Actively Recruiting
A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant
Led by Pfizer · Updated on 2026-05-14
1116
Participants Needed
89
Research Sites
568 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity. The main purpose of the study is to evaluate if the combination of Elranatamab, Daratumumab and Lenalidomide offers superior clinical benefit compared with the combination of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in people with newly diagnosed multiple myeloma. There are 2 parts to this study. Part 1 will characterize the safety and tolerability of elranatamab in combination with daratumumab and lenalidomide or in combination with lenalidomide and will identify the optimal dose(s) of the combination regimen. Part 2 of the study will evaluate the rate of minimal residual disease (MRD) negative CR and the progression free survival (PFS) of the combination of elranatamab, daratumumab, and lenalidomide compared with the combination of daratumumab, bortezomib, lenalidomide, and dexamethasone in participants with newly diagnosed multiple myeloma.
CONDITIONS
Official Title
A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of multiple myeloma as defined by IMWG criteria
- Measurable disease with serum M-protein ≥0.5 g/dL (Part 1) or ≥1 g/dL (Part 2), or urinary M-protein ≥200 mg/24 hours, or involved free light chain ≥10 mg/dL with abnormal kappa to lambda ratio
- Part 1: Relapsed/refractory multiple myeloma with 1-2 prior therapies including an immunomodulatory drug and a proteasome inhibitor, or newly diagnosed multiple myeloma transplant-ineligible by age ≥65 years or due to comorbidities if under 65
- Part 2: Newly diagnosed multiple myeloma transplant-ineligible due to age or comorbidities
- ECOG performance status of 0 to 2
- Not pregnant and willing to use contraception
- For relapsed/refractory participants: prior therapy effects resolved to baseline or CTCAE Grade ≤1
You will not qualify if you...
- Smoldering multiple myeloma
- Monoclonal gammopathy of undetermined significance
- Waldenström's Macroglobulinemia
- Plasma cell leukemia
- Active, uncontrolled infections including COVID-19, HBV, HCV, HIV or AIDS-related illness
- Any other active cancer within 3 years except certain treated skin cancers or carcinoma in situ
- For relapsed/refractory participants: previous BCMA or anti-CD38 therapy within 6 months, recent stem cell transplant within 3 months, or active graft versus host disease
- For newly diagnosed participants: prior systemic treatment for multiple myeloma except short corticosteroid course totaling ≤160 mg dexamethasone or equivalent
- Live attenuated vaccine within 4 weeks before study drug
- Use of investigational products within 30 days prior to study drug administration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 89 locations
1
Pindara Private Hospital
Benowa, Queensland, Australia, 4217
Actively Recruiting
2
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
Actively Recruiting
3
Epworth Freemasons
Melbourne, Victoria, Australia, 3002
Actively Recruiting
4
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
5
Epworth Healthcare
Richmond, Victoria, Australia, 3121
Actively Recruiting
6
Dr. Everett Chalmers Regional Hospital
Fredericton, New Brunswick, Canada, E3B 5N5
Not Yet Recruiting
7
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 2Y9
Actively Recruiting
8
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3S 0H6
Actively Recruiting
9
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
10
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100091
Actively Recruiting
11
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
12
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, China, 510515
Actively Recruiting
13
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510555
Actively Recruiting
14
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
15
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210008
Actively Recruiting
16
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
17
The first hospital of jilin university
Changchun, Jilin, China, 130021
Actively Recruiting
18
Tongji University - Shanghai Fourth People's Hospital
Shanghai, Shanghai Municipality, China, 200434
Actively Recruiting
19
Institute of hematology&blood disease hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
20
The first Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
21
The first Affiliated hospital of Wenzhou medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
22
Fakultní nemocnice Brno Bohunice
Brno, Brno-město, Czechia, 625 00
Actively Recruiting
23
Fakultni nemocnice Olomouc
Olomouc, Czechia, 779 00
Actively Recruiting
24
Vseobecna fakultni nemocnice v Praze
Prague, Czechia, 12808
Actively Recruiting
25
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
Toulouse, Haute-garonne, France, 31100
Not Yet Recruiting
26
Centre Hospitalier Universitaire de Poitiers
Poitiers, Vienne, France, 86021
Actively Recruiting
27
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, France, 44093 Cedex 1
Actively Recruiting
28
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, Germany, 72076
Not Yet Recruiting
29
Klinikum Chemnitz
Chemnitz, Germany, 09116
Not Yet Recruiting
30
Evangelismos General Hospital of Athens
Athens, Attikí, Greece, 106 76
Actively Recruiting
31
Alexandra General Hospital of Athens
Athens, Attikí, Greece, 115 28
Actively Recruiting
32
"Theagenio" Cancer Hospital of Thessaloniki
Thessaloniki, Kentrikí Makedonía, Greece, 540 07
Not Yet Recruiting
33
Evangelismos General Hospital of Athens
Athens, Greece, 10676
Actively Recruiting
34
University Hospital of Ioannina
Ioannina, Ípeiros, Greece, 455 00
Not Yet Recruiting
35
Rabin Medical Center
Petah Tikva, Central District, Israel, 4910021
Actively Recruiting
36
The Edmond and Lily Safra Children's Hospital; The Chaim Sheba Medical Center
Ramat Gan, Central District, Israel, 5265601
Not Yet Recruiting
37
Hadassah Medical Center
Jerusalem, Jerusalem, Israel, 9112001
Actively Recruiting
38
Soroka Medical Center
Beersheba, Southern District, Israel, 8410101
Actively Recruiting
39
Sourasky Medical Center
Tel Aviv, TELL ABĪB, Israel, 6423906
Actively Recruiting
40
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l
Meldola (Fc), Emilia-Romagna, Italy, 47014
Actively Recruiting
41
AUSL di Piacenza
Piacenza, Emilia-Romagna, Italy, 29121
Actively Recruiting
42
Ospedale Santa Maria delle Croci
Ravenna, Emilia-Romagna, Italy, 48121
Actively Recruiting
43
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, FG, Italy, 71013
Not Yet Recruiting
44
Cro-Irccs
Aviano, Friuli Venezia Giulia, Italy, 33081
Actively Recruiting
45
Fondazione IRCCS San Gerardo dei Tintori
Monza, Lombardy, Italy, 20900
Actively Recruiting
46
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Turin, Piedmont, Italy, 10126
Actively Recruiting
47
A.O.U. Policlinico Paolo Giaccone
Palermo, Sicily, Italy, 90127
Actively Recruiting
48
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy, 56126
Actively Recruiting
49
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, Italy, 24127
Actively Recruiting
50
Istituto Europeo di Oncologia IRCCS
Milan, Italy, 20141
Actively Recruiting
51
ASL PESCARA-Presidio Ospedaliero Pescara
Pescara, Italy, 65124
Actively Recruiting
52
Azienda Sanitaria Locale di Pescara
Pescara, Italy, 65124
Actively Recruiting
53
AOU Policlinico Umberto I
Roma, Italy, 00161
Actively Recruiting
54
University of Fukui Hospital
Yoshida-gun, Fukui, Japan, 910-1193
Actively Recruiting
55
Gunma University Hospital
Maebashi, Gunma, Japan, 371-8511
Actively Recruiting
56
Iwate Medical University Hospital
Yahaba-cho, Iwate, Japan, 028-3695
Actively Recruiting
57
Tohoku University Hospital
Sendai, Miyagi, Japan, 980-8574
Actively Recruiting
58
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka, Japan, 411-8777
Actively Recruiting
59
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo, Japan, 150-8935
Actively Recruiting
60
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Actively Recruiting
61
National Hospital Organization Okayama Medical Center
Okayama, Japan, 701-1192
Not Yet Recruiting
62
Osaka Metropolitan University Hospital
Osaka, Japan, 545-0051
Actively Recruiting
63
Yamagata University Hospital
Yamagata, Japan, 990-9585
Actively Recruiting
64
Albert Schweitzer Ziekenhuis, locatie Dordwijk
Dordrecht, South Holland, Netherlands, 3318 AT
Actively Recruiting
65
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, Lower Silesian Voivodeship, Poland, 50-367
Active, Not Recruiting
66
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, Poland, 80-214
Actively Recruiting
67
Pratia Onkologia Katowice
Katowice, Silesian Voivodeship, Poland, 40-519
Active, Not Recruiting
68
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeonranamdo, South Korea, 58128
Actively Recruiting
69
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, South Korea, 13620
Actively Recruiting
70
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03080
Actively Recruiting
71
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], South Korea, 06351
Not Yet Recruiting
72
The Catholic Univ. of Korea Seoul St. Mary's Hospital(Seoul St. Mary's Hospital)
Seoul, Seoul-teukbyeolsi [seoul], South Korea, 06591
Actively Recruiting
73
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea, 06591
Actively Recruiting
74
CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruña [LA Coruña], Spain, 15706
Not Yet Recruiting
75
Institut Català d'Oncologia (ICO) - Badalona
Badalona, Barcelona [barcelona], Spain, 08916
Actively Recruiting
76
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet Del Llobregat, Barcelona [barcelona], Spain, 08908
Actively Recruiting
77
Hospital Clínic de Barcelona
Barcelona, Catalunya [cataluña], Spain, 08036
Actively Recruiting
78
Institut Català d'Oncologia (ICO) - Girona
Girona, Girona [gerona], Spain, 17007
Actively Recruiting
79
Clinica Universidad de Navarra
Madrid, Madrid, Comunidad de, Spain, 28027
Actively Recruiting
80
Clinica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
81
Hospital Universitario Doctor Peset
Valencia, València, Spain, 46017
Actively Recruiting
82
Hospital San Pedro de Alcántara
Cáceres, Spain, 10003
Actively Recruiting
83
Hospital La Princesa
Madrid, Spain, 28006
Actively Recruiting
84
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040
Actively Recruiting
85
Kantonsspital Winterthur
Winterthur, Switzerland, 8401
Not Yet Recruiting
86
China Medical University Hospital
Taichung, Taiwan, 404332
Actively Recruiting
87
Taichung Veterans General Hospital
Taichung, Taiwan, 407
Not Yet Recruiting
88
National Taiwan University Hospital
Taipei, Taiwan, 10002
Active, Not Recruiting
89
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, Taiwan, 333
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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