The realMIND study is a multicenter, observational study intended to further characterize the safety and effectiveness data of US patients (with a focus on racial and ethnic minority patients) with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), treated with tafasitamab in combination with lenalidomide.
This observational study is intended to further characterize the safety and effectiveness of tafasitamab, in combination with lenalidomide, in patients with R/R DLBCL in the US, with a focus on racial and ethnic minorities. This study also characterizes the overall treatment patterns (e.g., line of treatment, dose modification, combination partners, use as monotherapy) of US patients with R/R DLBCL who have been treated with tafasitamab with a focus on racial and ethnic minorities This multicenter real-world study will help to characterize the use of tafasitamab (e.g., line of treatment, dose modification, combination partners, use as monotherapy) among US patients with R/R DLBCL with a focus on racial and ethnic minorities This is an observational study; as such, no study visits or assessments, laboratory tests or procedures are mandated by the study. Patients will be evaluated and treated according to the physician's usual practice and discretion. Patient data for this observational study will be collected in one of two ways; either * by prospective follow-up of patients included at study sites, or * by retrospective collection of data from patient records, at study sites or from vendor databases.
Study Type
OBSERVATIONAL
Enrollment
100
Observational Study on safety and effectiveness of tafasitamab in combination with lenalidomide inPatients With Relapsed or Refractory DLBCL.
Treatment Patterns - Safety
Incidence and severity of Treatment-emergent serious AEs (SAEs) and AEs (TEAs)
Time frame: 2 Years
Treatment Patterns - Effectiveness (a)
Objective response rate (ORR)
Time frame: 2 Years
Treatment Patterns - Effectiveness (b)
Complete response (CR) rate
Time frame: 2 Years
Treatment Patterns - Effectiveness (c)
Duration of response (DoR)
Time frame: 2 Years
Treatment Patterns - Effectiveness (d)
OS
Time frame: 2 Years
Treatment Patterns - Effectiveness (e)
Progression-free survival (PFS)
Time frame: 2 Years
Treatment Patterns - Effectiveness (f)
Event-free survival (EFS)
Time frame: 2 Years
Physician-reported clinical outcome (a)
Number of treatment lines prior to receiving tafasitamab
Time frame: 2 Years
Physician-reported clinical outcome (b)
Distribution of treatment regimens by lines of therapy prior to and subsequent to tafasitamab treatment Duration of tafasitamab treatment (regardless of concomitant treatment with lenalidomide)
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Alabama Oncology
Birmingham, Alabama, United States
RECRUITINGClearview Cancer Institute
Huntsville, Alabama, United States
RECRUITINGUniversity of California, Irvine Medical Center
Orange, California, United States
RECRUITINGMcFarland Clinic P.C.
Ames, Iowa, United States
RECRUITINGMission Cancer and Blood
Des Moines, Iowa, United States
RECRUITINGTulane Cancer Center
New Orleans, Louisiana, United States
COMPLETEDAmerican Oncology Partners of Maryland PA
Bethesda, Maryland, United States
RECRUITINGUniversity of Michigan Comprehensive Cancer Center Michigan Medicine
Ann Arbor, Michigan, United States
RECRUITINGHenry Ford Health System
Detroit, Michigan, United States
RECRUITINGMorristown Medical Center
Morristown, New Jersey, United States
RECRUITING...and 15 more locations
Time frame: 2 Years
Physician-reported clinical outcome (c)
Duration of combination treatment (i.e., duration of treatment with both tafasitamab and lenalidomide)
Time frame: 2 Years
Physician-reported clinical outcome (d)
Modifications of dose and treatment schedule of tafasitamab and/or lenalidomide
Time frame: 2 Years
Physician-reported clinical outcome (e)
Incidence of tafasitamab use with combination partners other than lenalidomide
Time frame: 2 Years
Physician-reported clinical outcome (f)
Incidence of tafasitamab use as monotherapy (i.e., without any combination partners)
Time frame: 2 Years