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Low dose dexamethasone plus lenalidomide (Len-dexa) versus thalidomide (Thal-dexa) as induction therapy for newly diagnosed multiple myeloma: A Phase III, randomized study
Abstracts At a median follow up of 97 months (range, 12 to 266 months), median progression free survival (PFS) and overall survival (OS) is 32 and 83.5 months, respectively. Estimated OS and PFS at 5 years is 63.2% and 38.5% and at 10 years is 43.6% and 29.7%, respectively. On multivariate analysis e presence of extra-medullary disease (EMD) (HR 3.05, p<.000), ISS III (HR 0.365, p<.02) correlated with inferior OS. For PFS: presence of EMD (HR 1.585, p<.03), more than 2 lines of induction therapy (HR 0.534, p<.02) predicted inferior PFS. Presence of DSS stage IIIA (OS and PFS : p<.000), serum albumin >3.5 G/dl (OS : p<.004), absolute lymphocyte count 3000/cmm (OS and PFS : p<.000) correlated with superior OS and PFS. Achievement of CR post- transplant (p<.000) was associated with superior OS and PFS. Conclusion: Further research is needed to improve the outcome of patients who fail to achieve CR post ASCT and those with extra-medullary disease.
median overall survival (OS) has not reached for patients in Len-dexa arm vs. 63 months for thal-dexa , p¼0.50. Median PFS and OS is higher for ASCT recipients; 58 (95% CI 53.2 e 62.8), vs. 29.2 months (95% CI 19.2-39.2), p<.001. OS: 70 vs. 63.0 months (95% CI 18.3- 107.7), p<.01. Grade II-III Leukopenia (p<.003), neutropenia (p<.006) was more pronounced in Len-dexa arm while constipation (p<0.004), Grade I-II sensory neuropathy (<.001) and somnolence (p<.02) was more in Thal-dexa arm. 3 cases of venous thrombosis were observed, 2 in Thal-dexa arm. No case of second malignancy was observed. Conclusion: Present study confirms that induction therapy with thalidomide e dexamethasone is similar to lenalidomide e dexamethasone, in terms of efficacy and outcome but with a different toxicity profile. . This trial is registered with clinical Trials.CTRI2010 001187.
PO-116 PO-115 Low dose dexamethasone plus lenalidomide (Len-dexa) versus thalidomide (Thal-dexa) as induction therapy for newly diagnosed multiple myeloma: A Phase III, randomized study
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Lenalidomide maintenance causes persistence of abnormal protein bands in multiple myeloma patients after induction with new drugs and autologous bone marrow transplantation B. Gamberi, E. Rivolti, M. Quaresima, L. Tognazzi, A. Fama, E. Bellesia, L. Facchini, A. Imovilli, F. Merli
L. Kumar, A. Mookerjee, A. Sharma, R. Gupta, O.D. Sharma, V. Srinivas
Haematology Unit, Oncology Department, Azienda Ospedaliera
Department of Medical Oncology, Lab Oncology and Bio-statistics, All
ical-Clinical Analysis and Endocrinology Laboratory, Diagnostic Im-
India Institute of Medical Sciences, New Delhi 110029, India
aging and Laboratory Medicine Department
Background: We studied whether thalidomide plus low dose dexamethasone (Thal-dexa) is non-inferior to Lenalidomide plus dexamethasone. Patients and Methods: Between April, 2009 and September, 2014, 200 newly diagnosed, symptomatic patients (median age 54.5 Years, range, 32 to 70) were randomly assigned to receive either Len-dexa (n¼102) or Thal -dexa (n¼98). 68% were males. 81(40.5%) patients had ISS stage III. Patients were planned for 4 cycles of induction therapy using either lenalidomide 25 mg day 1 to 21 every 4 weeks or thalidomide 200mg daily along with low dose dexamethasone 20 mg day 1 to 4 and day 9 to 12. Post induction, eligible patients were offered autologous stem cell transplantation followed by maintenance therapy. Response rate (International Myeloma Working Group criteria), progression free survival (PFS), toxicity and quality of life were the primary end points. Analysis was intention to treat. Results: 193 patients were evaluable for response; Len-dexa,n¼97, Thal-dexa¼96. 136 (70.5%) patients responded; stringent CR (sCR)-6.7%, CR-16.6%, very good partial response (VGPR) -10.4%, and PR: 36.8%. Response rates were similar in both arms; 72.2% vs. 68.7%, p¼0.34. PFS was higher for responders; Len-dexa : 41.5 (95% CI 31.0 - 56.9) vs. 14.7 months (95% CI 0 - 34.7),p<.000 ; Thal-dexa : 53.7 (95% CI 31.2 -76.2) vs. 11.0 months (95% CI 0 36.8),p<.000. Median time to achieve PR was similar in both arms, 95 vs. 99 days, p¼0.14. 37 patients underwent ASCT (Len-dexa-20, thal-dexa-17). At a median follow up of 70 months,
Introduction: multiple myeloma (MM) is characterized by the production of a unique monoclonal band synthesized by neoplastic plasmacells. It has been a long time since it has been demonstrated that after autologous bone marrow transplantation (ABMT) often appears an abnormal protein band (APB) (10-73%). More recently has been described that MM patients in complete remission (CR) after induction therapy with novel agents (i.e., thalidomide, bortezomib, lenalidomide) show a higher frequency of APB in peripheral blood (11 vs 60%). In this study we investigated the appearance of APB in patients in complete remission after therapy with novel drugs and ABMT, with or without lenalidomide maintenance. Patients and Methods: we retrospectively analyzed patients (pts) who obtained CR after ABMT performed between august 2006 and October 2013. Thirty-four patients (21 males, 13 females); median age was 59 years (ranging from 36 to 65). Seventeen patients were treated with VTD as induction therapy (only one with lenalidomide maintenance), 13 with VCD as induction therapy followed (6 pts) or not (7 pts) by VRD as consolidation with (11pts) or without (2 pts) lenalidomide maintenance, 3 patients with TD induction, and one with RD induction and lenalidomide maintenance. Altogheter, 12 pts underwent lenalidomide maintenance; Twenty two pts received only one transplant, while 12 received tandem transplant. Immunofixation were performed by Hydrasys 2 System (Sebia). Results: twenty-two patients out of 34 (65%) shown an APB after first transplantation, while a total of 28 after the second one (82%).
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15th International Myeloma Workshop, September 23-26, 2015
Arcispedale Santa Maria Nuova, IRCCS, Reggio Emilia, Italy. Chem-
median overall survival (OS) has not reached for patients in Len-dexa arm vs. 63 months for thal-dexa , p¼0.50. Median PFS and OS is higher for ASCT recipients; 58 (95% CI 53.2 e 62.8), vs. 29.2 months (95% CI 19.2-39.2), p<.001. OS: 70 vs. 63.0 months (95% CI 18.3- 107.7), p<.01. Grade II-III Leukopenia (p<.003), neutropenia (p<.006) was more pronounced in Len-dexa arm while constipation (p<0.004), Grade I-II sensory neuropathy (<.001) and somnolence (p<.02) was more in Thal-dexa arm. 3 cases of venous thrombosis were observed, 2 in Thal-dexa arm. No case of second malignancy was observed. Conclusion: Present study confirms that induction therapy with thalidomide e dexamethasone is similar to lenalidomide e dexamethasone, in terms of efficacy and outcome but with a different toxicity profile. . This trial is registered with clinical Trials.CTRI2010 001187.
PO-116 PO-115 Low dose dexamethasone plus lenalidomide (Len-dexa) versus thalidomide (Thal-dexa) as induction therapy for newly diagnosed multiple myeloma: A Phase III, randomized study
e146
Lenalidomide maintenance causes persistence of abnormal protein bands in multiple myeloma patients after induction with new drugs and autologous bone marrow transplantation B. Gamberi, E. Rivolti, M. Quaresima, L. Tognazzi, A. Fama, E. Bellesia, L. Facchini, A. Imovilli, F. Merli
L. Kumar, A. Mookerjee, A. Sharma, R. Gupta, O.D. Sharma, V. Srinivas
Haematology Unit, Oncology Department, Azienda Ospedaliera
Department of Medical Oncology, Lab Oncology and Bio-statistics, All
ical-Clinical Analysis and Endocrinology Laboratory, Diagnostic Im-
India Institute of Medical Sciences, New Delhi 110029, India
aging and Laboratory Medicine Department
Background: We studied whether thalidomide plus low dose dexamethasone (Thal-dexa) is non-inferior to Lenalidomide plus dexamethasone. Patients and Methods: Between April, 2009 and September, 2014, 200 newly diagnosed, symptomatic patients (median age 54.5 Years, range, 32 to 70) were randomly assigned to receive either Len-dexa (n¼102) or Thal -dexa (n¼98). 68% were males. 81(40.5%) patients had ISS stage III. Patients were planned for 4 cycles of induction therapy using either lenalidomide 25 mg day 1 to 21 every 4 weeks or thalidomide 200mg daily along with low dose dexamethasone 20 mg day 1 to 4 and day 9 to 12. Post induction, eligible patients were offered autologous stem cell transplantation followed by maintenance therapy. Response rate (International Myeloma Working Group criteria), progression free survival (PFS), toxicity and quality of life were the primary end points. Analysis was intention to treat. Results: 193 patients were evaluable for response; Len-dexa,n¼97, Thal-dexa¼96. 136 (70.5%) patients responded; stringent CR (sCR)-6.7%, CR-16.6%, very good partial response (VGPR) -10.4%, and PR: 36.8%. Response rates were similar in both arms; 72.2% vs. 68.7%, p¼0.34. PFS was higher for responders; Len-dexa : 41.5 (95% CI 31.0 - 56.9) vs. 14.7 months (95% CI 0 - 34.7),p<.000 ; Thal-dexa : 53.7 (95% CI 31.2 -76.2) vs. 11.0 months (95% CI 0 36.8),p<.000. Median time to achieve PR was similar in both arms, 95 vs. 99 days, p¼0.14. 37 patients underwent ASCT (Len-dexa-20, thal-dexa-17). At a median follow up of 70 months,
Introduction: multiple myeloma (MM) is characterized by the production of a unique monoclonal band synthesized by neoplastic plasmacells. It has been a long time since it has been demonstrated that after autologous bone marrow transplantation (ABMT) often appears an abnormal protein band (APB) (10-73%). More recently has been described that MM patients in complete remission (CR) after induction therapy with novel agents (i.e., thalidomide, bortezomib, lenalidomide) show a higher frequency of APB in peripheral blood (11 vs 60%). In this study we investigated the appearance of APB in patients in complete remission after therapy with novel drugs and ABMT, with or without lenalidomide maintenance. Patients and Methods: we retrospectively analyzed patients (pts) who obtained CR after ABMT performed between august 2006 and October 2013. Thirty-four patients (21 males, 13 females); median age was 59 years (ranging from 36 to 65). Seventeen patients were treated with VTD as induction therapy (only one with lenalidomide maintenance), 13 with VCD as induction therapy followed (6 pts) or not (7 pts) by VRD as consolidation with (11pts) or without (2 pts) lenalidomide maintenance, 3 patients with TD induction, and one with RD induction and lenalidomide maintenance. Altogheter, 12 pts underwent lenalidomide maintenance; Twenty two pts received only one transplant, while 12 received tandem transplant. Immunofixation were performed by Hydrasys 2 System (Sebia). Results: twenty-two patients out of 34 (65%) shown an APB after first transplantation, while a total of 28 after the second one (82%).
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15th International Myeloma Workshop, September 23-26, 2015
Arcispedale Santa Maria Nuova, IRCCS, Reggio Emilia, Italy. Chem-