Clinical trial NCT03106324: A Safety Study of Lenalidomide in Previously Untreated Adult Multiple Myeloma Patients Who Are Not Eligible for Transplant
Official title: A Prospective Non-interventional Post-authorization Safety Study (PASS) of Lenalidomide in Previously Untreated Adult Multiple Myeloma Patients Who Are Not Eligible for Transplant ("Transplant Noneligible" [TNE])
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Non transplant eligible
Revlimid
PASS
Non-interventional
Lenalidomide
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2017-04-10
Enrollment: 911
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for transplant (TNE) starting their first treatment for multiple myeloma. Patients receiving any first line regimen can be included into the study. Decision for treatment needs to be done before inclusion into the trial.

Brief summary: This post authorization safety study is designed as prospective non interventional study for patients with newly diagnosed multiple myeloma who are not eligible for transplant. The objective is to compare the incidence of cardiovascular events between patients treated with a first-line lenalidomide containing regimen and those treated with a first-line non-lenalidomide containing regimen. Treatment in both cohorts will be done according to standard care. The study will gather risk factor information at baseline and throughout follow-up. Any cardiovascular event occurring will be assessed by an independent committee. Other safety endpoints will be collected through standard procedures. Observation period will be 3 years on treatment, with an additional evaluation of cardiovascular events 6 months' post treatment and a follow up period until 5 years after inclusion. During follow up the incidence of second primary malignancies (SPM) and overall survival will be assessed.


Eligibility criteria: Inclusion Criteria:

1. Must have understood and voluntarily signed the Informed Consent Form (ICF)
2. Age ≥ 18 years at the time of signing the ICF
3. Newly diagnosed with multiple myeloma
4. Must not be eligible for transplant
5. Will be treated with a first-line lenalidomide-containing or nonlenalidomide-containing regimen, or currently is being treated with a first-line regimen and has received less than 2 cycles.

Exclusion Criteria:

1. Prior treatment for Monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma with lenalidomide, thalidomide, or pomalidomide or any agent considered to be a first-line Multiple myeloma (MM) therapy.
2. Prior treatment with lenalidomide, thalidomide, or pomalidomide or any agent considered to be a first-line MM therapy through clinical trial participation or patient access program
3. Two or more complete cycles of first-line therapy or any agent considered to be a firstline MM therapy for newly diagnosed multiple myeloma (NDMM) treatment before study enrollment
4. Refusal to participate in the Revlimid Transplant noneligible (TNE) Newly diagnosed multiple myeloma (NDMM) Post-authorization safety study (PASS) or current participation in the treatment phase of an interventional clinical trial.

Primary outcomes:
measure: Incidence of cardiovascular events
timeFrame: Approximately 8 years
Secondary outcomes:
measure: Incidence of renal impairment in NDMM patients
timeFrame: Approximately 8 years
measure: Incidence of infections in NDMM patients
timeFrame: Approximately 8 years
measure: Incidence of Second primary malignancy (SPM) in TNE NDMM patients treated with any first line regimen
timeFrame: Approximately 8 years
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Innsbruck University Hospital
city: Leoben
country: Austria
facility: LKH Hochsteiermark
city: Polten
country: Austria
facility: University hospital St. Pölten
city: Bruxelles
country: Belgium
facility: CHU Saint-Pierre
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Bruxelles
country: Belgium
facility: CHU-Charleroi
city: Charleroi
country: Belgium
facility: CHU-Charleroi
city: Gent
country: Belgium
facility: UZ Gent
city: Kortijk
country: Belgium
facility: AZ Groeninge
city: Liege
country: Belgium
facility: CHR Citadelle Liège
city: Limburg
country: Belgium
facility: Ziekehuis Oost Limburg
city: Mons
country: Belgium
facility: CHU Ambroise Pare
city: Sint Niklass
country: Belgium
facility: AZ Nikolaas
city: Verviers
country: Belgium
facility: CHPLT Verviers
city: Yvoir
country: Belgium
facility: CHU du Mont-Godinne
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Odense
country: Denmark
facility: Odense Hospital
city: Antony
country: France
facility: Hôpital privé d'Antony - Ramsay Générale de Santé
city: Argenteuil
country: France
facility: CH Victor Dupouy
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquaitaine
city: Cesson-Sevigne
country: France
facility: Hospital Prive Sevigne
city: Grenoble
country: France
facility: GHM Institut Daniel Hollard
city: Le Mans
country: France
facility: Clinique Victor Hugo
city: Libourne
country: France
facility: CH de Libourne
city: Mont de Marsan
country: France
facility: CH Mont de Marsan
city: Nice
country: France
facility: CHU de Nice
city: Orléans
country: France
facility: CHR Orleans
city: Perpignan
country: France
facility: CH St Jean
city: Saint-Etienne
country: France
facility: Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord
city: Villeneuve d'Ascq
country: France
facility: Hospital Prive de Villeneuve d'Ascq
city: Aachen
country: Germany
facility: W8 Praxis für Onkologie
city: Amberg
country: Germany
facility: Klinikum St. Marien Amberg
city: Bamberg
country: Germany
facility: Sozialstiftung Bamberg
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin - Campus Charité Mitte
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Kliniken Berlin Köpenick
city: Berlin
country: Germany
facility: HELIOS Klinikum Berlin Buch
city: Bottrop
country: Germany
facility: Gemeinschaftpraxis Pott/Tirier/Hannig
city: Deggendorf
country: Germany
facility: Medizinische Klinik II, DONAUISAR Klinikum Deggendorf, Akademisches Lehrkrankenhaus der Medizinischen Hochschule Hannover
city: Hildesheim
country: Germany
facility: St. Bernward Krankenhaus GmbH
city: Kiel
country: Germany
facility: Stadt. Krankenhaus Kiel, 2.med Klinik,
city: Koln
country: Germany
facility: Onkologie Koln
city: Krefeld
country: Germany
facility: Dres. Neise & Lollert, Praxis für Hämatologie & Onkologie
city: Leipzig
country: Germany
facility: MVZ Mitte - Onkologische Schwerpunktpraxis
city: Lubeck
country: Germany
facility: Lübecker Onkologische Schwerpunktpraxis
city: Magdeburg
country: Germany
facility: Klinikum Magdeburg
city: Memmingen
country: Germany
facility: Internistische Facharztzentrum mit Dialyse
city: Mulheim
country: Germany
facility: Onko-Log Mulheim Gbr
city: Munchen
country: Germany
facility: Medizinisches Zentrum für Hämatologie und Onkologie München MVZ GmbH
city: Mutlangen
country: Germany
facility: Stauferklinikum
city: Nurnberg
country: Germany
facility: Klinikum Nord, Klinik für Innere Medizin 5
city: Oldenburg
country: Germany
facility: Onkologische Praxis Oldenburg
city: Reutlingen
country: Germany
facility: Kreiskliniken Reutlingen
city: Schwabisch Hall
country: Germany
facility: Das Diak
city: Sindelfingen
country: Germany
facility: Klinikum Sindelfingen, Med.Klinik I
city: Stuttgart
country: Germany
facility: Onkologicum Stuttgart
city: Troisdorf
country: Germany
facility: Ueboroertliche Berugsausuebungsgemeinschaft
city: Villingen-Schwenningen
country: Germany
facility: Kliniken Villingen-Schwenningen
city: Wetzlar
country: Germany
facility: Lahn-Dill-Kliniken
city: Wiesbaden
country: Germany
facility: Hämatologie / Internistische Onkologie
city: Country Offaly
country: Ireland
facility: Midlands Regional Hospital , Hematology/Oncology
city: Waterford
country: Ireland
facility: Waterford Regional Hospital, Waterford
city: Chivasso
country: Italy
facility: Ospedale di Ivrea
state: Corso Galileo Ferraris, 3 Chivasso
city: Allessandria
country: Italy
facility: Ospedale Alessandria, Via Venezia, 16, 15121 Alessandria AL
city: Avianno
country: Italy
facility: Centro di Riferimento Oncologico di Aviano
city: Barletta
country: Italy
facility: UO di Ematologia Osp. Mons Di Miccolis
city: Bologna
country: Italy
facility: Istituto di Ematologia ed Ocnologia Medica "Seràgnoli" AUO Sant'Orsola - Bologna
city: Brindisi
country: Italy
facility: UO di Ematologia Osp. Perrino
city: Busto Arsizio
country: Italy
facility: Ospedale di Circolo di Busto Arsizio
city: Cagliari
country: Italy
facility: "S.C. di Ematologia e Centro Trapianti di Cellule Staminali Emopoietiche
city: Caserta
country: Italy
facility: Dipartimento di Oncologia Medica e Chirurgica AORN S. Anna e S. Sebastiano
city: Catania
country: Italy
facility: AO Garibaldi Catania - Via Palermo 636
city: Catania
country: Italy
facility: AO Garibaldi Catania
city: Ivrea
country: Italy
facility: Ospedale Ivrea , Areas Medica
city: Mestre
country: Italy
facility: Ospedale dell'Angelo
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda - Piazza Ospedale Maggiore, 3 -
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
city: Milan
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Milan
country: Italy
facility: Opsedale di Bolzano
city: Novara
country: Italy
facility: Ospedale Maggiore di Novara
city: Nuoro
country: Italy
facility: UO Ematologia e Centro Trapianti di Midollo Osseo dell'Ospedale San Francesco di Nuoro
city: Pavia
country: Italy
facility: IRCCS Policlinico di Pavia
city: Potenza
country: Italy
facility: UO di Ematologia Osp. S. Carlo - Potenza
city: Ragusa
country: Italy
facility: Servizio immunoematologia e medicina trasfusionale-ASP
city: Reggio-Emilia
country: Italy
facility: S.C. Ematologia, Dip.to Oncologico e Tecnologie Avanzate
city: Regio Calabria
country: Italy
facility: A.O Bianchi Melacrino Morelli - Presidio Riuniti
city: Rome
country: Italy
facility: Ospedale Sant'Eugenio
city: Rome
country: Italy
facility: Policlinico Gemelli Roma
city: Rome
country: Italy
facility: UOSD Ematologia Complesso Opsedaliero-Ospedale S. Spirito e Nuovo Regina Margherita
city: Varese
country: Italy
facility: Ospedale di Circolo, Fondazione Macchi
city: Verona
country: Italy
facility: Ospdeale Policlinico Borgo Roma
city: Viterbo
country: Italy
facility: Ospedale Belcolle Viterbo
city: Beverwijk
country: Netherlands
facility: Rode Kruis Hospital
city: Drachten
country: Netherlands
facility: Nij Smellinghe
city: Eindhoven
country: Netherlands
facility: Catharina Hospital, Hemato-Oncology
city: Goes
country: Netherlands
facility: Admiraal de Ruyter Hospital
city: Hardenberg
country: Netherlands
facility: Röpcke-Zweers Hospital
city: Maastricht
country: Netherlands
facility: Academic Hospital Maastricht
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Venlo
country: Netherlands
facility: VieCuri Medical Center
city: Førde
country: Norway
facility: Helse Førde HF sentralsjukehuset
city: Lørenskog
country: Norway
facility: Akershus universitetssykehus HF
city: Cadiz
country: Spain
facility: Hospital de Jerez
city: Cartagena
country: Spain
facility: Hospital Santa Lucía
city: Jaen
country: Spain
facility: Hospital de Jaen
city: Lugo
country: Spain
facility: IP HULA
city: Madrid
country: Spain
facility: Hospital Universitario Quironsalud Madrid
city: Oviedo
country: Spain
facility: Hospital Universitario Central Asturias
city: Palma de Mallorca
country: Spain
facility: Son Espases
city: Pamplona
country: Spain
facility: Complejo Universitario Navarra
city: Valencia
country: Spain
facility: Hospital Manises
city: Lund
country: Sweden
facility: Skåne University Hospital, Lund
city: Antrim
country: United Kingdom
facility: Northern Health and Social Care Trust -Antrim Area Hospital
city: Belfast
country: United Kingdom
facility: South Eastern Health and Social Care Trust - The Ulster Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Bodelwyddan
country: United Kingdom
facility: Betsi Cadwaladr University Health Board - Glan Clwyd Hospital
city: Bristol
country: United Kingdom
facility: Southmead Hospital -North Bristol NHS Trust
city: Cosham
country: United Kingdom
facility: Queen Alexandra Hospital - Portsmouth Hospitals NHS Trust
city: Lincoln
country: United Kingdom
facility: Lincoln County Hospital
city: Liverpool
country: United Kingdom
facility: The Clatterbridge Cancer Centre NHS Foundation Trust - The Royal Liverpool Hospital
city: London
country: United Kingdom
facility: St Georges Hospital
city: Norfolk
country: United Kingdom
facility: Norfolk and Norwich University Hospital
city: Southend-on-Sea
country: United Kingdom
facility: Southend Hospital
city: Stoke-on-Trent
country: United Kingdom
facility: Royal Stoke Hospital
city: Worcester
country: United Kingdom
facility: Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb, MD
role: STUDY_DIRECTOR
References: