Abstract

Abstract 354

Introduction

The Intergroupe Francophone du Myelome (IFM) has shown that induction tteatment prior to ASCT with VD is superior to VAD in terms of complete response (CR) or CR plus very good partial response(VGPR) both before and after ASCT (Harousseau 2008 Joint ASH/ASCO session). The Italian group has presented impressive results with the three-drug combination VTD.(Cavo Blood 2008;112:)However in both studies, peripheral neuropathy (PN)was the most frequent adverse event (9% Grade 3)

Patients and Methods.

The IFM has conducted a randomized trial comparing four 21-day cycles of induction with VD(V1.3 mg/m2/d on days 1,4,8,11 plus D 40mg:d on days 1-4 and 8-11 for the first 2 cycles, on days 1-4 for the last 2 cycles) or vTD (v 1mg/m2 /d on days 1,4,8,11 plus thalidomide 100mg:d d1-21 plus dexamethasone same dosing as for VD). Results were assessed after cycle 2 and 4 and after ASCT. Responses were evaluated according to IMW uniform criteria . Samples for serum and urine electrophoreses were centralized (HAL,CHU Nantes). In the vTD arm, if after cycle 2, the response was.

Results

From 03/2008 to 01/2009, 205 patients with newly diagnosed symptomatic MM and up to 65 years of age were recruited and randomized at diagnosis (stratification according to β-2 microglobulin and presence of del(13) by FISH). The two groups were well balanced as regards initial prognostic parameters : age, ISS,β-2microglobulin,hemoglobin,calcium and creatinine levels, incidence of del(13),t(4.14) and del(17p.).As of August 15th, 191 patients are evaluable for response after cycle 4 ( 95 VD,96 vTD). According to investigators'assessment,the efficacy results are the following (VD vs vTD): CR rate 12%vs 14% (p = 0.68), ,≥VGPR 36%vs 50 % (p=0.047), ≥PR 81%vs 91%(p = 0.06),stable disease 12%vs 5%, progression/failure 7%vs 4%.In the vTD arm the doses of v and T were increased due to ≥3 6 %vs 2 % (p=0.17)

Conclusion

The combination of reduced-dose bortezomid and thalidomide induces significantly more CR+VGPR than the VD with usual doses of V.Despite the addition of thalidomide, the incidence of PN was markedly reduced In the vTD arm with only 2% Grade ≥3 PN. vTD should be considered a new standard for induction treatment prior to ASCT

Disclosures:

Harousseau:Janssen Cilag: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees. Avet-Loiseau:janssen cilag: Honoraria; celgene: Honoraria. Facon:Janssen-Cilag: Membership on an entity's Board of Directors or advisory committees. Attal:Janssen Cilag: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees.

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Author notes

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Asterisk with author names denotes non-ASH members.