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A432 Long-Term Treatment with Lenalidomide in Previously Treated Subjects with Multiple Myeloma
Clinical Studies Including Transplantation A425 EGFR Based on Cystatin-C, Creatinine, and Age Is Independently Associated with Survival in Myeloma MA Dimopoulos, E Kastritis, E Katodritou, E Tsiftsakis, D Christoulas, E Verrou, E Michalis, A Pouli, K Zervas, E Terpos Greek Myeloma Study Group
Introduction and Aims: Renal impairment (RI) is a common complication of multiple myeloma (MM). Cystatin-C (Cys-C) is considered as a sensitive marker of glomerular filtration rate (GFR). A recent study in > 3400 patients with chronic kidney disease showed that estimating GFR (eGFR) based on serum creatinine, Cys-C, age, gender and race (eGFR/Cys/Cr) provides the most accurate GFR estimates: eGFR = 177.6×Scr-0.65×CysC-0.57 × age-0.20 × (0.82 if female) × (1.11 if black). The aim of this study was to evaluate eGFR/Cys/Cr, compare it with eGFR assessed by MDRD equation and explore possible correlations with clinical data, including survival. Patients and Methods: We studied 157 newly-diagnosed MM patients (87 male/70 female; median age, 68 years) before any kind of therapy and evaluated both eGFR/Cys/ Cr and eGFR/MDRD. Serum Cys-C was determined by particle enhanced immunonephelometry (Dade Behring, Liederbach, Germany). Results: Serum Cys-C was increased in MM patients compared to 52 controls [median: 1.01 mg/L vs. 0.72 mg/L; P < .0001], and correlated with ISS (P < 0.001), bone disease status (P < .01), beta2-microglobulin (r = 0.648; P < .0001), creatinine (r = 0.705; P < .0001), and urea (r = 0.471; P < .0001). Median values of eGFR/Cys/Cr (68.7 mL/min/1.73 m2) were not different compared with those of eGFR/MDR (66.1 mL/min/1.73 m2). Furthermore, there was no difference in terms of number of patients with RI of different stages between the two estimates (ie, 8 patients had stage 5 RI with both estimates, while stage 4 RI had 13 patients based on eGFR/Cys/Cr and 12 based on eGFR/MDRD, and stage 3 RI had 43 with eGFR/Cys/Cr and 41 with eGFR/MDRD). The median survival was 48 months (median follow-up, 20 months). In univariate analysis eGFR/Cys/Cr (but not eGFR/MDRD), Cys-C, LDH, ISS, bone disease and myeloma subtype (light chain only MM vs. others) predicted for survival. In multivariate analysis only eGFR/Cys/Cr (= 0.004), bone disease (P = .018) and LDH (P = .01) had independent prognostic value with eGFR/Cys/Cr having the higher prognostic significance. Conclusion: eGFR/Cys/Cr estimates RI comparable to eGFR/MDRD. However, only eGFR/Cys/Cr strongly correlates with survival. This may be due to the better reflection of both renal function and tumor burden by eGFR/Cys/Cr as Cys-C is also overproduced by myeloma cells.
A426 Bortezomib or Lenalidomide to Treat Disease Relapse After Allogeneic Transplantation in Myeloma V Montefusco,1 AP Falcone,1 AM Carella,1 A Olivieri,2 G Sanpaolo,1 L Farina,3 F Spina,3 A Dodero,3 M Morelli,3 R Milani,3 N Cascavilla,1 P Corradini3
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1
Department of Hematology, IRCCS ‘Casa Sollievo della Sofferenza’, San Giovanni Rotondo, Italy; 2Department of Oncology and Haematology, San Carlo Hospital, Potenza, Italy; 3Department of Haematology, Istituto Nazionale dei Tumori, Milano, Italy
Allogeneic stem cell transplantation (allo-HSCT) represents an effective treatment option for multiple myeloma (MM). However, clinical relapse or progression after allo-HSCT is rather common and new therapeutic strategies for salvage are needed. New drugs, in particular bortezomib and lenalidomide, are appealing for several reasons: (1) they have a very limited hematopoietic toxicity; (2) the mechanisms of antitumor activity are different from that of chemotherapy; (3) their activity encompasses also the modulation of immune response, with potential effects on the graft versus-myeloma effect. In order to evaluate the role of bortezomib and lenalidomide, we collected the data from 20 patients relapsing after allo-HSCT at 3 Italian institutions. Median age at transplantation was 53 years (range, 35-64 years). Donors were HLA-identical siblings in 15 and matched unrelated donors in 5 patients. After allo-HSCT, 9 patients developed acute graft-versus-host disease (GVHD), and 12 chronic GVHD (9 limited, 3 extensive). Nine patients were treated with bortezomib, 7 patients with lenalidomide, and 4 patients received bortezomib and, subsequently, lenalidomide. The median interval between allo-HSCT and bortezomib or lenalinomide treatments were 29 (range, 7-144), and 26 months (range, 7-66 months) respectively. The 13 patients treated with bortezomib received a median number of 3 courses (range, 1-7), in all cases with dexamethasone and, in 8 cases, also with thalidomide. Disease response was as follows: 5 CRs or nCRs, 4 VGPRs, 2 PRs, and 2 no response. The median duration of response (DOR) was 10 months (range, 6-43 months). Longer DOR were observed in patients receiving also thalidomide. The 11 patients treated with lenalidomide received a median number of 6 courses (range, 212), in all cases with dexamethasone. Disease response was as follows: 2 CRs, 2 VGPRs, 3 PRs, and 4 no response. The median DOR was 6 months (range, 4-12 months). Main toxicities were neuropathy for bortezomib, and neutropenia for lenalidomide. No grade IV toxicities were recorded. In one case only a GVHD worsening was observed. In conclusion, bortezomib and lenalidomide are effective therapeutic options for myeloma relapse after allo-HSCT. In addition, they can used safely before donor lymphocyte infusions.
A432 Long-Term Treatment with Lenalidomide in Previously Treated Subjects with Multiple Myeloma AA Amor, B Aguado, C Camara, A Velasco, F Garcia-Escribano Hematology Department, Hospital Universitario de la Princesa, Madrid
Introduction: Thalidomide or the proteasome inhibitor bortezomib improved the treatment outcomes in multiple myeloma, but the side effects of fatigue, neuropathy, constipation, and thrombotic events remain a concern. In nearly all patients who receive these drugs or other chemotherapy, the disease eventually relapses and is subsequently resistant to treatment. The published clinical trials of lenalidomide with dexamethasone in patients with treatment refractory or relapse multiple myeloma showed an increased efficacy and a tolerable safety
Clinical Lymphoma & Myeloma Supplement February 2009
XII International Myeloma Workshop profile, which allows to administered the treatment until disease progression, increasing the median TTP. We report the experience from those patients treated for more than 12 months in our centre. Methods: Patients diagnosed with multiple myeloma that is progressing after at least 2 cycles of anti-myeloma treatment or that has relapsed with progressive disease after treatment, were suitable to start the treatment with lenalidomide and dexamethasone. Efficacy and safety of the treatment were assessed in every treatment cycle. Lenalidomide treatment is maintained until disease progression or intolerance. Results: Two patients have received long treatment (14 months by the time of submission of this communication). Patient A: a 61-year-old male who received 2 previous therapy lines (stem cell transplantation and bortezomib). A complete response was achieved at the fifth cycle and its tolerability did not require any dose modification for the 14 cycles administered until now. Patient B: an 81-year-old female who previously received several lines of therapy (alkilators, anthracilines, bortezomib, thalidomide). Lenalidomide dose was reduced to 15 mg in the third cycle due to side effects. A Partial Response was achieved at the fifth cycle. The dose of 15 mg has been maintained after a total of 14 cycles. Conclusion: Lenalidomide could offer the possibility of treating patients suffering from multiple myeloma until progression, independently of when it could happen. Long term treatment until relapse or progression in Multiple Myeloma is feasible. Further experiences and results from other studies are expected.
samples availability. The measurements were performed by ELISA according to the manufacturer’s instructions (Diaclone Research for s-synd-1 and R&D Systems for the rest of the cytokines). Values under the median for each cytokine were defined as low. Statistical analysis was performed by standard methods. Median serum s-synd-1 was 72 ng/mL. Patients with low s-synd-1 had significantly higher 5year-survival (68 vs. 43%; P = .019). Median VEGF was 302 pg/mL. High VEGF levels correlated with high platelet counts (P = .003) and abnormal LDH (P = .017) while there was no correlation with survival. IL-6 was detectable in only 14 patients. Median sIL-6R was 5949 pg/mL. Patients with low sIL-6R had higher 5-year-survival (85 vs. 43%; P = .008) while high sIL-6R correlated with low platelet levels (P = .014). Median BlyS was 122 pg/mL and patients with low BLyS had higher 5-year survival (74% vs. 49%; P = .051). Serum s-synd-1 correlated with sIL-6R (P = .04) and BLyS (P = .033) while sIL-6R and BLyS also correlated between them (P = .003).In conclusion, baseline serum s-synd-1, sIL-6R and BLyS levels have a prognostic impact MM. Their levels correlated between them.
A435 Dex/Thal as Induction and Maintenance Treatment in Elderly Patients with MM: A Randomized Trial MM Mounier,1 D Clerc,1 K Beladj,2 R Delarue,3 B Joly,4 B Arnulf,5 A Jaccard,6 P Genet,7 D Bouscary,8 O Fain,9 S Choquet,10 M Janvier,11 S Chevret,12 JP Fermand12
A433 Comparison of Serum Cytokines with Prognostic Impact in MM
1
CHU Kremlin-Bicêtre; 2CHU Creteil; 3Hôpital Necker, Paris; 4CH
D Maltezas,1 T Tzenou,1 TP Vassilakopoulos,2 P Repousis,3 X Papanikolaou,3 M Dimou,2 N Stavropoulos,2 A Pouli,4 P Panayiotidis,2 GA Pangalis,2 MC Kyrtsonis1
Corbeil; 5Hôpital Saint Louis, Paris; 6CHU Limoges; 7CH Argenteuil; 8
Hôpital Cochin, Paris; 9CHU Bondy; 10Hôpital Pitié-Salpétrière,
Paris; 11CH Saint Cloud;
12
Hôpital Saint Louis, Paris
1
First Department of Propedeutic Internal Medicine, Laikon Hospital,
Athens; 2Haematology Department, Laikon Hospital, Athens; 3
Haematology, Department, Metaxas Hospital, Piraeus;
4
Haematology Department, Ag. Savvas Hospital, Athens
MM cell adhesion to the medullary milieu induces signaling and promotes cytokines secretion. Some of these cytokines were shown to play a role in MM pathophysiology and their baseline serum levels were found related to disease aggressiveness and/or patients’ survival; among them IL-6 and its soluble receptor (sIL-6R) are considered the major plasma cell growth factor complex, syndecan1 and its cleaved soluble form (s-synd-1) contribute to myeloma cell adhesion and behavior, VEGF promotes neoangiogenesis and BLyS modulates normal B-cell development and differentiation. The purpose of the present study was to determine the baseline serum levels of the aforementioned cytokines and to investigate the relationship between them and with disease parameters. We studied 134 MM patients. 68 were males and 64 females with a median age of 69 years (range, 42-87 years). 28.5% were ISS stage I, 26% stage II and 45.5% stage III respectively. Thirteen percent had impaired renal function, 27% presented anemia and 4% thrombocytopenia. S-synd-1 was measured in 134 patients while VEGF, IL-6, sIL-6R, and BLyS in 99, 90, 101, and 88, respectively, because of stored
One hundred sixty-four patients older than 66 years with untreated multiple myeloma (MM) were randomly assigned to receive melphalan, cytoxan and Dex alone (MCDex arm) or MCDex thalidomide (Thal). Then, in both groups, patients received a MCP (MC, prednisone) regimen until the achievement of a stable plateau phase. Patients in the MCDex arm received 3-monthly courses of M (6 mg/m2 D1 to 4), C (600 mg/m2 I.V. D1) and Dex (40 mg/d for 4 days). Patients in the MCDex/Thal arm received the same regimen plus Thal (200 mg/d) for 3 months. Anticoagulation prophylaxis wasn’t systematically given. Main characteristics of patients included in the MCDex/Thal arm (n = 82) and in the MCDex arm (n = 82) were similar including age (mean, 73 years) and ISS. After induction regimen, 32% of patients achieved a very good partial response (VGPR) in the MCDex/Thal arm as compared to 9% in the MCDex arm (P = .0010). After MCP (median 5 courses) 31% and 9% of patients reached VGPR (P = .0016). A thrombotic event (TE) was recorded in 22% vs. 13% patients (P = .22) and a symptomatic peripheral neuropathy in 20% and 4% respectively (P = .003). According to a second randomization, patients received either sequential Dex/Thal or no maintenance treatment. In the maintenance arm (n = 29), patients received Dex (40 mg/d for 4 days monthly) Thal (200 mg/d) every other 3 moths for 3 months.
Clinical Lymphoma & Myeloma Supplement February 2009
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Introduction and Aims: Renal impairment (RI) is a common complication of multiple myeloma (MM). Cystatin-C (Cys-C) is considered as a sensitive marker of glomerular filtration rate (GFR). A recent study in > 3400 patients with chronic kidney disease showed that estimating GFR (eGFR) based on serum creatinine, Cys-C, age, gender and race (eGFR/Cys/Cr) provides the most accurate GFR estimates: eGFR = 177.6×Scr-0.65×CysC-0.57 × age-0.20 × (0.82 if female) × (1.11 if black). The aim of this study was to evaluate eGFR/Cys/Cr, compare it with eGFR assessed by MDRD equation and explore possible correlations with clinical data, including survival. Patients and Methods: We studied 157 newly-diagnosed MM patients (87 male/70 female; median age, 68 years) before any kind of therapy and evaluated both eGFR/Cys/ Cr and eGFR/MDRD. Serum Cys-C was determined by particle enhanced immunonephelometry (Dade Behring, Liederbach, Germany). Results: Serum Cys-C was increased in MM patients compared to 52 controls [median: 1.01 mg/L vs. 0.72 mg/L; P < .0001], and correlated with ISS (P < 0.001), bone disease status (P < .01), beta2-microglobulin (r = 0.648; P < .0001), creatinine (r = 0.705; P < .0001), and urea (r = 0.471; P < .0001). Median values of eGFR/Cys/Cr (68.7 mL/min/1.73 m2) were not different compared with those of eGFR/MDR (66.1 mL/min/1.73 m2). Furthermore, there was no difference in terms of number of patients with RI of different stages between the two estimates (ie, 8 patients had stage 5 RI with both estimates, while stage 4 RI had 13 patients based on eGFR/Cys/Cr and 12 based on eGFR/MDRD, and stage 3 RI had 43 with eGFR/Cys/Cr and 41 with eGFR/MDRD). The median survival was 48 months (median follow-up, 20 months). In univariate analysis eGFR/Cys/Cr (but not eGFR/MDRD), Cys-C, LDH, ISS, bone disease and myeloma subtype (light chain only MM vs. others) predicted for survival. In multivariate analysis only eGFR/Cys/Cr (= 0.004), bone disease (P = .018) and LDH (P = .01) had independent prognostic value with eGFR/Cys/Cr having the higher prognostic significance. Conclusion: eGFR/Cys/Cr estimates RI comparable to eGFR/MDRD. However, only eGFR/Cys/Cr strongly correlates with survival. This may be due to the better reflection of both renal function and tumor burden by eGFR/Cys/Cr as Cys-C is also overproduced by myeloma cells.
A426 Bortezomib or Lenalidomide to Treat Disease Relapse After Allogeneic Transplantation in Myeloma V Montefusco,1 AP Falcone,1 AM Carella,1 A Olivieri,2 G Sanpaolo,1 L Farina,3 F Spina,3 A Dodero,3 M Morelli,3 R Milani,3 N Cascavilla,1 P Corradini3
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1
Department of Hematology, IRCCS ‘Casa Sollievo della Sofferenza’, San Giovanni Rotondo, Italy; 2Department of Oncology and Haematology, San Carlo Hospital, Potenza, Italy; 3Department of Haematology, Istituto Nazionale dei Tumori, Milano, Italy
Allogeneic stem cell transplantation (allo-HSCT) represents an effective treatment option for multiple myeloma (MM). However, clinical relapse or progression after allo-HSCT is rather common and new therapeutic strategies for salvage are needed. New drugs, in particular bortezomib and lenalidomide, are appealing for several reasons: (1) they have a very limited hematopoietic toxicity; (2) the mechanisms of antitumor activity are different from that of chemotherapy; (3) their activity encompasses also the modulation of immune response, with potential effects on the graft versus-myeloma effect. In order to evaluate the role of bortezomib and lenalidomide, we collected the data from 20 patients relapsing after allo-HSCT at 3 Italian institutions. Median age at transplantation was 53 years (range, 35-64 years). Donors were HLA-identical siblings in 15 and matched unrelated donors in 5 patients. After allo-HSCT, 9 patients developed acute graft-versus-host disease (GVHD), and 12 chronic GVHD (9 limited, 3 extensive). Nine patients were treated with bortezomib, 7 patients with lenalidomide, and 4 patients received bortezomib and, subsequently, lenalidomide. The median interval between allo-HSCT and bortezomib or lenalinomide treatments were 29 (range, 7-144), and 26 months (range, 7-66 months) respectively. The 13 patients treated with bortezomib received a median number of 3 courses (range, 1-7), in all cases with dexamethasone and, in 8 cases, also with thalidomide. Disease response was as follows: 5 CRs or nCRs, 4 VGPRs, 2 PRs, and 2 no response. The median duration of response (DOR) was 10 months (range, 6-43 months). Longer DOR were observed in patients receiving also thalidomide. The 11 patients treated with lenalidomide received a median number of 6 courses (range, 212), in all cases with dexamethasone. Disease response was as follows: 2 CRs, 2 VGPRs, 3 PRs, and 4 no response. The median DOR was 6 months (range, 4-12 months). Main toxicities were neuropathy for bortezomib, and neutropenia for lenalidomide. No grade IV toxicities were recorded. In one case only a GVHD worsening was observed. In conclusion, bortezomib and lenalidomide are effective therapeutic options for myeloma relapse after allo-HSCT. In addition, they can used safely before donor lymphocyte infusions.
A432 Long-Term Treatment with Lenalidomide in Previously Treated Subjects with Multiple Myeloma AA Amor, B Aguado, C Camara, A Velasco, F Garcia-Escribano Hematology Department, Hospital Universitario de la Princesa, Madrid
Introduction: Thalidomide or the proteasome inhibitor bortezomib improved the treatment outcomes in multiple myeloma, but the side effects of fatigue, neuropathy, constipation, and thrombotic events remain a concern. In nearly all patients who receive these drugs or other chemotherapy, the disease eventually relapses and is subsequently resistant to treatment. The published clinical trials of lenalidomide with dexamethasone in patients with treatment refractory or relapse multiple myeloma showed an increased efficacy and a tolerable safety
Clinical Lymphoma & Myeloma Supplement February 2009
XII International Myeloma Workshop profile, which allows to administered the treatment until disease progression, increasing the median TTP. We report the experience from those patients treated for more than 12 months in our centre. Methods: Patients diagnosed with multiple myeloma that is progressing after at least 2 cycles of anti-myeloma treatment or that has relapsed with progressive disease after treatment, were suitable to start the treatment with lenalidomide and dexamethasone. Efficacy and safety of the treatment were assessed in every treatment cycle. Lenalidomide treatment is maintained until disease progression or intolerance. Results: Two patients have received long treatment (14 months by the time of submission of this communication). Patient A: a 61-year-old male who received 2 previous therapy lines (stem cell transplantation and bortezomib). A complete response was achieved at the fifth cycle and its tolerability did not require any dose modification for the 14 cycles administered until now. Patient B: an 81-year-old female who previously received several lines of therapy (alkilators, anthracilines, bortezomib, thalidomide). Lenalidomide dose was reduced to 15 mg in the third cycle due to side effects. A Partial Response was achieved at the fifth cycle. The dose of 15 mg has been maintained after a total of 14 cycles. Conclusion: Lenalidomide could offer the possibility of treating patients suffering from multiple myeloma until progression, independently of when it could happen. Long term treatment until relapse or progression in Multiple Myeloma is feasible. Further experiences and results from other studies are expected.
samples availability. The measurements were performed by ELISA according to the manufacturer’s instructions (Diaclone Research for s-synd-1 and R&D Systems for the rest of the cytokines). Values under the median for each cytokine were defined as low. Statistical analysis was performed by standard methods. Median serum s-synd-1 was 72 ng/mL. Patients with low s-synd-1 had significantly higher 5year-survival (68 vs. 43%; P = .019). Median VEGF was 302 pg/mL. High VEGF levels correlated with high platelet counts (P = .003) and abnormal LDH (P = .017) while there was no correlation with survival. IL-6 was detectable in only 14 patients. Median sIL-6R was 5949 pg/mL. Patients with low sIL-6R had higher 5-year-survival (85 vs. 43%; P = .008) while high sIL-6R correlated with low platelet levels (P = .014). Median BlyS was 122 pg/mL and patients with low BLyS had higher 5-year survival (74% vs. 49%; P = .051). Serum s-synd-1 correlated with sIL-6R (P = .04) and BLyS (P = .033) while sIL-6R and BLyS also correlated between them (P = .003).In conclusion, baseline serum s-synd-1, sIL-6R and BLyS levels have a prognostic impact MM. Their levels correlated between them.
A435 Dex/Thal as Induction and Maintenance Treatment in Elderly Patients with MM: A Randomized Trial MM Mounier,1 D Clerc,1 K Beladj,2 R Delarue,3 B Joly,4 B Arnulf,5 A Jaccard,6 P Genet,7 D Bouscary,8 O Fain,9 S Choquet,10 M Janvier,11 S Chevret,12 JP Fermand12
A433 Comparison of Serum Cytokines with Prognostic Impact in MM
1
CHU Kremlin-Bicêtre; 2CHU Creteil; 3Hôpital Necker, Paris; 4CH
D Maltezas,1 T Tzenou,1 TP Vassilakopoulos,2 P Repousis,3 X Papanikolaou,3 M Dimou,2 N Stavropoulos,2 A Pouli,4 P Panayiotidis,2 GA Pangalis,2 MC Kyrtsonis1
Corbeil; 5Hôpital Saint Louis, Paris; 6CHU Limoges; 7CH Argenteuil; 8
Hôpital Cochin, Paris; 9CHU Bondy; 10Hôpital Pitié-Salpétrière,
Paris; 11CH Saint Cloud;
12
Hôpital Saint Louis, Paris
1
First Department of Propedeutic Internal Medicine, Laikon Hospital,
Athens; 2Haematology Department, Laikon Hospital, Athens; 3
Haematology, Department, Metaxas Hospital, Piraeus;
4
Haematology Department, Ag. Savvas Hospital, Athens
MM cell adhesion to the medullary milieu induces signaling and promotes cytokines secretion. Some of these cytokines were shown to play a role in MM pathophysiology and their baseline serum levels were found related to disease aggressiveness and/or patients’ survival; among them IL-6 and its soluble receptor (sIL-6R) are considered the major plasma cell growth factor complex, syndecan1 and its cleaved soluble form (s-synd-1) contribute to myeloma cell adhesion and behavior, VEGF promotes neoangiogenesis and BLyS modulates normal B-cell development and differentiation. The purpose of the present study was to determine the baseline serum levels of the aforementioned cytokines and to investigate the relationship between them and with disease parameters. We studied 134 MM patients. 68 were males and 64 females with a median age of 69 years (range, 42-87 years). 28.5% were ISS stage I, 26% stage II and 45.5% stage III respectively. Thirteen percent had impaired renal function, 27% presented anemia and 4% thrombocytopenia. S-synd-1 was measured in 134 patients while VEGF, IL-6, sIL-6R, and BLyS in 99, 90, 101, and 88, respectively, because of stored
One hundred sixty-four patients older than 66 years with untreated multiple myeloma (MM) were randomly assigned to receive melphalan, cytoxan and Dex alone (MCDex arm) or MCDex thalidomide (Thal). Then, in both groups, patients received a MCP (MC, prednisone) regimen until the achievement of a stable plateau phase. Patients in the MCDex arm received 3-monthly courses of M (6 mg/m2 D1 to 4), C (600 mg/m2 I.V. D1) and Dex (40 mg/d for 4 days). Patients in the MCDex/Thal arm received the same regimen plus Thal (200 mg/d) for 3 months. Anticoagulation prophylaxis wasn’t systematically given. Main characteristics of patients included in the MCDex/Thal arm (n = 82) and in the MCDex arm (n = 82) were similar including age (mean, 73 years) and ISS. After induction regimen, 32% of patients achieved a very good partial response (VGPR) in the MCDex/Thal arm as compared to 9% in the MCDex arm (P = .0010). After MCP (median 5 courses) 31% and 9% of patients reached VGPR (P = .0016). A thrombotic event (TE) was recorded in 22% vs. 13% patients (P = .22) and a symptomatic peripheral neuropathy in 20% and 4% respectively (P = .003). According to a second randomization, patients received either sequential Dex/Thal or no maintenance treatment. In the maintenance arm (n = 29), patients received Dex (40 mg/d for 4 days monthly) Thal (200 mg/d) every other 3 moths for 3 months.
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