A Safety Study of Lenalidomide in Previously Untreated Adult Multiple Myeloma Patients Who Are Not Eligible for Transplant

Multiple Myeloma Clinical Trial

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])

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03106324
• Other study ID #: CC-5013-MM-034
• Secondary ID: U1111-1194-5810
• Status: Active, not recruiting
• Start date: March 31, 2017
• Est. completion date: January 13, 2026

Study information

• Verified date: May 2022
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 911
• Est. completion date: January 13, 2026
• Est. primary completion date: July 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Revlimid (lenalidomide)
Treatment with first line Revlimid containing regimen as prescribed in routine clinical practice

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  France,  Germany,  Ireland,  Italy,  Netherlands,  Norway,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of cardiovascular events	Number of participants with cardiovascular adverse events	Approximately 8 years
Secondary	Incidence of renal impairment in NDMM patients	To document renal function among TNE NDMM patients treated with a first-line regimen	Approximately 8 years
Secondary	Incidence of infections in NDMM patients	To document the severity of infections among TNE NDMM patients treated with a first-line regimen.	Approximately 8 years
Secondary	Incidence of Second primary malignancy (SPM) in TNE NDMM patients treated with any first line regimen	Secondary primary malignancies will be categorized according to whether they are invasive and non-invasive malignancies.	Approximately 8 years