12th Congress of the European Hematology ... - Haematologica

12 th Congress of the European Hematology Association
progression within 3 months after MEL 100 occurred in 39% (7/18) of
patients. Time to progression (TTP) and overall survival (OS) were evaluated
in 78% (14/18) of patients who had median follow-up above 4
months or who died due to event. Median of TTP after MEL 100 was
+3.3 months (range 1-11 months) but TTP was +11, 5, 5, +4,+4 months
in patients at least in PR after MEL 100. Median OS was +5 months
(range 1-12 months) but will be further improved as 44% (8/18) of
patients still alive. Conclusions. Fulminant PGMM is usually fatal event
when conventional chemotherapy as well as new agens are used due to
very aggressive features of this event. MEL 100 is safe salvage regimen
for PGMM with good response rate (61% ORR) and acceptable toxicity.
However outcome is poor for substantial part of patients it is opportunity
for 1/3 of patients to achieve at least PR and stop rapid continuation
of progression. Such a strategy followed by optimal combination
with new drugs (Velcade, IMIDs) can further prolong survival of patients
with this fatal form of PGMM.
0263
THALIDOMIDE-DEXAMETHASONE AS EFFECTIVE TREATMENT OF THE FIRST RELAPSE
AFTER TANDEM AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS TRANSPLATATION OF
MULTIPLE MYELOMA
G. Charlinski, E. Wiater, W. Wiktor-Jedrzejczak,
J. Dwilewicz-Trojaczek
Medical University of Warsaw, WARSAW, Poland
Background. Thalidomide-Dexamethasone (TD) is an efficient drug
combination, which is used in primary treatment of patients with multiple
myeloma (MM). We have attempted to evaluate the use of this protocol
in pts with MM relapsing after tandem autologous peripheral blood
stem cells transplantation (auto-PBSCT). Aims. The end points of the
study were: response, EFS, OS and toxicity. Metods. An analysis was conducted
after the relapse MM in 30 patients (15F/15M) with a median age
of 50 years (range 44-60), who entered the study between February 2003
and October 2006. Nineteen patients had IgG producing MM, 4-IgA, 1nonsecretory,
6-light chain. Clinical stage according ISS: 21 pts in stage
1, 3-stage 2, 6-stage 3. Prior treatment included primary VAD protocol
(vincristin, adriamycin, dexamethasone) followed by cyclophosphamide
mobilization and tandem autoPBSCT after conditioning with high dose
melphalan. Patients were then observed until first signs of disease progression
and then treated with TD. Thalidomide was used in doses 200
mg/day po. continuously until any sign of progressive disease or relapse,
and dexamethasone 40 mg po. for 4 days every 3 weeks. Fifteen (50%)
patients received enoxaparin prophilaxis. The response rate was assessed
using EBMT/IBMTR criteria. Results. Four out of 30 patients (13.3%)
achieved complete remission (CR), 10 patients (33.3%) partial remission
(PR) (M-protein reduction 50-99%), 16 patients (53,4%) stable disease
(SD) (M-protein reduction 0-49%). Time to response was 6 weeks. Six
pts, who had initially stable disease a progression was observed after 6
months. These pts underwent another mobilization treatment with
cyclophosfamide 4 g/m2 and the 3rd autoPBSCT. For remaining patients
on TD the median EFS was 14 months (4-31.3). Duration of treatment
TD was 14.6 months (median), (3-48.6). The median OS has not been
reached. The major adverse events of TD were: constipation-2 patients,
somnolence-3 patients, deep-vein thrombosis-1 patient. We did not
observed neuropathy after TD in this particular group of patients. Conclusions.
The chemotherapy according TD protocol is effective in pts with
relapsing MM after tandem auto-PBSCT. Time to response was shortmedian
6 weeks. TD was well tolerated.
0264
PRACTICAL RECOMMENDATIONS ON THE MANAGEMENT OF VTE IN PATIENTS WITH
RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO ARE TREATED WITH
LENALIDOMIDE AND DEXAMETHASONE
A. Palumbo, 1 M. Dimopoulos, 2 J. San Miguel, 3 J.L. Harousseau, 4 M.
Attal, 5 M. Hussein, 6 S. Knop, 7 H. Ludwig, 8 M. von Lilienfeld-Toal, 9
P. Sonneveld10 1 Az. Osp. S. Giovanni Battista, TORINO, Italy; 2 University of Athens School
of Medicine, ATHENS, Greece; 3 University Hospital of Salamanca, SALA-
MANCA, Spain; 4 Hôtel-Dieu Hospital, NANTES, France; 5 Centre Hospitalier
Université de Purpan, TOULOUSE, France; 6 H.Lee Moffitt Cancer,
Research Institute, TAMPA, FL, USA; 7 University Hospital, WUERZBERG,
Germany; 8Wilhelminenspital, VIENNA, Austria; 9 St. Jamess University Hospital,
LEEDS, United Kingdom; 10 Erasmus Medical Center, ROTTERDAM,
Netherlands
96 | haematologica/the hematology journal | 2007; 92(s1)
Background. In January 2007, an international group of multiple myeloma
(MM) specialists reached a consensus on practical recommendations
regarding the management of lenalidomide treatment (in combination
with dexamethasone) in patients with relapsed/refractory MM, who
have received at least one prior therapy. Aims. To present practical commendations
for prevention and management of venous thromboembolism
(VTE) in these patients. Methods. A moderated round table discussion.
Results. Treatment with lenalidomide/dexamethasone
(Len/Dex) in patients with relapsed/refractory MM has been reported to
be associated with a rate of VTE of 12%. Therefore, it is important to
assess the VTE risk and consider the use of prophylaxis. There was consensus
that the following factors increase the risk for VTE in this setting:
high-tumour mass, concomitant chemotherapy, doxorubicin, high-dose
dexamethasone, erythropoietin use, ongoing infection/inflammation,
older age, thrombophilia, previous VTE, or pre-existing coagulation disorders.
Neither baseline coagulation studies nor screening for VTE in
asymptomatic patients are recommended. Sonography for diagnosis of
VTE is recommended in symptomatic patients. We recommend prophylactic
anticoagulation if any of the above risk factors is present at
treatment with Len/Dex and no prophylaxis in patients without risk
factors. The risk of VTE is particularly high in the first 4'6 months of
therapy. At present there is no evidence of the best prophylaxis: daily
aspirin, low-molecular-weight heparin (LMWH), or therapeutic doses of
warfarin, are the options. The panel suggests the use of low-dose aspirin
(ASA) (81-100 mg) or prophylactic dose of LMWH. Low-dose warfarin
is not recommended, therapeutic-dose warfarin seems to be associated
with an increased risk of severe haemorrhage. All patients need to
receive clear instructions on how to proceed in case clinical symptoms
of VTE occur. When VTE has occurred, the patient can be continued on
treatment with Len/Dex or retreated after stabilization depending on the
severity of the VTE. For therapeutic anticoagulation, patients previously
on ASA should be switched to LMWH; and patients already on prophylactic
doses of LMWH should receive therapeutic doses. Conclusions.
In relapsed/refractory MM patients who receive lenalidomide, VTE prophylaxis
with ASA or LMWH is suggested if at least one of the above
listed risk factors is present.
0265
PRACTICAL RECOMMENDATIONS ON THE MANAGEMENT OF CYTOPENIAS IN PATIENTS
WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO ARE TREATED WITH
LENALIDOMIDE AND DEXAMETHASONE
A. Palumbo, 1 P. Sonneveld, 2 M. Dimopoulos, 3 J. San Miguel, 4
J.L. Harousseau, 5 M. Attal, 6 M. Hussein, 7 S. Knop, 8 H. Ludwig, 9
M. von Lilienfeld-Toal10 1 Az. Osp. S. Giovanni Battista, TORINO, Italy; 2 Erasmus Medical Center,
ROTTERDAM, Netherlands; 3 University of Athens School of Medicine,
ATHENS, Greece; 4 University Hospital of Salamanca, SALAMANCA, Spain;
5 Hôtel-Dieu Hospital, NANTES, France; 6 Centre Hospitalier Université de Purpan,
TOULOUSE, France; 7 H.Lee Moffitt Cancer, Research Institute, TAM-
PA, FL, USA; 8 University Hospital, WUERZBERG, Germany; 9 Wilhelminenspital,
VIENNA, Austria; 10 St. Jamess University Hospital, LEEDS, United
Kingdom;
Background. In January 2007, an international group of multiple myeloma
(MM) specialists reached a consensus on practical recommendations
regarding management of lenalidomide treatment (in combination with
dexamethasone) in patients with relapsed/refractory MM, who received
?1 prior therapy. Aims. This communication focuses on recommendations
regarding the management of cytopenias in these patients. Methods.
Moderated round table discussion. Results. In published studies,
11.6% of patients treated with lenalidomide/dexamethasone (Len/Dex)
had NCI grade 3 neutropenia and 3.3% grade 4 neutropenia (Chen et al.,
Blood 2006; 108:3556). This was the most frequent reason for discontinuation
of therapy and dose reduction. The rate of grade 4 febrile neutropenia
was