PASS MDS del5q: Non-interventional Study of Lenalidomide in the Clinical Routine Treatment of TD Patients With IPSS Low or Int-1 MDS and Isolated Del(5q)

Sponsor

Celgene (Industry)

Overall Status

Completed

CT.gov ID

NCT02279654

Collaborator

(none)

389

Enrollment

149

Locations

87.4

Actual Duration (Months)

2.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This registry is a prospective, non-interventional, post authorisation safety study for patients diagnosed with Transfusion Dependent, IPSS low or intermediate-1-Risk Myelodysplastic Syndrome (MDS), associated to a single abnormality of the chromosome 5 [del(5q)].

The purpose of this study is to collect additional data about the safety of an oral drug (lenalidomide, Revlimid®) that may have been prescribed to relieve anemia and decrease the need of blood transfusions. However, also patients affected by the MDS del(5q) who receive other treatments different from lenalidomide can be included in this study, if they agree.

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndrome	Drug: Lenalidomide

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

389 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Post-authorization, Non-interventional, Safety Study Study of Patients With Myelodysplastic Syndromes (MDS) Treated With Lenalidomide.

Actual Study Start Date :

Dec 17, 2014

Actual Primary Completion Date :

Mar 29, 2022

Actual Study Completion Date :

Mar 29, 2022

Arms and Interventions

Arm	Intervention/Treatment
Lenalidomide Population Patients with transfusion-dependent, low- or intermediate (int)-1risk MDS and isolated del (5q) who receive at least 1 dose of lenalidomide after 15th June 2007 and have been followed up for on the registry for 3 years or until death/consent withdrawal	Drug: Lenalidomide Lenalidomide as prescribed in routine clinical practice for low to intermediate-1 risk MDS Other Names: Revlimid CC-5013
Background Population All MDS patients who have been diagnosed on 15th June 2007 or later, have never been exposed to lenalidomide and have been followed up on the registry for 3 years or until death/consent withdrawal	Drug: Lenalidomide Lenalidomide as prescribed in routine clinical practice for low to intermediate-1 risk MDS Other Names: Revlimid CC-5013

Arm

Intervention/Treatment

Lenalidomide Population

Patients with transfusion-dependent, low- or intermediate (int)-1risk MDS and isolated del (5q) who receive at least 1 dose of lenalidomide after 15th June 2007 and have been followed up for on the registry for 3 years or until death/consent withdrawal

Drug: Lenalidomide

Lenalidomide as prescribed in routine clinical practice for low to intermediate-1 risk MDS

Other Names:

Revlimid

CC-5013

Background Population

All MDS patients who have been diagnosed on 15th June 2007 or later, have never been exposed to lenalidomide and have been followed up on the registry for 3 years or until death/consent withdrawal

Drug: Lenalidomide

Lenalidomide as prescribed in routine clinical practice for low to intermediate-1 risk MDS

Other Names:

Revlimid

CC-5013

Outcome Measures

Primary Outcome Measures

Ascertain the Disease Progression to AML (through calculation of product limit estimators and incidence rates) for those with transfusion dependent Low to Intermediate 1 risk MDS del 5 q and have been treated with Revlimid [Up to 3 years]
Incidence, as well as the attributable risk (AR) and AR percent (%). Progressive Disease criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
Overall Survival for patients with transfusion-dependent low to intermediate 1 risk MDS and isolated del (5q) and who have been treated with Lenalidomide [Up to 3 years]
Number of MDS participants who survive

Secondary Outcome Measures

Overall Survival for patients with transfusion-dependent low to intermediate 1 risk MDS and isolated del (5q) and who have been treated with Lenalidomide [Up to 3 years]
Number of MDS participants who survive who have never been treated with Lenalidomide
Adverse Events [Up to 3 years]
Type, frequency, severity of advere events and relationship of adverse events to Lenalidomide. An adverse ecent is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment, ie, any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product
Evaluate risk factors associated with progression of AML [Up to 3 years]
Employ Cox proportional hazards models among MDS patients included in the primary population who have been treated with lenalidomide
Clinical practice [Up to 3 years]
Provide insight into treatment regimens and therapy sequence in clinical practice as they relate to clinical outcomes (response, overall survival, progression-free survival) in patients in MDS participants

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Are ≥ 18 years old at the time of signing the Informed consent form (ICF)
Are transfusion dependent or have an history of transfusion dependence; for the purpose of the current Myelodysplastic syndromes (MDS) Post-authorization safety study (PASS), transfusion-dependence is defined as requiring ≥2 RBC units over an 8 week period prior to the date of signature on the ICF (due to MDS-related causes and not because of hemorrhage, trauma, or other acute cause)
Are on active treatment with lenalidomide (Lenalidomide Cohort) or have never been exposed to lenalidomide at the time of signing the ICF (Background Cohort)
Have confirmed diagnosis of IPSS low or intermediate-1-risk MDS with isolated del (5q) (with morphological and cytogenetic information) diagnosed on 15 June 2007 (date of Revlimid first approved in Europe) or later

Exclusion Criteria:

Refuse to participate in the Myelodysplastic syndromes (MDS) Post-authorization safety study (PASS),
Are currently participating in an interventional therapeutic clinical trial for MDS (except for erythropoiesis-stimulating agents [ESAs] and granulocyte colonystimulating growth factors)
Receive any investigational agent the time of signing the ICF
Have previously been treated with lenalidomide and are no longer on active treatment with lenalidomide at the time of signing the ICF

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution - 0001	Centre City	New Jersey	United States	ZIP CODE
2	Local Institution - 0002	Centre City	New Jersey	United States	ZIP CODE
3	Local Institution - Belgium	No City Provided	New Jersey	United States	00000
4	Local Institution - Denmark	No City Provided	New Jersey	United States	00000
5	Local Institution - France	No City Provided	New Jersey	United States	00000
6	Local Institution - Germany	No City Provided	New Jersey	United States	00000
7	Local Institution - Greece	No City Provided	New Jersey	United States	00000
8	Local Institution - Italy	No City Provided	New Jersey	United States	00000
9	Local Institution - Luxembourg	No City Provided	New Jersey	United States	00000
10	Local Institution - Norway	No City Provided	New Jersey	United States	00000
11	Local Institution - Spain	No City Provided	New Jersey	United States	00000
12	Local Institution - Sweden	No City Provided	New Jersey	United States	00000
13	Local Institution - UK	No City Provided	New Jersey	United States	00000
14	AZ Klina	Brasschaat		Belgium	B -2930
15	AZ Sint Jan	Brugge		Belgium	B-8000
16	GHdCharleroi	Charleroi		Belgium	B-6000
17	Jessa Ziekenhuis	Hasselt		Belgium	B-35000
18	CHR Citadelle	Liège		Belgium	4000
19	CHU Vésale	Montigny- le- tilleul		Belgium	B-6110
20	Clinique Saint-Pierre Ottignie	Ottignies		Belgium	01340
21	Aalborg Sygehus, Dept of Hematology	Aalborg		Denmark	DK-9000
22	Århus University Hospital	Aarhus		Denmark	DK-8000
23	Herlev Hospital	Herlev		Denmark	2730
24	Odense University Hospital	Odense		Denmark	5000
25	Rokslide Hospital	Roskilde		Denmark	4000
26	Hopital de L'archet I	Nice	Alpes-Maritimes	France	6202
27	Institut Paoli Calmettes	Marseille	Bouches-du-Rhône	France	13273
28	CHU Haut-Lévêque	Pessac	Gironde	France	33604
29	CHU Hôtel Dieu	Nantes cedex 01	Loire-Atlantique	France	44093
30	CHU Hôtel Dieu	Angers		France	49933
31	Centre Hospitalier D'Avignon - Hopital Henri Duffaut	Avignon		France	84000
32	CH Chalon/Saone William Morey	Chalon Sur Saone		France	71100
33	CHU Grenoble	La Tronche		France	38700
34	CHRU De Lille - Hôpital Claude - Rue Michel Polonovski	Lille		France	59037
35	Centre Hospitalier Universitaire De Limoges - Hopital Dupuyt	Limoges		France	87042
36	CHU Hôtel Dieu - Place A Ricordeau	Nantes		France	44000
37	Hôpital St Louis	Paris		France	75475
38	Centre Hospitalier Lyon-SUD [U	Pierre- Bénite		France	69310
39	Hopital de Hautepierre CHRU de Strasbourg	Strasbourg		France	67091
40	Hopital Purpan-Place du Dr. Baylac	Toulouse		France	31059
41	CHU Bretonneau	Tours		France	37000
42	CHU Nancy Brabois Adultes - 58 Allee dy morvan	Vandoeuvre les Nancy		France	54500
43	Onkologische Schwerpunktpraxis Bielefeld	Bielefeld		Germany	33604
44	Hämatologie und Onkologie, Klinikum Chemnitz gGmbH International Patient Center	Chemnitz		Germany	09113
45	Gemeinschaftspraxis Hämatologie-Onkologie	Dresden		Germany	01307
46	Universitätsklinik Carl-Gustav	Dresden		Germany	01307
47	HELIOS St. Johannes Klinik	Duisburg		Germany	47166
48	Uniklinikum Düsseldorf, Klinik für Hämatologie, Onkologie und Klinische Immunologie	Düsseldorf		Germany	40225
49	Marien Hospital Düsseldorf	Düsseldorf		Germany	40479
50	St Antonius Hospital (SAH)	Eschweiler		Germany	52249
51	Kreiskrankenhaus St. Elisabeth - Von Werth-Str.	Grevenbroich		Germany	41515
52	Praxis, Onkologische Schwerpunktpraxis Dres. Verpoort	Hamburg		Germany	20095
53	Medizinische Hochschule Hannover	Hannover		Germany	30625
54	Institut für Versorgungsforschung in der Onkologie	Koblenz		Germany	56068
55	InVO Institut fur Versorgungsforschung	Koblenz		Germany	56068
56	Gemeinschaftspraxis fur Hamatologie und Onkologie, Onkologisches zentrum Lebach	Lebach		Germany	66822
57	Abteilung Hämatologie, Internistische Onkologie, Universitatklinikum Leipzig	Leipzig		Germany	04103
58	III. Medizinische Klinik, Hämatologie und internistische Onkologie , Univesitatsmedizin Mannheim	Mannheim		Germany	68167
59	Gesellschaft für Medizinische	Mönchengladbach		Germany	41239
60	MLL Münchner Leukämielabor GmbH	München		Germany	81377
61	III. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München	München		Germany	81675
62	Gemeinschaftspraxis für Hämatologie und Onkologie	Münster		Germany	48149
63	Innere Medizin II - Onkologie, Hämatologie, Univesitatklinikum Tubingen	Tübingen		Germany	72076
64	Klinik für Innere Medizin III	Ulm		Germany	89081
65	Gemeinschaftspraxis für Hämatologie und Onkologie	Westerstede		Germany	26655
66	Rems-Murr-Klinikum Winnenden	Winnenden		Germany	71364
67	Universitätsklinikum Würzburg	Würzburg		Germany	97080
68	ZENTRUM FÜR INNERE MEDIZIN, Universitatklinikum Wurzburg	Würzburg		Germany	97080
69	University Hospital of Alexandroupolis	Alexandroupolis		Greece	GR-68100
70	General Hospital of Athens - LAIKO	Athens		Greece	11527
71	University General Hospital	Athens		Greece	12461
72	Georgios Gennimatos General Hospital	Athens		Greece	GR 11527
73	University Hospital Of Herakli	Herakleion - Crete		Greece	71110
74	University General Hospital of Ioannina	Ioannina		Greece	45500
75	University General Hospital of Larissa	Larissa		Greece	4110
76	University General Hospital of Patras	Patras		Greece	26504
77	G. Papanikolaou General Hospital	Thessaloniki		Greece	57010
78	Irccs Crob	Rionero in Vulture	Potenza	Italy	85028
79	Ospedale di Castelfranco Venet	Castelfranco Veneto	Treviso	Italy	31033
80	AOU Ospedali Riuniti Umberto I G.M. Lancisi G. Salesi	Ancona		Italy	60020
81	U.O Ematologia con Trapianto	Bari		Italy	70124
82	Azienda Ospedaliera Papa Giovanni XX111 Piazza OMS	Bergamo		Italy	1 24127
83	Policlinico S.Orsola Malpighi, AOU di Bologna	Bologna		Italy	40138
84	AO Spedali Civili di Brescia	Brescia		Italy	25123
85	Policlinico di Catania	Catania		Italy	95124
86	AOU Careggi	Firenze		Italy	50134
87	U.O .C di Oncoematologia	Mirano		Italy	76 30035
88	Ospedale S. Luigi Gonzaga	Orbassano		Italy	10043
89	Azienda ospedaliero-universita	Parma		Italy	43126
90	Azienda Ospedaliera di Perugia	Perugia		Italy	106100
91	Ospedale Civile Santo Spirito	Pescara		Italy	65124
92	Arcispedale S.Maria Nuova	Reggio Emilia		Italy	42123
93	U.O Ematologia Azienda Ospedaliera	Regio Calabria		Italy	89100
94	Univesita La Sapienza	Roma		Italy	00161
95	AOU Policlinico Tor Vergata, Università Roma Tor Vergata	Roma		Italy	81 00133
96	Presidio Ospedaliero "A. Torto	Salerno		Italy	84016
97	Azienda Ospedaliera Universitaria di Sassari	Sassari		Italy	07100
98	A.O. Citta' della Salute e del	Torino		Italy	10126
99	Policlinico "G.B. Rossi" Verona	Veneto		Italy	37100
100	Centre Hospitalier de Luxembourg	Luxembourg		Luxembourg	01210
101	Haukeland Sykehus	Bergen		Norway	N-5021
102	Hospital Universitario de Gran Canaria Servicio de Hematología y	Las Palmas de Gran Canaria	Canarias	Spain	35010
103	H.U.Marq.Valdecilla, Hospital Universitario Marqués de Valdecilla. Hematología	Santander	Cantabria	Spain	39008
104	Hospital costa del sol	Marbella	Málaga	Spain	29603
105	H.U. Ribera de Alzira	Alzira		Spain	46600
106	Hospital de Cruces	Barakaldo		Spain	48903
107	Hospital del Mar,Hematologia Hemotheropia	Barcelona		Spain	08003
108	H. Clinic de Barcelona	Barcelona		Spain	08036
109	Pauc Tauli	Barcelona		Spain	08208
110	Hospital Vall d'Hebron	Barcelona		Spain	08835
111	Instit Catalia D'Oncologia	Barcelona		Spain	08916
112	Hospital Reina Sofia	Cordoba		Spain	14004
113	Hospital Josep Trueta (ICO Girona)	Girona		Spain	17007
114	Hospital Virgen de Las Nieves	Grenada		Spain	18014
115	Department of Hematology, Hospital Duran i Reynals	LLobregat		Spain	08908
116	Hospital Universitario Ramon Y Cajal	Madrid		Spain	28034
117	Hopsital Clinico San Carlos	Madrid		Spain	28040
118	Hospital Universitario fundacion Jiminez Diaz	Madrid		Spain	28040
119	Hospital Universitario 12 de Octobre	Madrid		Spain	28041
120	Hospital Universitario La Paz	Madrid		Spain	28046
121	H Universitario Puera de Hierro	Madrid		Spain	28222
122	Hospital Son Espaces	Mallorca		Spain	07120
123	Hospital Universitario central de Asturias	Oviedo		Spain	33011
124	Univesity Hospital de Salamanca	Salamenca		Spain	37007
125	Complejo Hospitalario Universitario de Santiago	Santiago de Compostela		Spain	15706
126	Hospital Virgen Macarena	Sevilla		Spain	41009
127	Hospital Virgen del Rocio	Sevilla		Spain	41013
128	Hopsital Nuestra Senora de Valme	Sevilla		Spain	41014
129	Hospital Clinico Universitario de Valencia	Valencia		Spain	46010
130	Hospiral Universitario de la Fe	Valencia		Spain	46026
131	Sahlgrenska University Hospital	Gothenburg		Sweden	413 45
132	Sahlgrenska University Hospital	Göteborg		Sweden	413 45
133	Länssjukhuset Kalmar	Kalmar		Sweden	391 85
134	Lund University Hospital - Lasarettsgatan 23	Lund		Sweden	22185
135	Karolinska University Hopsital	Stockholm		Sweden	141 86
136	Maidstone Hospital	Maidstone	Kent	United Kingdom	ME16 9QQ
137	Aberdeen Royal Infirmary - Foresterhill Road	Aberdeen		United Kingdom	AB25 2ZN
138	Queen Elizabeth Hospital	Birmingham		United Kingdom	B15 2TH
139	Pilgrim Hospital	Boston		United Kingdom	PE21 9QS
140	Monkton, Wishaw and Hairmyres Hospitals	East Kilbride		United Kingdom	G75 8RG
141	Broomfield Hospital - Mid-Essex Hospitals NHS Trust	Essex		United Kingdom	CM1 7ET
142	Basildon and Thurrock Hospitals	Essex		United Kingdom	SS16 5NL
143	Northwick Park Hospital	Harrow		United Kingdom	HA1 3UJ
144	Lincoln county Hospital	Lincoln		United Kingdom	LN2 5QY
145	Aintree Hospital - Longmoor Lane	Liverpool		United Kingdom	L9 7AL
146	University Hospital South Manc	Manchester		United Kingdom	M23 9LT
147	Royal Oldham Hospital	Oldham		United Kingdom	OL1 2JH
148	Radcliffe Hospitals and University - Headley Way, Headington	Oxford		United Kingdom	OX3 9DU
149	Great Western Hospital	Swindon		United Kingdom	SN3 6BB