Yasir Nagarwala

Efficacy and safety of long-term treatment with lenalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma

Data from two randomized pivotal, phase 3 trials evaluating the combination of lenalidomide and dexamethasone in relapsed/refractory multiple myeloma (RRMM) were pooled to characterize the subset of patients who achieved long-term benefit of therapy (progression-free survival ⩾3 years). Patients with long-term benefit of therapy (n=45) had a median duration of treatment of 48.1 months and a response rate of 100%. Humoral improvement (uninvolved immunoglobulin A) was more common in patients with long-term benefit of therapy (79% vs 55% P=0.002). Significant predictors of long-term benefit of therapy in multivariate analysis were age<65 years (P=0.03), β2-microglobulin <2.5 mg/l (P=0.002) and fewer prior therapies (P=0.002). The exposure-adjusted incidence rate (EAIR) of grade 3–4 neutropenia was lower in patients with long-term benefit of therapy (13.9 vs 38.2 per 100 patient-years). The EAIR for invasive second primary malignancy was the same in patients with long-term benefit of therapy and other patients (1.7 per 100 patient-years). These findings indicate that patients with RRMM can experience long-term benefit with lenalidomide and dexamethasone treatment with manageable side effects.

Patterns of total cost and economic consequences of progression for patients with newly diagnosed multiple myeloma.

Abstract Background: Few studies have addressed the cost patterns of patients with multiple myeloma (MM) before and after first relapse. This US claims analysis evaluated, from a US health plan perspective, patterns of total direct costs of care from treatment initiation to progression for patients with MM treated with novel agents, using time to next therapy (TTNT) as a proxy measure for progression. Methods: A retrospective study was conducted using a large US claims database, evaluating patients with claims for MM between 2006 and 2013. Patients with claims for stem cell transplant (SCT) were excluded. The analysis focused on patients receiving lenalidomide (LEN) or bortezomib (BORT) based treatment, for whom complete claim history was available through initiation of subsequent treatment. Average patient monthly direct costs were determined, including medical and pharmacy costs, and total cost patterns over quarterly time periods were calculated. Results: The study population comprised 2843 patients with newly diagnosed MM (NDMM) and 1361 with relapsed MM. Total monthly cost for patients with NDMM declined steadily, from

Connect MM registry: The importance of establishing baseline disease characteristics

15,734 initially to

Connect MM® – the Multiple Myeloma Disease Registry: incidence of second primary malignancies in patients treated with lenalidomide

5082 at 18+ months after therapy. Upon initiation of second-line therapy, total monthly costs rose to

Connect MM®—the Multiple Myeloma (MM) Disease Registry: Interim Analysis of Overall Survival and Outcomes in Patients with High-Risk Disease

13,876 and declined to

Cost-Effectiveness Of Lenalidomide and Bortezomib In Patients With Previously Untreated Multiple Myeloma (MM)

6446 18 months later. Although NDMM cost levels for individual ordinal months were similar between the LEN and BORT groups, TTNT was longer for LEN-based treatments (37 months). The BORT-treated cohort had higher average monthly total costs for NDMM and for the common time period through 37 months after initiation of therapy (

Lenalidomide Dose Modifications and Associated Patient Outcomes in Newly Diagnosed Multiple Myeloma (NDMM)

7534 vs

Cost of Treatment for Relapsed/Refractory Multiple Myeloma.

10,763 for LEN and BORT, respectively). Key limitations of this study, in addition to the lack of mortality and staging information available from claims data, include the definition of TTNT based on change in treatment or a defined gap in therapy prior to retreatment, which may differ from actual time of progression in some patients. Conclusions: For patients with NDMM receiving either LEN- or BORT-based treatment without SCT, followed until TTNT, total direct monthly costs (drug + medical) declined steadily over time. Monthly costs returned to near initial levels when patients began second-line therapy and then followed a similar pattern of decline. Due to the longer TTNT for patients initiated on LEN and the associated longer period of below-average costs, patients initiated with LEN-based treatments had mean monthly total costs >

Characteristics and survival of African American (AA) newly diagnosed multiple myeloma (NDMM) patients (Pts): A report from the Connect MM Registry.

3200 lower than total costs for patients initiated on BORT during the first 3 years after starting treatment, cumulating to nearly

MM-014: A phase 2 trial evaluating efficacy, safety, and biomarkers of pomalidomide plus low-dose dexamethasone (POM + LoDEX) in relapsed/refractory multiple myeloma (RRMM) following second-line lenalidomide plus dexamethasone (LEN + DEX).

120,000 in lower costs for patients initiated on LEN.