Bortezomib plus dexamethasone as induction treatment prior to autologous stem cell transplantation in patients with newly diagnosed multiple myeloma: results of an IFM phase II study.
OBJECTIVE
Induction regimens prior to autologous stem cell transplantation (ASCT) in newly diagnosed multiple myeloma patients usually result in complete remission (CR) rates of <10%. The use of novel agents may increase the CR rate before ASCT, which may improve post-transplantation response and survival.


METHODS
This was a phase II, open-label trial of bortezomib (1.3 mg/m(2), days 1,4,8,11) and dexamethasone (40 mg,days 1-4 and 9-12 for cycles 1-2,days 1-4 for cycles 3-4) administered for four 21-day cycles as induction therapy in chemotherapy-naïve myeloma patients.


RESULTS
Of 52 recruited patients, 48 were eligible for the study. The overall response rate was 66% including 21% CR and 10% very good partial remission (>90% reduction of the M-component). Four patients had a minimal response, six had stable disease and five had progression. One patient died after salvage therapy with VAD. The most common side effects were gastrointestinal symptoms, peripheral neuropathy, and fatigue. These were usually mild. Peripheral neuropathy was observed in 15 cases but was grade 2-3 in only seven cases (14%). There was no deep vein thrombosis and no hematologic toxicity greater than grade 2. Grade 3 infections were recorded in five patients including three who had herpes zoster infections. Stem cell collection was programmed in 44 cases and all patients had sufficient CD34+ cells to perform one ASCT (> 2 x 10(6)/kg).


CONCLUSIONS
This regimen of bortezomib plus dexamethasone appears effective and well tolerated in newly diagnosed myeloma patients.
Harousseau
Jean-Luc
JL
Hôpital Hotel-Dieu, Place Alexis Ricordeau, Nantes Cedex 44093, France. jlharousseau@sante.univ-nantes.fr
Attal
Michel
M
Leleu
Xavier
X
Troncy
Jacques
J
Pegourie
Brigitte
B
Stoppa
Anne-Marie
AM
Hulin
Cyrille
C
Benboubker
Lofti
L
Fuzibet
Jean-Gabriel
JG
Renaud
Marc
M
Moreau
Philippe
P
Avet-Loiseau
Hervé
H
D000328:Adult; D000368:Aged; D001897:Boronic Acids / Q000008:administration & dosage*; D000069286:Bortezomib; D003907:Dexamethasone / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D005602:France; D006801:Humans; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000175:diagnosis / Q000188:drug therapy* / Q000628:therapy*; D011719:Pyrazines / Q000008:administration & dosage*; D012074:Remission Induction; D033581:Stem Cell Transplantation / Q000379:methods; D014182:Transplantation, Autologous
D001897:Boronic Acids; D011719:Pyrazines; D000069286:Bortezomib; D003907:Dexamethasone