High-Dose Therapy/Stem Cell Support in
Multiple Myeloma: Update of the Spanish
Studies (PETHEMA/GEM)
J. Bladé, J.J. Lahuerta, A. Sureda, J. Díaz-Mediavilla, J.
García-Laraña, A. Alegre, J. de la Rubia, F. Prosper, F. de
Arriba, J. Bargay, M. Hernández, L. Rosiñol and J. San
Miguel. Spanish Myeloma Group (PETHEMA/GEM)
X International Myeloma Workshop
Sydney, April 13, 2005
HIGH-DOSE THERAPY
AUTOTRASPLANTATION/INTENSIFICATION vs
CONTINUED CONVENTIONAL CHEMOTHERAPY
IN MULTIPLE MYELOMA PATIENTS RESPONDING
TO INITIAL CHEMOTHERAPY. DEFINITIVE
RESULTS FROM THE PETHEMA-94 TRIAL.
J. Bladé, A. Sureda, J.M. Ribera, J. Díaz-Mediavilla, J.
García-Laraña, L. Palomera, J. Fernández-Calvo,
J.M. Martí, P. Giraldo, F. Carbonell, M. Callís, J.
Trujillo, S. Gardella, M.J. Moro, A. Barez, J. Soler,
Ll. Font, M. Fontanillas and J.F. San Miguel.
OBJECTIVE
To investigate the efficacy of HDT/SCT intensification
versus continuation of conventional chemotherapy in
patients with MM
HDT/SCT vs CONVENTIONAL CHEMOTHERAPY
Study Design
< 65 yrs, stage II & III, ECOG < 3
VBMCP/VBAD x 4
Response (CR, PR, MR)
Randomization
VBMCP/VBAD x 8
HDT/SCT
INF/DEXA
INF/DEXA
Accrual and Treatment Allocation
Registry
(216)
Response to chemotherapy
(185)
Randomization
(164)
Chemotherapy
HDT/SCT
83
81
Patient Characteristics (I)
Chemo
HDT/SCT
(N= 83)
(N= 81)
p-value
Age (median), yrs
56
57
NS
Gender (M/F)
43/40
52/29
NS
Hb < 10 g/dL (%)
47
30
0.03
Ca 11.5 mg/dL (%)
10
15
NS
Creatinine 2 mg/dL (%)
10
15
NS
Lytic bone lesions (%)
67
70
NS
Patient Characteristics (II)
Chemo
HDT/SCT
(N= 83)
(N= 81)
p-value
(%)
(%)
Beta2-microglobulin
37
30
NS
(> 4 mg/L)
S-phase (> 2%)
40
37
NS
M-protein type
IgG
65
47
0.02
IgA
11
30
0.003
Bence Jones
23
21
NS
Other
1
2
NS
Response to Initial Chemotherapy
Chemo
HDT/SCT
(N= 83)
(N= 81)
(%)
(%)
· Complete remission
15
14
· Partial response
68
68
· Minimal response
17
18
CR Rate According to Treatment Arm
Chemo*
HDT/SCT**
(N= 83)
(N= 81)
p-value
CR
11 %
30 %
0.002
* At completion of chemotherapy
** At 6 months after HDT/SCT
MM. PETHEMA-94
Progression-free Survival
1,0
0,9
0,8
0,7
0,6
0,5
Auto (median: 43 mos.)
0,4
Probability
0,3
Chemo (median: 34
0,2
mos.)
0,1
p=NS
0,0
0
1020304050
607080
90
100
110
Months
MM. PETHEMA-94
Overall Survival
1,0
0,9
Chemo (median: 66 mos.)
0,8
Auto
(median: 61 mos.)
0,7
0,6
0,5
Probability
0,4
0,3
0,2
p=NS
0,1
0,0
0
204060
80
100
120
Months
MM. PETHEMA-94
Survival after Relapse
1,0
0,9
Chemo (median: 15.9 mos.)
0,8
Auto
(median: 16.4 mos.)
0,7
0,6
0,5
Probability
0,4
0,3
p=NS
0,2
0,1
0,0
0
10203040
50
607080
Months
CONCLUSIONS
In patients with MM responding to the initial
chemotherapy HDT/SCT intensification:
· Increases CR rate
· Has no significant impact on PFS and OS
SPANISH PETHEMA/GEM-2000 TRIAL
VBMCP/VBAD
Bu-MEL or MEL-200 / SCT
1º HDT
CR or nCR
PR or MR
INF/PRED
CVB*/SCT or
2º HDT
"mini-allo**"
*Cyclophosphamide, etoposide, BCNU
INF/PRED
** Fludarabine/Melphalan-140
Prognostic Impact of CR in MM. Preliminary
Results of a Prospective Study in a Series of
Homogeneusly Treated Patients.
Lahuerta J.J., et al.
Abstract # 460. Poster session I
April 11, 2005
Incidence of Sinusoidal Obstruction
Syndrome in Multiple Myeloma Patients
Undergoing Autologous Transplantation
with BUMEL Regimen.
Lahuerta J.J., et al.
Abstract # 402. Poster session I.
April 11, 2005
Results of High-Dose Therapy in Primary
Refractory Myeloma.
Rosiñol L., et al.
Abstract # 382 . Poster session I
April 11, 2005
Feasibility and Efficacy of a Second High
Dose Procedure (second "auto" or "mini-allo")
in Patients Failing to Achieve at Least
near-CR with the First Transplant.
Rosiñol L., et al
Plenary Session 9: Allogeneic Transplantation
April 13, 2005
PETHEMA / GEM 2005 TRIAL
INDUCTION
HDT
MAINTENANCE
Thal / Dex x 6
Thal / Vel
Thal / Dex/ Vel x 6
MEL-200
Thal
VBMCP / VBAD x4
Interpheron
+ Vel x 2
Document Outline