Lenalidomide Monotherapy in R/R DLBCL (RE-MIND)

August 23, 2022 updated by: MorphoSys AG

An Observational Retrospective Cohort Study of Lenalidomide Monotherapy in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) to Generate a Historical Control for Clinical Trial MOR208C203 (RE-MIND)

This observational study is designed to characterise the effectiveness of lenalidomide monotherapy in the treatment of R/R DLBCL and to compare the results with the efficacy outcomes of a tafasitamab-lenalidomide combination therapy in the clinical trial MOR208C203 (L-MIND)

Study Overview

Status

Completed

Conditions

Detailed Description

Tafasitamab (MOR00208) is currently in development for the treatment of R/R DLBCL. An ongoing, single-arm, phase II, open label, multicenter study (MOR208C203) is evaluating the efficacy and safety of tafasitamab combined with lenalidomide in patients with R/R DLBCL. In order to establish a lenalidomide monotherapy as a control cohort, this observational study aims to collect retrospective lenalidomide monotherapy data from real-world-evidence and to compare it with the tafasitamab-lenalidomide combination therapy.

Study Type

Observational

Enrollment (Actual)

490

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 76038
        • MorphoSys Research Site
      • Le Mans, France, 72037
        • MorphoSys Research Site
      • Lille, France, 59037
        • MorphoSys Research Site
      • Lyon, France, 69495
        • MorphoSys Research Site
      • Paris, France, 75010
        • MorphoSys Research Site
      • Paris, France, 75743
        • MorphoSys Research Site
      • Poitiers, France, 86000
        • MorphoSys Research Site
      • Pontoise, France, 95300
        • MorphoSys Research Site
      • Rouen, France, 76038
        • MorphoSys Research Site
      • Toulouse, France, 31059
        • MorphoSys Research Site
      • Tours, France, 37044
        • MorphoSys Research Site
  • Italy
      • Aviano, Italy, 33081
        • MorphoSys Research Site
      • Bergamo, Italy, 24127
        • MorphoSys Research Site
      • Bologna, Italy, 40138
        • MorphoSys Research Site
      • Brescia, Italy, 25123
        • MorphoSys Research Site
      • Como, Italy, 22100
        • MorphoSys Research Site
      • Cuneo, Italy, 12100
        • MorphoSys Research Site
      • Firenze, Italy, 50134
        • MorphoSys Research Site
      • Meldola, Italy, 47014
        • MorphoSys Research Site
      • Milano, Italy, 20132
        • MorphoSys Research Site
      • Milano, Italy, 20141
        • MorphoSys Research Site
      • Milano, Italy, 20162
        • MorphoSys Research Site
      • Modena, Italy, 41124
        • MorphoSys Research Site
      • Napoli, Italy, 80131
        • MorphoSys Research Site
      • Napoli, Italy, 80131_2
        • MorphoSys Research Site
      • Novara, Italy, 28100
        • MorphoSys Research State
      • Padova, Italy, 35128
        • MorphoSys Research Site
      • Parma, Italy, 43126
        • MorphoSys Research Site
      • Pavia, Italy, 27100
        • MorphoSys Research Site
      • Perugia, Italy, 06129
        • MorphoSys Research Site
      • Piacenza, Italy, 29121
        • MorphoSys Research Site
      • Ponderano, Italy, 13875
        • MorphoSys Research Site
      • Ravenna, Italy, 48121
        • MorphoSys Research Site
      • Reggio Emilia, Italy, 42132
        • MorphoSys Research Site
      • Rimini, Italy, 47923
        • MorphoSys Research Site
      • Roma, Italy, 00128
        • MorphoSys Research Site
      • Roma, Italy, 00161
        • MorphoSys Research Site
      • Roma, Italy, 00189
        • MorphoSys Research Site
      • Salerno, Italy, 84131
        • MorphoSys Research Site
      • San Giovanni Rotondo, Italy, 71013
        • MorphoSys Research Site
      • Torino, Italy, 10126_2
        • MorphoSys Research Site
      • Torino, Italy, 10126
        • MorphoSys Research Site
      • Torino, Italy, 10128
        • MorphoSys Research Site
      • Udine, Italy, 33100
        • MorphoSys Research Site
      • Verona, Italy, 37100
        • MorphoSys Research Site
      • Vicenza, Italy, 36100
        • MorphoSys Research Site
  • Spain
      • Barcelona, Spain, 08003
        • MorphoSys Research Site
      • Madrid, Spain, 28041
        • MorphoSys Research Site
      • Salamanca, Spain, 37007
        • MorphoSys Research Site
  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • MorphoSys Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • MorphoSys Research Site
    • New York
      • Manhasset, New York, United States, 11030
        • MorphoSys Research Site
      • New York, New York, United States, 10013
        • MorphoSys Research Site
      • Rochester, New York, United States, 14642
        • MorphoSys Research Site
    • Ohio
      • Dublin, Ohio, United States, 43017
        • MorphoSys Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • MorphoSys Research Site
      • Greenville, South Carolina, United States, 29615
        • MorphoSys Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

R/R DLBCL patients not eligible for HDC followed by ASCT who were treated with lenalidomide monotherapy

Description

Inclusion Criteria:

  • Histologically confirmed diagnosis of DLBCL
  • Relapsed/refractory to at least one previous systemic therapy for DLBCL
  • Received at least one, but no more than three previous systemic regimens for the treatment of DLBCL, including at least one anti-CD20 containing therapy
  • Received lenalidomide monotherapy for R/R DLBCL while being considered not eligible for an ASCT

Exclusion Criteria:

  • CNS involvement by lymphoma
  • Patients who received lenalidomide in combination with another anti-lymphoma therapy (including radiation)
  • Previously treated with anti-CD19-targeted therapy or immunomodulatory drugs
  • Patients who previously underwent allogeneic SCT
  • Known simultaneous detection of MYC and BCL2 or BCL6 translocation according to FISH
  • Patients with a history of other malignancies within 5 years prior to lenalidomide treatment start

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best overall/objective response rate (ORR)
Time Frame: Through study completion, an average of 9 months
Proportion of patients with complete response (CR) or partial response (PR) as best response achieved at any time during the study
Through study completion, an average of 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Through study completion, an average of 9 months
Time from treatment start until death from any cause
Through study completion, an average of 9 months
Complete response rate
Time Frame: Through study completion, an average of 9 months
Proportion of patients having CR based on the best objective response achieved at any time during the study
Through study completion, an average of 9 months
Disease control rate
Time Frame: Through study completion, an average of 9 months
Proportion of patients having CR, PR or stable disease (SD) based on the best objective response achieved at any time during the study
Through study completion, an average of 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MorphoSys AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 12, 2019

Primary Completion (ACTUAL)

August 25, 2019

Study Completion (ACTUAL)

August 25, 2020

Study Registration Dates

First Submitted

October 31, 2019

First Submitted That Met QC Criteria

November 1, 2019

First Posted (ACTUAL)

November 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 24, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOR208C206

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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