Long-Term Outcomes of Dasatinib Therapy in Patients with Imatinib-Resistant or -Intolerant Chronic Myeloid Leukemia from Physician’s and Patient’s Perspective

Abstract Information about the efficacy and safety of the second-line therapy with dasatinib in patients in chronic phase chronic myeloid leukemia (CML-CP) at long-term follow-up is limited. Evaluation of benefits and risks of the treatment in a “real-world” study both from physician’s and patient’s perspective is worthwhile to better define treatment outcomes in this patients’ population. We aimed to study clinical and patient-reported outcomes as well as safety of the second-line therapy by dasatinib in CML-CP patients with imatinib resistance or intolerance treatment at long-term follow-up. 75 CML-CP patients resistant or -intolerant to imatinib were enrolled in the prospective, multicenter, non-interventional study (mean age 51.3 years old, SD 15.4; range 22–83 years; male/female – 37/38). All the patients received dasatinib as the second-line therapy (100 mg daily). Clinical and patient-reported outcomes were evaluated at base-line, 12, 18 and 24 months after treatment start. Twenty six patients were analyzed through all study time-points. For quality of life (QoL) and symptom assessment all the patients filled out the SF-36 and Comprehensive Symptom Profile in Chronic Myeloid Leukemia Patients (CSP Leuk-CML), respectively. Overall and progression-free survival rates as well as cumulative probability of achieving a complete cytogenetic response (CCgR) were calculated using Kaplan-Meier methods. To compare frequencies of CCgR χ2 criterion was applied. Comparison of QoL and symptom scores was conducted using t-test. QoL scores were analyzed using t-test, adjusting for sociodemographic and disease status. At 24 months of dasatinib treatment 94% patients achieved or maintained complete hematologic response and 69% – CCgR. The twenty four-month progression free survival rate was 79% (95% CI; 63.3–88%), overall survival rate – 93% (95% CI; 84–97%). One patient was resistant to dasatinib after 16 months of treatment. During the second year of dasatinib therapy one сase of pleural effusion (grade 3) was registered (at 18 months of treatment); other severe adverse effects (grade 4) were as follows: one patient – neutropenia (at 18 months), one patient – arthralgia/myalgia (at 18 months), one patient – memory loss (at 24 months), one patient – headache and hyperglycemia at 18 months and palpitations, alopecia, hyperglycemia at 24 months of treatment. At 24 months of dasatinib treatment improvement of QoL as compared with base-line was registered: Integral QoL index was significantly higher than at base-line (p<0.02). At 24 months follow-up the proportion of patients with no QoL impairment was 56%; 18.7% patients exhibited severe/critical QoL impairment. It was shown that 56.4% patients with no/mild QoL impairment before dasatinib treatment (favorable group) achieved CCgR as compared with 28% patients with severe/critical QoL impairment (unfavorable group). Progression-free survival rate was 87% in the favorable group vs 60% in the unfavorable group. Cumulative probability of CCgR achievement was higher in the favorable group vs the unfavorable group – 75% vs 50% (log-rank test, p<0.05). Thus, long-term outcomes of second-line therapy in CML-CP patients in a “real world” setting confirm that dasatinib treatment is effective both in terms of clinical outcomes and patient-reported outcomes, as well as exhibits good tolerability. At 24 months of treatment definite QoL improvement was registered. Patients with high QoL before second-line treatment have had better treatment outcomes at long-term follow-up. Comprehensive evaluation of the outcomes of the second-line treatment of CML-CP at long-term follow-up allows to assess the benefits and risks of therapy both from physician’s and patient’s perspective. Disclosures Ionova: BMS: Research Funding. Nikitina:BMS: Research Funding. Fedorenko:BMS: Research Funding. Gritsenko:BMS: Research Funding. Ivanova:BMS: Research Funding. Kuchma:BMS: Research Funding. Shnaider:BMS: Research Funding. Sannikova:BMS: Research Funding. Usacheva:BMS: Research Funding. Kurbatova:BMS: Research Funding.

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Efficacy Of Dasatinib Therapy In Patients With Imatinib-Resistant Or -Intolerant Chronic Myeloid Leukemia From Physician’s and Patient’s Perspective: “Real World” Data

Blood ◽

10.1182/blood.v122.21.5185.5185 ◽

2013 ◽

Vol 122 (21) ◽

pp. 5185-5185

Author(s):

Tatyana I Ionova ◽

Tatyana P Nikitina ◽

Taras A Gritsenko ◽

Valentina L Ivanova ◽

Galina B Kuchma ◽

...

Keyword(s):

Chronic Myeloid Leukemia ◽

Real World ◽

Myeloid Leukemia ◽

Research Funding ◽

Base Line ◽

Second Line ◽

Second Line Therapy ◽

Line Therapy ◽

Patient Reported ◽

Dasatinib Treatment

Abstract There is limited published data about the efficacy and safety of the second-line therapy with dasatinib in patients in chronic phase chronic myeloid leukemia (CML-CP) in a “real world” patients setting outside clinical trials. In addition, comprehensive evaluation of benefits and risks of the treatment is worthwhile to better define treatment outcomes in this patients’ population. We aimed to study clinical and patient-reported outcomes as well as safety of dasatinib treatment in a “real world” setting within the context of its approved indication through the analysis of prospectively collected data in patients with imatinib resistance or intolerance receiving dasatinib as the second-line therapy. 75 CML-CP patients resistant or -intolerant to imatinib were enrolled in the prospective, multicenter, non-interventional study (mean age 51.3 years old, SD 15.4; range 22–83 years; male/female – 37/38). The median of disease duration was 5.0 years (0.75–17 years). 63 patients had resistance to imatinib; 12 patients were intolerant to imatinib; the median duration of imatinib treatment 40 months (3–121 months). All the patients received dasatinib as the second-line therapy (100 mg daily). Median follow-up was 12 months. For quality of life (QoL) and symptom assessment patients filled out the SF-36 and Comprehensive Symptom Profile in Chronic Myeloid Leukemia Patients (CSP Leuk-CML), respectively, at base-line, in 1, 3, 6 months after treatment start and every 6 months thereafter. Comparison of QoL and symptom scores was conducted using t-test. QoL scores were analyzed using t-test, adjusting for sociodemographic and disease status. Mean symptom severity and percentage of patients with moderate-to-severe (ratings ³ 5) symptoms was evaluated. After 12 months of treatment 83% patients achieved or maintained complete hematologic response and 35 % – complete cytogenetic response. The twenty four-month progression free survival rate was 93% (95% CI; 84–97%). Four cases of pleural effusion events were registered: they were easily managed in 3 cases; one patient died at 1 month after treatment start due to accompanied infection complication. No severe hematological adverse effects were observed except two cases of grade III-IV neutropenia. Two patients were resistant to dasatinib. Two patients died of disease progression at 6 months of follow-up. At 12 months of dasatinib treatment QoL parameters were stable for 5 out of 8 scales; vitality, social functioning and mental health significantly improved as compared with base-line (p< 0.01). At 24 months of dasatinib treatment improvement of physical functioning, vitality, social functioning and mental health as compared with base-line was registered (p< 0.01); no worsening was observed for other QoL scales. Before treatment 75% of patients experienced at least one moderate-to-severe symptom; more than 40% had more than 7 moderate-to-severe symptoms. The majority of patients (96%) experienced fatigue; half of them suffered from moderate-to-severe fatigue. While treatment the number of patients with moderate-to-severe symptoms decreased. After 12 months of therapy only 25% of patients experienced moderate-to-severe fatigue. Before treatment 36% of patients exhibited critical or severe QoL impairment. Remarkably, in the subgroup of patients (44%) with critical or severe QoL impairment at base-line dramatic QoL improvement was observed: QoL index increased 3.4 fold (p<0.01). Thus, our study on “real world” patient data confirms that dasatinib as second-line therapy in CML-CP patients is effective both in terms of clinical outcomes and patient-reported outcomes, as well as exhibits good tolerability. Comprehensive evaluation of the outcomes of the second-line treatment of CML-CP allows to assess the benefits and risks of therapy both from physician’s and patient’s perspective. Disclosures: Ionova: BMS: Research Funding. Nikitina:BMS: Research Funding. Gritsenko:BMS: Research Funding. Ivanova:BMS: Research Funding. Kuchma:BMS: Research Funding. Shnaider:BMS: Research Funding. Sannikova:BMS: Research Funding. Fedorenko:BMS: Research Funding. Kurbatova:BMS: Research Funding.

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Paclitaxel, ifosfamide & cisplatin (TIP) as second-line therapy for germ cell tumors (GCT):Long-term follow-up and expansion cohort.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.6_suppl.386 ◽

2021 ◽

Vol 39 (6_suppl) ◽

pp. 386-386

Author(s):

Jack Patrick Gleeson ◽

Andrea Knezevic ◽

Maria Bromberg ◽

Sujata Patil ◽

Joel Sheinfeld ◽

...

Keyword(s):

Risk Factors ◽

Second Line ◽

Inclusion Criteria ◽

Second Line Therapy ◽

Original Cohort ◽

Line Therapy ◽

Long Term Follow Up ◽

Expansion Cohort

386 Background: TIP was established as an effective second-line regimen in a phase II study of 46 patients (pts) with relapsed GCT and favorable risk factors (Kondagunta, JCO 2005). Here, we report long-term follow up from this trial and outcomes for additional pts who subsequently received TIP off protocol. Methods: Eligiblepts included those who received TIP on the original phase II trial (original cohort) or who received TIP following study closure but would have met the trial inclusion criteria (expansion cohort). An additional exploratory cohort was comprised of pts with unfavorable risk factors who would not have met the original trial criteria. The primary endpoint was favorable response rate (FRR), which included complete responses (CR) and partial responses with negative markers (PR-). Overall survival (OS), progression free survival (PFS), and relapse rates were also evaluated. Results: Of 204 pts who received TIP for GCT at our institution from 5/1994 to 7/2019, 87 (original cohort, n=46; expansion cohort, n=41) met the inclusion criteria and were evaluable for the main analysis. An additional 17 pts were analyzed in the exploratory cohort (unfavorable risk factor: PR- lasting <6months or IR, n=13; prior adjuvant therapy, n=4). 100 pts were excluded due to participation in an ongoing clinical trial (n=17), receipt of TIP as their first regimen (n=74) or in the adjuvant (n=3) setting, or insufficient data (n=6). Baseline characteristics and efficacy data are displayed in the table below. In the main cohort, 70/87 (80%) pts achieved a favorable response. With median follow-up of 10.2 years (yrs) [original, 14.3 yrs; expansion 6.5 yrs] 26 deaths were observed. 5yr and 10yr OS rates were 72% (95% CI 63, 83) and 69% (95% CI 59, 80) respectively. 5yr and 10yr PFS were 70% (95% CI 61, 81) and 67% (95% CI 57, 78). In the exploratory cohort, there were 7 deaths at median follow-up of 6.2 yrs with 5yr OS of 56% (95% CI 35, 87) and 5yr PFS of 59% (95% CI 40, 88). Conclusions: Long-term follow-up and additional experience supports the use of TIP as second-line therapy for GCT. Similar outcomes were seen for our exploratory and main cohorts, suggesting benefit with TIP outside of those with a favorable prognosis. [Table: see text]

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Second Line Therapy with Second Generation TKI After Intolerance to Imatinib Based Treatments Showed High Overall Survival in Contrast to Second Line Therapy After Resistance; Results of the Randomized CML Study IV

Blood ◽

10.1182/blood.v118.21.781.781 ◽

2011 ◽

Vol 118 (21) ◽

pp. 781-781

Author(s):

Susanne Saussele ◽

Michael Lauseker ◽

Ulrike Proetel ◽

Martin C. Müller ◽

Benjamin Hanfstein ◽

...

Keyword(s):

Board Of Directors ◽

Research Funding ◽

Second Generation ◽

Chronic Phase ◽

Imatinib Therapy ◽

Second Line ◽

Second Line Therapy ◽

Advisory Committees ◽

Line Therapy

Abstract Abstract 781FN2 Introduction: Data on second line therapy with second generation tyrosine kinase inhibitors (TKI) in CML treatment were generated mainly from phase II/III industry initiated trials (Review Hehlmann Exp Op. 2011). 24-month overall survival (OS) varies between 88% and 94% after intolerance and/or resistance to imatinib for chronic phase (CP) and between 67% and 72% for accelerated phase (AP) or blast crisis (BC). Intention to treat analyses including outcome of patients after discontinuation of first line therapies have not been available as yet. We thought to evaluate overall and progression-free survival (OS and PFS) of imatinib intolerant vs. resistant patients under second line TKI with long-term follow-up within an investigator initiated trial. Methods: We analyzed data of the German CML study IV, a randomized 5-arm trial to optimize imatinib therapy on an intention to treat basis. According to protocol, follow-up of patients on and after second generation TKI after imatinib intolerance and/or resistance was continued for OS and PFS. Analysis of PFS was only relevant, if intolerance and resistance to imatinib therapy occurred while a patient was still in chronic phase (CP). Patients were censored at the time of allogeneic stem cell transplantation (allo-SCT). Results: From July 2002 to December 2010, 1,502 patients with Philadelphia chromosome and /or BCR-ABL positive CML in CP were randomized. 129 patients of the “imatinib after interferon arm” and 36 other patients had to be excluded (14 due to incorrect randomization or withdrawal of consent, 22 with missing baseline information). 1337 were randomized to primary imatinib treatment (imatinib 400 mg vs. imatinib 800 mg vs. imatinib in combination with either interferon alpha or araC). Of these, 234 (17%) discontinued imatinib therapy. 156 patients were treated with 2nd generation TKI, 61 were directly referred to allo-SCT, 17 patients received other regimens (including interferon alpha only or hydroxyurea). 120 of 156 patients started second generation TKI therapy (nilotinib, n=41, dasatinib, n=75, bosutinib, n=2, nilotinib and dasatinib, n=2) within 3 months after stopping imatinib, received treatment for at least one week and were evaluable for PFS and OS. 36 patients received second TKI later (median 10 months, range 3.5–61.4). Median age was 50 years (range 16–78), 42.5% were female. 48 patients were intolerant, 48 failed imatinib within CP and 24 after loss of CP (accelerated phase, n=10, blast crisis, n=14). Median time to second generation TKI was 17 months (range 1.4–97 months) and median follow-up after start of second-line TKI 31 months (range 0.2–71 months). Risk stratification according to the EUTOS Score was high in 20 patients (17%) and low in 94 patients (78%) and unknown in 6 patients (5%). OS for all 120 patients 3 years after start of second generation TKI was 73%, 96% for intolerant and 80% for resistant patients in CP and 19% for resistant patients in advanced disease (s. Fig. 1). According to EUTOS score, 3-year OS was 78% for low and 56% for high risk patients. Probability of PFS of the 96 patients in 1st CP after 3 years was 96% for intolerant and 76% for resistant patients. After 2nd generation TKI, 18 patients received an allo-SCT: all were in CP, 2 patients after imatinib intolerance, 16 patients after imatinib resistance. Conclusion: Survival on second generation TKI is high for imatinib intolerant patients in first CP but much lower for resistant patients in first CP or for patients with advanced disease phases. Alternative treatment strategies are warranted for these patient groups. Disclosures: Krause: Micromet: Research Funding. Kneba:Hoffmann La Roche: Honoraria. Hochhaus:Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Pfizer: Honoraria, Membership on an entity's Board of Directors or advisory committees; Ariad: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding. German CML Study Group:Deutsche Krebshilfe: Research Funding; Novartis: Research Funding; BMBF: Research Funding; EU: Research Funding; Roche: Research Funding; Essex: Research Funding.

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Comparison of Survival Rates, Healthcare Resource Use and Costs of Elderly Patients with Chronic Myeloid Leukemia Receiving Dasatinib or Nilotinib As Second-Line Therapy

Blood ◽

10.1182/blood.v124.21.2618.2618 ◽

2014 ◽

Vol 124 (21) ◽

pp. 2618-2618

Author(s):

B. Douglas Smith ◽

Jun Liu ◽

Dominick Latremouille-Viau ◽

Zhou Zhou ◽

Annie Guerin ◽

...

Keyword(s):

Research Funding ◽

Index Date ◽

Survival Rates ◽

Baseline Period ◽

Harvard University ◽

Second Line ◽

Second Line Therapy ◽

Analysis Group ◽

Line Therapy

Abstract Introduction: Dasatinib and nilotinib are two second-generation tyrosine kinase inhibitors (TKIs) that are well established as treatment options for patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase resistant or intolerant to imatinib and the treatment guidelines do not differentiate based on patient age. Importantly, elderly patients (≥65 years old) account for about half of CML patients; yet there are little data reported focusing on outcomes in this distinct group of patients, often with multiple medical problems and different socio-economic profiles when compared to younger patients. This study aimed to compare survival rates, healthcare resource utilization (HRU), and medical service costs between elderly CML patients receiving dasatinib versus nilotinib as second-line therapy after imatinib. Methods: Patients aged ≥65 years with ≥2 CML diagnoses who received imatinib as first-line therapy followed by nilotinib or dasatinib as second-line therapy were identified using the Medicare Research Identifiable Files (RIF) from 2006 to 2012. Selected patients were continuously enrolled in the Part A (i.e., institutional claims), Part B (i.e., non-institutional claims), and Part D (i.e., drug events) for ≥6 months before and ≥1 month after the second-line TKI therapy initiation date (i.e., index date). Patients enrolled in a clinical trial, those with a stem-cell transplant, or receiving chemotherapy (except hydroxyurea) during the 6 months before the index date (i.e., baseline period) were excluded from the study. Based on the second-line TKI, patients were classified as nilotinib users or dasatinib users. Survival rates were estimated using Kaplan Meir analyses and compared between nilotinib and dasatinib users using Cox proportional-hazards models. HRU and healthcare costs (USD 2013; payer’s perspective) were observed from the index date up to the end of follow-up. Because the length of follow-up varied across patients, HRU and costs were reported per-patient-per-month (PPPM). Incidence rate ratios (IRR) were estimated using Poisson regression models and monthly cost differences were estimated using general linear models with a log link and a gamma distribution or two-part models. Multivariate regression analyses were used to adjust for potential confounding factors measured during the baseline period or at the index date. Results: After applying the sample selection criteria, 659 patients using a second-line TKI therapy were selected; 280 were nilotinib users and 379 were dasatinib users. On average, patients had a follow-up of 24 months (median=22 months) after the index date. The mean age was 76 years and most patients were female (62%). Nilotinib and dasatinib users were generally similar in terms of gender, region of residence, prior imatinib treatment duration, CML complexity, and comorbidity profile. However, nilotinib users were slightly older than dasatinib users; a greater proportion of nilotinib users were 80+ years old at the index date (35% of nilotinib users vs. 27% of dasatinib users; p=.039). In addition, the proportion of patients with cardiovascular disease (40% of nilotinib users vs. 31% of dasatinib users; p=0.015) or congestive heart failure (23% of nilotinib users vs. 14% of dasatinib users; p=0.002) during the baseline period was higher in nilotinib users when compared to dasatinib users. Despite these differences, the median survival time was >4.9 years for nilotinib users and 4.0 years for dasatinib users (log rank test p=.032). After adjusting for potential confounding factors, nilotinib users had a mortality risk that was 38% lower than that of dasatinib users (p=.006) and, nilotinib users had 21% fewer inpatient admissions, 17% fewer inpatient days, 31% fewer emergency room visits, and 12% fewer outpatient visits when compared to dasatinib users (PPPM; all p≤.001). The adjusted monthly medical cost was $378 lower in nilotinib users when compared to dasatinib users (PPPM; p=.045). Conclusion: This retrospective study of elderly Medicare beneficiaries with CML receiving second-line therapy with dasatinib or nilotinib suggested that those receiving nilotinib had longer survival, lower HRU, and lower medical costs than those receiving dasatinib. Further health outcome researches and longer term studies focusing on elderly CML are needed to better define the best practice patterns. Disclosures Liu: Jun Liu is an employee of Harvard University which has received research funding from Analysis Group, Inc.: Employment. Latremouille-Viau:Dominick Latremouille-Viau is an employee of Analysis Group, Inc. which has received consulting fees from Novartis Pharmaceuticals Corporation: Employment. Zhou:Zhou Zhou is an employee of Analysis Group, Inc. which has received consulting fees from Novartis Pharmaceuticals Corporation: Employment. Guerin:Annie Guerin is an employee of Analysis Group, Inc. which has received consulting fees from Novartis Pharmaceuticals Corporation: Employment. Fernandez:Daniel Fernandez is an employee of Harvard University which has received research funding from Analysis Group, Inc.: Employment. Yi:Dingdong Yi is an employee of Harvard University which has received research funding from Analysis Group, Inc.: Employment. Wang:Xufei Wang is an employee of Harvard University which has received research funding from Analysis Group, Inc.: Employment. Wu:Eric Q. Wu is an employee of Analysis Group, Inc. which has received consulting fees from Novartis Pharmaceuticals Corporation: Employment. Mhatre:Novartis Pharmaceuticals Corporation: Employment. Keir:Novartis: Employment, Equity Ownership. Chen:Novartis: stock options Other; Novartis Pharmaceuticals Corporation: Employment.

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Use of Alkylating Agents Among Patients with Multiple Myeloma in a National Registry, 2006-2008.

Blood ◽

10.1182/blood.v114.22.4941.4941 ◽

2009 ◽

Vol 114 (22) ◽

pp. 4941-4941

Author(s):

Carla M Van Bennekom ◽

Theresa E Anderson ◽

Noopur Raje ◽

Kenneth C Anderson ◽

David W Kaufman

Keyword(s):

Multiple Myeloma ◽

Median Duration ◽

Research Funding ◽

Alkylating Agents ◽

Initial Therapy ◽

Novel Agents ◽

Second Line ◽

Second Line Therapy ◽

Line Therapy

Abstract Abstract 4941 Background While alkylating agents were among the earliest treatments for multiple myeloma, newer therapies have been available for several years. Here we describe patterns of use and effectiveness of alkylators in the modern landscape of myeloma treatment, based on a nationwide registry of recently diagnosed patients. Methods The “Patient Registries at Slone: Myeloma” is a national disease-based observational registry conducted by Boston University. All patients with myeloma diagnosed within 4 months of enrollment were eligible for inclusion. Subjects enrolled by mail or over the internet; information on treatment, clinical events, and quality of life was obtained by questionnaire and from medical record review at baseline and at six-month intervals. There were 342 patients with multiple myeloma residing in 43 states who were enrolled from June 2006-October 2008 and completed at least a baseline questionnaire. The median length of follow-up was 8 months after diagnosis (range 0.5-24). Results Alkylators were used as initial treatment in 26 patients (8%), as second-line treatment in 14 (4%), and as part of a transplant regimen in 76 (22%). Patients who received alkylators as initial or second-line therapy tended to be older (median age, 69 vs. 60 years, p<0.0005), and the combined prevalence of use was 17% among patients who did not have prescription drug insurance, compared with 11% among those who did (p=0.36). The prevalence of first-line use was 12% among patients diagnosed in 2006, 9% in 2007, and 4% in 2008 (p=0.09). Further results are confined to 34 of the 40 first or second-line alkylator recipients for whom medical records were available. The regimens used are shown in the table; the majority of patients received regimens that included melphalan. The median duration of initial therapy was 3 months (range 0.5-15); 6 patients (24%) had at least a partial response. Ten patients were still on treatment at the end of follow-up; in 15 (60%), alkylator therapy was changed to another regimen (11) or stopped without new therapy during the follow-up period (4), including 3 due to insufficient response and 5 due to toxicity. The new regimens were thalidomide-based in 2 patients, bortezomib-based in 3, bortezomib+lenalidomide in 1, dexamethasone without novel agents in 2, and 3 patients went directly to autologous stem-cell transplant. Second-line therapy with alkylators was initiated due to insufficient response from the previous regimen in 2 patients, because of side effects in 5, and for cost reasons in 2. The median duration was 2 months (range 0.5-12, with 4 patients still on treatment), and 4 (44%) had a partial or better response. The immediately preceding regimen was thalidomide-based in 5 patients, lenalidomide-based in 1, and bortezomib-based in 3; the median number of previous regimens was 2 per patient (range, 1-4). The median duration of previous therapy was 4 months (range 0.5-9). Conclusions The present population-based results indicate that in the modern era of myeloma treatment, the most prevalent use of alkylating agents is as conditioning for stem cell transplants; the drugs are also still used for initial treatment, mostly in combination with novel agents, although the prevalence was low overall and continued to decline during 2006-2008. Patients who received alkylators for initial or second-line therapy were older and the agents appeared to be somewhat more commonly used among those who did not have prescription drug insurance. The data suggest that there continues to be a useful role for alkylating agents as initial therapy, particularly for myeloma patients who are not transplant candidates, and occasionally as an early replacement for novel agents that prove ineffective or excessively toxic in individual patients. With a relatively short duration of follow-up, there was little information on the use of alkylators in the relapsed setting, where their high level of anti-myeloma activity might be expected to lead to more use. Disclosures Van Bennekom: Cephalon: Research Funding; Celgene: Research Funding; Millennium: Research Funding; Genentech: Research Funding. Anderson:Cephalon: Research Funding; Celgene: Research Funding; Millennium: Research Funding; Genentech: Research Funding. Raje:Celgene: Research Funding; Novartis: Research Funding; AstraZeneca: Research Funding. Anderson:Celgene: Consultancy, Research Funding, Speakers Bureau; Millennium: Consultancy, Research Funding, Speakers Bureau; Novartis: Consultancy, Research Funding, Speakers Bureau. Kaufman:Cephalon: Research Funding; Celgene: Research Funding; Millennium: Research Funding; Genentech: Research Funding.

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Updated 6 Year Follow-Up Of The PRIMA Study Confirms The Benefit Of 2-Year Rituximab Maintenance In Follicular Lymphoma Patients Responding To Frontline Immunochemotherapy

Blood ◽

10.1182/blood.v122.21.509.509 ◽

2013 ◽

Vol 122 (21) ◽

pp. 509-509 ◽

Cited By ~ 56

Author(s):

Gilles Andre Salles ◽

John Francis Seymour ◽

Pierre Feugier ◽

Fritz Offner ◽

Armando Lopez-Guillermo ◽

...

Keyword(s):

Board Of Directors ◽

Research Funding ◽

Progression Free Survival ◽

Second Line ◽

Second Line Therapy ◽

Advisory Committees ◽

Free Survival ◽

Rituximab Maintenance ◽

Line Therapy

Abstract The intergroup PRIMA Phase III study was designed to investigate the potential benefit of 2-years of rituximab maintenance in patients with follicular lymphoma (FL) responding to one of three non-randomised first line immunochemotherapy treatments. The results of the final analysis with 36 months follow-up (Salles et al., Lancet 2011) demonstrated a significant reduction of the risk of progression or death with a hazard ratio (HR) of 0.55 in favour of patients randomized to rituximab maintenance. We present here the updated results with 3 additional years of follow-up. From December 2004 until April 2007, 1217 patients were enrolled from 223 centres and complete data were available for 1193 patients who had the following pre-induction treatment characteristics: median age 56 years [range 22–87]; 52% male; 90% Ann Arbor stage III-IV; 33% B symptoms; 56% bone marrow involvement; 4% ECOG performance status >1; 34% elevated LDH; 32% β2-microglobulin >3mg/L; FLIPI score 0-1 (21%), FLIPI 2 (36%), FLIPI 3-5 (43%). Most patients (75%) received R-CHOP induction (22% R-CVP, 3% R-FCM). Patients responding to induction therapy were stratified based on their immunochemotherapy regimen and response [CR/CRu versus PR] and randomized to observation or rituximab maintenance, 1 infusion (375 mg/m2) every 8 weeks for 2 years. A total of 1018 randomised patients were analyzed according to the ITT principle (513 observation / 505 rituximab maintenance). All initial pre-treatment characteristics were well balanced between arms and the response status at time of randomization was CR=39%; CRu=32% and PR=28% (others 1%). With a median follow-up of 73 months from randomization, 6-year progression free survival estimate was 42.7% (95% CI 38 – 46.9%) in the observation arm (284 events, median=48 months) and 59.2% (95% CI 54.7 – 63.7%) in the rituximab maintenance arm (194 events, median not reached), respectively (stratified Log-Rank, P<. 0001; HR = 0.58 ; 95% CI 0.48 - 0.69). In pre-planned analyses of patients subgroups categorized by age, sex, FLIPI score category, induction chemotherapy and response to induction, the effect of rituximab maintenance was examined and found to be consistent among these different subgroups. In a Cox regression multivariate analysis, rituximab maintenance (HR=0.57; P<.0001) as well as older age (HR=0.79; P=.015), female sex (HR=0.72; P=.0003) and low or intermediate FLIPI groups (HR=0.67; P<.0001) were all significant variables associated with superior progression free survival. A significant reduction in the risk of starting a new anti-lymphoma treatment (HR=0.63, 95% CI 0.52 - 0.76) or starting a new chemotherapy (HR=0.70, 95% CI 0.57 - 0.86) were also observed for rituximab maintenance. The rate of histological transformation did not appear to differ between the 2 treatment arms: in the observation arm, transformation was documented in 24 patients (114 cases with morphological documentation out of 278 progressions) versus 16 patients in the rituximab maintenance arm (80 out of 186) respectively. Overall response rate to second-line therapy was reported by investigators to be 180/227 (79%) in patients from the observation arm (CR/CRu=61%; PR=19%) versus 109/144 (76%) in patients from the rituximab maintenance arm (CR/CRu =51%; PR=22%) (P=NS). At the time of the data cut-off, overall survival (OS) remains favourable in both study arms: 58 patients (11.3%) have died in the observation arm (6-years OS estimate 88.7%) compared to 59 patients (11.7%) in the rituximab maintenance arm (6-year OS estimate 87,4%). Main causes documented for death in the observation and rituximab maintenance arm respectively were lymphoma (28 ; 28), other malignancy (19 ; 5) and infections (4 ; 7). No new significant safety data were captured with this additional follow-up period. In conclusion, with 3 additional years of follow-up, these data demonstrate a sustained and persistent benefit of 2 years of rituximab maintenance therapy after immunochemotherapy, resulting in improved progression free survival. No additional or unexpected long term toxicities were observed and second line therapy efficacy results did not significantly differ between the 2 study arms. Overall survival appears very favourable for these randomized patients. Disclosures: Salles: Roche: Consultancy, Honoraria, Research Funding. Seymour:Roche: Consultancy, Honoraria, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau, Travel support Other; Genetech: Honoraria, Membership on an entity’s Board of Directors or advisory committees. Feugier:Roche: Honoraria, Membership on an entity’s Board of Directors or advisory committees. Offner:Lilly: Membership on an entity’s Board of Directors or advisory committees. Lopez-Guillermo:Roche: Membership on an entity’s Board of Directors or advisory committees. Belada:Roche: Consultancy. Catalano:Roche: Membership on an entity’s Board of Directors or advisory committees. Haioun:Roche: Honoraria, Membership on an entity’s Board of Directors or advisory committees, Research Funding. Simpson:Janssen Research & Development: Honoraria. Leppa:Roche: Consultancy, Honoraria, Research Funding, Travel support Other. Soubeyran:Roche: Honoraria, Membership on an entity’s Board of Directors or advisory committees, Research Funding. Hagenbeek:Takeda/Millennium: Consultancy. Casasnovas:ROCHE: Consultancy, Honoraria, Research Funding. Coiffier:Millennium Pharmaceuticals : Consultancy. Tilly:Roche: Honoraria; Celgene: Honoraria, Membership on an entity’s Board of Directors or advisory committees, Research Funding; Takeda: Membership on an entity’s Board of Directors or advisory committees; Pfizer: Honoraria; Janssen: Honoraria; Amgen: Research Funding.

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Clinical Characteristics and Long Term Outcomes of Warm Type Autoimmune Hemolytic Anemia

Blood ◽

10.1182/blood.v124.21.4874.4874 ◽

2014 ◽

Vol 124 (21) ◽

pp. 4874-4874

Author(s):

Adisak Tantiworawit ◽

Prot Eiamprapai ◽

Sasinee Hantrakool ◽

Chatree Chai-adisaksopha ◽

Ekarat Rattarittamrong ◽

...

Keyword(s):

Response Rate ◽

Good Prognosis ◽

Line Treatment ◽

Second Line ◽

Long Term Outcomes ◽

Second Line Therapy ◽

Common Cause ◽

Line Therapy

Abstract Back ground Warm type autoimmune hemolytic anemia (AIHA) is the disease which antibody reacts with self-antigen on red blood cell. Due to the uncommon of this disease, there is a little data about long term outcomes and response to therapy especially second line treatment. Methods This is a retrospective single center study from 2002 to 2013. The diagnosis of AIHA was made by positive direct Coombs’ test with clinical hemolysis and confirmed by Hematologist. Clinical data and long term outcome were reviewed and analyzed. Results During that period, 101 patients were reviewed, 77% were female, median age was 43 (15-83) years. The median hemoglobin level at diagnosis was 5.4 (2-10) g/dl. Primary AIHA was found in 61%. The secondary causes were SLE (64%), solid malignancy (13%), lymphoma (10%), drug (8%) and infection (5%). The secondary cause from SLE was commonly found in female (96%) (P<0.001). There was the difference of age between secondary cause from SLE (<50 years) and malignancy (>50 years) (p=0.013). These results showed the interesting data that secondary cause of AIHA needed to be searching especially SLE in young female and secondary cancer in elderly patients. Not only cause could be identified but also the specific treatment needed to be given according to secondary cause. Interestingly, most patients (96%) were initially response to steroid which was not different between primary and secondary AIHA. Second line treatments were required in 33 patients (33%). The indications were steroid dependent (58%), relapse (30%) and others (12%). The second line treatments were including cyclophosphamide (52%), azathioprine (21%), cyclosporine (6%), splenectomy (6%), danazol (6%) and others (9%). The overall response rate for second line was 93%. SLE group received second line therapy more than non SLE group (p<0.001). In the light of data from this study showed that this disease had a good prognosis in both frontline steroid and second line treatment. Relapse was occurred in 50 patients (50%). Most relapse occurred > 3 years after diagnosis (58%) and more common in SLE group (p<0.001). These findings illustrated the importance nature of the disease that need long follow up due to high relapse rate around half of patients. At the median follow up 53 months, the overall survival (OS) and event free survival (relapse and death) were 84% and 48%, respectively. The independent factor for decreasing OS was age >50 years with HR 3.09 (95% CI 1.09-8.73, p=0.03) and malignancy with HR 4.06 (95% CI 1.18-13.97, p=0.03). The only significant factor for relapse is age >50 years with HR 2.08 (95% CI 1.21-3.57, p = 0.008). Twenty patients were death. The common cause of death was sepsis (30%) due to heavily immunosuppressive treatment. Conclusion AIHA has good prognosis and long term survival especially in young patient without secondary malignancy. The search for secondary cause especially malignancy is important. Most patients have responded initially to steroid and high response rate to second line therapy. The most common cause of death was sepsis which related to treatment side effect. Carefully adjust and rapid taper immunosuppressant is considerable to avoid serious complication. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.

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Second-Line Therapy for Immune Thrombocytopenia: Real-World Experience

Blood ◽

10.1182/blood-2019-128336 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 2120-2120

Author(s):

Hasmik Nazaryan ◽

Yang Liu ◽

Emily Sirotich ◽

Joanne M Duncan ◽

Donald M. Arnold

Keyword(s):

Real World ◽

Research Funding ◽

Immune Thrombocytopenia ◽

Line Treatment ◽

Second Line ◽

Second Line Therapy ◽

Start Date ◽

Line Therapy ◽

Treatment Start

Background: Immune Thrombocytopenia (ITP) is an autoimmune platelet disorder that can lead to serious morbidity caused by bleeding and therapy-associated toxicities. The sequence of first-line therapies is well-defined, but the sequence of second-line therapies lacks consensus. A description of real-world experience is necessary to understand practice patterns with respect to second-line therapies and identify gaps in care. The objective of this study was to describe the types and chronological sequences of second-line therapies in a large cohort of ITP patients. Methods: This was a retrospective cohort study. The population was derived from the McMaster ITP Registry, a prospective longitudinal registry of patients presenting with thrombocytopenia (platelets <150 × 109/L) to an academic hematology clinic in Hamilton, Canada. Inclusion criteria were: 1) diagnosis of primary or secondary ITP at most recent follow-up; 2) received one or more second-line therapy since initial ITP diagnosis; and 3) ≥6 months of follow up. No exclusions were applied. The sequence of second-line therapies was determined by treatment start dates. For treatments that were administered before enrollment in the registry, the order of treatment was determined by the reported treatment start date. When the start date was not reported, the sequence of treatments was assumed to be the order in which they were mentioned in the medical records. Second-line therapies included: splenectomy; rituximab; danazol; dapsone; thrombopoietin receptor agonists (TPO-RAs): eltrombopag or romiplostim; and immunosuppressants: mycophenolate, cyclosporine, azathioprine or cyclophosphamide. Results: From January 2010 to December 2017, 789 patients with thrombocytopenia were registered in the McMaster ITP Registry. Of those, 204 had ITP and received second-line therapy (57.4% female). Median duration of ITP from the initial presentation to the most recent diagnosis was 9 years (IQR, 4-19). The proportion of patients who received each type of second-line therapy at any time were immunosuppressants (n=106, 52.0%), splenectomy (n=106, 52.0%), TPO-RAs (n=75, 36.8%), danazol (n=73, 35.8%), rituximab (n=67, 32.8%), and dapsone (n=4, 2.0%). Overall, 69 unique treatment sequences were identified. For patients who received one second-line treatment only (n=88), the most common single treatment was splenectomy (n=28, 31.8%), followed by immunosuppressants (n=21, 23.9%) and danazol (n=18, 20.5%) (Figure 1). For patients who received more than one second-line therapy (n=116), the most common treatment sequences were splenectomy followed by immunosuppressants (n=7, 6.0%); immunosuppressants followed by rituximab (n=6, 5.0%), and immunosuppressants followed by danazol (n=5, 4.0%). In patients who received each of these therapies, the last second-line treatments received were TPO-RAs (52/75, 69.3%), immunosuppressants (45/106, 42.5%), rituximab (37/67, 55.2%), splenectomy (36/106, 33.9%), danazol (33/73, 45.2%), and dapsone (1/4, 25%). Conclusion: The types and sequences of second-line therapies for ITP were variable in a large Canadian academic center, where access to certain treatments including TPO-RAs and rituximab is limited. In this setting, splenectomy and immunosuppressant medications were commonly used as early second-line therapies. TPO-RAs were most often the last second-line treatment in the sequence of therapies used. Drug accessibility and other factors related to the choice of second-line therapies require further evaluation. Disclosures Arnold: Bristol-Myers Squibb: Research Funding; Principia: Consultancy; Rigel: Consultancy, Research Funding; Novartis: Honoraria, Research Funding.

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Lenalidomide Maintenance Does Not Negatively Impact Overall and Progression Free Survival Using Lenalidomide-Based Regimens for Multiple Myeloma in First Relapse

Blood ◽

10.1182/blood-2018-99-117705 ◽

2018 ◽

Vol 132 (Supplement 1) ◽

pp. 5643-5643 ◽

Cited By ~ 1

Author(s):

Hannah Cherniawsky ◽

Zack M. Breckenridge ◽

Irwindeep Sandhu ◽

Michael P. Chu ◽

Joanne D. Hewitt ◽

...

Keyword(s):

Multiple Myeloma ◽

Real World ◽

Research Funding ◽

Second Line ◽

Second Line Therapy ◽

Aggressive Disease ◽

Line Therapy ◽

First Relapse ◽

The Impact

Abstract BACKGROUND Outcomes in multiple myeloma have improved dramatically over the last decade however, optimal sequencing of therapy remains unknown. Specifically, in an era where post-transplant lenalidomide (L) maintenance is now as established standard of care, questions remain around the utility of full dose L-based regimens in second line therapy. In this series, we sought to evaluate the impact of different regimens used at first relapse in patients who received autologous stem cell transplant (ASCT) in the frontline setting treated with and without lenalidomide maintenance (LM). We focused on the impact of L-based therapies in patients relapsing on LM. METHODS Using our prospectively maintained institutional MM database we retrospectively analyzed patients treated at the Cross Cancer Institute from January, 2005 to January, 2016 to ensure 2 years of follow-up for surviving patients. 4 categories were identified based on 2 variables: receipt of LM following 1st line therapy (yes or no) and receipt of L-based 2nd line therapy (yes or no). The primary endpoint was 2nd PFS defined as time of initiation of second line therapy to relapse, death or last follow-up. OS was defined as time of initiation of first line induction therapy to death or last follow-up. Second OS was defined as time of initiation of second line therapy to death or last follow-up. Survival statistics were determined using the Kaplan-Meier method with SPSS software. A p - value of <0.05 was considered significant. RESULTS 213 patients received standard bortezomib-based induction and ASCT of which 132 (62%) received LM. Median follow up for the LM patients was 48 months compared to 74.6 months in non-LM patients. 103 patients (48%) required treatment with second line therapy. Forty-four percent patients were treated with LM while 56% were not. Sixty-nine percent received L-based therapy at relapse, 21% received PI-based therapy and 8% were treated with a PI-IMID combination (table 1). Focusing on the cohort of relapsed patients who received LM (n=44), the median 2nd PFS was 9.3 months in those that received L-based second line therapy vs 4.1 months in those that did not (p = 0.28, figure 1b]. In patients who did not receive LM (n = 55) the median 2nd PFS was 14.0 months in those who received L-based second line therapy vs 6.9 months in those who did not (p = 0.19, figure 1a. Examining all patients who received L-based therapy at relapse there was no difference in 2nd PFS based on whether LM was given (p = 0.42). The median 2nd OS was not statistically significant between the groups (p = 0.39, figure 1b. Patients on LM had a median 2nd OS of 34 months with L-based therapy at relapse compared to 39.2 months without. The median 2nd OS in non-LM patients was 34.5 months in those receiving L-based therapy at first relapse and 23.4 months in those that did not (p=0.10). There was no statistically significant differences in median OS between the 4 groups (p = 0.83). For patients who received LM the median OS was not reached in those receiving L-based therapies at relapse and was 78.1 months in patients who did not. In patients who did not receive LM the median OS was 78.0 months in those receiving L-based therapies at relapse and 69.3 months in those who did not. CONCLUSION Our data suggests that receiving LM does not negatively impact survival outcomes after receiving full dose L-based therapy at relapse. Both median 2nd PFS and 2nd OS were similar with L-based therapies regardless of prior LM. While the 2nd PFS at relapse does fall short of recently published trials in relapsed MM there are some notable confounders here. Firstly, this real-world data includes frailer patients with potentially greater co-morbidities possibly influencing choice and duration of therapy as well as reflect more aggressive disease biology. Secondly, given the relatively short median follow-up of the relapsed LM patients to date, the cohort may be enriched with "early" relapsers (< 2-years) also potentially indicative of biologically more aggressive disease. As such, this may underestimate the true impact of L-based therapies in patients relapsing on LM. Larger series with longer follow-up are necessary to formally examine whether multi-agent L-based regimens confer additional benefit over L-Dexamethasone or non-L based regimens. Real world registries will be useful as prospective trials are unlikely to be done. Disclosures Sandhu: Novartis: Honoraria; Bioverativ: Honoraria; Janssen: Honoraria; Celgene: Honoraria; Amgen: Honoraria. Venner:Janssen: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Amgen: Honoraria; Takeda: Honoraria.

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Lenalidomide Maintenance Prolongs Progression-Free Survival and Does Not Impact the Aggressiveness of Clinical Relapse: Data from Long-Term Follow up of the Myeloma XI Trial

Blood ◽

10.1182/blood-2019-126103 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 1889-1889 ◽

Cited By ~ 2

Author(s):

Charlotte Pawlyn ◽

Faith E. Davies ◽

Kara-Louise Royle ◽

David Cairns ◽

Gordon Cook ◽

...

Keyword(s):

Research Funding ◽

Progression Free Survival ◽

Clinical Relapse ◽

Second Line ◽

Long Term Follow Up ◽

Biochemical Progression ◽

Line Of Therapy ◽

The Impact

Background: The impact of the selective pressure of maintenance Lenalidomide has the potential to enhance disease aggressiveness at relapse and if this were the case would shorten the time to next therapy. Previously we have shown that Lenalidomide maintenance therapy in myeloma is associated with improved progression-free survival (PFS). This initial analysis defined PFS as the time to biochemical progression but at that time point not all patients will go on to second line treatment, with the time to treatment being variable dependent on the aggressiveness of disease behavior at relapse. We have used time to next treatment as a marker of the impact of maintenance on disease behavior by analyzing long-term follow-up data from 1971 patients in the Myeloma XI trial. Methods: Myeloma XI is a phase III trial with pathways for transplant eligible (TE) and transplant ineligible (TNE) newly diagnosed myeloma patients who, after immunomodulatory agent-based induction therapy +/- autologous stem cell transplant, were randomized between lenalidomide maintenance (Len, 10mg 21/28 days) or observation (Obs). Maintenance Len ceased at the time of biochemical progression; neither the timing of commencement, nor agents used for second line therapy were mandated in the protocol. Taking advantage of the large sample size and median 50 months of follow-up we present updated PFS data, time to next treatment (TTNT) and an exploratory analysis to compare an estimate of the aggressiveness of relapse. We included all patients who progressed on trial excluding that defined by death. From the time of biochemical progression we compared the time to the start of next line of therapy between those patients who had received Len vs observation defining this as Time to Clinical Relapse (TCR). Hazard ratios (HR) were adjusted for induction/consolidation treatment and pathway. Results: Len was associated with a significant improvement in PFS compared to Obs. The median PFS was 41 months [95% CI 38,45] for those allocated to Len and 21 [19,23] for Obs (HR 0.50 [0.44,0.56], P <0.01). This was consistent in both the TE (median PFS Len 64 [54,76] vs Obs 32 [28,36], HR 0.52 [0.45,0.61] P <0.01) and TNE (median PFS Len 26 [22,31] vs Obs 11 [9,13], HR 0.47 [0.40,0.55] P <0.01) pathways. TTNT was also significantly longer with Len compared to Obs. The median TTNT was 52 months [95% CI 46,60] for those allocated to Len and 28 [26,32] for Obs (HR 0.55 [0.49, 0.62] P < 0.01). This was consistent in both the TE (median TTNT Len 72 [64,NR] vs Obs 43 [38,49], HR 0.59 [0.49,0.70] P<0.01) and TNE (median TTNT Len 33 [28,38] vs Obs 17 [15,20], HR 0.51 [0.43,0.60] P <0.01) pathways. At the time of analysis 569 patients had progressed on trial without progression defined by death. Of these 254 (148 TE, 106 TNE) were receiving Len and 315 (189 TE, 126 TNE) Obs. 422 (74.2%) had received a subsequent line of therapy or had died following progression. The most common second line therapy was a bortezomib containing regimen (45.6%). Overall the median TCR was 7.6 months [95%CI 6.4, 8.5]. There was no difference in TCR between patients receiving Len (median 6.3 months [95% CI 5.0, 8.1]) and Obs (8.1 months [7.0, 9.7]), HR 1.06 [0.87, 1.29]. This was consistent for both the TE and TNE pathways. Conclusions: We found no difference in the aggressiveness of relapse dependent upon whether patients received Lenalidomide maintenance or observation, using long term follow-up data and an exploratory analysis of time to clinical relapse. This is consistent with our data showing an absence of a significant change in mutational landscape between the groups. Further, the data are consistent with results of meta-analyses showing improved PFS and OS providing further support for the use of maintenance strategies with IMiD drugs. on behalf of the NCRI Haematological Oncology Clinical Studies Group Disclosures Pawlyn: Amgen, Celgene, Takeda: Consultancy; Amgen, Celgene, Janssen, Oncopeptides: Honoraria; Amgen, Janssen, Celgene, Takeda: Other: Travel expenses. Davies:Amgen, Celgene, Janssen, Oncopeptides, Roche, Takeda: Membership on an entity's Board of Directors or advisory committees, Other: Consultant/Advisor; Janssen, Celgene: Other: Research Grant, Research Funding. Royle:Celgene, Amgen, Merck, Takeda: Other: Research Funding to Institution. Cairns:Celgene, Amgen, Merck, Takeda: Other: Research Funding to Institution. Cook:Amgen, Bristol-Myers Squib, GlycoMimetics, Seattle Genetics, Sanofi: Honoraria; Celgene, Janssen-Cilag, Takeda: Honoraria, Research Funding; Janssen, Takeda, Sanofi, Karyopharm, Celgene: Consultancy, Honoraria, Speakers Bureau. Drayson:Abingdon Health: Consultancy, Equity Ownership. Gregory:Amgen, Merck: Research Funding; Celgene: Consultancy, Research Funding; Abbvie, Janssen: Honoraria. Jenner:Abbvie, Amgen, Celgene, Novartis, Janssen, Sanofi Genzyme, Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Jones:Celgene: Honoraria, Research Funding. Kaiser:Celgene, Janssen: Research Funding; Abbvie, Celgene, Takeda, Janssen, Amgen, Abbvie, Karyopharm: Consultancy; Takeda, Janssen, Celgene, Amgen: Honoraria, Other: Travel Expenses. Owen:Celgene, Janssen: Honoraria; Celgene: Research Funding; Janssen: Other: Travel expenses; Celgene, Janssen: Consultancy. Russell:Astellas: Consultancy, Honoraria, Speakers Bureau; Jazz: Consultancy, Honoraria, Speakers Bureau; Pfizer Inc: Consultancy, Honoraria, Speakers Bureau; DSI: Consultancy, Honoraria, Speakers Bureau. Morgan:Celgene Corporation, Janssen: Research Funding; Bristol-Myers Squibb, Celgene Corporation, Takeda: Consultancy, Honoraria; Amgen, Janssen, Takeda, Celgene Corporation: Other: Travel expenses. Jackson:Celgene, Amgen, Roche, Janssen, Sanofi: Honoraria. OffLabel Disclosure: Lenalidomide for myeloma as maintenance therapy 10mg 21/28 days

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