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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05317416
Registration number
NCT05317416
Ethics application status
Date submitted
18/03/2022
Date registered
7/04/2022
Titles & IDs
Public title
Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant
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Scientific title
A RANDOMIZED, 2-ARM, PHASE 3 STUDY OF ELRANATAMAB (PF-06863135) VERSUS LENALIDOMIDE IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA AFTER UNDERGOING AUTOLOGOUS STEM-CELL TRANSPLANTATION
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Secondary ID [1]
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2021-006052-14
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Secondary ID [2]
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C1071007
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Universal Trial Number (UTN)
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Trial acronym
MagnetisMM-7
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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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0
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Elranatamab
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Elranatamab
Experimental: Arm A - Part 1 - Elranatamab
Active comparator: Arm B - Part 1 - Lenalidomide
Active comparator: Arm B - Part 2 - Lenalidomide
Experimental: Arm C - Part 2 - Elranatamab
Treatment: Drugs: Elranatamab
BCMA-CD3 bispecific antibody
Treatment: Drugs: Lenalidomide
Immunomodulatory drug
Treatment: Drugs: Lenalidomide
Immunomodulatory drug
Treatment: Drugs: Elranatamab
BCMA-CD3 bispecific antibody
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Intervention code [1]
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0
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
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Assessment method [1]
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Progression Free Survival assessed by Blinded Independent Central review per IMWG response criteria
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Timepoint [1]
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Assessed for 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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Defined as the time from randomization until death due to any cause
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Timepoint [1]
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Assessed for up to approximately 5 years
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Secondary outcome [2]
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Minimal Residual Disease negativity rate
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Assessment method [2]
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Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing
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Timepoint [2]
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12 months after randomization
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Secondary outcome [3]
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0
Sustained MRD negativity rate
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Assessment method [3]
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Sustained Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing
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Timepoint [3]
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0
24 months after randomization
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Secondary outcome [4]
0
0
Progression Free Survival
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Assessment method [4]
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Progression Free Survival by investigator per IMWG response criteria
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Timepoint [4]
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0
Assessed for up to approximately 5 years
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Secondary outcome [5]
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Overall minimal residual disease negativity rate
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Assessment method [5]
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Minimal residual disease negativity rate per IMWG criteria
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Timepoint [5]
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0
Assessed for up to approximately 5 years
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Secondary outcome [6]
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Duration of minimal residual disease negativity
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Assessment method [6]
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Minimal residual disease negativity per IMWG criteria
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Timepoint [6]
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0
Assessed for up to approximately 5 years
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Secondary outcome [7]
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Sustained minimal residual disease negativity rate
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Assessment method [7]
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Minimal residual disease negativity per IMWG criteria that has lasted a minimum of 12 months
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Timepoint [7]
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Assessed for up to approximately 5 years
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Secondary outcome [8]
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Complete response rate
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Assessment method [8]
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Complete response rate by blinded independent central review and by investigator per IMWG criteria
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Timepoint [8]
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Assessed for up to approximately 5 years
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Secondary outcome [9]
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Duration of complete response
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Assessment method [9]
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Duration of complete response by blinded independent central review and by investigator per IMWG criteria
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Timepoint [9]
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Assessed for up to approximately 5 years
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Secondary outcome [10]
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Frequency of adverse events
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Assessment method [10]
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Adverse event as characterized by type, frequency, severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5, seriousness and relationship to the study intervention
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Timepoint [10]
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Up to 90 days after last dose
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Secondary outcome [11]
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Frequency of laboratory abnormalities
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Assessment method [11]
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0
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Timepoint [11]
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Assessed for up to approximately 5 years
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Secondary outcome [12]
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Pre-dose concentrations of elranatamab
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Assessment method [12]
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Pharmacokinetics of elranatamab (trough concentrations of elranatamab)
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Timepoint [12]
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Assessed for up to approximately 5 years
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Secondary outcome [13]
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Post-dose concentrations of elranatamab
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Assessment method [13]
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Pharmacokinetics of elranatamab (Post-dose serum concentrations of elranatamab)"
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Timepoint [13]
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Assessed for up to approximately 5 years
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Secondary outcome [14]
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Incidence and titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab
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Assessment method [14]
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Immunogenicity of elranatamab
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Timepoint [14]
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Assessed for up to approximately 5 years
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Secondary outcome [15]
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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 [15]
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Higher scores on the functional scales represent higher levels of functioning. Higher scores on the global health status/quality of life scale represent higher health status/quality of life. Higher scores on symptom scales/items represent a greater presence of symptoms
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Timepoint [15]
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0
Assessed for up to approximately 5 years
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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 - Myeloma 20
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Assessment method [16]
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Higher scores on the functioning subscales (body image, future perspective) represent higher levels of functioning, whereas higher scores on the symptom subscales (disease symptoms, side effects) represent a greater presence of symptoms
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Timepoint [16]
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Assessed for up to approximately 5 years
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Secondary outcome [17]
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Progression Free Survival 2
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Assessment method [17]
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Progression Free Survival to the date of second objective disease progression by investigator per IMWG response criteria
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Timepoint [17]
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Assessed for up to approximately 5 years
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Eligibility
Key inclusion criteria
* Diagnosis of MM as defined according to IMWG criteria (Rajkumar, 2014) with measurable disease at diagnosis
* Part 1 patients must be MRD positive, Part 2 patients can be MRD negative or MRD positive
* History of induction therapy for newly diagnosed MM, followed by high dose therapy and autologous stem cell transplant. Randomization must occur within 120 days from the stem cell transplant. For participants who receive consolidation therapy after ASCT, randomization must occur within 60 days of consolidation and within 7 months from ASCT.
* Partial Response or better according to IMWG criteria at the time of randomization
* Must have an archival bone marrow aspirate sample(s) to identify the dominant malignant (index) clone by central laboratory NGS test (ClonoSEQ assay) that is used to track MRD status. This sample should preferably be collected before induction treatment (eg, at diagnosis) or before transplant.
* ECOG performance status =1
* Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade = 1
* Not pregnant 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
* Plasma cell leukemia
* Amyloidosis, Waldenström's macroglobulinemia
* POEMS syndrome
* Known active CNS involvement or clinical signs of myelomatous meningeal involvement
* Previous MM maintenance treatment
* Prior treatment with BCMA targeted therapy
* Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
* Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, and known HIV or AIDS-related illness
* Previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
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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
25/03/2022
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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
31/10/2029
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Actual
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Sample size
Target
760
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Pindara Private Hospital - Benowa
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Recruitment hospital [2]
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QScan Radiology Clinics - Clayfield
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Recruitment hospital [3]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [4]
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Epworth Healthcare - East Melbourne
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Recruitment hospital [5]
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Precision Haematology - East Melbourne
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Recruitment hospital [6]
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St Vincent's Hospital (Melbourne) - Fitzroy
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Recruitment hospital [7]
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Slade Pharmacy - Richmond
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Recruitment postcode(s) [1]
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4217 - Benowa
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Recruitment postcode(s) [2]
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4011 - Clayfield
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Recruitment postcode(s) [3]
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4102 - Woolloongabba
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Recruitment postcode(s) [4]
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3002 - East Melbourne
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Recruitment postcode(s) [5]
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3065 - Fitzroy
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Recruitment postcode(s) [6]
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3121 - Richmond
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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United States of America
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California
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Kansas
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Michigan
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United States of America
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Mississippi
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United States of America
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Ohio
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United States of America
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Texas
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Austria
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Wien
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Austria
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Vienna
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Belgium
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Bruxelles-capitale, Région DE
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Belgium
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Hainaut
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Belgium
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Namur
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Belgium
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Antwerpen
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Belgium
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Brussel
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Bahia
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Brazil
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RIO Grande DO SUL
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SÃO Paulo
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Jaú
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Rio de Janeiro
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China
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China
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Olomouc
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Vienne
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La Tronche
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Lille
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France
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Paris Cedex 12
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France
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Pierre Benite
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France
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Tours
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Sachsen
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Chemnitz
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Essen
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Debrecen
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Haryana
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Tamil NADU
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Hadarom
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Israel
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Hatsafon
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Tell Abib
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Yerushalayim
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Israel
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Jerusalem
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Lazio
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Gunma
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Iwate
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Kyoto
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Miyagi
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Shizuoka
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Kagoshima
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Kumamoto
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Okayama
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Osaka
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Tokyo
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Yamagata
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Korea, Republic of
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Incheon-gwangyeoksi [incheon]
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Korea, Republic of
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Jeonranamdo
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Korea, Republic of
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Kyonggi-do
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Korea, Republic of
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Netherlands
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Maastricht
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Zwolle
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Hordaland
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Norway
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Oslo
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Norway
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Stavanger
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Wielkopolskie
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Gdansk
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Poznan
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Warszawa
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Wroclaw
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Poland
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Slaskie
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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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Castilla Y LEÓN
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Catalunya [cataluña]
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Spain
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Madrid, Comunidad DE
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Spain
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Madrid
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Spain
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Navarra
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Gerona
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Salamanca
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València
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Sweden
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Skåne LÄN [se-12]
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Sweden
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Stockholms LÄN [se-01]
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Sweden
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Sweden
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Falun
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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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Switzerland
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Winterthur
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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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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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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Kayseri
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Turkey
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Kocaeli
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United Kingdom
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Glasgow
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years
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Trial website
https://clinicaltrials.gov/study/NCT05317416
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Public notes
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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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0
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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
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
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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/NCT05317416