RE-MIND study: A propensity score-based 1:1 matched comparison of tafasitamab + lenalidomide (L-MIND) versus lenalidomide monotherapy (real-world data) in transplant-ineligible patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 8020-8020 ◽  
Author(s):  
Grzegorz S. Nowakowski ◽  
Thomas David Rodgers ◽  
Dario Marino ◽  
Maurizio Frezzato ◽  
Anna Maria Barbui ◽  
...  
Keyword(s):  
Propensity Score ◽  
Primary Endpoint ◽  
Real World ◽  
B Cell Lymphoma ◽  
Cell Transplant ◽  
Primary Analysis ◽  
Real World Data ◽  
World Data ◽  
Matching Criteria ◽  
Matched Comparison

8020 Background: Patients with R/R DLBCL ineligible for autologous stem cell transplant (ASCT) have a poor prognosis. In these patients, tafasitamab (anti-CD19 antibody) plus lenalidomide (LEN) has shown encouraging results in the open-label, single-arm, phase II L-MIND study (n = 81; NCT02399085). To evaluate the contribution of tafasitamab to the activity of this doublet, we conducted a global, real-world study of patients treated with LEN monotherapy (RE-MIND; NCT04150328). Here we present the primary analysis of a 1:1 patient-level matched comparison between the L-MIND and RE-MIND cohorts. Methods: Patients treated with LEN monotherapy for R/R DLBCL were enrolled in the observational, retrospective RE-MIND cohort. As in L-MIND, patients had 1–3 prior systemic therapies, including ≥1 CD20-targeting regimen; were aged ≥18 years; and were not eligible for ASCT. A 1:1 estimated propensity score (ePS) matching methodology ensured balancing of nine pre-specified baseline covariates. The primary analysis set, Matched Analysis Set 25 (MAS25), included patients who received a LEN starting dose of 25 mg/day. The primary endpoint was investigator-assessed best objective response rate (ORR). Key secondary endpoints included overall survival (OS) and complete response (CR) rate. Results: 490 patients were enrolled in RE-MIND across 58 centers in the US and Europe, of which 140 fulfilled the ePS matching criteria. The MAS25 included 76 patients each from the two cohorts. Baseline characteristics between cohorts were comparable. The primary endpoint was met with a significantly better ORR of 67.1% (95% CI: 55.4–77.5) for the L-MIND cohort versus 34.2% (95% CI: 23.7–46.0) for the RE-MIND cohort (odds ratio 3.89; 95% CI: 1.90–8.14; p < 0.0001). The CR rate was 39.5% (95% CI: 28.4–51.4) in the L-MIND cohort and 13.2% (95% CI: 6.5–22.9) in the RE-MIND cohort. A significant difference in OS favored the L-MIND cohort (HR = 0.499; 95% CI: 0.317–0.785). ORR and CR outcomes in the RE-MIND cohort were similar to the published literature for LEN monotherapy in R/R DLBCL. Conclusions: Significantly better ORR, CR and OS indicate potential synergistic effects of the tafasitamab + LEN combination in ASCT-ineligible R/R DLBCL. ePS-based 1:1 matching allows robust estimation of the treatment effect of tafasitamab when added to LEN. RE-MIND demonstrates the utility of real-world data in interpreting non-randomized trials. Clinical trial information: NCT04150328 .

scholarly journals Utilizing HealthTree ® Cure Hub's Real-World Data to Assess Treatment Management of Patients with Multiple Myeloma during the COVID-19 Pandemic

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 5026-5026
Author(s):  
Nathan W. Sweeney ◽  
Jennifer M. Ahlstrom
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Real World ◽  
Online Survey ◽  
Stem Cell Transplant ◽  
Oral Treatment ◽  
Cell Transplant ◽  
Real World Data ◽  
World Data ◽  
Treatment Management

Abstract Background: Patients with multiple myeloma (MM) are uniquely susceptible to viral and bacterial illnesses, including COVID-19, due to their immunocompromised state, age, treatments, and comorbidities. With the advent of COVID-19, changes to treatment were recommended whenever possible, in order to reduce visits to the clinic. The total effect of these changes on cancer patients with multiple myeloma remains unclear. The aim of this project was to assess treatment management by changes to treatment of patients with MM during the COVID-19 pandemic. Methods: We utilized HealthTree ® Cure Hub for Multiple Myeloma (healthree.org) and invited patients with active MM cancer or precursor conditions to participate in an online survey. We analyzed patient responses to questions regarding their myeloma treatments during the COVID-19 pandemic. Results: 978 MM patients participated in the survey between February to June 2021. Since March 2020, 151 patients (15%) either delayed, postponed, or stopped a myeloma treatment because of COVID-19. The four most common treatments were daratumumab (20%), lenalidomide (15%), stem cell transplant (13%) and zoledronic acid (11%). There were 110 patients that canceled a planned myeloma treatment. Of these patients, 55 (50%) canceled a planned chemotherapy, 15 (14%) canceled a stem cell transplant, 1 (1%) canceled radiation and 39 (35%) indicated other. Eight patients replaced an intravenous or subcutaneous treatment with an oral treatment because of COVID-19. There were 9 patients that started a new myeloma treatment because of COVID-19, the most common being daratumumab (44%), ixazomib (22%), lenalidomide (22%) and carfilzomib (11%). Finally, 15 patients had their lenalidomide (50%), steroid (42%) and carfilzomib (8%) dose changed. Conclusions: Our results show that decision-making regarding treatment changes were made on an individual basis and that patients who required a change in treatment were the minority. Aggregating real-world data can provide evidence that despite the changes, patients with MM still received and efficacious treatment and avoided putting these patients at risk or mortality. Disclosures Ahlstrom: Bristol Myers Squibb: Other: Patient Advisory; Janssen: Other: Patient Advisory; Pfizer: Other: Patient Advisory; Takeda: Other: Patient Advisory.

Weekly as Opposed to Bi-Weekly Bortezomib as Part of Induction Chemotherapy in Newly Diagnosed Multiple Myeloma is Better Tolerated and Equally Efficient in Terms of Initial Therapeutic Response: Real-World Data from a Retrospective Audit

2021 ◽  
Vol 8 (11) ◽  
Author(s):  
Faulkner LG ◽  
◽  
Suresh C ◽  
Sachedina S ◽  
Barton L ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Adverse Effects ◽  
Real World ◽  
Therapeutic Response ◽  
Hospital Admissions ◽  
Cell Transplant ◽  
Newly Diagnosed ◽  
Real World Data ◽  
World Data ◽  
Retrospective Audit

Bortezomib is a proteasome inhibitor that has shown efficacy in the treatment of newly diagnosed multiple myeloma. The VTD (Bortezomib, Thalidomide, Dexamethasone) triplet chemotherapy regime is frequently used as induction prior to autologous stem cell transplant, in line with national and international recommendations. The manufacturer’s protocol for Bortezomib recommend a twice weekly dosing schedule. Adverse effects are common, most notably peripheral and autonomic neuropathy. These adverse effects can be disabling, even at lower grades and often limit drug tolerance. We propose a once weekly Bortezomib treatment regime as an alternate modus operandi. Here we use real-world data to demonstrate that weekly compared to bi-weekly Bortezomib is better tolerated whilst achieving similar outcomes in terms of initial therapeutic response. We demonstrate a trend of lower incidence of neuropathy- both peripheral and autonomic- with the weekly regime. There was also a trend of fewer serious adverse events with the weekly regime with lower rates of hospital admissions due to infections. In addition, we show that this regime is associated with better Thalidomide tolerance. We believe that delivery of Bortezomib through a weekly regime facilitates patients being able to maintain on Bortezomib longer and receive higher cumulative doses.

MM-257: It’s the Response That Matters: Real-World Data of Multiple Myeloma Patients Treated without Upfront Stem Cell Transplant

2021 ◽  
Vol 21 ◽  
pp. S433
Author(s):  
Rohit Reddy Lavu ◽  
Lalit Kumar ◽  
Raja Mounika Velagapudi ◽  
Sreenivas Konda ◽  
Shalabh Arora
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Real World ◽  
Stem Cell Transplant ◽  
Cell Transplant ◽  
Real World Data ◽  
World Data

scholarly journals Are CAR-T therapies living up to their hype? A study using real-world data in two cohorts to determine how well they are actually working in practice compared with bone marrow transplants

2019 ◽  
pp. bmjebm-2019-111226 ◽  
Author(s):  
Duane Schulthess ◽  
Daniel Gassull ◽  
Amr Makady ◽  
Anna Ludlow ◽  
Brian Rothman ◽  
...  
Keyword(s):  
Real World ◽  
Rank Test ◽  
Cell Transplant ◽  
Real World Data ◽  
Accurate Analysis ◽  
Test Analysis ◽  
World Data ◽  
Car T ◽  
European Health ◽  
And Performance

With the increasing use of new regulatory tools, like the Food and Drug Administration’s breakthrough designation, there are increasing challenges for European health technology assessors (HTAs) to make an accurate assessment of the long-term value and performance of chimeric antigen receptor T-cell (CAR-T) therapies, particularly for orphan conditions, such as acute lymphoblastic leukaemia. The aim of this study was to demonstrate a novel methodology harnessing longitudinal real-world data, extracted from the electronic health records of a medical centre functioning as a clinical trial site, to develop an accurate analysis of the performance of CAR-T compared with the next-best treatment option, namely allogeneic haematopoietic cell transplant (HCT). The study population comprised 43 subjects in two cohorts: 29 who had undergone HCT treatment and 14 who had undergone CAR-T therapy. The 3-year relapse-free survival probability was 46% (95% CI: 08% to 79%) in the CAR-T cohort and 68% (95% CI: 46% to 83%) in the HCT cohort. To explain the lower RFS probability in the CAR-T cohort compared with the HCT cohort, the authors hypothesised that the CAR-T cohort had a far higher level of disease burden. This was validated by log-rank test analysis (p=0.0001) and confirmed in conversations with practitioners at the study site. The authors are aware that the small populations in this study will be seen as limiting the generalisability of the findings to some readers. However, in consultation with many European HTAs and regulators, there is broad agreement that this methodology warrants further investigation with a larger study.

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