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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1194-5810 | Other Identifier | World Health Organization |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revlimid (lenalidomide) | Drug | Treatment with first line Revlimid containing regimen as prescribed in routine clinical practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of cardiovascular events | Number of participants with cardiovascular adverse events | Approximately 8 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of renal impairment in NDMM patients | To document renal function among TNE NDMM patients treated with a first-line regimen | Approximately 8 years |
| Incidence of infections in NDMM patients |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb, MD | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innsbruck University Hospital | Innsbruck | A-6020 | Austria | |||
| LKH Hochsteiermark |
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To document the severity of infections among TNE NDMM patients treated with a first-line regimen.
| Approximately 8 years |
| 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 |
| Leoben |
| A-8700 |
| Austria |
| University hospital St. Pölten | Pölten | A-3100 | Austria |
| CHU Saint-Pierre | Brussels | 1000 | Belgium |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| CHU-Charleroi | Brussels | 6110 | Belgium |
| CHU-Charleroi | Charleroi | 6042 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| AZ Groeninge | Kortijk | 8500 | Belgium |
| CHR Citadelle Liège | Liège | 4000 | Belgium |
| Ziekehuis Oost Limburg | Limbourg | 3600 | Belgium |
| CHU Ambroise Pare | Mons | 7000 | Belgium |
| AZ Nikolaas | Sint Niklass | 9100 | Belgium |
| CHPLT Verviers | Verviers | 4800 | Belgium |
| CHU du Mont-Godinne | Yvoir | 5530 | Belgium |
| Aalborg University Hospital | Aalborg | 9100 | Denmark |
| Odense Hospital | Odense | 115000 | Denmark |
| Hôpital privé d'Antony - Ramsay Générale de Santé | Antony | 92160 | France |
| CH Victor Dupouy | Argenteuil | 95100 | France |
| Polyclinique Bordeaux Nord Aquaitaine | Bordeaux | 33300 | France |
| Hospital Prive Sevigne | Cesson-Sévigné | 35510 | France |
| GHM Institut Daniel Hollard | Grenoble | 38000 | France |
| Clinique Victor Hugo | Le Mans | 72015 | France |
| CH de Libourne | Libourne | 33505 | France |
| CH Mont de Marsan | Mont-de-Marsan | 40000 | France |
| CHU de Nice | Nice | O6200 | France |
| CHR Orleans | Orléans | 45100 | France |
| CH St Jean | Perpignan | 66093 | France |
| Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord | Saint-Etienne | 42270 | France |
| Hospital Prive de Villeneuve d'Ascq | Villeneuve-d'Ascq | 59650 | France |
| W8 Praxis für Onkologie | Aachen | 52064 | Germany |
| Klinikum St. Marien Amberg | Amberg | 92224 | Germany |
| Sozialstiftung Bamberg | Bamberg | 96040 | Germany |
| Charité - Universitätsmedizin Berlin - Campus Charité Mitte | Berlin | 10117 | Germany |
| Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin | Berlin | 12200 | Germany |
| Kliniken Berlin Köpenick | Berlin | 12559 | Germany |
| HELIOS Klinikum Berlin Buch | Berlin | 13125 | Germany |
| Gemeinschaftpraxis Pott/Tirier/Hannig | Bottrop | 46236 | Germany |
| Onkologie Koln | Cologne | 50677 | Germany |
| Medizinische Klinik II, DONAUISAR Klinikum Deggendorf, Akademisches Lehrkrankenhaus der Medizinischen Hochschule Hannover | Deggendorf | 94469 | Germany |
| St. Bernward Krankenhaus GmbH | Hildesheim | 31134 | Germany |
| Stadt. Krankenhaus Kiel, 2.med Klinik, | Kiel | 24116 | Germany |
| Dres. Neise & Lollert, Praxis für Hämatologie & Onkologie | Krefeld | 47805 | Germany |
| MVZ Mitte - Onkologische Schwerpunktpraxis | Leipzig | 4103 | Germany |
| Lübecker Onkologische Schwerpunktpraxis | Lübeck | 23562 | Germany |
| Klinikum Magdeburg | Magdeburg | 39130 | Germany |
| Internistische Facharztzentrum mit Dialyse | Memmingen | 87700 | Germany |
| Stauferklinikum | Mutlangen | 73557 | Germany |
| Onko-Log Mulheim Gbr | Mülheim | 454680 | Germany |
| Medizinisches Zentrum für Hämatologie und Onkologie München MVZ GmbH | München | D-80639 | Germany |
| Klinikum Nord, Klinik für Innere Medizin 5 | Nuremberg | 90419 | Germany |
| Onkologische Praxis Oldenburg | Oldenburg | 26121 | Germany |
| Kreiskliniken Reutlingen | Reutlingen | 72764 | Germany |
| Das Diak | Schwäbisch Hall | 74523 | Germany |
| Klinikum Sindelfingen, Med.Klinik I | Sindelfingen | 71065 | Germany |
| Onkologicum Stuttgart | Stuttgart | 70174 | Germany |
| Ueboroertliche Berugsausuebungsgemeinschaft | Troisdorf | 53840 | Germany |
| Kliniken Villingen-Schwenningen | Villingen-Schwenningen | 78052 | Germany |
| Lahn-Dill-Kliniken | Wetzlar | 35578 | Germany |
| Hämatologie / Internistische Onkologie | Wiesbaden | 65189 | Germany |
| Midlands Regional Hospital , Hematology/Oncology | Country Offaly | R35 NY51 | Ireland |
| Waterford Regional Hospital, Waterford | Waterford | X91 ER8E | Ireland |
| Ospedale di Ivrea | Chivasso | Corso Galileo Ferraris, 3 Chivasso | 10034 | Italy |
| Ospedale Alessandria, Via Venezia, 16, 15121 Alessandria AL | Allessandria | 15121 | Italy |
| Centro di Riferimento Oncologico di Aviano | Avianno | 33081 | Italy |
| UO di Ematologia Osp. Mons Di Miccolis | Barletta | 76121 | Italy |
| Istituto di Ematologia ed Ocnologia Medica "Seràgnoli" AUO Sant'Orsola - Bologna | Bologna | 40138 | Italy |
| UO di Ematologia Osp. Perrino | Brindisi | 72100 | Italy |
| Ospedale di Circolo di Busto Arsizio | Busto Arsizio | 21052 | Italy |
| "S.C. di Ematologia e Centro Trapianti di Cellule Staminali Emopoietiche | Cagliari | 0-9121 | Italy |
| Dipartimento di Oncologia Medica e Chirurgica AORN S. Anna e S. Sebastiano | Caserta | 81100 | Italy |
| AO Garibaldi Catania - Via Palermo 636 | Catania | 95122 | Italy |
| AO Garibaldi Catania | Catania | 95122 | Italy |
| Ospedale Ivrea , Areas Medica | Ivrea | 10015 | Italy |
| Ospedale dell'Angelo | Mestre | 30121 | Italy |
| Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | 20162 | Italy |
| Opsedale di Bolzano | Milan | 39100 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda - Piazza Ospedale Maggiore, 3 - | Milan | 20162 | Italy |
| Ospedale Maggiore di Novara | Novara | 28100 | Italy |
| UO Ematologia e Centro Trapianti di Midollo Osseo dell'Ospedale San Francesco di Nuoro | Nuoro | 8100 | Italy |
| IRCCS Policlinico di Pavia | Pavia | 27100 | Italy |
| UO di Ematologia Osp. S. Carlo - Potenza | Potenza | 85100 | Italy |
| Servizio immunoematologia e medicina trasfusionale-ASP | Ragusa | 97100 | Italy |
| S.C. Ematologia, Dip.to Oncologico e Tecnologie Avanzate | Reggio Emilia | 42123 | Italy |
| A.O Bianchi Melacrino Morelli - Presidio Riuniti | Regio Calabria | 89125 | Italy |
| Ospedale Sant'Eugenio | Rome | 00-144 | Italy |
| Policlinico Gemelli Roma | Rome | 00-168 | Italy |
| UOSD Ematologia Complesso Opsedaliero-Ospedale S. Spirito e Nuovo Regina Margherita | Rome | 153 | Italy |
| Ospedale di Circolo, Fondazione Macchi | Varese | 21100 | Italy |
| Ospdeale Policlinico Borgo Roma | Verona | 37134 | Italy |
| Ospedale Belcolle Viterbo | Viterbo | 1100 | Italy |
| Rode Kruis Hospital | Beverwijk | 1942 LE | Netherlands |
| Nij Smellinghe | Drachten | 9202 NN | Netherlands |
| Catharina Hospital, Hemato-Oncology | Eindhoven | 5623 EJ | Netherlands |
| Admiraal de Ruyter Hospital | Goes | 4462 RA | Netherlands |
| Röpcke-Zweers Hospital | Hardenberg | 7772 SE | Netherlands |
| Academic Hospital Maastricht | Maastricht | 3526 KV | Netherlands |
| University Medical Center Utrecht | Utrecht | 3584 CX | Netherlands |
| VieCuri Medical Center | Venlo | 5912 BL | Netherlands |
| Helse Førde HF sentralsjukehuset | Førde | 6807 | Norway |
| Akershus universitetssykehus HF | Lørenskog | 1478 | Norway |
| Hospital de Jerez | Cadiz | 11408 | Spain |
| Hospital Santa Lucía | Cartagena | 30202 | Spain |
| Hospital de Jaen | Jaén | 23007 | Spain |
| IP HULA | Lugo | 27004 | Spain |
| Hospital Universitario Quironsalud Madrid | Madrid | 28223 | Spain |
| Hospital Universitario Central Asturias | Oviedo | 33011 | Spain |
| Son Espases | Palma de Mallorca | 0-7120 | Spain |
| Complejo Universitario Navarra | Pamplona | 31008 | Spain |
| Hospital Manises | Valencia | 46940 | Spain |
| Skåne University Hospital, Lund | Lund | 22185 | Sweden |
| Northern Health and Social Care Trust -Antrim Area Hospital | Antrim | BT41 2RL | United Kingdom |
| South Eastern Health and Social Care Trust - The Ulster Hospital | Belfast | BT16 1RH | United Kingdom |
| Birmingham Heartlands Hospital | Birmingham | B9 5SS, | United Kingdom |
| Betsi Cadwaladr University Health Board - Glan Clwyd Hospital | Bodelwyddan | LL18 5UJ | United Kingdom |
| Southmead Hospital -North Bristol NHS Trust | Bristol | BS10 5NB | United Kingdom |
| Queen Alexandra Hospital - Portsmouth Hospitals NHS Trust | Cosham | PO6 3LY | United Kingdom |
| Lincoln County Hospital | Lincoln | LN2 5QY | United Kingdom |
| The Clatterbridge Cancer Centre NHS Foundation Trust - The Royal Liverpool Hospital | Liverpool | L9 7AL | United Kingdom |
| St Georges Hospital | London | SW17 0QT | United Kingdom |
| Norfolk and Norwich University Hospital | Norfolk | NR4 7UY | United Kingdom |
| Southend Hospital | Southend-on-Sea | SS0 0RY | United Kingdom |
| Royal Stoke Hospital | Stoke-on-Trent | ST4 6QG | United Kingdom |
| Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital | Worcester | WR5 1DD | United Kingdom |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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