Actively Recruiting
Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation
Led by European Myeloma Network B.V. · Updated on 2026-03-25
1594
Participants Needed
211
Research Sites
499 weeks
Total Duration
On this page
Sponsors
E
European Myeloma Network B.V.
Lead Sponsor
J
Janssen Pharmaceutica
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.
CONDITIONS
Official Title
Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- New diagnosis of multiple myeloma according to IMWG criteria with induction +/- consolidation therapy
- Received only one line of therapy and achieved at least a partial response (>=PR) without progression at first treatment dose
- Not intolerant to the starting dose of lenalidomide
- No prior maintenance therapy received
- ECOG performance status score of 0, 1, or 2 at screening and before starting study treatment
- Clinical laboratory values within prespecified range
You will not qualify if you...
- Received any prior BCMA-directed therapy
- Previous treatment with immune cell redirecting agents or gene modified adoptive cell therapy (e.g., CAR T cells, NK cells)
- Discontinued lenalidomide due to adverse events
- Disease progression on multiple myeloma therapy before screening
- Received corticosteroids equivalent to >=140 mg prednisone within 14 days before first treatment dose
- Received live attenuated vaccine within 4 weeks before first treatment dose (non-live vaccines allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 211 locations
1
Banner University Medical Center Tucson, University of Arizona
Phoenix, Arizona, United States, 85004
Not Yet Recruiting
2
UCLA Medical Center
Los Angeles, California, United States, 90095
Not Yet Recruiting
3
University of California-Davis Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
4
University of California, San Diego (UCSD) Medical Center
San Diego, California, United States, 92093
Actively Recruiting
5
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Not Yet Recruiting
6
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Actively Recruiting
7
Yale New Haven Hospital
New Haven, Connecticut, United States, 06519
Actively Recruiting
8
Christiana Care
Newark, Delaware, United States, 19718
Actively Recruiting
9
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016
Not Yet Recruiting
10
Blood & Marrow Transplant Center, Florida Hospital Medical Group
Orlando, Florida, United States, 32804
Not Yet Recruiting
11
Moffitt at Memorial Healthcare System
Tampa, Florida, United States, 33612
Not Yet Recruiting
12
Emory University Hospital
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
13
University of Illinois Medical Center at Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
14
Greenebaum Cancer Center UM of MD
Baltimore, Maryland, United States, 21201
Actively Recruiting
15
John Hopkins
Baltimore, Maryland, United States, 21218
Actively Recruiting
16
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
17
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
18
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Withdrawn
19
Mount Sinai Medical Center - 2
New York, New York, United States, 10029
Actively Recruiting
20
Montefiore Medical Cente
The Bronx, New York, United States, 10467
Actively Recruiting
21
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Not Yet Recruiting
22
Duke University
Durham, North Carolina, United States, 27708
Actively Recruiting
23
East Carolina University
Greenville, North Carolina, United States, 27858
Not Yet Recruiting
24
University of Cincinnati
Cincinnati, Ohio, United States, 45221
Actively Recruiting
25
Seidman Cancer Center-University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
26
Ohio State Medical Center, James Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
27
Ohio Health Research Institute
Columbus, Ohio, United States, 43214
Not Yet Recruiting
28
Lehigh Valley Health Network
Allentown, Pennsylvania, United States, 18103
Actively Recruiting
29
Penn Medicine Lancaster General
Lancaster, Pennsylvania, United States, 17602
Not Yet Recruiting
30
Abramson Cancer Center University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
31
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
32
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Not Yet Recruiting
33
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
Not Yet Recruiting
34
Gibbs Cancer Center
Spartanburg, South Carolina, United States, 29303
Not Yet Recruiting
35
Vanderbilt-Ingram Cancer Center (VICC)
Nashville, Tennessee, United States, 37240
Actively Recruiting
36
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
37
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
38
St Vincent HSHS (Green Bay Oncology)
Green Bay, Wisconsin, United States, 54301
Actively Recruiting
39
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Actively Recruiting
40
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
41
Hospital Italiano
Buenos Aires, Argentina
Actively Recruiting
42
Hospital Privado
Córdoba, Argentina
Actively Recruiting
43
Sanatorio Britanico Rosario
Rosario, Argentina
Actively Recruiting
44
Sunshine Coast Health
Birtinya, Queensland, Australia
Actively Recruiting
45
Flinders Medical Centre
Adelaide, Australia
Actively Recruiting
46
Townsville University Hospital
Douglas, Australia
Actively Recruiting
47
Barwon Health University Hospital Geelong Andrew Love Cancer Centre
Geelong, Australia
Actively Recruiting
48
Alfred Hospital
Melbourne, Australia
Actively Recruiting
49
Austin Health
Melbourne, Australia
Actively Recruiting
50
Calvary Mater Hospital
Newcastle, Australia
Actively Recruiting
51
Sunshine Coast Health
Sunshine Coast, Australia
Actively Recruiting
52
Concord Repatriation General Hospital
Sydney, Australia
Actively Recruiting
53
Royal North Shore Hospital
Sydney, Australia
Actively Recruiting
54
Landeskrankenhaus, Feldkirch
Feldkirch, Austria
Actively Recruiting
55
Medizinische Universitaet Innsbruck
Innsbruck, Austria
Actively Recruiting
56
University Hospital Krems/Donau
Krems, Austria
Actively Recruiting
57
Kepler Universitätsklinikum Med Campus III
Linz, Austria
Actively Recruiting
58
Ordensklinikum Linz GmbH
Linz, Austria
Actively Recruiting
59
Uniklinikum Salzburg
Salzburg, Austria
Actively Recruiting
60
Clinic Ottakring
Vienna, Austria
Actively Recruiting
61
LKH Hochsteiermark
Vienna, Austria
Actively Recruiting
62
Jessa Ziekenhuis
Hasselt, Belgium
Actively Recruiting
63
Department of Hematology, CH Jolimont
La Louvière, Belgium
Not Yet Recruiting
64
Algemeen Ziekenhuis Delta
Leuven, Belgium
Actively Recruiting
65
University Hospital Leuven
Leuven, Belgium
Actively Recruiting
66
Centre hospitalier universitaire de Liege
Liège, Belgium
Actively Recruiting
67
Hospital Mãe de Deus - Centro Integrado de Oncologia
Porto Alegre, Brazil
Actively Recruiting
68
Hospital Santa Rita
Porto Alegre, Brazil
Actively Recruiting
69
Instituto Americas de Ensino,Pesquisa e Inovação
Rio de Janeiro, Brazil
Not Yet Recruiting
70
IDOR- Instituto D'or de pesquisa. Av. São Rafael
Salvador, Brazil
Actively Recruiting
71
A Real e Benemérita Associação Portuguesa de Beneficência
São Paulo, Brazil
Actively Recruiting
72
Clínica Medica São Germano,Grupo Oncoclínicas Pesquisa Clínica
São Paulo, Brazil
Actively Recruiting
73
Departamento de Oncologia Clínica AC Camargo Cancer Center
São Paulo, Brazil
Actively Recruiting
74
Grupo Oncoclínicas Pesquisa Clínica
São Paulo, Brazil
Not Yet Recruiting
75
Hcor, Associacao Siria
São Paulo, Brazil
Not Yet Recruiting
76
Hemocentro UNICAMP, Universidade Estadual de Campinas
São Paulo, Brazil
Actively Recruiting
77
Hospital das Clínicas da Universidade de São Paulo
São Paulo, Brazil
Actively Recruiting
78
Hospital Paulistano, Centro de Pesquisa Clinica R. Martiniano de Carvalho
São Paulo, Brazil
Not Yet Recruiting
79
Onco Star
São Paulo, Brazil
Actively Recruiting
80
Universidade Federal de São Paulo - Hospital São Paulo
São Paulo, Brazil
Actively Recruiting
81
Cross Cancer Institute
Edmonton, Canada
Actively Recruiting
82
QEII Health Sciences Centre
Halifax, Canada
Actively Recruiting
83
The Ottawa General Hospital
Ottawa, Canada
Actively Recruiting
84
Saskatoon Cancer Center
Saskatoon, Canada
Actively Recruiting
85
"Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)"
Sherbrooke, Canada
Actively Recruiting
86
Princess Margaret Cancer Centre
Toronto, Canada
Actively Recruiting
87
BC Cancer
Vancouver, Canada
Not Yet Recruiting
88
Beijing Chaoyang Hospital
Beijing, China
Actively Recruiting
89
Peking University First Hospital
Beijing, China
Actively Recruiting
90
The First Hospital of Jilin University
Changchun, China
Not Yet Recruiting
91
North China University of Science and Technology Affiliated Hospital.Hematology Department
Hebei, China
Actively Recruiting
92
Henan Cancer Hospital
Henan, China
Actively Recruiting
93
Shandong Qilu Hospital
Shandong, China
Actively Recruiting
94
Shanghai Fourth People's Hospital
Shanghai, China
Actively Recruiting
95
Shenyang City, Liaoning Province, Hematology department
Shenyang, China
Actively Recruiting
96
Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
Tianjin, China
Actively Recruiting
97
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Actively Recruiting
98
Tongji Hospital, Tongji Medical College of Hust
Wuhan, China
Actively Recruiting
99
The First Affiliated Hospital, Zhejiang University College of Medicine
Zhejiang, China
Actively Recruiting
100
Fakultni Nemocnice Hradec Kralove
Hradec Králové, Czechia
Actively Recruiting
101
University Hospital Olomouc
Olomouc, Czechia
Actively Recruiting
102
Fakultni Nemocnice Ostrava
Ostrava, Czechia
Actively Recruiting
103
Fakultni Nemocnice Plzen
Pilsen, Czechia
Actively Recruiting
104
Vseobecna Fakultni Nemocnice V Praze
Prague, Czechia
Actively Recruiting
105
Aarhus Universitetshospital
Aarhus, Denmark
Actively Recruiting
106
Rigshospitalet
Copenhagen, Denmark
Actively Recruiting
107
Odense University Hospital
Odense, Denmark
Actively Recruiting
108
Lillebaelt Hospital
Vejle, Denmark
Actively Recruiting
109
Centre Hospitalier Universitaire De Bordeaux
Bordeaux, France
Actively Recruiting
110
Department of Hematology, CHU Lille
Lille, France
Actively Recruiting
111
Institut Paoli Calmettes
Marseille, France
Actively Recruiting
112
Centre Hospitalier Universitaire De Montpellier
Montpellier, France
Actively Recruiting
113
Centre Hospitalier Universitaire De Nantes
Nantes, France
Actively Recruiting
114
Hopital Saint Louis
Paris, France
Actively Recruiting
115
Hôpital Saint-Antoine
Paris, France
Actively Recruiting
116
Centre Hospitalier Universitaire De Poitiers
Poitiers, France
Actively Recruiting
117
Centre Hospitalier Universitaire De Toulouse
Toulouse, France
Actively Recruiting
118
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Actively Recruiting
119
Universitaetsklinikum Heidelberg AöR
Heidelberg, Germany
Actively Recruiting
120
Universitaetsklinikum Jena KöR
Jena, Germany
Actively Recruiting
121
Universitaetsklinikum Schleswig-Holstein AöR
Lübeck, Germany
Active, Not Recruiting
122
Klinikum rechts der Isar der TU Muenchen AöR
München, Germany
Actively Recruiting
123
Klinikum Nuernberg
Nuremberg, Germany
Actively Recruiting
124
Universitaetsklinikum Tuebingen AöR
Tübingen, Germany
Actively Recruiting
125
University Hospital of Würzburg
Würzburg, Germany
Actively Recruiting
126
University General Hospital Of Alexandroupoli
Alexandroupoli, Greece
Actively Recruiting
127
Evaggelismos Hospital
Athens, Greece
Actively Recruiting
128
Regional General Hospital Alexandra
Athens, Greece
Actively Recruiting
129
Theageneio Cancer Hospital
Thessaloniki, Greece
Actively Recruiting
130
Cork University Hospital
Cork, Ireland
Actively Recruiting
131
Beaumont Hospital
Dublin, Ireland
Actively Recruiting
132
St James's Hospital
Dublin, Ireland
Actively Recruiting
133
St Vincent's University Hospital
Dublin, Ireland
Actively Recruiting
134
University Hospital Galway
Galway, Ireland
Actively Recruiting
135
University Hospital Limerick
Limerick, Ireland
Actively Recruiting
136
The Barzilai Medical Center
Beersheba, Israel
Actively Recruiting
137
Health Care Campus
Haifa, Israel
Actively Recruiting
138
Hadassah Medical Center
Jerusalem, Israel
Actively Recruiting
139
Beilinson Hospital
Petah Tikva, Israel
Actively Recruiting
140
Chaim Sheba Medical Center
Ramat Gan, Israel
Actively Recruiting
141
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel
Actively Recruiting
142
Azienda Sanitaria Locale Al Di Alessandria
Alessandria, Italy
Actively Recruiting
143
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
Ancona, Italy
Actively Recruiting
144
AOU G. Baccelli
Bari, Italy
Actively Recruiting
145
Policlinico di Bari
Bari, Italy
Actively Recruiting
146
A.O. Papa Giovanni XXIII
Bergamo, Italy
Actively Recruiting
147
A.O.U. di Bologna - Policlinico S. Orsola Malpighi
Bologna, Italy
Actively Recruiting
148
A.O.Spedali Civili di Brescia
Brescia, Italy
Actively Recruiting
149
Ospedale Oncologico 'A. Businco'
Cagliari, Italy
Actively Recruiting
150
Azienda Ospedaliera-Universitaria Di Cosenza
Cosenza, Italy
Actively Recruiting
151
Careggi University Hospital
Florence, Italy
Actively Recruiting
152
IRCCS Ospedale Policlinico San Martino
Genova, Italy
Actively Recruiting
153
IRCCS Ospedale Maggiore Policlinico
Milan, Italy
Actively Recruiting
154
Azienda Ospedaliero Universitaria Di Modena
Modena, Italy
Actively Recruiting
155
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
Naples, Italy
Actively Recruiting
156
UOC Oncoematologia, Ospedale Policlinico Federico II
Naples, Italy
Not Yet Recruiting
157
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Novara, Italy
Actively Recruiting
158
UOC Ematologia - Azienda Ospedale - Università Padova Ospedale Giustinianeo
Padova, Italy
Actively Recruiting
159
Department of Hematology and Bone Marrow Transplant Centre, Azienda Ospedaliero - Universitaria di Parma
Parma, Italy
Not Yet Recruiting
160
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Actively Recruiting
161
Azienda Sanitaria Locale Di Pescara
Pescara, Italy
Actively Recruiting
162
Ospedale Santa Maria delle Croci
Ravenna, Italy
Actively Recruiting
163
Azienda USL IRCCS Di Reggio Emilia
Reggio, Italy
Actively Recruiting
164
Ospedale "Infermi" di Rimini
Rimini, Italy
Actively Recruiting
165
Ematologia, Azienda Policlinico Umberto I
Roma, Italy
Actively Recruiting
166
Casa Sollievo Della Sofferenza
San Giovanni Rotondo, Italy
Actively Recruiting
167
A.O.U. Città della Salute e della Scienza di Torino - SC Ematologia U
Torino, Italy, 10126
Actively Recruiting
168
A.O.U. Ospedali Riuniti di Trieste
Trieste, Italy
Actively Recruiting
169
Azienda Sanitaria Universitaria Friuli Centrale
Udine, Italy
Actively Recruiting
170
Noordwest Ziekenhuisgroep Stichting
Alkmaar, Netherlands
Actively Recruiting
171
Amsterdam University Medical Center
Amsterdam, Netherlands
Actively Recruiting
172
Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands
Actively Recruiting
173
Maxima Medisch Centrum
Eindhoven, Netherlands
Actively Recruiting
174
University Medical Center Groningen
Groningen, Netherlands
Actively Recruiting
175
Dijklander Ziekenhuis
Hoorn, Netherlands
Actively Recruiting
176
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Actively Recruiting
177
Erasmus University Medical Center Rotterdam
Rotterdam, Netherlands
Actively Recruiting
178
Maasstad Ziekenhuis
Rotterdam, Netherlands
Actively Recruiting
179
St. Olavs hospital HF
Trondheim, Norway
Actively Recruiting
180
Department of Hematology and Transplantology University Clinical Center
Gdansk, Poland
Active, Not Recruiting
181
SPZOZ MSWiA w Poznaniu im. Prof. Ludwika Bierkowskiego, Poznań
Poznan, Poland
Actively Recruiting
182
CCAB Centro Clinico Academico Braga Associacao
Braga, Portugal
Not Yet Recruiting
183
Champalimaud Clinical Centre
Lisbon, Portugal
Actively Recruiting
184
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Lisbon, Portugal
Not Yet Recruiting
185
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Porto, Portugal
Withdrawn
186
Sao Joao University Hospital Center
Porto, Portugal
Not Yet Recruiting
187
Unidade Local De Saude De Gaia/Espinho E.P.E.
Porto, Portugal
Withdrawn
188
Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.
Vila Real, Portugal
Actively Recruiting
189
University Clinical Center of Serbia
Belgrade, Serbia
Actively Recruiting
190
Clinical Centre of Kragujevac
Kragujevac, Serbia
Actively Recruiting
191
Clinical Centre of Nis
Niš, Serbia
Actively Recruiting
192
Clinical Centre of Vojvodina
Novi Sad, Serbia
Actively Recruiting
193
Chonnam National University Hwasun Hospital
Gwangju, South Korea
Actively Recruiting
194
Department of Oncology, Asan Medical Center
Seoul, South Korea
Not Yet Recruiting
195
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
196
Seoul National University Hospital, Internal Medicine
Seoul, South Korea
Actively Recruiting
197
Severance Hospital
Seoul, South Korea
Actively Recruiting
198
St. Mary's Hospital
Seoul, South Korea
Actively Recruiting
199
University Hospital Basel
Basel, Switzerland
Actively Recruiting
200
Inselspital
Bern, Switzerland
Actively Recruiting
201
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Actively Recruiting
202
Ankara Liv Hospital
Ankara, Turkey (Türkiye)
Actively Recruiting
203
Ankara University Hospital
Ankara, Turkey (Türkiye)
Actively Recruiting
204
Florence Nightingale Hospital
Istanbul, Turkey (Türkiye)
Actively Recruiting
205
Memorial Sisli Hospital, Dept of Hematology
Istanbul, Turkey (Türkiye)
Actively Recruiting
206
Ege University Medical faculty Hospital Internal Medicine Department Adult Hematology Unit
Izmir, Turkey (Türkiye)
Actively Recruiting
207
Izmir Economy University, Medical Point Hospital
Izmir, Turkey (Türkiye)
Not Yet Recruiting
208
Erciyes University Hospital
Kayseri, Turkey (Türkiye)
Actively Recruiting
209
Hammersmith Hospital - Imperial College NHS Healthcare Trust
London, United Kingdom
Actively Recruiting
210
University College London (UCL)
London, United Kingdom
Actively Recruiting
211
The Royal Marsden Hospital
Sutton, United Kingdom
Actively Recruiting
Research Team
C
Christine Witty
CONTACT
S
Sabrin Tahri
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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