Triplet Therapy & Overall Survival (OS) in Routine Practice among Transplant-Ineligible Patients (pts) with Newly Diagnosed Multiple Myeloma (NDMM) in the United States (US)

2017 ◽  
Vol 17 (1) ◽  
pp. e80
Author(s):  
Dorothy Romanus ◽  
Aditya Raju ◽  
Brian Seal ◽  
Eileen Farrelly ◽  
Katarina Luptakova ◽  
...  
Keyword(s):  
United States ◽  
Multiple Myeloma ◽  
Overall Survival ◽  
The United States ◽  
Routine Practice ◽  
Newly Diagnosed

Patient preferences for interferon alfa in multiple myeloma.

1997 ◽  
Vol 15 (4) ◽  
pp. 1672-1679 ◽  
Author(s):  
H Ludwig ◽  
E Fritz ◽  
J Neuda ◽  
B G Durie
Keyword(s):  
United States ◽  
Multiple Myeloma ◽  
Overall Survival ◽  
Patient Preferences ◽  
Maintenance Treatment ◽  
The United States ◽  
Interferon Alfa ◽  
Medical Decision ◽  
Published Data ◽  
Financial Cost

PURPOSE Interferon alfa treatment in multiple myeloma marginally improves relapse-free and overall survival. Often it does so at the expense of toxicity and financial cost. If patients are unwilling or unable to participate in the decision of whether to initiate such treatment, known patient preferences can serve as guidelines for the physician. We interviewed myeloma patients in the United States to obtain information that might facilitate medical decision-making. PATIENTS AND METHODS Three hundred fifty-five myeloma patients throughout the United States were interviewed by telephone. Without identifying interferon alfa as the treatment agent, interviewers described potential adverse effects, financial cost, and self-injection procedures. The potential benefits of four treatment choices, derived from a meta-analysis of published data, were presented as gains in remission rate (+10%), remission duration (an additional 4 and 7 months, respectively, for induction and maintenance treatment), and overall survival (an additional 3 and 6 months, respectively, for induction and maintenance treatment). Patients' choices for or against use of the unidentified substance were recorded, and interferon was subsequently disclosed as the treatment. The profiles of patients making different choices were determined using multivariate regression techniques. RESULTS Approximately half of the patients accepted the unidentified treatment if remission and/or survival improved by at least 6 months. Accepters were younger and more likely to have used interferon. Of patients who rejected the unidentified treatment, 25% to 50% would have been willing to accept it if the benefits were > or = 12 months. Test/retest reliability of all choices, determined in 36 cancer patients, was 0.896. CONCLUSION In multiple myeloma, interferon therapy and, by inference, other treatments with comparable features are acceptable to approximately half of the patients if a 6-month gain in relapse-free or overall survival can be expected.

Treatment Patterns From 2009-2015 in Patients With Newly Diagnosed Multiple Myeloma in the United States: A Report From the Connect® MM Registry

2017 ◽  
Vol 17 (1) ◽  
pp. e20-e21 ◽  
Author(s):  
Robert Rifkin ◽  
Rafat Abonour ◽  
Brian Durie ◽  
Cristina Gasparetto ◽  
Sundar Jagannath ◽  
...  
Keyword(s):  
United States ◽  
Multiple Myeloma ◽  
The United States ◽  
Treatment Patterns ◽  
Newly Diagnosed

scholarly journals The Incidence of Thromboembolism for Lenalidomide Versus Thalidomide in Older Patients with Newly Diagnosed Multiple Myeloma

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 361-361
Author(s):  
Ang Li ◽  
Qian V. Wu ◽  
Greg Warnick ◽  
Edward N. Libby ◽  
David A. Garcia ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Survival ◽  
Propensity Score ◽  
Older Patients ◽  
Research Funding ◽  
The United States ◽  
Immunomodulatory Drugs ◽  
Newly Diagnosed ◽  
Treatment Groups ◽  
To Receive

Abstract Introduction: Chemotherapy backbones with immunomodulatory drugs have become the standard of care for the treatment of multiple myeloma (MM). Despite improved survival outcomes, thrombotic complications remain a concern especially in the older patients with co-morbidities. A meta-analysis showed that lenalidomide might be associated with lower rate of thromboembolism than thalidomide-containing regimen in patients with newly diagnosed MM with (0.7 vs. 2.6 per 100-patient-cycle) or without prophylaxis (0.8 vs. 4.1 per 100-patient-cycle) (JTH 2011;9:653). As thalidomide is still commonly used outside of the United States, it is important to understand if the thromboprophylaxis guideline is generalizable to all immunomodulatory drugs. However, no prior study has directly compared the thrombotic incidence between the two regimens while accounting for confounders. In the current propensity score weighted study, we have examined the incidence of venous (VTE) and arterial (ATE) thromboembolism and survival for older patients with newly diagnosed MM treated with lenalidomide- versus thalidomide-containing regimen. Methods: We performed a retrospective cohort study using the SEER-Medicare database and selected all patients 66 or older with newly diagnosed MM 2007 to 2013. Patients were included if they had a prescription of IMID within twelve months of diagnosis and complete enrollment for fee-for-service and prescription drug coverage. Patients were followed from the IMID index date until first VTE occurrence or death and they were censored for disenrollment from Medicare A/B/D, enrollment in health maintenance organization, or 12/31/2014. We defined VTE (including pulmonary embolism and deep vein thrombosis) and ATE (including acute stroke and myocardial infarction) using previously validated ICD-9-CM codes with positive predictive value of 75-95% (Thromb Res 2010;126:61, Am Heart J 2004;148:99, Stroke 2014;45:3219). We used inverse probability of treatment weighting (IPTW) to balance potential confounders (demographics, year of diagnosis, co-morbidities, concurrent medications) where a standardized difference (SD) of <0.1 was considered adequate balance. Weighted Kaplan-Meier curves and Cox models (HR) were used to compare overall survival. Weighted cumulative incidence curves and Fine-Gray subdistribution hazards models (SHR) were used to compare VTE and ATE incidence where death was treated as a competing risk. Variance was estimated via 200 bootstraps. Results: Among 2397 older MM patients that met the study criteria, 78% received lenalidomide (n=1863) and 22% thalidomide (n=534). There was a strong temporal trend of increasing lenalidomide use over time (Table 1). The lenalidomide group was more likely to receive bortezomib and lower dose of dexamethasone and less likely to receive anticoagulant prophylaxis. All confounders were balanced between the two treatment groups after IPTW. The 12-month incidence of VTE (10%) and ATE (5%) were similarly high in both groups (Figure 1a-b). Lenalidomide vs. thalidomide had a SHR of 1.11 (0.59-2.02) for VTE and a SHR 0.96 (0.45-1.98) for ATE. Overall survival was also not significantly different with a HR of 0.88 (0.60-1.18) for lenalidomide vs. thalidomide. Conclusion: In this propensity score weighted study of older patients with newly diagnosed MM, the cumulative incidences of VTE and ATE were similarly high in both lenalidomide- and thalidomide-treatment groups. The lack of difference in overall survival should be interpreted with caution as residual confounding such as severity of disease could influence this outcome. Our results suggest that appropriate risk stratification and vigilant thromboprophylaxis remain essential for MM patients receiving all types of immunomodulatory drugs. Disclosures Garcia: Retham Technologies LLC: Consultancy; Shingoi: Consultancy; Portola: Research Funding; Boehringer Ingelheim: Consultancy; Bristol Meyers Squibb: Consultancy; Janssen: Consultancy, Research Funding; Incyte: Research Funding; Daiichi Sankyo: Research Funding; Pfizer: Consultancy. Lyman:Amgen: Other: Research support; Halozyme; G1 Therapeutics; Coherus Biosciences: Consultancy; Generex Biotechnology: Membership on an entity's Board of Directors or advisory committees.

Phase 3 FIRST Trial in Transplant-Ineligible Newly Diagnosed Multiple Myeloma: Subgroup Analysis of Patients From Canada and the United States

2019 ◽  
Vol 19 (10) ◽  
pp. e225
Author(s):  
Andrew Belch ◽  
Nizar J. Bahlis ◽  
Darrell White ◽  
Matthew Cheung ◽  
Christine Chen ◽  
...  
Keyword(s):  
United States ◽  
Multiple Myeloma ◽  
Subgroup Analysis ◽  
The United States ◽  
Newly Diagnosed ◽  
Phase 3

An Adjusted Treatment Comparison of Bortezomib/Cyclophosphamide /Dexamethasone and Bortezomib/Thalidomide/Dexamethasone from Real-World Data in Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant-Eligible

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2142-2142
Author(s):  
Maneesha Mehra ◽  
Sarah Cote ◽  
Tobias Kampfenkel ◽  
Sandhya Nair
Keyword(s):  
United States ◽  
Multiple Myeloma ◽  
Real World ◽  
The United States ◽  
Induction Treatment ◽  
Newly Diagnosed ◽  
Real World Data ◽  
Employment Equity ◽  
Equity Ownership ◽  
Baseline Characteristics

Introduction: For patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem-cell transplantation (ASCT), two standard of care (SoC) induction regimens are bortezomib/cyclophosphamide/dexamethasone (VCd) and bortezomib/thalidomide/dexamethasone (VTd), each followed by ASCT. While VCd and VTd are both treatment options according to international guidelines, treatment selection varies by country. Additionally, while some clinical studies have evaluated the efficacy and safety of these therapies, direct comparisons have been limited to response endpoints post-induction and post-transplant (Moreau P, et al. Blood. 2016;127[21]2569-2574; Cavo M, et al. Blood. 2014;124[21]197; Cavo M, et al. Leukemia. 2015;29[12]2429-31). Herein we describe real-world treatment patterns in the United States for patients with NDMM who are transplant-eligible, and report results from a matched adjusted comparison to evaluate real-world long-term efficacy (overall survival, OS) for VCd +ASCT versus VTd +ASCT. Methods: Data for the VCd and VTd real-world evidence (RWE) cohorts were identified from 3 US data sources collectively covering the period January 2000 to March 2017: the OPTUM™ Commercial Claims database, the OPTUM™ Integrated (CLAIMS+EMR) database, and the Surveillance, Epidemiology, and End Results (SEER)-Medicare Linked database. RWE data were from patients with an index MM diagnosis on or after 1 January 2007, medical prescription coverage in place at diagnosis, no prior malignancies in the 1-year period prior to index diagnosis, a 1-year look-back period prior to index diagnosis, received ≥1 line of therapy, and received stem cell transplantation with induction as frontline treatment. The Kaplan-Meier method and Cox proportional hazard model compared outcomes with and without adjustments for baseline characteristics (age, sex, renal impairment, and anemia) and induction treatment duration; comparisons were also conducted with inverse probability of treatment weighting (IPTW). Results: Analysis of RWE from the United States demonstrated that bortezomib (V)-based regimens were the most common induction treatment (together accounting for approximately 75% of therapies), with bortezomib/lenalidomide/dexamethasone (VRd) being the most common (31%). Use of VCd (13%) and VTd (5%) was limited. Comparisons were conducted for VCd (n = 135) and VTd (n = 51). Baseline characteristics were generally similar between groups, except for fewer male patients in the VCd group than the VTd group (57% vs 65%), and lower rates of renal impairment in the VCd group than the VTd group (29% vs 43%; Table 1). The naïve and adjusted comparisons of OS for VCd versus VTd therapy showed these treatments were not statistically different (adjusted hazard ratio, 1.180 [95%: 0.468-2.972]; P = 0.7260; Figure 1). The IPTW method generated similar results. Conclusions: Real-world data from the United States show that V-based induction regimens are the most commonly used for treatment of patients with NDMM who are transplant-eligible. Results from the naïve, adjusted, and IPTW comparisons all showed that OS was not significantly different for VCd + ASCT versus VTd + ASCT. Survival data for VTd from RWE are generally consistent with VTd data reported in the recent phase 3 CASSIOPEIA study, although OS data from CASSIOPEIA remain immature (Moreau P, et al. Lancet. 2019;394[10192]:29-38). Disclosures Cote: Janssen: Employment, Equity Ownership. Kampfenkel:Janssen: Employment, Equity Ownership. Nair:Janssen: Employment, Equity Ownership.

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