A Study to Evaluate the Relationship of Lenalidomide With Tumor Flare Reaction and High Tumor Burden in Participants With Relapsed or Refractory Mantle Cell Lymphoma

NCT03647124 | Completed

• 3 other identifiers: CC-5013-MCL-005U1111-1213-1816EUPAS23366
• Study Type: observational
• Target: 105
• Locations: 7 countries
• Sites: 79

Brief Summary

The purpose of this study is to investigate and characterize the association of lenalidomide with tumor flare reaction and high tumor burden in participants with relapsed or refractory mantle cell lymphoma.

Conditions

Lymphoma, Mantle-Cell

Keywords

Mantle Cell Lymphoma; MCL; Revlimid; Non-Interventional; PASS; CC-5013; Relapsed; Refractory; TFR; Tumor Flare Reaction; High Tumor Burden

Outcome Measures

Primary Outcomes (1)

• To quantify and characterize the event of TFR by tumor burden in R/R MCL patients treated with lenalidomide in a real-world setting.

  To quantify and characterize the event of TFR by tumor burden (assessed based on the last CT scan performed within a maximum of 2 months prior to initiation of administration of lenalidomide) in R/R MCL patients treated with lenalidomide in a real-world setting.

  Approximately 8.5 years

Secondary Outcomes (1)

• To quantify and characterize the proportion of early deaths by tumor burden in R/R MCL patients treated with lenalidomide in a real-world setting

  Approximately 8.5 years

Study Arms (1)

Lenalidomide treated Relapsed or refractory mantle cell lymphoma (R/R-MCL) participants in Europe

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

Specified dose on specified days

Also known as: Revlimid, L04AX04

Lenalidomide treated Relapsed or refractory mantle cell lymphoma (R/R-MCL) participants in Europe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of a retrospective cohort of participants with refractory mantle cell lymphoma (R/R-MCL) who have commenced treatment with lenalidomide after 08 July 2016 (date marketing authorization was granted). Three datasets will be described for the study population and will form the basis of subsequent analyses: Population dataset, Treatment dataset, Outcomes dataset

You may qualify if:

• Received at least one dose of lenalidomide commencing after 08 July 2016 for the treatment of relapsed refractory mantle cell lymphoma.
• Informed consent of the patient or an authorized third person or authority, if required by law, given prior to data collection.
• Patient must be ≥18 years of age at the time of signing the informed consent form.

You may not qualify if:

• \) Patients will be excluded if they were participating in an interventional clinical trial during the treatment period under observation in this Post Authorization Safety Study.

Sponsors & Collaborators

• Celgene: lead

Study Sites (79)

Local Institution - 105

Graz, 73013, Austria

Location

LKH Graz Medizinische Universitätsklinik

Graz, 8036, Austria

Location

LKH Hochsteiermark, Standort Leoben

Leoben, 8700, Austria

Location

Local Institution - 104

Leoben, 8700, Austria

Location

Local Institution - 102

Salzburg, 5020, Austria

Location

Salzburger Landeskliniken - Universitaetsklinikum Salzburg

Salzburger, 5020, Austria

Location

AKH Wien, Universitaetsklinik fuer Innere Medizin III

Vienna, 1090, Austria

Location

Local Institution - 101

Vienna, 1090, Austria

Location

Landesklinikum Wiener Neustadt

Wiener Neustadt, 2700, Austria

Location

Local Institution - 103

Wiener Neustadt, 2700, Austria

Location

Centre Hospitalier de Versailles André Mignot

Le Chesnay, 78157, France

Location

Local Institution - 303

Le Chesnay, 78157, France

Location

Institution: Hopital Prive du Confluent

Nantes, 4402, France

Location

Local Institution - 308

Nantes, 4402, France

Location

Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Universitaire Pitie Salpetriere (Hopital Pitie-Salpetriere)

Paris, 75013, France

Location

Centre Hospitalier de Saint-Quentin

Saint Quentin Picardie, 2321, France

Location

Institut Universitaire du Cancer Toulouse - Oncopole

Toulouse, 31000, France

Location

Local Institution - 305

Toulouse, 31059, France

Location

Berufsausuebungsgemeinschaft Kiehl/Stein

Frankfurt/ Oder Brandenburg, 15236, Germany

Location

Praxis fuer Haematolgie, Onkologie und Palliativmedizin

Leipzig, 04289, Germany

Location

Local Institution - 256

Würzburg, 97080, Germany

Location

Universitaetsklinikum Wuerzburg

Würzburg, 97080, Germany

Location

General University Hospital of Alexandroupolis

Alexandrouppoli, 68100, Greece

Location

General Anti-Cancer Hospital "Agios Savvas"

Athens, 11522, Greece

Location

Local Institution - 501

Athens, 11525, Greece

Location

Private hospital "Iatriko Psychikou", Athens

Athens, 11525, Greece

Location

General University Hospital of Athens "LAIKO", Athens

Athens, 11527, Greece

Location

Local Institution - 502

Athens, GR 115-27, Greece

Location

Local Institution - 506

Athens Goudi, 11527, Greece

Location

General University Hospital "Attikon"

Chaïdári, 12462, Greece

Location

Metaxa Cancer Hospital, Athens

Piraeous, 18537, Greece

Location

Local Institution - 511

Rio, Patras, 265 04, Greece

Location

Theageneio General Hospital, Thessaloniki

Thessaloniki, 54007, Greece

Location

Local Institution - 601

Busto Arsizio, 21052, Italy

Location

Ospedale di Busto Arsizio - ASST Valle Olona

Busto Arsizio, 21052, Italy

Location

Local Institution - 607

Genova, 16132, Italy

Location

Ospedale Policlinico San Martino - IRCCS

Genova, 16132, Italy

Location

Istituto Clinico Humanitas IRCCS

Milan, 20089, Italy

Location

Fondazione IRCCS Ca' Cranda, Ospedale Maggiore Policinico

Milan, 20122, Italy

Location

Local Institution - 614

Milan, 20122, Italy

Location

Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

Azienda Ospedaliera Niguarda Ca' Granda

Milan, 20162, Italy

Location

Local Institution - 603

Milan, 20162, Italy

Location

Local Institution - 617

Padua, 35043, Italy

Location

Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia

Padua, 35128, Italy

Location

Local Institution - 613

Padua, 35128, Italy

Location

Azienda Ospedaliero - Universiaria di Parma

Parma, 43126, Italy

Location

Amyloidosis Research & Treatment Center, Fondazione Irccs Policlinico San Matteo

Pavia, 27100, Italy

Location

Local Institution - 609

Pavia, 27100, Italy

Location

Local Institution - 610

Pisa, 56100, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126, Italy

Location

Arcispedale Santa Maria Nuova - AUSL Reggio Emilia

Reggio Emilia, 42122, Italy

Location

Local Institution - 602

Reggio Emilia, 42122, Italy

Location

Infermi Hospital

Rimini, 47923, Italy

Location

Local Institution - 605

Rimini, 47923, Italy

Location

Policlinico Umberto I , Universita La Sapienza

Roma, 161, Italy

Location

Local Institution - 611

Rome, 00161, Italy

Location

Local Institution - 608

Siena, 53100, Italy

Location

Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte

Siena, 53100, Italy

Location

Azienda Ospedaliera Citta della Salute e della Scienza di Torino

Torino, 10126, Italy

Location

Local Institution - 616

Torino, 10126, Italy

Location

Presidio Ospedaliero Molinette - A.O.U. Citta della Salute e della Scieza

Torino, 10126, Italy

Location

Ospedale Dell'Angelo Di Mestre

Venezia, 30174, Italy

Location

Local Institution - 606

Venezia - Mestre, 30174, Italy

Location

HagaZiekenhuis van Den Haag - Juliana Kinderziekenhuis (JKZ) - Leyweg

The Hague, 2545 AA, Netherlands

Location

Local Institution - 401

The Hague, 2545 CH, Netherlands

Location

Local Institution - 204

Alava, 01009, Spain

Location

Hospital universitario de Alava

Alava País Vasco, 1009, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Local Institution - 207

Madrid, 28041, Spain

Location

Local Institution - 201

Málaga, 29010, Spain

Location

Hospital Regional Universitario Carlos Haya

Málaga, 29730, Spain

Location

Hospital de Orense

Ourense, 32005, Spain

Location

Local Institution - 206

Ourense, 32005, Spain

Location

Local Institution - 202

Salamanca, 37003, Spain

Location

Hospital Clínico Universiatrio de Salamanca

Salamanca, 37007, Spain

Location

Local Institution - 209

Santa Cruz de Tenerife, 38010, Spain

Location

Local Institution - 205

Seville, 41014, Spain

Location

Nuestra Senora de Valme

Seville, 41014, Spain

Location

MeSH Terms

Conditions

Lymphoma, Mantle-Cell; Recurrence

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 27, 2018
• Study Start: March 13, 2019
• Primary Completion: January 10, 2024
• Study Completion: January 10, 2024
• Last Updated: March 4, 2025

Record last verified: 2025-03

Locations

ES (13); GR (11); DE (4); FR (8); AU (10); IT (31); NL (2)