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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

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
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United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
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United States of America
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Louisiana
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United States of America
State/province [5] 0 0
New Jersey
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United States of America
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New Mexico
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United States of America
State/province [7] 0 0
New York
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United States of America
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Texas
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Argentina
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Buenos Aires
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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
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Belgium
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Namur
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Brazil
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Bahia
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Brazil
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RIO Grande DO SUL
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Brazil
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SP
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Brazil
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SÃO Paulo
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Brazil
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Rio de Janeiro
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Brazil
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São Paulo
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Canada
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Alberta
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Nova Scotia
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Ontario
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Quebec
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Saskatchewan
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Beijing
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Fujian
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Guangdong
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China
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Hebei
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Heilongjiang
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China
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Henan
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China
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Hubei
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China
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Jiangsu
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China
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Jiangxi
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China
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Jilin
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China
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Shandong
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China
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Tianjin
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China
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Zhejiang
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Chongqing
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China
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Jinan
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Czechia
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Brno-m?sto
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Plzenský KRAJ
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Praha 2
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Hradec Kralove
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Olomouc
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Aquitaine
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Limousin
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Paris Cedex 12
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Paris
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Pierre Benite Cedex
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Poitiers Cedex
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Toulouse
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Germany
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Baden-württemberg
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Germany
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Bayern
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Germany
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Nordrhein-westfalen
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Germany
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Aachen
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Germany
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Berlin
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Germany
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Braunschweig
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Germany
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Chemnitz
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Germany
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Hamm
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Germany
State/province [72] 0 0
Muenchen
Country [73] 0 0
Greece
State/province [73] 0 0
Attikí
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Greece
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Kentrikí Makedonía
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Greece
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Ioannina
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Italy
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Emilia-romagna
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Italy
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Liguria
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Italy
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Lombardia
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Italy
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Milan
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Italy
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Sicilia
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Italy
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Toscana
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Italy
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Bologna
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Italy
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Roma
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Japan
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Aichi
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Japan
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Fukui
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Japan
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Gunma
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Iwate
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Miyagi
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Shizuoka
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Japan
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Tokyo
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Japan
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Akita
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Japan
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Fukuoka
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Japan
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Kagoshima
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Japan
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Kumamoto
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Japan
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Nagasaki
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Okayama
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Osaka
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Tokushima
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Yamagata
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Jeonranamdo
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Korea, Republic of
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Pusan-kwangyokshi
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Korea, Republic of
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Seoul-teukbyeolsi [seoul]
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Korea, Republic of
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Taegu-kwangyokshi
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Mexico
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México
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Mexico
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Nuevo LEÓN
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Mexico
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Oaxaca
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Mexico
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Veracruz
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Netherlands
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Zuid-holland
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Netherlands
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Maastricht
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New Zealand
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Auckland
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New Zealand
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Hamilton
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New Zealand
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Milford, Auckland
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New Zealand
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Newtown, Wellington
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New Zealand
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Palmerston North
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New Zealand
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Roslyn
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New Zealand
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Takapuna, Auckland
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New Zealand
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Wellington
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Norway
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Hordaland
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Norway
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Rogaland
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Norway
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Oslo
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Norway
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Trondheim
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Poland
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Bydgoszcz
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Poland
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Gdansk
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Poland
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Katowice
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Poznan
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Poland
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Skorzewo
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Warszawa
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Poland
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Wroclaw
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Spain
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A Coruna
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Spain
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Barcelona [barcelona]
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Spain
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Barcelona
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Spain
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Cantabria
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Spain
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Navarra
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Spain
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Other
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Spain
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Cordoba
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Spain
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Girona
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Madrid
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Salamanca
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Sevilla
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Spain
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Valencia
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Sweden
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Skåne LÄN [se-12]
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Sweden
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Borås
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Sweden
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Falun
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Sweden
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Göteborg
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Sweden
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Luleå
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Sweden
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Örebro LÄN [se-18]
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Sweden
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Östergötlands LÄN [se-05]
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Turkey
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I?stanbul
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Turkey
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I?zmir
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Antalya
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Turkey
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Aydin
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Turkey
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Gaziantep
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Turkey
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Kayseri
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Turkey
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Kocaeli
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Turkey
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Malatya
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United Kingdom
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Dorset
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United Kingdom
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Oxfordshire
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United Kingdom
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South Glamorgan
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United Kingdom
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Bristol
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United Kingdom
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Canterbury
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United Kingdom
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Manchester

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
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Pfizer CT.gov Call Center
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1-800-718-1021
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05020236