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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05243797




Registration number
NCT05243797
Ethics application status
Date submitted
27/01/2022
Date registered
17/02/2022
Date last updated
22/05/2024

Titles & IDs
Public title
Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation
Scientific title
Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation - MajesTEC-4
Secondary ID [1] 0 0
EMN30/64007957MMY3003
Universal Trial Number (UTN)
Trial acronym
MajesTEC-4
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 - Teclistamab
Treatment: Drugs - Lenalidomide

Experimental: Arm A: Teclistamab-Lenalidomide (Tec-Len) - Teclistamab will be administered via a subcutaneous injection (SC)

Active Comparator: Arm B Lenalidomide Alone (Len) - Lenalidomide orally.

Experimental: Arm C Teclistamab-Alone (Tec) - Teclistamab will be administered via a subcutaneous injection (SC)


Treatment: Drugs: Teclistamab
Teclistamab will be administered via a subcutaneous injection (SC)

Treatment: Drugs: Lenalidomide
Lenalidomide will be administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
from randomization to the date of disease progression or death (approximately up to 8 years)
Secondary outcome [1] 0 0
Comparison of efficacy
Timepoint [1] 0 0
from randomization to the date of disease progression or death (approximately up to 8 years)
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
from the date of from randomization to the date the subject's death, assessed up to 8 years]
Secondary outcome [3] 0 0
Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core module (EORTC QLQ-C30) score and the difference between-treatment arms
Timepoint [3] 0 0
baseline up to 8 years
Secondary outcome [4] 0 0
EQ-5D-5L health utility values and the difference between-treatment arms
Timepoint [4] 0 0
baseline up to 8 years
Secondary outcome [5] 0 0
MySIm-Q Symptom and Impacts in Patients With Multiple Myeloma and the difference between treatment arms
Timepoint [5] 0 0
baseline up to 8 years
Secondary outcome [6] 0 0
PRO-CTCAE to evaluate symptomatic toxicities by self-report and the difference between treatment arms
Timepoint [6] 0 0
baseline up to week 24
Secondary outcome [7] 0 0
PGIS to evaluate the patient global impression of severity of the Multiple Myeloma and the difference between treatment arms
Timepoint [7] 0 0
baseline up to 8 years

Eligibility
Key inclusion criteria
- Must have a new diagnosis of multiple myeloma according to IMWG criteria and have
received induction +/- consolidation.

- Must have received only one line of therapy and achieved at least a partial response
(=PR) as per IMWG 2016 response criteria (Kumar 2016) without evidence of progression
at the time of first treatment dose.

- Must not be intolerant to the starting dose of lenalidomide.

- Must not have received any maintenance therapy.

- Have an ECOG performance status score of 0, 1, or 2 at screening and immediately prior
to the start of administration of study treatment

- Have clinical laboratory values within prespecified range.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Received any prior BCMA-directed therapy.

- Any previous therapy with an immune cell redirecting agent or gene modified adoptive
cell therapy (eg, chimeric antigen receptor modified T cells, NK cells).

- Discontinued treatment due to any AE related to lenalidomide as determined by the
investigator.

- Progressed on multiple myeloma therapy at any time prior to screening.

- Received a cumulative dose of corticosteroids equivalent to =140 mg of prednisone
within the 14 days prior to first treatment dose.

- Received a live, attenuated vaccine within 4 weeks before first treatment dose.
Non-live vaccines or non-replicating authorized for emergency use (eg. COVID-19) are
allowed.

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
8/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2032
Actual
Sample size
Target
1572
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [2] 0 0
Barwon Health - Geelong
Recruitment hospital [3] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
Calvary Mater Hospital - Newcastle
Recruitment hospital [5] 0 0
Concord Hospital - Sydney
Recruitment hospital [6] 0 0
St Vincent's hospital - Sydney
Recruitment hospital [7] 0 0
Townsville Hospital - Townsville
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Geelong
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Newcastle
Recruitment postcode(s) [5] 0 0
- Sydney
Recruitment postcode(s) [6] 0 0
- Townsville
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Belgium
State/province [2] 0 0
Leuven
Country [3] 0 0
Brazil
State/province [3] 0 0
São Paulo
Country [4] 0 0
Czechia
State/province [4] 0 0
Brno
Country [5] 0 0
Czechia
State/province [5] 0 0
Hradec Králové
Country [6] 0 0
Czechia
State/province [6] 0 0
Olomouc
Country [7] 0 0
Czechia
State/province [7] 0 0
Ostrava
Country [8] 0 0
Czechia
State/province [8] 0 0
Pilsen
Country [9] 0 0
Czechia
State/province [9] 0 0
Praha
Country [10] 0 0
Denmark
State/province [10] 0 0
Copenhagen
Country [11] 0 0
Germany
State/province [11] 0 0
Würzburg
Country [12] 0 0
Greece
State/province [12] 0 0
Athens
Country [13] 0 0
Italy
State/province [13] 0 0
Bologna
Country [14] 0 0
Italy
State/province [14] 0 0
Brescia
Country [15] 0 0
Netherlands
State/province [15] 0 0
Amsterdam
Country [16] 0 0
Netherlands
State/province [16] 0 0
Rotterdam
Country [17] 0 0
Norway
State/province [17] 0 0
Oslo
Country [18] 0 0
Serbia
State/province [18] 0 0
Belgrade
Country [19] 0 0
Switzerland
State/province [19] 0 0
Saint Gallen
Country [20] 0 0
Turkey
State/province [20] 0 0
Ankara
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Leeds

Funding & Sponsors
Primary sponsor type
Other
Name
Stichting European Myeloma Network
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Janssen Pharmaceutica
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a multicenter, randomized, open-label, Phase 3 study in participants with newly
diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with
lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after
autologous stem cell transplant.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05243797
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Niels van de Donk, Professor
Address 0 0
Amsterdam UMC, Vrije Universiteit Amsterdam
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sabrin Tahri
Address 0 0
Country 0 0
Phone 0 0
+31 653367481
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05243797