EBMT

Chronic Leukaemia Working Party Study Update

The MMVAR / IFM 2005-04 trial

In multiple myeloma, high dose melphalan with autologous stem cell support increases survival but the vast majority of the patients relapse. Besides alkylating agents and steroids, two new drugs are active to treat myeloma: thalidomide and bortezomib (Velcade). There is a need for new treatment and the myeloma community is currently testing new drug combinations.

The EBMT is sponsoring a randomised, prospective, international study comparing two regimens to treat myeloma patients relapsing after autologous transplantation: Velcade + Thalidomide + Dexamethasone versus Thalidomide + Dexamethasone (the MMVAR trial: Multiple Myeloma Velcade At Relapse). Both drugs, Thalidomide and Velcade, are given for free to participating centers.

Patients are treated for one year and are monitored for one year after treatment. We are planning to accrue 360 patients. The total duration of the study is 4 years. The primary objective is to compare the time to progression between the two groups and the secondary endpoint to evaluate the toxicity (mostly neurological). Preliminary studies, in this setting or as an upfront treatment strategy, have shown for both regimens high response rates with acceptable toxicity. Moreover, they are mainly non myelotoxic regimens given to outpatients. Four interim analyses are planned with a regular update in the EBMT E-News.

In 2005 the first patient was included in the MMVAR trial. Currently there are 34 centres taking part and a total number of 60 patients included. The accrual to date has been mainly with French centres, but patients have also been included in Belgium, Italy, Switzerland and Israel. One of reasons that patient accrual has been slower than anticipated has been the delay in being granted approval for the study in some countries, but we have finally managed to solve these problems and look forward to all the remaining countries opening to accrual within the next months. Germany and the Czech Republic have recently opened and have started to screen patients, The Intergroupe Francophone Myelome have requested that 11 of their centres be allowed participate, in addition to the current French centres, and have also offered to monitor the study in France and Belgium. Similarly the SAKK group in Switzerland will involve more centres in the study and help with the monitoring in the French and Italian speaking centres.

We welcome their participation and help. The degree of collaboration between the EBMT and other collaborative groups underlines the importance of this study to the scientific community.

To view the Study Schema please click here.

If you want to join the MMVAR /IFM 2005-04 trial, do not hesitate to contact Laurent Garderet or Zoë Doran.

Zoë Doran                                               
z.doran@ucl.ac.uk                                     
tel. +44 (0)20 7380 9351                       
fax: +44 (0)20 7380 9597                        

Laurent Garderet
laurent.garderet@sat.aphp.fr
tel. +33 (0)1 4928 2621
fax: +33 (0)1 4928 3200