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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
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
Secondary ID [1] 0 0
2021-006052-14
Secondary ID [2] 0 0
C1071007
Universal Trial Number (UTN)
Trial acronym
MagnetisMM-7
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 - 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival
Timepoint [1] 0 0
Assessed for up to approximately 5 years
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Assessed for up to approximately 5 years
Secondary outcome [2] 0 0
Minimal Residual Disease negativity rate
Timepoint [2] 0 0
12 months after randomization
Secondary outcome [3] 0 0
Sustained MRD negativity rate
Timepoint [3] 0 0
24 months after randomization
Secondary outcome [4] 0 0
Progression Free Survival
Timepoint [4] 0 0
Assessed for up to approximately 5 years
Secondary outcome [5] 0 0
Overall minimal residual disease negativity rate
Timepoint [5] 0 0
Assessed for up to approximately 5 years
Secondary outcome [6] 0 0
Duration of minimal residual disease negativity
Timepoint [6] 0 0
Assessed for up to approximately 5 years
Secondary outcome [7] 0 0
Sustained minimal residual disease negativity rate
Timepoint [7] 0 0
Assessed for up to approximately 5 years
Secondary outcome [8] 0 0
Complete response rate
Timepoint [8] 0 0
Assessed for up to approximately 5 years
Secondary outcome [9] 0 0
Duration of complete response
Timepoint [9] 0 0
Assessed for up to approximately 5 years
Secondary outcome [10] 0 0
Frequency of adverse events
Timepoint [10] 0 0
Up to 90 days after last dose
Secondary outcome [11] 0 0
Frequency of laboratory abnormalities
Timepoint [11] 0 0
Assessed for up to approximately 5 years
Secondary outcome [12] 0 0
Pre-dose concentrations of elranatamab
Timepoint [12] 0 0
Assessed for up to approximately 5 years
Secondary outcome [13] 0 0
Post-dose concentrations of elranatamab
Timepoint [13] 0 0
Assessed for up to approximately 5 years
Secondary outcome [14] 0 0
Incidence and titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab
Timepoint [14] 0 0
Assessed for up to approximately 5 years
Secondary outcome [15] 0 0
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30
Timepoint [15] 0 0
Assessed for up to approximately 5 years
Secondary outcome [16] 0 0
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20
Timepoint [16] 0 0
Assessed for up to approximately 5 years
Secondary outcome [17] 0 0
Progression Free Survival 2
Timepoint [17] 0 0
Assessed for up to approximately 5 years

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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)

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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
25/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2029
Actual
Sample size
Target
760
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Shoalhaven District Memorial Hospital - Nowra
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [5] 0 0
Pindara Private Hospital - Benowa
Recruitment hospital [6] 0 0
QScan Radiology Clinics - Clayfield
Recruitment hospital [7] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [8] 0 0
Epworth Healthcare - East Melbourne
Recruitment hospital [9] 0 0
Precision Haematology - East Melbourne
Recruitment hospital [10] 0 0
St Vincent's Hospital (Melbourne) - Fitzroy
Recruitment hospital [11] 0 0
Slade Pharmacy - Richmond
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2541 - Nowra
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
4217 - Benowa
Recruitment postcode(s) [6] 0 0
4011 - Clayfield
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 0 0
3002 - East Melbourne
Recruitment postcode(s) [9] 0 0
3065 - Fitzroy
Recruitment postcode(s) [10] 0 0
3121 - Richmond
Recruitment outside Australia
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United States of America
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Arizona
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Vienna
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Hainaut
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Namur
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Bahia
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Yamagata
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Jeonranamdo
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Östergötlands LÄN [se-05]
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Switzerland
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Zürich (DE)
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Switzerland
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Baden
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Berne
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Winterthur
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Taoyuan
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I?stanbul
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Belfast
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Reading
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Wolverhampton

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
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Country 0 0
Phone 0 0
1-800-718-1021
Fax 0 0
Email 0 0
ClinicalTrials.gov_Inquiries@pfizer.com
Contact person for scientific queries

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/NCT05317416