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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05020236




Registration number
NCT05020236
Ethics application status
Date submitted
11/08/2021
Date registered
25/08/2021
Date last updated
10/10/2024

Titles & IDs
Public title
MagnetisMM-5: Study of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Scientific title
AN OPEN-LABEL, 3-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) MONOTHERAPY AND ELRANATAMAB + DARATUMUMAB VERSUS DARATUMUMAB + POMALIDOMIDE + DEXAMETHASONE IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 1 PRIOR LINE OF THERAPY INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR
Secondary ID [1] 0 0
2021-000044-22
Secondary ID [2] 0 0
C1071005
Universal Trial Number (UTN)
Trial acronym
MAGNETISMM-5
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Elranatamab
Treatment: Drugs - Daratumumab
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Dexamethasone

Experimental: Part 1 Safety Lead-In Dose Escalation: Elranatamab + Daratumumab -

Experimental: Part 2 Randomized Arm A: Elranatamab -

Experimental: Part 2 Randomized Arm B: Elranatamab + Daratumumab -

Active comparator: Part 2 Randomized Arm C: Daratumumab + Pomalidomide + Dexamethasone -


Treatment: Drugs: Elranatamab
subcutaneous

Treatment: Drugs: Daratumumab
Daratumumab / hyaluronidase, subcutaneous

Treatment: Drugs: Pomalidomide
oral

Treatment: Drugs: Dexamethasone
oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1 Safety Lead-In: Incidence of dose limiting toxicities
Timepoint [1] 0 0
First 42 days after first elranatamab dose
Primary outcome [2] 0 0
Part 2 Randomized: Progression free survival per International Myeloma Working Group criteria
Timepoint [2] 0 0
From date of randomization to date of progressive disease, discontinuation from the study, death, or censoring, whichever occurs first, assessed up to 51 months
Secondary outcome [1] 0 0
Part 1 Safety Lead-In: Progression free survival per International Myeloma Working Group criteria
Timepoint [1] 0 0
From date of randomization to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months
Secondary outcome [2] 0 0
Overall survival
Timepoint [2] 0 0
From date of randomization to date of discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months
Secondary outcome [3] 0 0
Objective response rate per International Myeloma Working Group criteria
Timepoint [3] 0 0
From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months
Secondary outcome [4] 0 0
Duration of response per International Myeloma Working Group criteria
Timepoint [4] 0 0
From date of confirmed objective response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months
Secondary outcome [5] 0 0
Time to response per International Myeloma Working Group criteria
Timepoint [5] 0 0
From date of randomization to date of confirmed objective response, assessed up to 51 months
Secondary outcome [6] 0 0
Complete response rate per International Myeloma Working Group criteria
Timepoint [6] 0 0
From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months
Secondary outcome [7] 0 0
Duration of complete response per International Myeloma Working Group criteria
Timepoint [7] 0 0
From date of confirmed complete response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months
Secondary outcome [8] 0 0
Minimal residual disease negativity rate per International Myeloma Working Group criteria
Timepoint [8] 0 0
From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months
Secondary outcome [9] 0 0
Sustained minimal residual disease negativity rate per International Myeloma Working Group criteria
Timepoint [9] 0 0
From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months
Secondary outcome [10] 0 0
Progression free survival on next-line treatment per International Myeloma Working Group criteria
Timepoint [10] 0 0
From date of randomization to date of second objective disease progression, discontinuation from the study, death, or censoring, whichever occurs first, assessed up to 51 months
Secondary outcome [11] 0 0
Frequency of treatment-emergent adverse events
Timepoint [11] 0 0
From date of first dose of study intervention through minimum of 90 days after last study intervention administration. Reporting of non-serious AEs ends at start of new anti-cancer therapy.
Secondary outcome [12] 0 0
Frequency of abnormal laboratory results
Timepoint [12] 0 0
From date of first dose of study intervention through minimum of 90 days after last study intervention administration. Reporting of non-serious AEs ends at start of new anti-cancer therapy.
Secondary outcome [13] 0 0
Rate of Grade =2 cytokine release syndrome
Timepoint [13] 0 0
First 28 days after first elranatamab dose
Secondary outcome [14] 0 0
Elranatamab pharmacokinetics by pre- and post-dose concentrations
Timepoint [14] 0 0
From date of first dose through up to 14 days after date of last dose of elranatamab
Secondary outcome [15] 0 0
Elranatamab immunogenicity by anti-drug antibodies against elranatamab
Timepoint [15] 0 0
From date of first dose through up to 14 days after date of last dose of elranatamab
Secondary outcome [16] 0 0
Daratumumab pharmacokinetics by pre-dose concentrations
Timepoint [16] 0 0
From date of first dose through up to 14 days after date of last dose of daratumumab
Secondary outcome [17] 0 0
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30
Timepoint [17] 0 0
From date of informed consent through up to 35 days after date of last dose of study intervention
Secondary outcome [18] 0 0
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20
Timepoint [18] 0 0
From date of informed consent through up to 35 days after date of last dose of study intervention

Eligibility
Key inclusion criteria
* Prior diagnosis of multiple myeloma as defined by IMWG criteria (Rajkumar et al, 2014).
* Measurable disease based on IMWG criteria as defined by at least 1 of the following:

* Serum M-protein =0.5 g/dL.
* Urinary M-protein excretion =200 mg/24 hours.
* Serum immunoglobulin FLC =10 mg/dL (=100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
* Prior anti-multiple myeloma therapy including treatment with lenalidomide and a proteasome inhibitor.
* ECOG performance status =2.
* Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade =1.
* Not pregnant and willing to use contraception.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Smoldering multiple myeloma.
* Plasma cell leukemia.
* Amyloidosis.
* POEMS Syndrome.
* Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
* Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection.
* Any other active malignancy within 3 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
* Previous treatment with a BCMA-directed therapy.
* Anti-CD38-directed therapy within 6 months preceding the first dose of treatment in this study.
* Live attenuated vaccine within 4 weeks of the first dose of study intervention.
* Administration with an investigational product (e.g. drug or vaccine) concurrent with study intervention or within 30 days preceding the first dose of study intervention used in this study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2027
Actual
Sample size
Target
761
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Pindara Private Hospital - Benowa
Recruitment hospital [2] 0 0
Gallipoli Medical Research Ltd - Brisbane
Recruitment hospital [3] 0 0
QScan Radiology Clinics - Clayfield
Recruitment hospital [4] 0 0
Gallipoli Medical Research Foundation - Greenslopes
Recruitment hospital [5] 0 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [7] 0 0
Epworth Freemasons - East Melbourne
Recruitment hospital [8] 0 0
St Vincent's Hospital (Melbourne) - Fitzroy
Recruitment hospital [9] 0 0
Barwon Health - Geelong
Recruitment hospital [10] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [11] 0 0
Epworth Healthcare - Richmond
Recruitment hospital [12] 0 0
Slade Pharmacy - Richmond
Recruitment hospital [13] 0 0
Linear Clinical Research - Nedlands
Recruitment hospital [14] 0 0
Linear Clinical Research - Perth
Recruitment postcode(s) [1] 0 0
4217 - Benowa
Recruitment postcode(s) [2] 0 0
4120 - Brisbane
Recruitment postcode(s) [3] 0 0
4011 - Clayfield
Recruitment postcode(s) [4] 0 0
4120 - Greenslopes
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
3002 - East Melbourne
Recruitment postcode(s) [7] 0 0
3065 - Fitzroy
Recruitment postcode(s) [8] 0 0
3220 - Geelong
Recruitment postcode(s) [9] 0 0
3004 - Melbourne
Recruitment postcode(s) [10] 0 0
3121 - Richmond
Recruitment postcode(s) [11] 0 0
6009 - Nedlands
Recruitment postcode(s) [12] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
New Mexico
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Argentina
State/province [9] 0 0
Buenos Aires
Country [10] 0 0
Argentina
State/province [10] 0 0
Santa FE
Country [11] 0 0
Austria
State/province [11] 0 0
Niederösterreich
Country [12] 0 0
Austria
State/province [12] 0 0
Wien
Country [13] 0 0
Austria
State/province [13] 0 0
Innsbruck
Country [14] 0 0
Austria
State/province [14] 0 0
Salzburg
Country [15] 0 0
Belgium
State/province [15] 0 0
Hainaut
Country [16] 0 0
Belgium
State/province [16] 0 0
Namur
Country [17] 0 0
Brazil
State/province [17] 0 0
Bahia
Country [18] 0 0
Brazil
State/province [18] 0 0
RIO Grande DO SUL
Country [19] 0 0
Brazil
State/province [19] 0 0
SP
Country [20] 0 0
Brazil
State/province [20] 0 0
SÃO Paulo
Country [21] 0 0
Brazil
State/province [21] 0 0
Rio de Janeiro
Country [22] 0 0
Brazil
State/province [22] 0 0
São Paulo
Country [23] 0 0
Canada
State/province [23] 0 0
Alberta
Country [24] 0 0
Canada
State/province [24] 0 0
Nova Scotia
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
Canada
State/province [27] 0 0
Saskatchewan
Country [28] 0 0
China
State/province [28] 0 0
Beijing
Country [29] 0 0
China
State/province [29] 0 0
Fujian
Country [30] 0 0
China
State/province [30] 0 0
Guangdong
Country [31] 0 0
China
State/province [31] 0 0
Hebei
Country [32] 0 0
China
State/province [32] 0 0
Heilongjiang
Country [33] 0 0
China
State/province [33] 0 0
Henan
Country [34] 0 0
China
State/province [34] 0 0
Hubei
Country [35] 0 0
China
State/province [35] 0 0
Jiangsu
Country [36] 0 0
China
State/province [36] 0 0
Jiangxi
Country [37] 0 0
China
State/province [37] 0 0
Jilin
Country [38] 0 0
China
State/province [38] 0 0
Shandong
Country [39] 0 0
China
State/province [39] 0 0
Tianjin
Country [40] 0 0
China
State/province [40] 0 0
Zhejiang
Country [41] 0 0
China
State/province [41] 0 0
Chongqing
Country [42] 0 0
China
State/province [42] 0 0
Jinan
Country [43] 0 0
Czechia
State/province [43] 0 0
Brno-m?sto
Country [44] 0 0
Czechia
State/province [44] 0 0
Plzenský KRAJ
Country [45] 0 0
Czechia
State/province [45] 0 0
Praha 2
Country [46] 0 0
Czechia
State/province [46] 0 0
Hradec Kralove
Country [47] 0 0
Czechia
State/province [47] 0 0
Olomouc
Country [48] 0 0
Czechia
State/province [48] 0 0
Ostrava-Poruba
Country [49] 0 0
Finland
State/province [49] 0 0
Pirkanmaa
Country [50] 0 0
Finland
State/province [50] 0 0
Pohjois-pohjanmaa
Country [51] 0 0
Finland
State/province [51] 0 0
Pohjois-savo
Country [52] 0 0
Finland
State/province [52] 0 0
Varsinais-suomi
Country [53] 0 0
Finland
State/province [53] 0 0
Helsinki
Country [54] 0 0
Finland
State/province [54] 0 0
Tampere
Country [55] 0 0
France
State/province [55] 0 0
Aquitaine
Country [56] 0 0
France
State/province [56] 0 0
Limousin
Country [57] 0 0
France
State/province [57] 0 0
Nord
Country [58] 0 0
France
State/province [58] 0 0
Nantes Cedex 1
Country [59] 0 0
France
State/province [59] 0 0
Paris Cedex 12
Country [60] 0 0
France
State/province [60] 0 0
Paris
Country [61] 0 0
France
State/province [61] 0 0
Pierre Benite Cedex
Country [62] 0 0
France
State/province [62] 0 0
Poitiers Cedex
Country [63] 0 0
France
State/province [63] 0 0
Toulouse
Country [64] 0 0
Germany
State/province [64] 0 0
Baden-württemberg
Country [65] 0 0
Germany
State/province [65] 0 0
Bayern
Country [66] 0 0
Germany
State/province [66] 0 0
Nordrhein-westfalen
Country [67] 0 0
Germany
State/province [67] 0 0
Aachen
Country [68] 0 0
Germany
State/province [68] 0 0
Berlin
Country [69] 0 0
Germany
State/province [69] 0 0
Braunschweig
Country [70] 0 0
Germany
State/province [70] 0 0
Chemnitz
Country [71] 0 0
Germany
State/province [71] 0 0
Hamm
Country [72] 0 0
Germany
State/province [72] 0 0
Muenchen
Country [73] 0 0
Greece
State/province [73] 0 0
Attikí
Country [74] 0 0
Greece
State/province [74] 0 0
Kentrikí Makedonía
Country [75] 0 0
Greece
State/province [75] 0 0
Ioannina
Country [76] 0 0
Italy
State/province [76] 0 0
Emilia-romagna
Country [77] 0 0
Italy
State/province [77] 0 0
Liguria
Country [78] 0 0
Italy
State/province [78] 0 0
Lombardia
Country [79] 0 0
Italy
State/province [79] 0 0
Milan
Country [80] 0 0
Italy
State/province [80] 0 0
Sicilia
Country [81] 0 0
Italy
State/province [81] 0 0
Toscana
Country [82] 0 0
Italy
State/province [82] 0 0
Bologna
Country [83] 0 0
Italy
State/province [83] 0 0
Roma
Country [84] 0 0
Japan
State/province [84] 0 0
Aichi
Country [85] 0 0
Japan
State/province [85] 0 0
Fukui
Country [86] 0 0
Japan
State/province [86] 0 0
Gunma
Country [87] 0 0
Japan
State/province [87] 0 0
Iwate
Country [88] 0 0
Japan
State/province [88] 0 0
Miyagi
Country [89] 0 0
Japan
State/province [89] 0 0
Shizuoka
Country [90] 0 0
Japan
State/province [90] 0 0
Tokyo
Country [91] 0 0
Japan
State/province [91] 0 0
Akita
Country [92] 0 0
Japan
State/province [92] 0 0
Fukuoka
Country [93] 0 0
Japan
State/province [93] 0 0
Kagoshima
Country [94] 0 0
Japan
State/province [94] 0 0
Kumamoto
Country [95] 0 0
Japan
State/province [95] 0 0
Nagasaki
Country [96] 0 0
Japan
State/province [96] 0 0
Okayama
Country [97] 0 0
Japan
State/province [97] 0 0
Osaka
Country [98] 0 0
Japan
State/province [98] 0 0
Tokushima
Country [99] 0 0
Japan
State/province [99] 0 0
Yamagata
Country [100] 0 0
Korea, Republic of
State/province [100] 0 0
Gyeonggi-do
Country [101] 0 0
Korea, Republic of
State/province [101] 0 0
Jeonranamdo
Country [102] 0 0
Korea, Republic of
State/province [102] 0 0
Pusan-kwangyokshi
Country [103] 0 0
Korea, Republic of
State/province [103] 0 0
Seoul-teukbyeolsi [seoul]
Country [104] 0 0
Korea, Republic of
State/province [104] 0 0
Taegu-kwangyokshi
Country [105] 0 0
Korea, Republic of
State/province [105] 0 0
Incheon
Country [106] 0 0
Korea, Republic of
State/province [106] 0 0
Seoul
Country [107] 0 0
Mexico
State/province [107] 0 0
México
Country [108] 0 0
Mexico
State/province [108] 0 0
Nuevo LEÓN
Country [109] 0 0
Mexico
State/province [109] 0 0
Oaxaca
Country [110] 0 0
Mexico
State/province [110] 0 0
Veracruz
Country [111] 0 0
Netherlands
State/province [111] 0 0
Zuid-holland
Country [112] 0 0
Netherlands
State/province [112] 0 0
Maastricht
Country [113] 0 0
New Zealand
State/province [113] 0 0
Auckland
Country [114] 0 0
New Zealand
State/province [114] 0 0
Hamilton
Country [115] 0 0
New Zealand
State/province [115] 0 0
Milford, Auckland
Country [116] 0 0
New Zealand
State/province [116] 0 0
Newtown, Wellington
Country [117] 0 0
New Zealand
State/province [117] 0 0
Palmerston North
Country [118] 0 0
New Zealand
State/province [118] 0 0
Roslyn
Country [119] 0 0
New Zealand
State/province [119] 0 0
Takapuna, Auckland
Country [120] 0 0
New Zealand
State/province [120] 0 0
Wellington
Country [121] 0 0
Norway
State/province [121] 0 0
Hordaland
Country [122] 0 0
Norway
State/province [122] 0 0
Rogaland
Country [123] 0 0
Norway
State/province [123] 0 0
Oslo
Country [124] 0 0
Norway
State/province [124] 0 0
Trondheim
Country [125] 0 0
Poland
State/province [125] 0 0
Bydgoszcz
Country [126] 0 0
Poland
State/province [126] 0 0
Gdansk
Country [127] 0 0
Poland
State/province [127] 0 0
Katowice
Country [128] 0 0
Poland
State/province [128] 0 0
Poznan
Country [129] 0 0
Poland
State/province [129] 0 0
Skorzewo
Country [130] 0 0
Poland
State/province [130] 0 0
Warszawa
Country [131] 0 0
Poland
State/province [131] 0 0
Wroclaw
Country [132] 0 0
Spain
State/province [132] 0 0
A Coruna
Country [133] 0 0
Spain
State/province [133] 0 0
Barcelona [barcelona]
Country [134] 0 0
Spain
State/province [134] 0 0
Barcelona
Country [135] 0 0
Spain
State/province [135] 0 0
Cantabria
Country [136] 0 0
Spain
State/province [136] 0 0
Navarra
Country [137] 0 0
Spain
State/province [137] 0 0
Other
Country [138] 0 0
Spain
State/province [138] 0 0
Cordoba
Country [139] 0 0
Spain
State/province [139] 0 0
Girona
Country [140] 0 0
Spain
State/province [140] 0 0
Madrid
Country [141] 0 0
Spain
State/province [141] 0 0
Salamanca
Country [142] 0 0
Spain
State/province [142] 0 0
Sevilla
Country [143] 0 0
Spain
State/province [143] 0 0
Valencia
Country [144] 0 0
Sweden
State/province [144] 0 0
Skåne LÄN [se-12]
Country [145] 0 0
Sweden
State/province [145] 0 0
Borås
Country [146] 0 0
Sweden
State/province [146] 0 0
Falun
Country [147] 0 0
Sweden
State/province [147] 0 0
Göteborg
Country [148] 0 0
Sweden
State/province [148] 0 0
Luleå
Country [149] 0 0
Sweden
State/province [149] 0 0
Örebro LÄN [se-18]
Country [150] 0 0
Sweden
State/province [150] 0 0
Östergötlands LÄN [se-05]
Country [151] 0 0
Taiwan
State/province [151] 0 0
Kaohsiung
Country [152] 0 0
Taiwan
State/province [152] 0 0
Taichung
Country [153] 0 0
Taiwan
State/province [153] 0 0
Tainan
Country [154] 0 0
Taiwan
State/province [154] 0 0
Taipei
Country [155] 0 0
Turkey
State/province [155] 0 0
I?stanbul
Country [156] 0 0
Turkey
State/province [156] 0 0
I?zmir
Country [157] 0 0
Turkey
State/province [157] 0 0
Adana
Country [158] 0 0
Turkey
State/province [158] 0 0
Ankara
Country [159] 0 0
Turkey
State/province [159] 0 0
Antalya
Country [160] 0 0
Turkey
State/province [160] 0 0
Aydin
Country [161] 0 0
Turkey
State/province [161] 0 0
Gaziantep
Country [162] 0 0
Turkey
State/province [162] 0 0
Kayseri
Country [163] 0 0
Turkey
State/province [163] 0 0
Kocaeli
Country [164] 0 0
Turkey
State/province [164] 0 0
Malatya
Country [165] 0 0
United Kingdom
State/province [165] 0 0
Dorset
Country [166] 0 0
United Kingdom
State/province [166] 0 0
Oxfordshire
Country [167] 0 0
United Kingdom
State/province [167] 0 0
South Glamorgan
Country [168] 0 0
United Kingdom
State/province [168] 0 0
Bristol
Country [169] 0 0
United Kingdom
State/province [169] 0 0
Canterbury
Country [170] 0 0
United Kingdom
State/province [170] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate whether the BCMA-CD3 bispecific antibody elranatamab, alone and/or in combination with the anti-CD38 monoclonal antibody, daratumumab, can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone. People with multiple myeloma who have received previous treatment including lenalidomide and a proteasome inhibitor 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 compare the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab compared to daratumumab, pomalidomide, and dexamethasone. Participants in all parts of 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.
Trial website
https://clinicaltrials.gov/study/NCT05020236
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Pfizer
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Contact person for public queries
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Pfizer CT.gov Call Center
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1-800-718-1021
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[email protected]
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05020236