Myeloma XI

• Research type

  Research Study

• Full title

  A randomised comparison of thalidomide and lenalidomide combinations in myeloma patients of all age groups

• IRAS ID

  17211

• Eudract number

  2009-010956-93

• ISRCTN Number

  pending

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Myeloma is a bone marrow cancer, specifically of the plasma cells, characterised by symptoms of bone pain, fractures, fatigue, anaemia, infections and kidney problems. Almost 4000 new cases are diagnosed annually in the UK. With modern treatments, the median overall survival is approximately 4-5 years. The last ten years has seen the introduction of a number of effective new anti-myeloma agents into the clinical arena. These agents have been shown to be highly effective in the relapse setting and now are being introduced as treatment earlier in the disease course. This study therefore aims to address in the randomised setting some of the key questions concerning the use of thalidomide, bortezomib and lenalidomide in the initial treatment of multiple myeloma patients. Newly diagnosed patients of all ages with symptomatic myeloma requiring treatment are eligible. For initial treatment, thalidomide in combination with cyclophosphamide and dexamethasone, the UK gold standard, will be compared with the newer combination of lenalidomide, cyclophosphamide and dexamethasone. For patients with a sub-optimal response to initial therapy, the response to the proteasome inhibitor, bortezomib, will be assessed, as previous studies have demonstrated that it is able to induce responses and improve progression free and overall survival in patients resistant to standard chemotherapy. Patients young and fit enough to tolerate an autologous transplant will then proceed to standard treatment of high dose melphalan with peripheral blood stem cell rescue. The value of lenalidomide maintenance will then be assessed by randomising all eligible patients to receive either lenalidomide maintenance therapy or close observation. The primary end points of the study are overall and progression free survival (OS and PFS). Secondary end points include response and toxicity. A number of laboratory based studies will also be performed in order to determine patient specific factors predicting response to treatment and overall survival.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  09/H0604/79

• Date of REC Opinion

  17 Sep 2009

• REC opinion

  Further Information Favourable Opinion