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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06152575
Registration number
NCT06152575
Ethics application status
Date submitted
17/11/2023
Date registered
30/11/2023
Date last updated
2/07/2025
Titles & IDs
Public title
MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)
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Scientific title
A PHASE 3, OPEN-LABEL STUDY OF ELRANATAMAB MONOTHERAPY VERSUS ELOTUZUMAB, POMALIDOMIDE, DEXAMETHASONE (EPd) OR POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE (PVd) OR CARFILZOMIB, DEXAMETHASONE (Kd) IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO RECEIVED PRIOR ANTI-CD38 DIRECTED THERAPY
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Secondary ID [1]
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2023-507871-23-00
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Secondary ID [2]
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C1071032
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
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Condition category
Condition code
Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Elranatamab
Treatment: Drugs - Elotuzumab
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Bortezomib
Treatment: Drugs - Carfilzomib
Experimental: Elranatamab - Participants will receive elranatamab monotherapy
Active comparator: Investigator's Choice - Participants will receive either Elotuzumab, Pomalidomide and Dexamethasone (EPd), or Pomalidomide, Bortezomib and Dexamethasone (PVd), or Carfilzomib and Dexamethasone (Kd)
Treatment: Drugs: Elranatamab
Elranatamab will be administered subcutaneously
Treatment: Drugs: Elotuzumab
Elotuzumab will be administered intravenously
Treatment: Drugs: Pomalidomide
Pomalidomide will be administered orally
Treatment: Drugs: Dexamethasone
Dexamethasone will be administered orally
Treatment: Drugs: Bortezomib
Bortezomib will be administered subcutaneously or intravenously
Treatment: Drugs: Carfilzomib
Carfilzomib will be administered intravenously
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression free survival per International Myeloma Working Group criteria
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Assessment method [1]
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From date of randomization to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first
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Timepoint [1]
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Up to approximately 5 years
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Secondary outcome [1]
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Overall survival
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Assessment method [1]
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From date of randomization to date of discontinuation from study, death, or censoring, whichever occurs first
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Timepoint [1]
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Up to approximately 5 years
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Secondary outcome [2]
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Progression free survival on next-line treatment per International Myeloma Working Group criteria
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Assessment method [2]
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From date of randomization to date of second objective disease progression, discontinuation from the study, death, or censoring, whichever occurs first
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Timepoint [2]
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0
Up to approximately 5 years
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Secondary outcome [3]
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Objective response rate per International Myeloma Working Group criteria
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Assessment method [3]
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0
From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy
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Timepoint [3]
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0
Up to approximately 5 years
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Secondary outcome [4]
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Duration of response per International Myeloma Working Group criteria
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Assessment method [4]
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From date of confirmed objective response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first
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Timepoint [4]
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0
Up to approximately 5 years
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Secondary outcome [5]
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Very good partial response or better response rate per International Myeloma Working Group criteria
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Assessment method [5]
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0
From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first
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Timepoint [5]
0
0
Up to approximately 5 years
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Secondary outcome [6]
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Complete response rate per International Myeloma Working Group criteria
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Assessment method [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
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Timepoint [6]
0
0
Up to approximately 5 years
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Secondary outcome [7]
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Duration of complete response per International Myeloma Working Group criteria
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Assessment method [7]
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0
From date of confirmed complete response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first
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Timepoint [7]
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Up to approximately 5 years
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Secondary outcome [8]
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Time to response per International Myeloma Working Group criteria
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Assessment method [8]
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From date of randomization to date of confirmed objective response
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Timepoint [8]
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Up to approximately 5 years
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Secondary outcome [9]
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Minimal residual disease negativity rate per International Myeloma Working Group criteria
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Assessment method [9]
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From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first
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Timepoint [9]
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0
Up to approximately 5 years
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Secondary outcome [10]
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Sustained minimal residual disease negativity rate per International Myeloma Working Group criteria
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Assessment method [10]
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From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first
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Timepoint [10]
0
0
Up to approximately 5 years
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Secondary outcome [11]
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0
Duration of minimal residual disease negativity rate per International Myeloma Working Group criteria
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Assessment method [11]
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0
From date of minimal residual disease negativity to date of relapse, death, or censoring, whichever occurs first
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Timepoint [11]
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Up to approximately 5 years
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Secondary outcome [12]
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Frequency of treatment-emergent adverse events
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Assessment method [12]
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0
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Timepoint [12]
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From date of first dose of study intervention up to 90 days after last study intervention administration
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Secondary outcome [13]
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Frequency of abnormal laboratory results
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Assessment method [13]
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0
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Timepoint [13]
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From date of first dose of study intervention up to 90 days after last study intervention administration
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Secondary outcome [14]
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Free elranatamab serum trough concentration [Ctrough]
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Assessment method [14]
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0
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Timepoint [14]
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From date of first dose of elranatamab up to approximately 14 days after last dose of elranatamab
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Secondary outcome [15]
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Elranatamab immunogenicity by anti-drug antibodies against elranatamab
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Assessment method [15]
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0
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Timepoint [15]
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From date of first dose of elranatamab up to approximately 14 days after last dose of elranatamab
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Secondary outcome [16]
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Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30
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Assessment method [16]
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Change from baseline scores
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Timepoint [16]
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From date of informed consent up to approximately 35 days after last administration of study intervention
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Secondary outcome [17]
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Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20
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Assessment method [17]
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Change from baseline scores
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Timepoint [17]
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From date of informed consent up to approximately 35 days after last administration of study intervention
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Eligibility
Key inclusion criteria
* Prior diagnosis of multiple myeloma as defined by International Myeloma Working Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy including prior anti-cluster of differentiation 38 (CD38) antibody and prior lenalidomide.
* Documented evidence of progressive disease or failure to achieve a response to last line of therapy per IMWG criteria.
* Measurable disease defined as at least 1 of the following: (a) Serum M-protein =0.5 g/dL; (b) Urinary M-protein excretion =200 mg/24 hours; (c) Serum involved immunoglobulin FLC =10 mg/dL AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
* Have clinical laboratory values within the specified range.
* ECOG (Eastern Cooperative Oncology Group) performance status =2.
* Not pregnant or breastfeeding and willing to use contraception.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Smoldering multiple myeloma.
* Plasma cell leukemia.
* Amyloidosis.
* Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin abnormalities (POEMS) syndrome.
* Known central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement.
* Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
* Any active, uncontrolled bacterial, fungal, or viral infection.
* Any other active malignancy within 3 years prior to enrolment (exceptions include, adequately treated basal cell or squamous cell skin cancer, carcinoma in situ)
* Previous treatment with a B cell maturation antigen (BCMA)-directed therapy or CD3-redirecting therapy.
* Unable to receive investigator's choice therapy.
* Live attenuated vaccine within 4 weeks of the first dose of study intervention.
* Administration with an investigational product (e.g. drug or vaccine) within 30 days preceding the first dose of study intervention used in this study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/02/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/12/2027
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Actual
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Sample size
Target
492
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Blacktown Hospital - Blacktown
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Recruitment hospital [2]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [3]
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Sunshine Coast University Hospital - Birtinya
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Recruitment hospital [4]
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St Vincent's Hospital (Melbourne) - Fitzroy
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Recruitment hospital [5]
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Barwon Health - Geelong
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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2139 - Concord
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Recruitment postcode(s) [3]
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4575 - Birtinya
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Recruitment postcode(s) [4]
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3065 - Fitzroy
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Recruitment postcode(s) [5]
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3220 - Geelong
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Recruitment outside Australia
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Kagoshima
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Japan
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Kyoto
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Japan
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Limburg
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Akershus
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Sør-trøndelag
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Martin
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PAÍS Vasco
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Spain
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Madrid
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Taichung
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United Kingdom
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Dorset
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EAST Sussex
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United Kingdom
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England
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Kent
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United Kingdom
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London, CITY OF
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United Kingdom
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Oxfordshire
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United Kingdom
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United Kingdom
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Sutton
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Canterbury
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United Kingdom
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Summary
Brief summary
The purpose of this study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer). This study is seeking participants who: * Are 18 years of age or older and have MM. * Have received treatments before for MM. * Have MM that has returned or not responded to their most recent treatment. Half of the participants will receive elranatamab. The other half of participants will receive a combination therapy selected by the study doctor. The selected combination therapy will include 2 to 3 different medicines commonly used to treat MM. Elranatamab will be given as a shot under the skin at the study clinic about once a week. This may change to a smaller number of shots later in the study. The medicines in the combination therapy will be taken by mouth (at home or at the study clinic) AND will be given either as: * a shot under the skin at the study clinic * through a needle in the vein at the study clinic The number of times these medicines will be taken depends on what combination therapy the study doctor selects. Participants may continue to receive elranatamab or a combination therapy until their MM is no longer responding. The study team will see how each participant is doing with the study treatment during regular visits at the study clinic. The study team will continue to follow-up with participants after study treatment with telephone contacts (or visits). The study will compare the experiences of people receiving elranatamab to those people receiving a combination therapy. This will help learn about the safety and how effective elranatamab is.
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Trial website
https://clinicaltrials.gov/study/NCT06152575
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Contacts
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Pfizer CT.gov Call Center
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Pfizer
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Pfizer CT.gov Call Center
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Phone
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1-800-718-1021
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[email protected]
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Contact person for scientific queries
Data sharing statement
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/NCT06152575
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