone resoption in preliminary studies. In the present study the effect of VELCADE© on bone formation will be assessed by dual energy x-ray absorptometry (DXA) measuring bone mineral density. In addition, biochemical bone markers indicating signs of the bone turnover will be measured on blood samples. This is a multicentre, open-label, parallel group study in which eligible subjects will be assigned by chance (randomly) to either VELCADE© or no such consolidation treatment. About 120 subjects will be enrolled in several European Countries (Austria, Czech Republic, Denmark, Germany, Sweden) and Turkey. The Study is funded by Janssen-Cilag International NV. The expected duration of participation in the study for each subject is 24 months including a 20 weeks treatment phase (4 cycles) and follow-up visits at 4, 6, 12 and 18 months after the End-of-Treatment Visit. The potential benefits to research participants randomised to the Velcade arm are improvement in bone density and less myeloma related bone complications but we are testing this hypothesis as at present there is no recognised standard of care in this setting.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  09/H1307/90

• Date of REC Opinion

  11 Nov 2009

• REC opinion

  Further Information Favourable Opinion