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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05623020




Registration number
NCT05623020
Ethics application status
Date submitted
26/10/2022
Date registered
21/11/2022

Titles & IDs
Public title
A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135), Daratumumab, Lenalidomide or Elranatamab and Lenalidomide Compared With Daratumumab, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant
Scientific title
AN OPEN-LABEL, 2-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) + DARATUMUMAB + LENALIDOMIDE OR ELRANATAMAB + LENALIDOMIDE VERSUS DARATUMUMAB + LENALIDOMIDE + DEXAMETHASONE IN TRANSPLANT-INELIGIBLE PARTICIPANTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
Secondary ID [1] 0 0
2021-000803-20
Secondary ID [2] 0 0
C1071006
Universal Trial Number (UTN)
Trial acronym
MagnetisMM-6
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 - Lenalidomide
Treatment: Drugs - Dexamethasone

Experimental: Part 1, Dose Level 1: Elranatamab + Daratumumab + Lenalidomide -

Experimental: Part 1, Multiple Dose Levels, Elranatamab + Daratumumab + Lenalidomide -

Experimental: Part 2 Randomized Arm A: Elranatamab + Daratumumab + Lenalidomide -

Active comparator: Part 2 Randomized Arm B: Daratumumab + Lenalidomide + Dexamethasone -

Experimental: Part 1: Elranatamab + Lenalidomide -

Experimental: Part 2: Randomized Arm A: Elranatamab + Lenalidomide -


Treatment: Drugs: Elranatamab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.

Treatment: Drugs: Daratumumab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.

Treatment: Drugs: Lenalidomide
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.

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

Outcomes
Primary outcome [1] 0 0
Part 1 Dose Limiting Toxicity
Timepoint [1] 0 0
From the first dose of elranatamab/first full dose in combination with EDR until 28 days (+/- visit window) from the first administration of elranatamab with daratumumab and lenalidomide
Primary outcome [2] 0 0
Part 2: Progression free survival by blinded independent central review
Timepoint [2] 0 0
From randomization up to 79 months.
Primary outcome [3] 0 0
Part 2: Minimal Residual Disease negativity rate
Timepoint [3] 0 0
At 12 months after randomization
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
From date of randomization up to 79 months
Secondary outcome [2] 0 0
Overall minimal residual disease negativity rate
Timepoint [2] 0 0
From date of randomization up to 79 months
Secondary outcome [3] 0 0
Sustained MRD negativity rate (Part 2)
Timepoint [3] 0 0
From date of randomization up to 79 months
Secondary outcome [4] 0 0
Duration of minimal residual disease negativity (Part 2)
Timepoint [4] 0 0
From date of minimal residual disease negative status up to 79 months
Secondary outcome [5] 0 0
PFS by investigator
Timepoint [5] 0 0
From date of randomization up to 79 months
Secondary outcome [6] 0 0
PFS2 by investigator (Part 2)
Timepoint [6] 0 0
From the date of randomization up to 79 months
Secondary outcome [7] 0 0
Objective Response Rate
Timepoint [7] 0 0
From the date of randomization up to 79 months
Secondary outcome [8] 0 0
Complete Response Rate
Timepoint [8] 0 0
From the date of randomization up to 79 months
Secondary outcome [9] 0 0
Time to Response
Timepoint [9] 0 0
From the date of randomization to date of confirmed objective response up to 79 months
Secondary outcome [10] 0 0
Duration of Response
Timepoint [10] 0 0
From the date of confirmed objective response up to 79 months
Secondary outcome [11] 0 0
Duration of Complete Response
Timepoint [11] 0 0
From the date of confirmed complete response up to 79 months
Secondary outcome [12] 0 0
Frequency of treatment-emergent adverse events
Timepoint [12] 0 0
From the date of first dose of study intervention up to 79 months
Secondary outcome [13] 0 0
Frequency of abnormal laboratory results
Timepoint [13] 0 0
From the date of first dose of study intervention up to 79 months
Secondary outcome [14] 0 0
Pharmacokinetics of elranatamab when used in the elranatamab + daratumumab + lenalidomide or elranatamab + lenalidomide combinations
Timepoint [14] 0 0
From date of first dose of study intervention up to 79 months
Secondary outcome [15] 0 0
Incidence of Anti-Drug Antibody and Neutralizing Antibody against elranatamab
Timepoint [15] 0 0
From date of first dose of study intervention up to 79 months
Secondary outcome [16] 0 0
Pharmacokinetics of daratumumab and lenalidomide when used in the elranatamab+daratumumab+lenalidomide or elranatamab+lenalidomide combinations (Part 1)
Timepoint [16] 0 0
From date of first dose of study intervention up to 79 months
Secondary outcome [17] 0 0
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (Part 2)
Timepoint [17] 0 0
From date the informed consent is signed up to 79 months
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 (Part 2)
Timepoint [18] 0 0
From date the informed consent is signed up to 79 months

Eligibility
Key inclusion criteria
* Diagnosis of multiple myeloma (MM) 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;
* Involved FLC =10 mg/dL (=100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
* Part 1: Participants with relapsed/refractory multiple myeloma (RRMM) who have received 1-2 prior lines of therapy including at least one immunomodulatory drug and one proteasome inhibitor: or participants with newly-diagnosed multiple myeloma (NDMM) that are transplant-ineligible as defined by age =65 years or transplant-ineligible as defined by age <65 years with comorbidities impacting the possibility of transplant.
* Part 2: participants with newly-diagnosed multiple myeloma that are transplant-ineligible as defined by age =65 years or transplant-ineligible as defined by age <65 years with comorbidities impacting the possibility of transplant
* ECOG performance status =2.
* Not pregnant and willing to use contraception
* For participants with RRMM: Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade =1.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Smoldering Multiple Myeloma.
* Monoclonal gammopathy of undetermined significance.
* Waldenströms Macroglobulinemia
* Plasma cell leukemia.
* Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) COVID-19/SARS-CoV-2, HBV, HCV, and known HIV or AIDS-related illness.
* Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or Stage 0/1 with minimal risk of recurrence per investigator.
* For participants with RRMM: Previous treatment with a BCMA-directed therapy or anti-CD38-directed therapy within 6 months preceding the first dose of study intervention in this study. Stem cell transplant =3 months prior to first dose of study intervention or active GVHD.
* For participants with NDMM: Previous systemic treatment for MM except for a short course of corticosteroids (ie, up to 4 days of 40 mg dexamethasone or equivalent before the first dose of study intervention).
* Live attenuated vaccine administered within 4 weeks of the first dose of study intervention.
* Administration of investigational product (eg, drug or vaccine) concurrent with study intervention or within 30 days (or as determined by the local requirement) 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
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
10/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/11/2031
Actual
Sample size
Target
1116
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Pindara Private Hospital - Benowa
Recruitment hospital [2] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [3] 0 0
Epworth Freemasons - Melbourne
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [5] 0 0
Epworth Hospital - Richmond
Recruitment postcode(s) [1] 0 0
4217 - Benowa
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
3002 - Melbourne
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Nova Scotia
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Czechia
State/province [3] 0 0
Brno-mesto
Country [4] 0 0
Czechia
State/province [4] 0 0
Moravskoslezský KRAJ
Country [5] 0 0
Czechia
State/province [5] 0 0
Olomouc
Country [6] 0 0
Czechia
State/province [6] 0 0
Praha 2
Country [7] 0 0
France
State/province [7] 0 0
Haute-garonne
Country [8] 0 0
France
State/province [8] 0 0
Vienne
Country [9] 0 0
France
State/province [9] 0 0
Nantes
Country [10] 0 0
Germany
State/province [10] 0 0
Baden-württemberg
Country [11] 0 0
Germany
State/province [11] 0 0
Chemnitz
Country [12] 0 0
Greece
State/province [12] 0 0
Attikí
Country [13] 0 0
Greece
State/province [13] 0 0
Ípeiros
Country [14] 0 0
Israel
State/province [14] 0 0
Hadarom
Country [15] 0 0
Israel
State/province [15] 0 0
Hamerkaz
Country [16] 0 0
Israel
State/province [16] 0 0
Tell Abib
Country [17] 0 0
Israel
State/province [17] 0 0
Yerushalayim
Country [18] 0 0
Italy
State/province [18] 0 0
Emilia-romagna
Country [19] 0 0
Italy
State/province [19] 0 0
FG
Country [20] 0 0
Italy
State/province [20] 0 0
Foggia
Country [21] 0 0
Italy
State/province [21] 0 0
Lombardia
Country [22] 0 0
Italy
State/province [22] 0 0
Piemonte
Country [23] 0 0
Italy
State/province [23] 0 0
Sicilia
Country [24] 0 0
Italy
State/province [24] 0 0
Toscana
Country [25] 0 0
Italy
State/province [25] 0 0
Milano
Country [26] 0 0
Italy
State/province [26] 0 0
Pescara
Country [27] 0 0
Italy
State/province [27] 0 0
Roma
Country [28] 0 0
Japan
State/province [28] 0 0
Fukui
Country [29] 0 0
Japan
State/province [29] 0 0
Gunma
Country [30] 0 0
Japan
State/province [30] 0 0
Iwate
Country [31] 0 0
Japan
State/province [31] 0 0
Miyagi
Country [32] 0 0
Japan
State/province [32] 0 0
Shizuoka
Country [33] 0 0
Japan
State/province [33] 0 0
Tokyo
Country [34] 0 0
Japan
State/province [34] 0 0
Fukuoka
Country [35] 0 0
Japan
State/province [35] 0 0
Okayama
Country [36] 0 0
Japan
State/province [36] 0 0
Osaka
Country [37] 0 0
Japan
State/province [37] 0 0
Yamagata
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Incheon-gwangyeoksi [incheon]
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Jeonranamdo
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Kyonggi-do
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Seoul-teukbyeolsi [seoul]
Country [42] 0 0
Netherlands
State/province [42] 0 0
Zuid-holland
Country [43] 0 0
Poland
State/province [43] 0 0
Dolnoslaskie
Country [44] 0 0
Poland
State/province [44] 0 0
Mazowieckie
Country [45] 0 0
Poland
State/province [45] 0 0
Pomorskie
Country [46] 0 0
Poland
State/province [46] 0 0
Wielkopolskie
Country [47] 0 0
Poland
State/province [47] 0 0
Slaskie
Country [48] 0 0
Spain
State/province [48] 0 0
Barcelona [barcelona]
Country [49] 0 0
Spain
State/province [49] 0 0
Catalunya [cataluña]
Country [50] 0 0
Spain
State/province [50] 0 0
Girona [gerona]
Country [51] 0 0
Spain
State/province [51] 0 0
Madrid, Comunidad DE
Country [52] 0 0
Spain
State/province [52] 0 0
Navarra
Country [53] 0 0
Spain
State/province [53] 0 0
València
Country [54] 0 0
Spain
State/province [54] 0 0
Cáceres
Country [55] 0 0
Spain
State/province [55] 0 0
Madrid
Country [56] 0 0
Taiwan
State/province [56] 0 0
Taichung
Country [57] 0 0
Taiwan
State/province [57] 0 0
Taipei
Country [58] 0 0
Taiwan
State/province [58] 0 0
Taoyuan

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
[email protected]
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/NCT05623020