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

  • Clinicaltrials.gov identifier

    NCT03106324

  • Recruitment Status

    Recruiting

  • First Posted

    April 10, 2017

  • Last update posted

    March 19, 2021

Study Description

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.

  • Condition or Disease:Multiple Myeloma
  • Intervention/Treatment: Drug: Revlimid (lenalidomide)
  • Phase: N/A

Detailed Description

N/A

Study Design

  • Study Type: Observational [Patient Registry]
  • Estimated Enrollment: 888 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • 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])
  • Actual Study Start Date: March 2017
  • Estimated Primary Completion Date: March 2025
  • Estimated Study Completion Date: March 2025

Groups and Cohorts

Groups/Cohorts Intervention/treatment
: TNE NDMM patients treated with lenalidomide regimen
Newly diagnosed multiple myeloma patients who are not eligible for transplant and who are treated with a first-line regimen containing lenalidomide
Drug: Revlimid (lenalidomide)
Treatment with first line Revlimid containing regimen as prescribed in routine clinical practice
: TNE NDMM patients treated with non-lenalidomide
Newly diagnosed multiple myeloma patients who are not eligible for transplant and who are treated with a first-line regimen not containing lenalidomide
Drug: Revlimid (lenalidomide)
Treatment with first line Revlimid containing regimen as prescribed in routine clinical practice

Outcome Measures

  • Primary Outcome Measures: 1. Incidence of cardiovascular events [ Time Frame: Approximately 8 years ]
    Number of participants with cardiovascular adverse events
  • Secondary Outcome Measures: 1. Incidence of renal impairment in NDMM patients [ Time Frame: Approximately 8 years ]
    To document renal function among TNE NDMM patients treated with a first-line regimen
  • 2. Incidence of infections in NDMM patients [ Time Frame: Approximately 8 years ]
    To document the severity of infections among TNE NDMM patients treated with a first-line regimen.
  • 3. Incidence of Second primary malignancy (SPM) in TNE NDMM patients treated with any first line regimen [ Time Frame: Approximately 8 years ]
    Secondary primary malignancies will be categorized according to whether they are invasive and non-invasive malignancies.

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • 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.

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.

Contacts and Locations

Contacts

Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations

Austria
Innsbruck University Hospital
Innsbruck

Austria
LKH Hochsteiermark
Leoben

Austria
University hospital St. Pölten
Polten

Belgium
CHU Saint-Pierre
Bruxelles

Belgium
Cliniques Universitaires Saint-Luc
Bruxelles

Belgium
CHU-Charleroi
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
Hospital Nord-Comte
Belfort

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 Charité Mitte
Berlin

Germany
Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin
Berlin

Germany
Kliniken Berlin Köpenick
Berlin

Germany
HELIOS Klinikum Berlin Buch
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
Dr. med. Christoph Losem Praxis für Onkologie und Hämatologie
Neuss

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

Germany
überörtl. Gem. Praxis, Dr. med. Markus Klein und Olav Heringer
Wiesbaden

Ireland
Midlands Regional Hospital , Hematology/Oncology
Country Offaly

Ireland
Waterford Regional Hospital, Waterford
Waterford

Italy, Corso Galileo Ferraris, 3 Chivasso
Ospedale di Ivrea
Chivasso

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 - Via Palermo 636
Catania

Italy
AO Garibaldi Catania
Catania

Italy
Ospedali a Cosenza
Cosenza

Italy
Ospedale Ivrea , Areas Medica
Ivrea

Italy
Ospedale dell'Angelo
Mestre

Italy
ASST Grande Ospedale Metropolitano Niguarda - Piazza Ospedale Maggiore, 3 -
Milano

Italy
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan

Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan

Italy
Opsedale di Bolzano
Milan

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

Netherlands
Isala Hospital
Zwolle

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

Sweden
Skanes Universitetssjukhus Malmo
Malmo

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
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
Colchester General Hospital
Colchester

United Kingdom
Queen Alexandra Hospital - Portsmouth Hospitals NHS Trust
Cosham

United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow

United Kingdom
Lincoln County Hospital
Lincoln

United Kingdom
Lincoln County Hospital
Lincoln

United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust - The Royal Liverpool Hospital
Liverpool

United Kingdom
London North West University Healthcare NHS Trust -Northwick Park Hospital
London

United Kingdom
St Georges Hospital
London

United Kingdom
Norfolk and Norwich University Hospital
Norfolk

United Kingdom
Royal Hallamshire Hospital - Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield

United Kingdom
Southend Hospital
Southend-on-Sea

United Kingdom
Southend Hospital
Southend-on-Sea

United Kingdom
Royal Stoke Hospital
Stoke-on-Trent

United Kingdom
Royal Stoke Hospital
Stoke-on-Trent

United Kingdom
Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital
Worcester

Sponsors and Collaborators

Celgene

Investigators

Study Director: Elisabeth Kueenburg, MD Study physician for Celgene

More Information

  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT03106324 History of Changes
  • Other Study ID Numbers: CC-5013-MM-034, U1111-1194-5810
  • First Posted: April 10, 2017 Key Record Dates
  • Last Update Posted: March 19, 2021
  • Last Verified: March 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Keywords provided by Celgene: Multiple Myeloma
    PASS
    Lenalidomide
    Revlimid
    Non-interventional
    Non transplant eligible
  • Additional relevant MeSH terms: Multiple Myeloma Neoplasms, Plasma Cell