Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05243797

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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