Analysis of Common Eligibility Criteria of Randomized Controlled Trials in Newly Diagnosed Multiple Myeloma Patients and Extrapolating Outcomes

Randomized Clinical Trial Representativeness and Outcomes in Real-World Patients: Comparison of 6 Hallmark Randomized Clinical Trials of Relapsed/Refractory Multiple Myeloma

“…In our study, the patients with RRMM who were deemed RCT ineligible had worse OS than those who were RCT eligible, concordant with previous data from patients with NDMM. 22 Similar to other research of NDMM, we found that RI and hematopoietic instability with a greater number of cytopenias were predictive of OS in RRMM. 22 However, our data have also revealed that in the RRMM patient population, older age and refractory status to a previous LOT are both adverse prognostic factors and both independently associated with lower odds of trial eligibility.…”

Heterogeneity of Second-Line Treatment for Patients With Multiple Myeloma in the Connect MM Registry (2010-2016)

“…Because a high proportion (84%) of patients are enrolled from community sites, Connect MM is a valuable resource for characterizing treatment uptake in daily practice. Connect MM has previously been used to describe the demographic and disease characteristics of NDMM patients in clinical practice 2 and how these differ compared to patients enrolled onto clinical trials, 3 to establish the low incidence of second primary malignancies associated with lenalidomide in this community-based population, 4 and to construct a matrix to predict individual patient risk of early mortality. 5 The objective of this study was to describe second-line treatment patterns over time for patients with relapsed or refractory MM.…”

Development of a prognostic model for overall survival in multiple myeloma using the Connect® MM Patient Registry

“…A potential application of this matrix is to identify patients with poor prognosis (e.g. estimated 3‐year OS: 30–40%) who might benefit from clinical trial interventions for which they might not routinely qualify (Shah et al , ); outcomes could be judged relative to estimated OS. This is especially pertinent in the era of triplet therapy, which has improved prognosis for patients irrespective of risk profile (Jakubowiak et al , ; Moreau et al , ; Attal et al , ).…”

“…The current standard for MM staging has evolved to the International Staging System (ISS; which uses β 2 ‐microglobulin and serum albumin) and the revised ISS [R‐ISS; which incorporates serum lactate dehydrogenase (LDH) and high‐risk chromosomal abnormalities], which are commonly used to stratify patients and compare outcomes in clinical trials (Greipp et al , ; Biran et al , ; Palumbo et al , ). Given its primary use in clinical trials, application of the R‐ISS in daily clinical practice is limited and may not apply to typical patients receiving treatment, considering that 40% of patients with NDMM are projected to be ineligible for clinical trials (Hanbali et al , ; Shah et al , ). The R‐ISS was developed using few prognostic factors and data from selected groups ( N = 3060) enrolled in clinical trials (68% ≤65 years, 65% eligible for ASCT) (Palumbo et al , ).…”

“…Most knowledge of factors associated with outcomes is based on clinical trial data in which selection bias often excludes certain patients [i.e., the elderly (>70 years), those who are transplant ineligible, or those with comorbidities] (Polite et al , ), which prevent application of prognostic data to these patients. Assessing factors associated with outcomes in an unselected community setting would better reflect the heterogeneity of patients in routine clinical practice (Shah et al , ).…”