1. Roman Hájek on behalf of CMG March 27, 2010 Roman Hájek on behalf of CMG March 27, 2010 „Treatment standards, in Czech Republic”.

2. Initial Treatment Strategy Induction: VAD or VDD Thal + Dex MP or MPT High dose chemotherapy Interferon / corticoids Thalidomide or Thal + Dexamethasone InductionConsolidationMaintenance Lenalidomide + Dex Bortezomib + Dex PAD … others Novel consolidation Lenalidomide + DEX Bortezomib combo ’ s, others or No Maintenance

4. FOCUS ON LONG PERIOD OF LIFE WITH CANCER FOCUS ON LONG PERIOD OF LIFE WITH CANCER 10 YEARS 10 YEARS 4 RELAPSES 4 RELAPSES FOCUS ON LONG PERIOD OF LIFE WITH CANCER FOCUS ON LONG PERIOD OF LIFE WITH CANCER 10 YEARS 10 YEARS 4 RELAPSES 4 RELAPSES Basic Treatment Strategy

6. If we have more than one treatment options than we has change treatment when it is: A: NOT EFFECTIVE A: NOT EFFECTIVE B: POORLY TOLERATED B: POORLY TOLERATED /neropathy/ /neropathy/ If we have more than one treatment options than we has change treatment when it is: A: NOT EFFECTIVE A: NOT EFFECTIVE B: POORLY TOLERATED B: POORLY TOLERATED /neropathy/ /neropathy/ Reason for the Treatment Discontinuation Reason for the Treatment Discontinuation

7. STABLE DISEASE STABLE DISEASE IS NOT SUTISFIED RESPONSE IS NOT SUTISFIED RESPONSE MINIMAL RESPONSE (M-Ig < 50%) MINIMAL RESPONSE (M-Ig < 50%) IS NOT SUTISFIED RESPONSE IS NOT SUTISFIED RESPONSE STABLE DISEASE STABLE DISEASE IS NOT SUTISFIED RESPONSE IS NOT SUTISFIED RESPONSE MINIMAL RESPONSE (M-Ig < 50%) MINIMAL RESPONSE (M-Ig < 50%) IS NOT SUTISFIED RESPONSE IS NOT SUTISFIED RESPONSE Reason for the Treatment Discontinuation

8. STABLE DISEASE STABLE DISEASE IS NOT SUTISFIED RESPONSE IS NOT SUTISFIED RESPONSE MINIMAL RESPONSE (M-Ig < 50%) MINIMAL RESPONSE (M-Ig < 50%) IS NOT SUTISFIED RESPONSE IS NOT SUTISFIED RESPONSE STABLE DISEASE STABLE DISEASE IS NOT SUTISFIED RESPONSE IS NOT SUTISFIED RESPONSE MINIMAL RESPONSE (M-Ig < 50%) MINIMAL RESPONSE (M-Ig < 50%) IS NOT SUTISFIED RESPONSE IS NOT SUTISFIED RESPONSE Reason for the Treatment Discontinuation WE NEED AT LEAST PARTIAL RESPONSE

9. New drugs have significant benefit for patients with relapse and resistant disease The key rules are: 1. Do not use monotherapy 2. Reserve other new drugs for the future Benefit of the new drugs - thalidomide and bortezomibe, lenalidomide Benefit of the new drugs - thalidomide and bortezomibe, lenalidomide

11. 1. NEW DIAGNOSIS: THALIDOMID + TRANSPLANTATION (gold standard)

12. 2. FIRST RELAPSE NEUROPATHY: NO VELCADE based regimen NEUROPATHY: YES REVLIMIDE based regimen + re-transplantation if the regimen is toxic or response after 4 cycle is less than 50% (PR)

13. 3 3. THIRD RELAPSE: THALIDOMID VELCADE REVLIMID based regimen + re-transplantation if the regimen is toxic or response after 4 cycle is less than 50% (PR)

15. 1. NEW DIAGNOSIS: 80% THALIDOMID 20% VELCADE based regimen 1-3. FIRST RELAPSE: THALIDOMID VELCADE REVLIMIDE based regimen

16. CTD junior and senior JUNIOR SENIOR C yclophosphamide 500mg p.o. day 1, 8, 15 50mg daily Thalidomid 200 mg 100 mg Dexamethazon 40 mg day 1-4, 10-13, 20-23 20 mg

17. VELCADE based regimens CVD junior and senior VMP junior and senior VD junior and senior THALIDOMIDE based regimens CTD junior and senior MPT junior and senior TD junior and senior (C yclophosphamide or melphalan; corticoids; new drug)

19. Česká myelomová skupina a její nadační fond spolupracují při zajišťování informačního servisu pro lékaře a nemocné s mnohočetným myelomem Total 660 1100 1200 (Total of 1200 from 1600 pts. indicated for the treatment in the year 2010 received effective treatment Treatment of Multiple Myeloma in Czech Republic Effective drugs used in the period 2007-2009.

21. HOW TO INTRODUCE THE BENEFIT OF treatment TO ALL SUITABLE PATIENTS How can patient organization help? How can patient organization help?

22. . KEY FOR EVERYDAY ROUTINE: EFECTIVE AND SHORT TRANSMISSION OF CLINICAL TRIALS RESULTS INTO EVERYDAY USE WITH POSITIVE BENEFIT FOR THE PATIENTS. ACCURATE AND MAXIMAL ENROLMENT TO TRANSPLANTATION PROGRAM

25. To use thalidomide or Velcade based regiment as first line treatment in all elderly patients up front To use thalidomide or Velcade based regiment as first line treatment in all elderly patients up front Our strategy for routine life in period 2007-2010 Our strategy for routine life in period 2007-2010

26. To use VELCADE/THALIDOMIDE/REVLIMIDE based regiment as 2 – 4 lines treatment in all patients To use VELCADE/THALIDOMIDE/REVLIMIDE based regiment as 2 – 4 lines treatment in all patients Our strategy for routine life in period 2006-2010 Our strategy for routine life in period 2006-2010

27. There is evidence that new drugs can significantly change prognosis of more than 50% of patients who can t benefit from autologous transplantation as primary treatment There is evidence that new drugs can significantly change prognosis of more than 50% of patients who can t benefit from autologous transplantation as primary treatment Where we are going ? Where we are going ?

28. Long-term treatment results Period Medián Overall Surivval (months) 10 60 70 20 30 40 50 1971–19761977–19821983–19881989–19941995–20002000–2006 0 n = 2981 Kumar, et al., 2008, Blood 111(5): 2516

29. We need use new drugs in elderly patients to achive the similar results as in younger patients using autologous transplantation We need less toxic and more safe induction treatment than VAD for younger patients We need use new drugs in elderly patients to achive the similar results as in younger patients using autologous transplantation We need less toxic and more safe induction treatment than VAD for younger patients Our strategy for routine life in period 2006-2010 SUMMARY Our strategy for routine life in period 2006-2010 SUMMARY

30. How can patient organizations help? It is very important, if any of evalauted therapies is considered as new perspective treatment. The more important is, if the most patients can benefit from this treatment in the short time period. Rapid introduction of new effective therapeutic strategy is the place for active patient organizations. It is very important, if any of evalauted therapies is considered as new perspective treatment. The more important is, if the most patients can benefit from this treatment in the short time period. Rapid introduction of new effective therapeutic strategy is the place for active patient organizations.

31. Thank you for you attention