Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05020236

A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments

Led by Pfizer · Updated on 2026-05-05

944

Participants Needed

90

Research Sites

295 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this clinical trial is to (1) learn whether the BCMA-CD3 bispecific antibody elranatamab can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone, and (2) learn about the safety and activity of elranatamab in combination with the anti-CD38 monoclonal antibody daratumumab. People with multiple myeloma who have received previous treatment including lenalidomide will be enrolled in the study. Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab. People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will evaluate the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab. Part 3 will assess the effect of increased measures to protect against infection in people treated with either elranatamab alone or together with daratumumab. All people participating in the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study.

CONDITIONS

Official Title

A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Prior diagnosis of multiple myeloma based on IMWG criteria
  • Measurable disease with serum M-protein 650.5 g/dL, or urinary M-protein 65200 mg/24 hours, or serum immunoglobulin FLC 6510 mg/dL with abnormal kappa to lambda ratio
  • Previous treatment including lenalidomide for multiple myeloma
  • ECOG performance status of 2 or less
  • Acute effects of prior therapy resolved to baseline or CTCAE Grade 1 or less
  • Not pregnant and willing to use contraception
Not Eligible

You will not qualify if you...

  • Smoldering multiple myeloma
  • Plasma cell leukemia
  • Amyloidosis
  • POEMS Syndrome
  • Stem cell transplant within 12 weeks before enrollment or active graft versus host disease
  • Active infections including HBV, HCV, SARS-CoV2, HIV, or uncontrolled bacterial, fungal, or viral infections
  • Any other active cancer within 3 years except treated basal cell or squamous cell skin cancer or carcinoma in situ
  • Prior treatment with BCMA-directed therapy
  • Live attenuated vaccine within 4 weeks before first study dose
  • Use of investigational products within 30 days before first study dose

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 90 locations

1

Clovis Community Medical Center

Clovis, California, United States, 93611

Active, Not Recruiting

2

Community Regional Medical Center

Fresno, California, United States, 93721

Active, Not Recruiting

3

UCHealth Poudre Valley Hospital

Fort Collins, Colorado, United States, 80524

Active, Not Recruiting

4

UCHealth Greeley Hospital

Greeley, Colorado, United States, 80634

Active, Not Recruiting

5

Sylvester Comprehensive Cancer Center - Aventura

Aventura, Florida, United States, 33180

Actively Recruiting

6

Sylvester Comprehensive Cancer Center - Coral Springs

Coral Springs, Florida, United States, 33065

Actively Recruiting

7

University of Miami Hospital and Clinics - Deerfield Beach

Deerfield Beach, Florida, United States, 33442

Actively Recruiting

8

Sylvester Comprehensive Cancer Center - Hollywood

Hollywood, Florida, United States, 33021

Actively Recruiting

9

University of Miami Hospital and Clinics

Miami, Florida, United States, 33136

Actively Recruiting

10

Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).

New York, New York, United States, 10021

Actively Recruiting

11

Memorial Sloan Kettering Cancer Center - Main Campus

New York, New York, United States, 10065

Actively Recruiting

12

Hospital Universitario Austral

Presidente Derqui, Buenos Aires, Argentina, B1629AHJ

Active, Not Recruiting

13

Pindara Private Hospital

Benowa, Queensland, Australia, 4217

Actively Recruiting

14

QScan Radiology Clinics

Clayfield, Queensland, Australia, 4011

Actively Recruiting

15

Gallipoli Medical Research Foundation

Greenslopes, Queensland, Australia, 4120

Active, Not Recruiting

16

Slade Pharmacy

Richmond, Victoria, Australia, 3121

Actively Recruiting

17

Linear Clinical Research

Perth, Western Australia, Australia, 6009

Active, Not Recruiting

18

Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador

Salvador, Estado de Bahia, Brazil, 41253-190

Active, Not Recruiting

19

Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa

Porto Alegre, Rio Grande do Sul, Brazil, 90110-270

Active, Not Recruiting

20

Hospital Mae de Deus

Porto Alegre, Rio Grande do Sul, Brazil, 90880-480

Active, Not Recruiting

21

Clínica Médica São Germano LTDA

SP, São Paulo, Brazil, 04537-080

Active, Not Recruiting

22

Instituto de Educação, Pesquisa e Gestão em Saúde

Rio de Janeiro, Brazil, 22793-080

Active, Not Recruiting

23

HU UNIFESP / SPDM - Hospital São Paulo

São Paulo, Brazil, 04024-002

Active, Not Recruiting

24

Clínica Médica São Germano S/S Ltda

São Paulo, Brazil, 04537-080

Active, Not Recruiting

25

Instituto D'Or de Pesquisa e Ensino (IDOR)

São Paulo, Brazil, 04543-000

Active, Not Recruiting

26

Instituto D'Or de Pesquisa e Ensino (IDOR)

São Paulo, Brazil, 04544-000

Active, Not Recruiting

27

CIUSSS de l'Est-de-l'Île-de-Montréal

Montreal, Quebec, Canada, H1T2M4

Active, Not Recruiting

28

Saskatoon Cancer Center

Saskatoon, Saskatchewan, Canada, S7N4H4

Actively Recruiting

29

Fujian Medical University Union Hospital

Fuzhou, Fujian, China, 350001

Actively Recruiting

30

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China, 510515

Actively Recruiting

31

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510555

Actively Recruiting

32

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China, 430030

Actively Recruiting

33

Nanjing Drum Tower Hospital , The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China, 210008

Actively Recruiting

34

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China, 221006

Active, Not Recruiting

35

Shandong Provincial Hospital

Jinan, Shandong, China, 250021

Active, Not Recruiting

36

Institute of hematology&blood disease hospital

Tianjin, Tianjin Municipality, China, 301636

Actively Recruiting

37

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, China, 100730

Active, Not Recruiting

38

Chongqing University Cancer Hospital

Chongqing, China, 400030

Actively Recruiting

39

Fakultní nemocnice Brno Bohunice

Brno, Brno-m?sto, Czechia, 625 00

Active, Not Recruiting

40

Fakultni Nemocnice Plzen

Plzen - Lochotin, Plzeň Region, Czechia, 304 60

Actively Recruiting

41

Fakultni poliklinika

Prague, Praha 2, Czechia, 120 00

Actively Recruiting

42

Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)

Helsinki, Finland, 00029

Active, Not Recruiting

43

Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren

Limoges, Limousin, France, 87042

Actively Recruiting

44

Hôpital Saint Antoine

Paris, France, 75571

Actively Recruiting

45

Centre Hospitalier Lyon Sud - Service d'Hematologie Clinique

Pierre-Bénite, France, 69495

Active, Not Recruiting

46

Charité Universitätsmedizin Berlin

Berlin, Germany, 12203

Active, Not Recruiting

47

Universitätsklinikum rechts der Isar, Technische Universität München (TUM)

München, Germany, 81675

Actively Recruiting

48

Alexandra General Hospital of Athens

Athens, Attikí, Greece, 115 28

Active, Not Recruiting

49

Theageneio Cancer Hospital of Thessaloniki

Thessaloniki, Kentrikí Makedonía, Greece, 546 39

Active, Not Recruiting

50

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Lombardy, Italy, 20122

Actively Recruiting

51

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

Bologna, Italy, 40138

Active, Not Recruiting

52

National Hospital Organization Shibukawa Medical Center

Shibukawa, Gunma, Japan, 377-0280

Active, Not Recruiting

53

Tohoku University Hospital

Sendai, Miyagi, Japan, 980-8574

Active, Not Recruiting

54

Akita University Hospital

Akita, Japan, 010-8543

Actively Recruiting

55

National Hospital Organization Kumamoto Medical Center

Kumamoto, Japan, 860-0008

Actively Recruiting

56

Nagasaki University Hospital

Nagasaki, Japan, 852-8501

Actively Recruiting

57

National Hospital Organization Okayama Medical Center

Okayama, Japan, 701-1192

Active, Not Recruiting

58

Yamagata University Hospital

Yamagata, Japan, 990-9585

Active, Not Recruiting

59

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, Mexico, 66460

Active, Not Recruiting

60

North Shore Hospital

Auckland, New Zealand, 0622

Active, Not Recruiting

61

Labtests Auckland Ltd.

Auckland, New Zealand, 1060

Active, Not Recruiting

62

Aotearoa Clinical Trials

Auckland, New Zealand, 2025

Active, Not Recruiting

63

Waikato District Health Board, Waikato Hospital

Hamilton, New Zealand, 3204

Active, Not Recruiting

64

Palmerston North Hospital

Roslyn, New Zealand, 4414

Active, Not Recruiting

65

Oslo Universitetssykehus Ullevål

Oslo, Norway, 0450

Active, Not Recruiting

66

St Olavs Hospital

Trondheim, Norway, 7030

Active, Not Recruiting

67

Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy Klinika Hematologii

Bydgoszcz, Poland, 85-168

Active, Not Recruiting

68

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Poland, 60-569

Active, Not Recruiting

69

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

Wroclaw, Poland, 50-367

Active, Not Recruiting

70

Institut Català d'Oncologia - L'Hospitalet

L'Hospitalet Del Llobregat, Barcelona [barcelona], Spain, 08908

Actively Recruiting

71

Hospital Universitari Mutua Terrassa

Terrassa, Barcelona, Spain, 08221

Active, Not Recruiting

72

Clinica Universidad de Navarra

Pamplona, Navarre, Spain, 31008

Actively Recruiting

73

Hospital Universitario de Toledo

Toledo, Other, Spain, 45007

Active, Not Recruiting

74

Hospital Universitari Vall d'Hebron

Barcelona, Spain, 08035

Actively Recruiting

75

Hospital Universitari De Girona Doctor Josep Trueta

Girona, Spain, 17007

Active, Not Recruiting

76

Hospital Universitario La Princesa

Madrid, Spain, 28006

Actively Recruiting

77

Hospital Universitario Madrid Sanchinarro

Madrid, Spain, 28050

Active, Not Recruiting

78

Hospital Universitario de Salamanca

Salamanca, Spain, 37007

Active, Not Recruiting

79

Hospital Universitario Virgen Del Rocio

Seville, Spain, 41013

Active, Not Recruiting

80

Skånes Universitetssjukhus Lund

Lund, Skåne LÄN [se-12], Sweden, 22185

Active, Not Recruiting

81

Falu Lasarett

Falun, Sweden, 791 82

Active, Not Recruiting

82

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden, 41345

Active, Not Recruiting

83

Universitetssjukhuset Örebro

Örebro, Örebro LÄN [se-18], Sweden, 701 85

Active, Not Recruiting

84

China Medical University Hospital

Taichung, Taiwan, 40447

Active, Not Recruiting

85

National Cheng Kung University Hospital

Tainan, Taiwan, 704

Active, Not Recruiting

86

National Taiwan University Hospital

Taipei, Taiwan, 10002

Active, Not Recruiting

87

Ege Universitesi Hastanesi

Izmir, İ̇zmir, Turkey (Türkiye), 35100

Active, Not Recruiting

88

Dokuz Eylul Universitesi Hastanesi

Izmir, İ̇zmir, Turkey (Türkiye), 35340

Active, Not Recruiting

89

Akdeniz Universitesi Hastanesi

Antalya, Turkey (Türkiye), 07070

Active, Not Recruiting

90

University Hospital of Wales

Cardiff, South Glamorgan, United Kingdom, CF14 4XW

Active, Not Recruiting

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Research Team

P

Pfizer CT.gov Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

6

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