An Experience on Pomalidomide in Patients within Relapsed/Refractory Multiple Myeloma - A Multicenter Study in Turkey

2021 ◽  
pp. 92-98
Author(s):  
Mehmet Ali Erkurt ◽  
Fehmi Hindilerden ◽  
Omer Ekinci ◽  
Jale Yildiz ◽  
Mehmet Sinan Dal ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Side Effects ◽  
Cox Regression ◽  
Single Agent ◽  
Eastern Cooperative Oncology Group ◽  
Cox Regression Analysis ◽  
Refractory Multiple Myeloma ◽  
Thalidomide Analogue ◽  
New Generation

Objective: Pomalidomide is a new generation thalidomide analogue. Effectiveness as a single agent or combination with low dose dexamethasone has been in the treatment of relapse/refractory Multiple Myeloma (MM). The aim of the present study was to share the experience of different oncology centres with pomalidomide treatment in patients with relapsed/refractory MM. Materials and Methods: Seventy-three patients from 16 centres were enrolled into the study. The patients were followed for a median of 6 months. Relapsed/refractory MM patients who received at least one line of treatment before pomalidomide were included into the study.  ISS, R-ISS and Eastern Cooperative Oncology Group (ECOG) scores of the patients and treatment-related side effects were evaluated. Results: As a result of the median follow-up for 6 months, 36% (26/72) of the patients presented progression. The estimated median PFS was found 29 months. The Cox regression analysis revealed that ECOG affected PFS only, myeloma subtype; ISS and R-ISS scores did not affect PFS. The most common side effects with pomalidomide treatment in our population include neutropenia, infections, anaemia and thrombocytopenia. Conclusion: In our study, it was statistically shown that the ECOG score was effective in survival in relapsed / refractory MM patients treated by pomalidomide. Therefore, we recommend evaluation of the ECOG score for each patient before treatment in eligible cases.

Intensive Versus Double Intensive Therapy in Untreated Multiple Myeloma: Updated Analysis of the Randomized Phase III Study HOVON 24 MM.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 948-948 ◽  
Author(s):  
Pieter Sonneveld ◽  
Bronno van der Holt ◽  
Christine Segeren ◽  
Edo Vellenga ◽  
Reinier Raymakers ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Cox Regression ◽  
Intensive Therapy ◽  
Elevated Serum ◽  
Intensive Treatment ◽  
Phase Iii ◽  
Remission Induction ◽  
Free Survival ◽  
Cox Regression Analysis

Abstract In 1995 HOVON started a prospective randomized multicenter trial to compare the efficacy of intensified treatment followed by myelo-ablative therapy and stem cell transplantation (PBSCT) with intensified treatment alone in patients with myeloma. We now report the results of a second analysis in 441 eligible patients with stage II (22%) and III (78%) disease. The median age was 55 years. Remission induction consisted of 3 courses of VAD. 63 patients with an HLA identical sibling were candidates for an allogeneic transplantation. After VAD, patients without donor were randomized to melphalan 140 mg/m2 divided in 2 doses of 70 mg/m2 (IDM) without PBSCT (arm A) or this regimen followed by myelo-ablation with cyclophosphamide (120 mg/kg) and TBI with PBSCT (arm B). Peripheral stem cells were mobilized by cyclophosphamide and G-CSF after VAD. Interferon-a -2a was given as maintenance therapy in both arms. Of 441 patients, 303 were eligible for randomization. Patient characteristics were not significantly different between the two arms. The median follow-up from randomization was 56 months. 81% of patients received both cycles of IDM (79% in arm A and 83% in arm B) and 79% of patients received myeloablative therapy followed by autologous PBSCT in arm B. The median duration of maintenance treatment was 12 (arm A) vs 7 months (arm B). The CR rate was better in Arm B (28% vs 13% , p=0.002), while overall response rate (PR + CR) was not different (90% vs 86% , p=0.23). Median event-free survival (EFS) from randomization was 22 (arm B) vs 20 months (arm A) (logrank p=0.016). Median progression-free survival (PFS) was significantly better in patients treated with double intensification (24 vs 23 months, logrank p=0.036). Time to Progression (TTP) was significantly worse in arm A (median 25 vs 33 months, logrank p=0.001). The difference for EFS, PFS and TTP became only evident after at least 4 years of follow-up. Overall survival (OS) was not different (55 months in arm A vs 50 in arm B, logrank p=0.38). Multivariate analysis showed that treatment arm A, higher age, hemoglobin < 6.21 mmol/l, stage 3 and elevated serum LDH were significant adverse prognostic factors for EFS. Cytogenetic analysis, available in 151 registered patients was abnormal in 37% (45% del 13/13q-, 51% abnormal 1p/q, 33% del 6q, 89% complex abnormalities). Cox regression analysis showed that 1p/q was an independent unfavourable prognostic factor for OS, EFS, PFS and TTP (p<0.001), calculated from start VAD. Del 13/13q- was highly correlated with 1p/q abnormalities. By combining B2M > 3 mg/L with del13/13q- and 1p/q, prognostic groups could be defined with a significant impact on OS (p<0.000002), EFS (p< 0.0002), PFS (p <0.00006) and TTP (p<0.0000002). Quality of Life analysis showed significant improvement of disease-related variables in double intensive treatment. In conclusion, in this trial second intensification by myeloablative treatment with cyclophosphamide/TBI when added to intensified chemotherapy alone resulted in a superior EFS, PFS and TTP, but not OS. The results of this trial indicate that double intensive treatment results in superior outcome, but not cure in multiple myeloma.

Extended follow-up of outcome measures and analysis of prognostic factors in multiple myeloma patients treated on a phase I study with bortezomib and pegylated liposomal doxorubicin

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7617-7617 ◽  
Author(s):  
S. E. Biehn ◽  
D. T. Moore ◽  
P. M. Voorhees ◽  
R. A. Garcia ◽  
M. J. Lehman ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Phase I ◽  
Liposomal Doxorubicin ◽  
Cox Regression ◽  
Single Agent ◽  
Pegylated Liposomal Doxorubicin ◽  
Rank Test ◽  
Significant Activity ◽  
Prior Therapy

7617 Background: Preclinical studies of bortezomib (bort) with pegylated liposomal doxorubicin (PLD) showed enhanced anti-tumor efficacy compared with either single agent. This led to a phase I trial in patients (pts) with advanced hematologic malignancies who received bort on days 1, 4, 8 and 11 at 0.9–1.5 mg/m2, and PLD on day 4 at 30 mg/m2, every three weeks (Blood 105:3058, 2005). Significant activity was seen, with 36% of relapsed/refractory multiple myeloma (MM) pts achieving a complete or near-complete response, while 73% attained at least a partial response. It was therefore of interest to define time to progression (TTP) and overall survival (OS) with this regimen. Methods: Additional follow-up was obtained on all 22 evaluable MM pts. TTP and OS were determined from day 1 of bort/PLD, and the Kaplan-Meier method was used to calculate time-to-event estimators. The log-rank test was used to compare TTP and time to retreatment (TTR) on bort/PLD vs. the prior therapy. Cox regression was used to evaluate covariates for association with TTP and OS. Results: Median TTP with bort/PLD was 9.3 months (mos)(95% confidence interval (CI) 8.3–22.4) versus 3.8 mos (95% CI 2.3–10.0) on the pt’s prior therapy (p=0.04). Similarly, the median TTR after bort/PLD was prolonged (p=0.04) compared with TTR after the prior regimen, with 3 pts having not yet received their next therapy. With a median follow-up of 36 mos, 13 of these patients (59%) remain alive, and the median OS has not yet been reached. Karnofsky performance status was significantly associated with TTP (p=0.02), while the hematocrit (hct; p=0.06) and IgA subtype (p=0.08) had borderline significance. Hct was significantly associated with OS (p=0.03), while the number of prior regimens (p=0.07) and the platelet count (p=0.06) had borderline significance. Conclusions: Bort alone induced a median TTP of 6.6 mos and OS of 16 mos in MM (N Engl J Med 348: 2609, 2003). The current results support the possibility that the bort/PLD regimen may improve upon TTP, and especially OS, compared with bort alone. This hypothesis is being studied in a randomized, international phase 3 trial ( NCT00103506 ) comparing bort and bort/PLD. No significant financial relationships to disclose.

Thalidomide Based Regimens for Treatment of Unfit Patients with Relapsed and Refractory Multiple Myeloma: a Monocentric Experience

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 5048-5048
Author(s):  
Alessandro Moscetti ◽  
Francesca Saltarelli ◽  
Maria Paola Bianchi ◽  
Bruno Monarca ◽  
Giacinto La Verde
Keyword(s):  
Multiple Myeloma ◽  
Side Effects ◽  
Response Rate ◽  
Conflicts Of Interest ◽  
Therapeutic Option ◽  
Alkylating Agents ◽  
High Dose ◽  
Refractory Multiple Myeloma ◽  
Unfit Patients

Abstract Abstract 5048 Thalidomide, an immunomodulating drug with antiangiogenic activity, is an efficacious therapeutic option for unfit patients with multiple myeloma. Its efficacy may be increased by the addiction of steroids or other cytotoxic drugs such melphalan or cyclophosphamide. In this study we assessed the efficacy and toxicity of thalidomide based regimens as savage therapy in a series of elderly patients with relapsed/refractory multiple myeloma. Previous treatments included at least one therapy (range 1–4), such as high dose dexamethasone, alkylating agents, anthracyclines, IFN-α and autologous graft. Thalidomide 50–200 mg/die was administered orally in a total of 16 patients (median age 73.8 years, range 59–84) with relapsed/refractory multiple myeloma observed in our Hematology Department between May 2004 and January 2010. Oral dexamethasone or prednisone was added to the treatment. All patients continued therapy until relapse or progression and were prospectively followed-up including accurate monitoring of side effects. Response to thalidomide was assessed according to the European Group for Blood and Marrow Transplantation criteria. The median follow-up time was 25.6 months (range 8 – 68). Overall response rate was 81.2% (13/16 patients) with a median duration of response of 26.7 months (range 7 – 67): 3 patients showed a very good partial remission, 10 partial response, 1 stable disease and 2 progression of disease. During follow-up, 6 patients died (3 due to progression, 2 due to other neoplasm, 1 due to heart failure), 10 patients are still alive (2 VGPR and 7 PR in continuous therapy, 1 PD in third line therapy). No response was observed in 3/16 patients (18.7%). Despite the following side effects, mild to moderate bradycardia (25%, 1 needed PMK positioning and 1 dose reduction), peripheral sensitive polyneuropathy (18.7%) and constipation (6%), no patient discontinued therapy. This study shows that thalidomide based regimens are an effective therapy with a high response rate and manageable side effects when used in patient with multiple myeloma with relapsed/refractory disease. Disclosures: No relevant conflicts of interest to declare.

Prognostic implication of p53 mutations in HNSCC: Results of Intragroup margin study (E4393)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 5504-5504
Author(s):  
L. M. Poeta ◽  
M. A. Goldwasser ◽  
A. Forastiere ◽  
N. Benoit ◽  
J. Califano ◽  
...  
Keyword(s):  
Overall Survival ◽  
Cox Regression ◽  
Eastern Cooperative Oncology Group ◽  
P53 Mutation ◽  
Rank Test ◽  
Curative Intent ◽  
Cox Regression Analysis ◽  
Linear Effect ◽  
Genetic Status

5504 Background: The role of p53 as a prognostic marker in head and neck squamous cell carcinoma (HNSCC) is controversial. The intent of this study was to evaluate rigorously the prognostic value of p53 genetic status. Methods: Tumor samples from 480 HNSCC patients treated surgically with curative intent were collected in a prospective multicenter study over 5 years. 57 cases were not analyzed due to technical or administrative factors. Mutation status was determined in the 423 remaining cases, using p53 chip (GP53 GeneChip from Affymetrix, Inc., Santa Clara, CA) which identifies mutations in exons 2 through 11. Indeterminate calls were investigated using Surveyor and/or DHPLC analysis and all mutations were confirmed with an automated fluorescent system or manual sequencing. Clinical follow-up was accomplished following Eastern Cooperative Oncology Group protocol. Results: Median follow-up of the 423 evaluable subjects was 5.4 years with all patients followed at least 3 years. Mutation of p53 gene was present in 224 (53%) cases. There we significantly fewer mutations in tumors arising in the oropharynx (chi-square p = 0.02). The presence of p53 mutation was significantly associated with decreased overall survival. Median survival for patients with tumors with p53 mutation was 3.1 years compared to 5.4 years fro WT tumors (HR = 1.4, 95% CI =1.1 to 1.8, p = 0.01 log-rank test). This proved to be independent of tumor site in multivariate analysis. When mutations were segregated according to their effect on biological function through alteration of key DNA binding domains a Cox regression analysis revealed a statistically significant linear effect of the more disruptive mutations on overall survival with a HR of 1.3 for comparison of each group to the one of lower risk (more vs. less disruptive mutation v. WT (p = 0.001 Wald test). Conclusions: This large prospective series shows a strong relationship between TP53 mutation and prognosis in HNSCC patients. Furthermore, the biological impact of specific mutations has a predictable graded relation to clinical outcome. The results set the stage for use of p53 genetic status in the design of future clinical trials and support the development of targeted therapy to restore wild-type p53 function. No significant financial relationships to disclose.

scholarly journals Components of metabolic syndrome in patients with multiple myeloma and smoldering multiple myeloma

2020 ◽  
Author(s):  
Efrat Markus ◽  
Svetlana Trestman ◽  
Yael Cohen ◽  
Yoel Angel ◽  
Yael Sofer ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Metabolic Syndrome ◽  
Multiple Myeloma ◽  
Regression Analysis ◽  
Cox Regression ◽  
Healthy Controls ◽  
Cox Regression Analysis ◽  
Smoldering Multiple Myeloma ◽  
Metabolic Syndrome Components

Abstract Background: The prevalences of diabetes mellitus and hypertension, both of which are components of metabolic syndrome, are known to be increased among patients with multiple myeloma (MM), but remain undetermined among patients with smoldering MM (SMM). Methods: Changes in various components of metabolic syndrome were investigated during the follow-up of patients with either MM or SMM compared to healthy controls. The data of 153 patients (105 with MM and 48 with SMM) and 138 controls were accessed from our medical center’s records between 2008-2015. We analyzed the patients’ data at diagnosis (baseline) and after 1, 3, and 5 years of follow-up. Results: Patients with SMM had a significantly higher prevalence of diabetes, hypertension, and dyslipidemia at baseline compared to controls. A multivariate Cox regression analysis revealed a higher risk to develop dyslipidemia after 1, 3, and 5 years of follow-up among the SMM patients. The MM patients had a higher risk to develop diabetes after 1 year, hypertension after 5 years, and dyslipidemia after 1, 3, and 5 years of follow-up. Conclusions: These data demonstrate that patients with SMM and those with MM are more prone to develop various components of metabolic syndrome, and they stress the importance of following-up metabolic syndrome components in both groups of patients.

Intensive Versus Double Intensive Therapy in Untreated Multiple Myeloma: Final Analysis of the HOVON 24 Trial.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 2545-2545 ◽  
Author(s):  
Pieter Sonneveld ◽  
Bronno van der Holt ◽  
Edo Vellenga ◽  
Sandra Croockewit ◽  
Gregor Verhoef ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Cox Regression ◽  
Intensive Therapy ◽  
Final Analysis ◽  
Remission Induction ◽  
High Dose ◽  
Free Survival ◽  
Cox Regression Analysis

Abstract The benefit of high-dose therapy for multiple myeloma has been demonstrated in phase lI/lII studies. HOVON started a randomized multicenter trial to compare the efficacy of intensified treatment followed by myelo-ablative therapy with intensified treatment alone in newly diagnosed patients. We now report the results of the final analysis in 441 eligible patients with stage II (22%) and stage III (78%) disease. The median age was 55 years (range 31–65 ). Remission induction consisted of 3–4 cycles of VAD. 63 patients who had an HLA identical sibling were candidates for an allogeneic transplantation. After VAD, patients were randomized to receive melphalan 140 mg/m2 divided in 2 doses of 70 mg/m2 (IDM) without stem cell rescue (arm A) or the same regimen followed by myelo-ablative treatment with cyclophosphamide (120 mg/kg) and TBI with stem cell transplantation (ASCT, arm B). Peripheral stem cells were mobilized by cyclophosphamide (4 g/m2) and G-CSF after VAD. Interferon-a -2a was given as maintenance therapy in both arms. Of 441 registered patients, 303 were eligible for randomization. Patient characteristics with regard to sex, age, stage of disease, Ig isotype, and b2-M were not different between the two arms. The median follow-up from randomization was 56 months. 81% of patients received both cycles of IDM (79% in arm A and 83% in arm B) and 79% of patients actually received myeloablative therapy followed by ASCT in arm B. Median duration of Interferon-a-2a maintenance treatment was 12 months (arm A) vs 7 months (arm B). CR rate was significantly better in Arm B (28% vs 13%, p=0.002), while the overall response rate (PR + CR) was not different (90% vs 86%, p=0.23). Median event-free survival (EFS) from randomization was 22 months (arm B) vs 20 months (arm A) (logrank p=0.014). Median progression-free survival (PFS) was significantly better in patients treated with double intensification (24 vs 23 months, logrank p=0.032). Time to Progression (TTP) was significantly worse in arm A (median 25 vs 33 months, logrank p=0.001). The difference for EFS, PFS and TTP between the 2 treatment arms became only evident after 4 years of follow-up. Overall survival (OS) was not different between both treatments (median 55 months vs 50 months, logrank p=0.39). Multivariate analysis showed that treatment arm A, higher age, hemoglobin &gt; 6.21 mmol/l, stage 3 and high serum LDH were significant adverse prognostic factors for EFS. Cytogenetic analysis in 151 patients was abnormal in 37% (45% del 13/13q-, 51% abnormal 1p/q, 33% del 6q, 89% complex abnormalities). Cox regression analysis showed that 1p/q was an independent unfavourable prognostic factor for OS, EFS, PFS and TTP (p&lt;0.001), calculated from start VAD. Del 13/13q- was highly correlated with 1p/q abnormalities. By combining B2M &gt; 3 mg/L with del13/13q- and 1p/q, prognostic groups were defined with a significant impact on OS (p&lt;0.000002), EFS (p&lt; 0.0002), PFS (p&lt;.00006) and TTP (p&lt;0.0000002). In conclusion, second intensification when added to intensified chemotherapy alone resulted in a superior EFS, PFS and TTP, but not OS. The latter difference is probably due to the high proportion of patients from the control arm who were treated with ASCT at first relapse. It is concluded that double intensive therapy leads to a higher CR rate and a longer PFS.

scholarly journals Components of metabolic syndrome in patients with multiple myeloma and smoldering multiple myeloma

2019 ◽  
Author(s):  
Efrat Markus ◽  
Svetlana Trestman ◽  
Yael Cohen ◽  
Yoel Angel ◽  
Yael Sofer ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Metabolic Syndrome ◽  
Multiple Myeloma ◽  
Regression Analysis ◽  
Cox Regression ◽  
Healthy Controls ◽  
Cox Regression Analysis ◽  
Smoldering Multiple Myeloma ◽  
Metabolic Syndrome Components

Abstract Background: The prevalences of diabetes mellitus and hypertension, both of which are components of metabolic syndrome, are known to be increased among patients with multiple myeloma (MM), but remain undetermined among patients with smoldering MM (SMM). Methods: Changes in various components of metabolic syndrome were investigated during the follow-up of patients with either MM or SMM compared to healthy controls. The data of 153 patients (105 with MM and 48 with SMM) and 138 controls were accessed from our medical center’s records between 2008-2015. We analyzed the patients’ data at diagnosis (baseline) and after 1, 3, and 5 years of follow-up. Results: Patients with SMM had a significantly higher prevalence of diabetes, hypertension, and dyslipidemia at baseline compared to controls. A multivariate Cox regression analysis revealed a higher risk to develop dyslipidemia after 1, 3, and 5 years of follow-up among the SMM patients. The MM patients had a higher risk to develop diabetes after 1 year, hypertension after 5 years, and dyslipidemia after 1, 3, and 5 years of follow-up. Conclusions: These data demonstrate that patients with SMM and those with MM are more prone to develop various components of metabolic syndrome, and they stress the importance of following-up metabolic syndrome components in both groups of patients.

scholarly journals Components of metabolic syndrome in patients with multiple myeloma and smoldering multiple myeloma

2020 ◽  
Author(s):  
Efrat Markus ◽  
Svetlana Trestman ◽  
Yael Cohen ◽  
Yoel Angel ◽  
Yael Sofer ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Metabolic Syndrome ◽  
Multiple Myeloma ◽  
Regression Analysis ◽  
Cox Regression ◽  
Healthy Controls ◽  
Cox Regression Analysis ◽  
Smoldering Multiple Myeloma ◽  
Metabolic Syndrome Components

Abstract Background: The prevalences of diabetes mellitus and hypertension, both of which are components of metabolic syndrome, are known to be increased among patients with multiple myeloma (MM), but remain undetermined among patients with smoldering MM (SMM). Methods: Changes in various components of metabolic syndrome were investigated during the follow-up of patients with either MM or SMM compared to healthy controls. The data of 153 patients (105 with MM and 48 with SMM) and 138 controls were accessed from our medical center’s records between 2008-2015. We analyzed the patients’ data at diagnosis (baseline) and after 1, 3, and 5 years of follow-up. Results: Patients with SMM had a significantly higher prevalence of diabetes, hypertension, and dyslipidemia at baseline compared to controls. A multivariate Cox regression analysis revealed a higher risk to develop dyslipidemia after 1, 3, and 5 years of follow-up among the SMM patients. The MM patients had a higher risk to develop diabetes after 1 year, hypertension after 5 years, and dyslipidemia after 1, 3, and 5 years of follow-up. Conclusions: These data demonstrate that patients with SMM and those with MM are more prone to develop various components of metabolic syndrome, and they stress the importance of following-up metabolic syndrome components in both groups of patients.

Lenalidomide, Adriamycin and Dexamethason (RAD) in Relapsed and Refractory Multiple Myeloma: Final Results from a Phase I/II Trial of “Deutsche Studiengruppe Multiples Myelom”

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 2782-2782
Author(s):  
Christian Gerecke ◽  
Stefan Knop ◽  
Max S. Topp ◽  
Peter Liebisch ◽  
Christina Vollmuth ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Side Effects ◽  
Phase I ◽  
Disease Progression ◽  
Response To Therapy ◽  
Combination Regimen ◽  
Refractory Multiple Myeloma ◽  
Β2 Microglobulin ◽  
Grade 3

Abstract Background: Lenalidomide (Revlimid®) is an analogue of thalidomide, with immunomodulatory properties and is effective and safe in the treatment of multiple myeloma. We report follow-up data of effects of a combination regimen of lenalidomide, adriamycin and dexamethasone (RAD) on toxicity, prognostic factors, time to progression, and overall survival in patients with multiple myeloma. Patients and Methods: From January 2005 through June 2007 we enrolled 69 patients, 66 patients between 46 and 77 (median age 65) were eligible for evaluation. To be included, patients had to have multiple myeloma with Durie-Salmon stage II or III and considered to have disease progression after 1 to 3 previous anti-myeloma regimens. The feasibility of administering lenalidomide in combination with Doxorubicin and Dexamethasone and the MTD of the combination were determined in the phase I part of the study (Part A). RAD was administered for six 28-day cycle. The MTD was not reached at the highest dose level G5 (R 25 mg d1–21, Adriamycin 9 mg/m2 d1–4 as a 24h infusion, Dex 40 mg d1–4 and 17–20) This dose was used for the phase II part. Results: Forty-eight of 66 patients (73%) achieved an objective response to therapy. Respectively, 10 (15%) of 66 patients achieved a immunofixation-negativ CR, 30 patients (45%) a VGPR and additional 8 patients (12%) a PR. The median follow up was 14,6 (range 7–35) months. Median time to disease progression (TTP) was 45 weeks (95% confidence interval [39,3 to 50,7 weeks] and the one-year survival probability was 88%. 63/66 patients (95%) were evaluable for β2-Microglobulin serum level. Forty-four patients had a level lower than 3,5 mg/l and 19 patients had a higher level than 3,5 mg/l. Subgroup analyses showed a statistical benefit for the group with β2-Microglobulin level &lt; 3,5 mg/l in terms of response (p = 0,002). 37 patients were evaluable for cytogenetic abnormalities with FISH analyses. We found in 15 patients (41%) a Del 13q, four patients (11%) had a t(4;14) and 5 patients (14%) had a Del 17p. There was no significant correlation between response to treatment and the Del 13q (p = 0,40) and the t(4;14) translocation (p = 0,176). Although absolute numbers of patients were low, presence of Del 17p was identified as adverse prognostic factor: 87% without versus 20% with Del 17p responded (p = 0,001). The most common side effects was haematological toxicity with grade 3/4 neutropenia (48%), thrombocytopenia (38%) and anemia (16,6%). Under thrombosis prophylaxis with aspirin 100 mg or enoxaparin 40 mg per day we observed thrombembolic complications in 3 patients (4,5%). Other non haematological side effects were pain (grade 3/4-1 patient), infection (grade 3/4-7 patients), diarrhoea (grade 3/4-1 patient). Neither neurotoxicity nor constitutional symptoms of grade 3/4 was found. Conclusion: In our study, lenalidomide in combination with doxorubicin and dexamethason has shown encouraging activity in heavily pretreated patients with relapsed or refractory multiple myeloma. The combination was well tolerated with a mild toxicity profile. Lower level of β2-Microglobulin and the absence of the deletion 17p had a statistical benefit in terms of response. An update of these data will be presented at the meeting.

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