scholarly journals Narcotic Use in Multiple Myeloma Patients at the Time of ASCT and One-Year Follow up

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4726-4726
Author(s):  
Matthew Danish ◽  
Tabitha Copeland ◽  
Joseph Ho ◽  
Mansi Shah ◽  
Dennis Cooper
Keyword(s):  
Multiple Myeloma ◽  
Clinical Response ◽  
Bone Pain ◽  
Novel Agents ◽  
Cell Transplant ◽  
Post Transplant ◽  
Opiate Use ◽  
The Impact

Background: Bone pain is one of the most common presentations of multiple myeloma and nearly all patients have skeletal involvement in the course of disease. Consequently, many patients require narcotics for symptom management at the time of diagnosis but the long term impact of MM treatment on pain control remains uncertain. With the advent of combination therapy for MM with novel agents followed by transplant and then maintenance therapy, clinical response is nearly universal and greater than 30% of patients achieve a serologic complete response. Therefore, we examined the impact of modern myeloma-directed therapy and high response rates on the use of narcotics up to 1 year after transplant in this group of patients. Methods: A retrospective review of data collected from the Rutgers-CINJ database was conducted. All patients who received induction inducing therapy (e.g. bortezomib, lenalidomide and dexamethasone or cyclophosphamide, bortezomib and dexamethasone) followed by high dose melphalan and autologous stem cell transplant (ASCT) and who had adequate post-transplant follow up (at least 100 days) were included. Morphine use was assessed at the time of transplant and at follow-up visits. All opiates (e.g. oxycodone, fentanyl, MS contin, etc.) where converted to morphine equivalents/day (ME/day) and recorded. Treatment responses were determined based on the International Myeloma Working Group Response Criteria. We compared the incidence and amount of narcotic use over time using one-way analysis of variance (ANOVA) and Dunn's multiple-comparison test. Results: 189 patients were included in the analysis. 38% were using opiates at the time of transplant. At 100 days post-transplant 35.5% were using opiates and at 1 year post transplant 30.9% were using opiates (p=0.04) . Average opiate use was 74.1 ME/day (95% CI: 55.2 to 92.9), 69.45 ME/day (95% CI: 50.5 to 88.3), and 70.78 ME/day (95% CI: 43.5 to 98) for each of the aforementioned time points (p=0.088) (Figure 1). For example, 74 ME/day would be equal to approximately 50 mg of Oxycodone daily. 74 patients were active opiate users at the time of transplant (Table 1). Response to myeloma treatment (remission, progression, relapse) was not different in opiate-using patients at the time of transplant or at 100 days and 1 year after transplant (Table 2). Conclusion : Early studies from the 1960's reported on the rapid reduction of bone pain in treatment responsive patients with MM (Hogstrata et al.). Recently, treatment modalities for MM have significantly improved, leading to markedly increased remission rates (>90%), progression-free and overall survival. With dramatically increased serologic responses, one would hypothesize that there would be a decline in pain and a subsequent decrease in opiate use. However, in this retrospective chart review we found that 30% of multiple myeloma patients continued to use opiates following transplant and that ongoing use of opiates appeared to be independent of clinical response. Interestingly, at the time of transplant active opiate users had a CR of 27.2% while the non-opiate using patients had a CR of 13.3%. Although there was a slight decline in the number of opiate users at the 1 year follow up, 33% of opiate users continued at their original level of opiate use and 22% increased their opiate use at 1 year post ASCT. Persistent long term use of opiates is of particular concern given that the survival of patients with MM has significantly improved with the use of novel agents and autologous transplant with an increasing number of patients surviving 10 years or more. In patients who have achieved an excellent response (e.g. serologic CR and negative PET scan), ongoing narcotic use should be addressed at each visit and other advanced pain management techniques should be considered. Disclosures No relevant conflicts of interest to declare.

Treatment of Persons with Multiple Myeloma in Underprivileged Circumstances: Real-World Data from a Single Institution

2020 ◽  
Vol 143 (6) ◽  
pp. 552-558 ◽  
Author(s):  
Iván  Murrieta-Álvarez ◽  
David P. Steensma ◽  
Juan Carlos Olivares-Gazca ◽  
Mauricio Olivares-Gazca ◽  
Andrés León-Peña ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Median Overall Survival ◽  
Low Cost ◽  
Novel Agents ◽  
Cell Transplant ◽  
Hematopoietic Cell Transplant ◽  
Real World Data ◽  
Term Survival

<b><i>Background:</i></b> The treatment of patients with multiple myeloma (MM) has evolved in recent years, and the disease-associated prognosis has improved substantially. This improvement has been driven largely by the approval of novel agents, many of which are expensive and not universally available. Less expensive but effective approaches would be of value globally. <b><i>Patients and Methods:</i></b> All consecutive MM patients diagnosed in the Centro de Hematología y Medicina Interna de Puebla after 1993 were included in this study. Patients were given oral thalidomide (100 mg/day), oral dexamethasone (36–40 mg/week), and aspirin 100 mg/day. Bor­tezomib (1.75 mg s.c. every week) was administered to those who could afford it. After 4–6 weeks of treatment, patients were offered an outpatient-based hematopoietic cell transplant (HCT). After the recovery of granulocytes following HCT, patients continued indefinitely on thalidomide; those who failed to tolerate thalidomide were switched to lenalidomide (25 mg/day). <b><i>Results:</i></b> The median overall survival (OS) for all patients has not been reached and is &#x3e;157 months. Median follow-up of the patients lasted 14 months (range 1.3–157). The median OS of patients with and without HCT was similar. The response rate (complete remission or very good partial remission) was 72% for those given thalidomide plus dexamethasone versus 88% for those given bortezomib, thalidomide, and dexamethasone before HCT, but OS was not different. As post-HCT maintenance, 37 patients received thalidomide; 26 of those (70%) could be maintained indefinitely on thalidomide, whereas 11 were switched to lenalidomide after a median of 7 months; median OS of patients maintained on thalidomide or lenalidomide after HCT was not different. <b><i>Conclusion:</i></b> In this series, a regimen incorporating low-cost novel agents and outpatient HCT was associated with excellent long-term survival in the treatment of MM patients. This approach may be a model for MM treatment in underprivileged circumstances.

Very Good Partial Response and Complete Response Predict Superior Overall Survival and Progression Free Survival After Single Autologous Stem Cell Transplant in Patients with Multiple Myeloma,

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 4111-4111
Author(s):  
Victor H Jimenez-Zepeda ◽  
Donna E. Reece ◽  
Suzanne Trudel ◽  
Christine Chen ◽  
Andrew Winter ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Research Funding ◽  
Progression Free Survival ◽  
Complete Response ◽  
Autologous Stem Cell Transplant ◽  
Novel Agents ◽  
Cell Transplant ◽  
Free Survival ◽  
The Impact

Abstract Abstract 4111 In multiple myeloma (MM), the impact of complete response (CR) and very good partial response (VGPR) achievement has been shown mostly after introduction of high dose therapy (HDT) supported by autologous stem cell transplant (ASCT). Recently, the IFM group reported the impact of achievement of CR and VGPR in double ASCT. The purpose of this study is to confirm the prognostic value of CR/VGPR in a large group of patients treated with single ASCT. Methods All consecutive patients who underwent single ASCT at Princess Margaret Hospital between January 2000 and December 2007 were evaluated. Patients were mobilized with cyclophosphamide and G-CSF and majority were conditioned with melphalan 200mg/m2. Response to therapy was assessed according to the IMWC including VGPR. Progression Free Survival (PFS) and Overall Survival (OS) were measured from transplant date to the date of death or last follow-up. OS and DFS were analyzed using the Kaplan-Meier Method. The Cox proportional hazard model was used to assess CR and VGPR and some other prognostic markers at presentation such as age, B2Mg> 460 μmol/L, LDH> 350 IU/L, CRP> 20mg/L, albumin<35g/L and creatinine > 200 μmol/L. All p-values were 2-sided and statistically significant if <0.05. Results 788 patients were identified for the study; their median age was 56 years (30–73). Patient's characteristics are listed in Table 1. Response was assessed at day 100 after ASCT and showed a CR of 6%, PR of 37.5%, and VGPR of 53% (Overall Response rate of 95.5%). Median OS and PFS for the group were 77.43 months and 20.63 months respectively. The median OS and PFS were significantly better for patients who achieved CR/VGPR, 104.5 months versus 51.7 months, and 26.3 months versus 13.53 months respectively. With a median follow-up of 44 months there is no significant difference in OS for those patients who achieved VGPR/CR after induction therapy with novel agents. However, PFS is better in those patients receiving novel agents who achieved VGPR/CR (Median PFS of 24.63months versus 12.4 months respectively (p=0.01). Multivariate analysis shows CR/VGPR as an independent prognostic factor for OS and PFS (Fig 1 and 2). B2Mg> 460 μmol/L, LDH> 350 IU/L, CRP > 20mg/L, albumin<35g/L and creatinine > 200 μmol/L failed to be important factor for survival in the multivariate analysis. Our data suggests that VGPR/CR is clearly important in the pre-novel agents era and for the smaller group of patients who had novel agents induction there is a benefit in PFS and with a longer follow-up perhaps in OS. In conclusion, VGPR/CR remains a simple and powerful indicator in the context of single ASCT and should be considered a relevant objective for MM treatment. Table 1. Clinical characteristics of patients with Multiple Myeloma undergoing single ASCT Clinical characteristic N=788 Median Range % Age (years) 58 31–74 Male 59.4% Female 40.6% Hemoglobin (g/L) 114 54–180 Creatinine (μmol/L) 107 28–1409 B2-microglobulin ((μmol/L) (N=718) 508 260–7270 Albumin (g/L) (N=650) 38 23–54 IgG 51.1% IgA 31.3% IgM 0.4% IgD 0.7% Biclonal 9.9% Not Detected 6.6 Kappa 59.4% Lambda 32.9% Biclonal 2% Not Detected 5.7% Calcium (μmol/L) 2.29 1.62–4.66 LDH (IU/L) (N=754) 235 50–1470 Induction Treatment: 52.2% VAD 22.8% Dexamethasone 6.3% TD 2.3% CP 3.8% DPACE/DTPACE 1.7% DVD 8% CyBORD 2% VD Ab: VAD: Vincristine, Adriamycin and dexamethasone, TD: Thalidomide and Dexamethasone; CP: Cyclophosphamide and Prednisone, DVD: Doxil, Velcade and Dexamethasone, CyBORD: Cyclophosphamide, Bortezomib and Dexamethasone and VD: Valcade and Dexamethasone Disclosures: Jimenez-Zepeda: J & J: Honoraria. Reece:Bristol, Meyers, Squibb: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Johnson&Johnson: Research Funding; Merck: Honoraria, Research Funding; Otsuka: Honoraria, Research Funding; Millennium: Research Funding; Amgen: Honoraria. Chen:Celgene Corporation: Consultancy, Honoraria, Research Funding. Kukreti:Celgene: Honoraria.

Immunologic Recovery after Autologous Transplant in Multiple Myeloma and Progression Free Survival

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 4444-4444
Author(s):  
Fernanda Maria Rodrigues Trigo-Miranda ◽  
Rui Cordeiro Bergantim ◽  
Ricardo Moreira Pinto ◽  
Patricia Guimarães ◽  
Jose E. Guimaraes
Keyword(s):  
Multiple Myeloma ◽  
Progression Free Survival ◽  
Response To Treatment ◽  
Cell Transplant ◽  
Haematopoietic Progenitor Cell ◽  
Free Survival ◽  
Post Transplant ◽  
Historical Comparison ◽  
Significant Difference

Abstract Several factors influencing disease progression and survival have been identified in multiple myeloma (MM). We analysed a series of 49 consecutive patients with MM that underwent autologous haematopoietic progenitor cell transplant (HPCT) in one center regarding the following variables: use of G-CSF for haematopoietic recovery post-transplant; recovery of normal IgM levels at day +100 post-transplant; levels of lymphocytes namely of the CD4+ and CD8+ subsets also at day +100. Before 2006, all patients had G-CSF starting 24 hours after the cell infusion until neutrophil &gt; 500×10^9/L in two consecutive days; in the years 2006–2008, no G-CSF was given to transplanted patients. A historical comparison was done and at the time of this study no significant difference in progression free survival (Kaplan-Meyer analysis), was detected between the two groups, possibly due to the shorter follow-up of the “no G-CSF” (n=19) group; nevertheless median progression free survival (PFS) in the “G-CSF” group was 12 months while median PFS was not attained in the “no G-CSF” group (median follow-up = 7 months). Post transplant IgM levels were also determined in 39 patients. Eighteen patients recovered normal IgM levels at day +100 (46.8 %) and 21 (53.8 %) did not. Comparison of Kaplan-Meyer curves for the two groups did not show any statistically significant difference but there is a sharp difference between median PFS of the “low IgM” (10 months) and the “normal IgM” (27 months) groups. CD4/CD8 ratio was determined in 18 patients at day +100. The ratio varied between 0 and 0.63 (median – 0.305). No correlation was found between post-transplant IgM recovery and CD4/CD8 ratio. In conclusion, in our series of MM patients treated with autologous HPCT we could not find a definite relationship between immunologic recovery and response to treatment although there is a trend to a better outlook of the patients which recover normal IgM levels. It is also uncertain whether use of G-CSF in the post-transplant period would have any effect on disease behaviour.

A Long-Term Follow-up Report on Autologous Hematopoetic Cell Transplant (AuHCT) for Patients with Hodgkin Lymphoma — Limited Utility of Post-Transplant Surveillance Computerized Axial Tomography (CAT scan) and/or PET Scan,

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 4205-4205
Author(s):  
Henry C. Fung ◽  
Sunita Nathan ◽  
Neel B. Shah ◽  
John J. Maciejewski ◽  
Elizabeth Shima Rich ◽  
...  
Keyword(s):  
Disease Progression ◽  
Hodgkin Lymphoma ◽  
Pet Scan ◽  
Late Relapse ◽  
Cell Transplant ◽  
Post Transplant ◽  
Cat Scan ◽  
Long Term Follow Up

Abstract Abstract 4205 Background: Autologous Hematopoetic Cell Transplant (AuHCT) is the treatment of choice for patients with relapsed or refractory Hodgkin Lymphoma. Approximately 40–60% of patients achieve a durable response and possible cure after the transplant with progressive disease accounts for most of the treatment failures. CAT scan +/− PET scan are usually performed before AuHCT and repeated post-transplant to assess responses. As part of the long term follow-up; post-transplant surveillance CAT scan +/− PET scan are often performed with intent to detect early disease progression and possible early intervention. Here, we attempt to evaluate the utility of this approach by examining the patterns of treatment failures for patients with Hodgkin Lymphoma who received AuHCT. Patients/Methods: A retrospective chart review was performed. Between 01/94 and 12/06, 55 consecutive patients with refractory or relapsed Hodgkin Lymphoma underwent autologous HCT at our institution. All patients underwent a CAT scan and FDG-PET before AuHCT and approximately 2–3 months following the transplant to evaluate the response to HCT. As part of the long-term follow-up; post-transplant surveillance CAT scan were performed every 3–6 months for 2–3 years, then every 6–12 months up to 5 years post-transplant. Results: A total of 55 patients were followed post autologous HCT. The median age at HCT was 32 (ranging from 15–66); 27 were male. Seventeen patients had primary progressive HL and 38 had relapsed HL. Eighteen patients had extra-nodal disease at disease progression. With a minimal follow-up of 4 years (range 4 to 7 years) for living patients; 40 patients are alive and well with no evidence of disease. Thirteen patients developed disease progression after transplant at a median of 3 months (range 0 – 32 months) post-HCT. All the disease progression developed within the first 7 months after transplant except 2 who developed late relapse 28 and 32 months post-HCT. Fifteen patients died with 10 from progressive disease and 5 from non-relapse causes: auto accident: 1, breast cancer (incident diagnosed of late recurrent Hodgkin lymphoma): 1, AML:1 and 2 from chronic graft versus host disease after salvage allogeneic HCT. All 55 patients underwent PET scan evaluation 2–3 months after HCT to evaluate post-HCT responses. Twenty-nine patients had no evidence of PET activity post transplant, while 26 patients had evidence of activity. While there were 2 subsequent progressions in the PET negative group (1 of them was a late relapse), there were 9 progressions in the PET positive group. The 5-years estimated survival was 65%. Conclusion: In summary: 1) Most of the disease progressions after AuHCT for relapsed and refractory Hodgkin Lymphoma occurred within the first seven months after the transplant and were associated with abnormal first post-transplant CT +/− PET scan. Thus, the utility of long term surveillance radiological studies is very limited and is not recommended. 2) With longer follow-up, long-term complications including second cancer replace disease as the primary cause of treatment failure. This underscores the importance of long-term follow-up for HCT long-term survivors. Disclosures: No relevant conflicts of interest to declare.

Long-Term Survival In Patients With Acute Steroid Refractory Graft-Versus-Host-Disease (SR-GVHD) Treated With Infliximab Combined With Daclizumab

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 4624-4624
Author(s):  
Sanaz Nicky Soltani ◽  
Ramaprasad Srinivasan ◽  
Theresa Jerussi ◽  
A. John Barrett ◽  
Thomas E Hughes ◽  
...  
Keyword(s):  
High Probability ◽  
Chronic Gvhd ◽  
Complete Response ◽  
Cell Transplant ◽  
Term Survival ◽  
Hematopoietic Stem ◽  
Long Term Survival ◽  
Post Transplant

Acute SR-GVHD occurs in approximately 15% of patients undergoing allogeneic hematopoietic stem cell transplant (HSCT), and is associated with a 70-90% long-term mortality rate. We previously reported that concomitant blockade of TNF-α and IL-2 pathways with infliximab combined with daclizumab have a synergistic therapeutic effect, with a high probability of complete resolution of SR-GVHD. Although various treatment modalities are effective in the treatment of SR-GVHD, minimal long-term follow up data exists for complete responders to second line treatments. Here we report long-term outcomes in a cohort of 23 subjects developing SR-GVHD treated with infliximab/daclizumab. A consecutive series of 141 patients with a variety of hematological and non-hematological malignancies as well as nonmalignant hematological disorders including severe aplastic anemia (SAA), paroxysmal nocturnal hemoglobinuria and pure red cells aplasia, underwent a reduced intensity allogeneic HSCT from an HLA identical or single antigen mismatched relative at a single institution between 2/2001 and 12/2008. Transplant conditioning consisted of cyclophosphamide (60 mg/kg days -7, -6) and fludarabine (25 mg/m2days -5 to -1) with or without equine ATG or 6-12 Gy of total body irradiation. GVHD prophylaxis was with cyclosporine with or without additional MMF or MTX. Twenty three patients (median age 35 years, range 13-65 years) developed SR-GVHD at a median of 28 days post transplant. SR-GVHD was defined as absence of response to at least 6 days of high dose methylprednisolone therapy. Following a diagnosis of SR-GVHD, patients received a combination of daclizumab (1mg/kg given on days 1, 4, 8, 15, 22), infliximab (10mg/kg given on days 1, 8, 15, 22), broad spectrum bacterial and anti-fungal prophylaxis, and had their methylprednisolone tapered to 1mg/kg/day. Combined cytokine blockade was highly active against SR-GVHD, with 21/23 (87.5%) patients achieving a complete response (CR), defined as total resolution of GVHD in all involved organ systems. All complete responders survived to hospital discharge. With a median follow-up of 9 years (range 5-10 years), 9/23 (39%) survive, including 6 patients without chronic GVHD whose immunosuppressive therapy (IST) has been discontinued and 3 patients with chronic GVHD (2 limited and 1 extensive) who continue to be tapered off IST. Fourteen of 21 patients with resolution of SR-GVHD died a median 173 days post transplant (range 67-1039 days), including 1 from complications related to recurrent SR-GVHD, 6 from progression of malignancy (all solid tumors), 2 from bleeding related to peptic ulcer disease and 5 from infectious complications including invasive fungal infection and CMV disease. A subgroup analysis showed 5/6 patients with SAA developing SR-GVHD had a complete response to combined infliximab/daclizimab. Remarkably, at a median 6 years follow up, 67% (4/6) of these SAA patients were long-term survivors. All these survivors have maintained normal blood counts and remained transfusion independent with 100% donor chimerism in myeloid and T-cell lineages. Conclusion Patients with SR-GVHD treated with infliximab combined with daclizumab had a high probability of achieving a complete response with nearly 40% of patients having long-term survival. This is the first report to show that long-term survival can be achieved in a substantial proportion of patients receiving combined IL-2 and TNF blockade for SR-GVHD. Disclosures: Off Label Use: Infliximab is FDA approved for the treatment of psoriasis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis. Daclizumab gained FDA approval for use in transplant rejection.

scholarly journals Multiple Myeloma in Adolescent and Young Adults: A SEER and CIBMTR Analysis

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 12-13
Author(s):  
Steven J Gibson ◽  
Jennifer A Thornton ◽  
Christin B DeStefano
Keyword(s):  
Multiple Myeloma ◽  
Young Adults ◽  
Medical Center ◽  
The United States ◽  
Marrow Transplant ◽  
Cell Transplant ◽  
Blood And Marrow Transplant ◽  
Race Ethnicity

Background Multiple myeloma (MM) is a disease of the elderly, with less than 3% of cases diagnosed in adolescents and young adults (AYA). Data on demographics, use of autologous stem cell transplant (ASCT), second primary malignancies (SPMs) and survival are scant to non-existent in the AYA MM population. To our knowledge, this study is the first to better understand characteristics and survival trends of this unique population. Methods The Surveillance, Epidemiology, and End Results (SEER)-18 and Center for International Blood and Marrow Transplant Research (CIBMTR) datasets were utilized. Inclusion criteria were patients younger than 40 years old diagnosed with MM (ICD-O code 9732/3) between 2000-2017 (SEER) and 2008-2018 (CIBMTR). Variables assessed included age (&lt;30 vs. 30-39), gender, income (&lt;65K vs. ≥65K), race/ethnicity, place of residence (metropolitan vs. non-metropolitan), and year diagnosed (2000-2005 vs. 2006-2011 vs. 2012-2017). Incident SPMs were characterized as standardized incidence ratios (SIR). Analyses were conducted with STATA and data were censored at time of death or loss to follow up. Kaplan-Meier curves were generated for myeloma-specific survival (MSS). Individual variables were compared via log rank tests and Cox proportional hazard regression models. Model fit was assessed with Akaike's information criterion and Snell residuals. Assumptions of the Cox proportional hazards model were evaluated with log-time. Results There were 1,087 and 1,142 patients meeting criteria in SEER and CIBMTR, respectively. Median MSS was 181 months (15 years). The most common causes of death were MM (76%), SPMs (5.5%), and infection (3.6%). Statistically significant incident SPMs were lung cancers (SIR 4.94, p&lt;0.05), non-Hodgkin lymphoma (NHL) (SIR 5.28, p&lt;0.05), and acute myeloid leukemia (AML) (SIR 14.62, p&lt;0.05). Year of diagnosis strongly influenced survival. Compared to those diagnosed in 2000-2005, there was a 36% reduction in the risk of death among those diagnosed 2006-2011 (HR 0.64, 95% CI 0.49-0.82, p=0.001), and a 61% reduction among those diagnosed 2012-2017 (HR 0.39, 95% CI 0.26-0.58, p&lt;0.001). Race/ethnicity, gender, and age did not impact MSS. Among the AYA MM patients who received ASCT, notably 26% had a hematopoietic cell transplant comorbidity index (HCT-CI) of ≥ 3, nearly all received melphalan conditioning, and 80% received ASCT within the first year of diagnosis. One and four-year post-ASCT survival were 96% and 81%, respectively. Discussion To our knowledge, this is the first study assessing MM trends in the AYA population. Despite AYAs being underrepresented in MM clinical trials, the dramatic improvement in survival over time reflects efficacy of new drug approvals in this young population. It is also interesting that racial and socioeconomic disparities which are pervasive in the older adult MM population were not demonstrated in AYAs. AYA patients died from SPMs at rates similar to the adult MM population (3-6%), and notable incident SPMs in the AYA population were lung cancer, NHL, and AML. Also noteworthy was the high number of AYA MM patients who underwent up-front ASCT, which was nearly the same number of patients from the SEER dataset over half the amount of time. Since AYA MM patients have been underrepresented in trials utilizing ASCT, a survival benefit of ASCT in this population has not been demonstrated in the era of novel therapies. Further, given possible underlying genetic predisposition in AYA MM patients, long-term post-ASCT follow up is needed to better understand long-term toxicities including risk of hematological SPMs. Disclosures The findings and opinions contained herein are those of the authors and do not represent the views/opinions of the United States Air Force, Walter Reed National Military Medical Center, David Grant Medical Center, Department of Defense, or the Center for International Blood and Marrow Transplant Research (CIBMTR). Disclosures No relevant conflicts of interest to declare.

scholarly journals Long-term outcome with lenalidomide and dexamethasone therapy for newly diagnosed multiple myeloma.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 8096-8096 ◽  
Author(s):  
Geetika Srivastava ◽  
Vishal Rana ◽  
Martha Lacy ◽  
Morie A. Gertz ◽  
Angela Dispenzieri ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Initial Therapy ◽  
Cell Transplant ◽  
Newly Diagnosed ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Entire Cohort ◽  
Dexamethasone Therapy

8096 Background: The combination of lenalidomide and dexamethasone (Len-Dex) is a commonly used initial therapy for newly diagnosed multiple myeloma. While the short-term outcomes with respect to response and toxicity is well-known, long-term outcome with this combination as initial therapy is not well described. Methods: We studied 286 consecutive patients with newly diagnosed MM seen at our institution, who received initial therapy with Len-Dex, and who had complete follow up records. Data regarding the clinical course was obtained from medical records. Results: The median (range) age at diagnosis was 63 (28-92) yrs; 166 (58% were ≤ 65 yrs and175 (61%) were male. The median estimated follow-up was 3.9 yrs (95% CI, 3.4, 4.2) and 203 (71%) pts were alive at the time of last follow up. The median estimated duration on Len-Dex was 5.3 mos (95% CI, 4.6, 6.4). The best overall response (≥PR) was 72%, including 26% with VGPR or better and 14 (5%) not being evaluable for a response. At last follow up, 41 (14%) patients were continuing on therapy. There were 93 pts (32%) who stayed on therapy for 12 months or more. Among these patients, the ORR was 86%, including 45% with VGPR or better. The median overall survival (OS) for the entire cohort from diagnosis was 7.4 yrs (95% CI; 5.8, NR) and the estimated 5-yr survival was 67%. There were 16 (5.5%) pts who died within a year of diagnosis. The median time to first disease progression, irrespective of transplant status, was 30.2 mos (95% CI, 25, 42). Overall, 143 (50%) of the patients have gone to stem cell transplant. Censoring those patients who proceeded to SCT prior to relapse at the time of BMT, the median TTP was 25.5 mos (95% CI, 22, 29). The median OS was 7.4 yrs for those ≤65 yrs, compared with 6.2 yrs for the older patients (P=0.01). The 5-yr OS estimate for patients in ISS stage 1, 2 and 3 were 82, 65, and 44 months respectively. Conclusions: The current study provides long-term estimates of responses and survival in a series of patients treated initially with lenalidomide and dexamethasone. The median survival of nearly 8 years reflects the efficacy of the novel agents both at diagnosis and at relapse and confirms the survival improvements seen in MM in the last decade.

Measures of immune recovery following autologous stem cell transplantation for multiple myeloma and outcome.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 8581-8581
Author(s):  
Livia Hegerova ◽  
Morie Gertz ◽  
Martha Lacy ◽  
Angela Dispenzieri ◽  
Francis Buadi ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Retrospective Analysis ◽  
Cell Transplant ◽  
Monocyte Count ◽  
Immune Recovery ◽  
Post Transplant ◽  
Clinical Databases ◽  
Normal Monocyte ◽  
The Impact

8581 Background: Autologous stem cell transplant (ASCT) improves survival in patients with multiple myeloma (MM). Recent studies have elucidated the relationship in ASCT between absolute lymphocyte count (ALC) recovery and improved survival, highlighting the importance of immune recovery. We conducted a retrospective analysis of patients with multiple myeloma to observe the impact of different measures of immune recovery at day 100 post-ASCT on outcome. Methods: Retrospective analysis of data from the existing clinical databases identified 1184 patients with multiple myeloma that underwent ASCT at Mayo Clinic between 1987-2011. Markers of immune recovery analyzed on day 100 status-post ASCT included ALC, monocyte count, and immunoglobulin levels. Kaplan Meier analysis was performed to determine progression free survival (PFS) and overall survival (OS). Results: Among the 1184 patients, median age at diagnosis of multiple myeloma was 57 (range, 23-75 yr), and median age at time of transplantation was 59 (range, 24-75 yr); 59% were male. The median OS and PFS post-transplant were 80 months and 34 months respectively. 62% of patients were alive 5-years post-transplant. The median OS was not improved with normal vs. abnormal IgG levels at day 100 (p=.298). In contrast, monocyte recovery was a significant predictor of OS. Patients with normal monocyte counts of greater than 0.3 x 10⁹ cells/L at day 100 showed superior survival (65 vs. 37 months, p= .001). Similarly, patients with normal monocyte recovery at day 15 post-transplant showed a significant survival benefit (68 vs. 50 months, p=.007). Early ALC recovery, which has been shown to be a positive prognostic indicator at day 15 post-transplant, was not prognostic at day 100 (p= .960). Conclusions: The present study further elucidates prognostic indicators after ASCT for MM highlighting the importance of various markers of immune recovery. Immunoglobulin recovery was not associated with superior survival, while monocyte recovery at day 15 and day 100 post-transplant translated to an improved survival and requires further study. It may be hypothesized that early immune system reconstitution may have a positive effect against disease post-transplant.

Follow up Analysis for MRC Myeloma VII Trial.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 927-927
Author(s):  
Gareth J. Morgan ◽  
Faith E. Davies ◽  
Kim Hawkins ◽  
Susan E. Bell ◽  
Julia M. Brown ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Therapy Group ◽  
Intensive Treatment ◽  
High Dose ◽  
Cell Transplant ◽  
High Dose Therapy ◽  
Dose Therapy ◽  
Conventional Dose

Abstract The results of the MRC Myeloma VII trial and overview analysis of comparable trials have suggested that VAD-like induction chemotherapy followed by high dose therapy (HDT) with autologous transplantation may be regarded as a new standard treatment for multiple myeloma. However, there is a need for data from the extended follow up of patients in such trials to provide confirmatory evidence of the benefit of treatment incorporating HDT compared with conventional dose treatment, in particular to determine the long term difference in survival and the impact of attaining a complete response (CR) following intensive treatment. We present an updated analysis of Myeloma VII with median follow up of 5.5 years. Myeloma VII is the largest trial of its type in which patients with previously untreated multiple myeloma, age <65 years, were randomized to receive either standard conventional-dose combination chemotherapy (ABCM) or a sequence of treatment, C-VAMP followed by high dose therapy (HDT), typically melphalan 200g/m2 with autologous stem cell transplant. The planned maintenance in both arms was interferon α-2a. The trial, initiated in 1993 and closed to entry in 2000 and was conducted to MRC guidelines for good clinical practice in clinical trials. In the 401 evaluable patients the CR rate was 44% in the intensive therapy group, 8% in the standard therapy group (p<0.001). Intention to treat analysis showed a survival benefit of 14.1 months in the intensive arm (Figure 1); median 56.3 months (95% CI 46.0–74.6) vs. 42.2 months (95% CI 33.1–48.9), p=0.004 (log rank test). Progression free survival was also improved in the intensive group, median 31.2 months (95% CI 27.1–37.5) compared with 19.5 months (95% CI 16.2–21.6) in the standard group (p=<0.001). This analysis provides confirmatory evidence that treatment including high dose therapy is superior to conventional dose chemotherapy. Long term follow up of this study shows that the benefits of intensive treatment are maintained long term and that an important therapeutic aim is the achievement of CR. For the patients receiving the full protocol, the differences are accentuated, implying that maximising numbers of patients getting to transplant is an important therapeutic aim. These results would also support the continuing development of peri-HDT strategies to further improve outcomes. Figure Figure

Dose-Dense Induction Followed by Autologous Stem Cell Transplant (ASCT) as 1st Line Treatment in Peripheral T-Cell Lymphomas (PTCL) - A Phase II Study of the Nordic Lymphoma Group (NLG).

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 401-401 ◽  
Author(s):  
Francesco d’Amore ◽  
Thomas Relander ◽  
Grete Lauritzsen ◽  
Esa Jantunen ◽  
Hans Hagberg ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Large Cell ◽  
High Dose ◽  
Cell Transplant ◽  
Post Transplant ◽  
Patient Cohort ◽  
Alk Positive ◽  
The Impact

Abstract Systemic PTCL, with the exception of alk-positive anaplastic large cell lymphoma (ALCL), have a poor prognosis. ASCT has been shown to have a favourable impact on relapsed PTCL. Therefore, the NLG designed a prospective multicenter phase II study to evaluate the impact of a dose-intensified induction schedule (6 courses of two-weekly CHOEP) consolidated in 1st PR/CR with high-dose therapy (BEAM) followed by ASCT in previously untreated systemic PTCL. This is the largest prospective PTCL-specific trial published so far. Newly diagnosed non-primary cutaneous PTCL cases aged 18–67 yrs were eligible for enrollment. Cases of alk-positive ALCL were excluded. From Oct 2001 to Feb 2006, 99 histologically confirmed PTCL cases were included in the study: PTCL unspecified (n=41), alk-neg ALCL (n=24), AILT (n=15), enteropathy-type (n=12), panniculitis-like (n=3), T/NK nasal-type (n=2), hepatosplenic (n=2). The M/F ratio was 1.8 and the median age 55 yrs (range 20–67 yrs). Although almost 2/3 of the cases presented with advanced-stage disease (62%), B-symptoms (61%) and/or elevated s-LDH (63%), the majority of them (65%) had a good performance score (WHO 0–1) at diagnosis. Of the 77 patients, where information was available for all 6 induction courses, 68 (88%) were in CR (31) or PR (37) after the 3rd and 66 (86%) after the 6th course. A total of 58 patients (75%) went through ASCT indicating that at least a fourth of this younger patient cohort has a primary refractory disease and fails therapy before reaching the transplant. Treatment-related toxicity after both induction and high-dose treatment was manageable. Of the 58 transplanted patients, 50 (86%) were still in remission at re-evaluation short after transplant. In 39 patients follow-up data one year post-transplant were available: 30 are still in CR and 9 have relapsed, suggesting that post-transplant relapses probably account for another 25% of the original patient cohort. In conclusion, the present data indicate that a time- and dose-intensified schedule is feasible and effective in previously untreated systemic PTCL. Continuous remissions are not uncommon, but a longer follow-up is needed to further characterize long-term remission rates and evaluate their impact on time-to-treatment failure and overall survival.

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