Bortezomib consolidation trial

• Research type

  Research Study

• Full title

  PHASE II STUDY OF BORTEZOMIB CONSOLIDATION AFTER HIGH DOSE THERAPY AND AUTOLOGOUS STEM CELL TRANSPLANTATION FOR MULTIPLE MYELOMA

• IRAS ID

  19710

• Contact name

  Kwee L Yong

• Eudract number

  2008-006751-48

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  For young patients with multiple myeloma, high dose chemotherapy with stem cell transplantation is still the standard of care, however this is not curative and almost all patients will relapse. Any treatment that delays relapse will benefit patients in terms of quality of life, and perhaps, overall survival. This study will test the effectiveness of a short period of consolidation therapy with bortezomib (Velcade) in improving response and thus prolonging remission in patients who have recently undergone high dose chemotherapy and stem cell transplantation. The treatment will consist of 4 injections of bortezomib a month for 3 - 8 months, and disease response will be assessed using blood tests and bone marrow examination. These assessments will be carried out at 6, and 12 months following the stem cell transplant. Further assessments will document the effect of this treatment on bone health, as this cancer can cause damage to bones.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  09/H0703/75

• Date of REC Opinion

  12 Aug 2009

• REC opinion

  Further Information Favourable Opinion