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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05572515




Registration number
NCT05572515
Ethics application status
Date submitted
5/10/2022
Date registered
7/10/2022

Titles & IDs
Public title
A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma
Scientific title
A Phase 3 Randomized Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide
Secondary ID [1] 0 0
64007957MMY3006
Secondary ID [2] 0 0
CR109244
Universal Trial Number (UTN)
Trial acronym
MajesTEC-9
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed or Refractory Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Teclistamab
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Bortezomib
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Carfilzomib

Experimental: Teclistamab - Participants will receive teclistamab monotherapy.

Experimental: Pomalidomide, Bortezomib and Dexamethasone (PVd) or Carfilzomib and Dexamethasone (Kd) - Participants will receive either PVd or Kd based on principal investigator's choice.


Treatment: Drugs: Teclistamab
Teclistamab will be administered subcutaneously.

Treatment: Drugs: Pomalidomide
Pomalidomide will be administered orally.

Treatment: Drugs: Bortezomib
Bortezomib will be administered subcutaneously.

Treatment: Drugs: Dexamethasone
Dexamethasone will be administered orally in PVd and intravenously or orally in Kd.

Treatment: Drugs: Carfilzomib
Carfilzomib will be administered intravenously.
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
Up to 9 years
Secondary outcome [1] 0 0
Overall Response (Partial Response [PR] or Better)
Timepoint [1] 0 0
Up to 9 years
Secondary outcome [2] 0 0
Very Good Partial Response (VGPR) or Better Response
Timepoint [2] 0 0
Up to 9 years
Secondary outcome [3] 0 0
Complete Response (CR) or Better Response
Timepoint [3] 0 0
Up to 9 years
Secondary outcome [4] 0 0
Duration of Response (DOR)
Timepoint [4] 0 0
Up to 9 years
Secondary outcome [5] 0 0
Time to Next Treatment (TTNT)
Timepoint [5] 0 0
Up to 9 years
Secondary outcome [6] 0 0
Progression-free Survival on Next-line Therapy (PFS2)
Timepoint [6] 0 0
Up to 9 years
Secondary outcome [7] 0 0
Overall Survival (OS)
Timepoint [7] 0 0
Up to 9 years
Secondary outcome [8] 0 0
Number of Participants with Adverse Events (AEs) by Severity
Timepoint [8] 0 0
Up to 9 years
Secondary outcome [9] 0 0
Number of Participants with Serious Adverse Events (SAEs) by Severity
Timepoint [9] 0 0
Up to 9 years
Secondary outcome [10] 0 0
Number of Participants with Abnormal Laboratory Results
Timepoint [10] 0 0
Up to 9 years
Secondary outcome [11] 0 0
Serum Concentrations of Teclistamab
Timepoint [11] 0 0
Up to 9 years
Secondary outcome [12] 0 0
Number of Participants with Anti-drug Antibodies (ADAs) to Teclistamab
Timepoint [12] 0 0
Up to 9 years
Secondary outcome [13] 0 0
Change from Baseline in Symptoms, Functioning, and Overall Health-related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30)
Timepoint [13] 0 0
Baseline up to 9 years
Secondary outcome [14] 0 0
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Score
Timepoint [14] 0 0
Baseline up to 9 years
Secondary outcome [15] 0 0
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Timepoint [15] 0 0
Baseline up to 6 months
Secondary outcome [16] 0 0
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
Timepoint [16] 0 0
Baseline up to 9 years
Secondary outcome [17] 0 0
Time to Worsening in Symptoms, Functioning, and Overall HRQoL
Timepoint [17] 0 0
Up to 9 years
Secondary outcome [18] 0 0
PFS in Participants in High-risk Molecular Features
Timepoint [18] 0 0
Up to 9 years
Secondary outcome [19] 0 0
Depth of Response in Participants in High-risk Molecular Features
Timepoint [19] 0 0
Up to 9 years

Eligibility
Key inclusion criteria
* Documented diagnosis of multiple myeloma as defined by the criteria below: (a)Multiple myeloma diagnosis according to International Myeloma Working Group (IMWG) diagnostic criteria (b) Measurable disease at screening as defined by any of the following: (1) Serum M-protein level greater than or equal to (>=)0.5 grams per deciliter (g/dL) (central laboratory); or (2) Urine M-protein level >=200 milligrams (mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain >=10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio
* Received 1 to 3 prior lines of antimyeloma therapy including a minimum of 2 consecutive cycles of an anti- cluster of differentiation 38 (CD38) monoclonal antibody at the approved dosing regimen in any prior line and 2 consecutive cycles of lenalidomide in any prior line
* Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by International myeloma working group (IMWG) criteria
* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
* A female participant must agree not to be pregnant, breast-feeding, or plan to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
* Must be willing and able to adhere to the lifestyle restrictions specified in this protocol
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Received any prior B cell maturation antigen (BCMA)-directed therapy
* A participant is not eligible to receive PVd as control therapy if any of the following are present: (1) Received prior pomalidomide therapy, (2) Does not meet criteria for bortezomib retreatment (3) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide or bortezomib, (4) Grade 1 peripheral neuropathy with pain or Grade greater than or equal to (>=) 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, (5) Received a strong cytochrome P (CYP) 3A4 inducer within 5 half-lives prior to randomization; A participant is not eligible to receive Kd as control therapy if any of the following are present:(1) Received prior carfilzomib therapy, (2) Uncontrolled hypertension, defined as an average systolic blood pressure greater than (>)159 millimeters of mercury (mmHg) or diastolic blood pressure >99 mmHg despite optimal treatment (3) Grade 2 peripheral neuropathy with pain or Grade >=3 peripheral neuropathy as defined by NCI-CTCAE Version 5.0, (4) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to carfilzomib (intolerance defined as prior therapy discontinued due to any adverse event [AE] related to carfilzomib)
* Central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma.
* Received a live, attenuated vaccine within 4 weeks before randomization
* Plasma cell leukemia at the time of screening, Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein (POEMS) syndrome and skin changes, or primary amyloid light chain amyloidosis
* Received a maximum cumulative dose of corticosteroids of >=140 mg of prednisone or equivalent within 14 days prior to randomization

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
29/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/08/2031
Actual
Sample size
Target
590
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [3] 0 0
Box Hill Hospital - Melbourne
Recruitment hospital [4] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [5] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
3128 - Melbourne
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alaska
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United States of America
State/province [2] 0 0
California
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Connecticut
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Utah
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Virginia
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Salzburg
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Brasschaat
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Haine-St-Paul
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Kortrijk
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Leuven
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Liege
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Natal
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Hospitalet de Llobregat
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Leon
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Pontevedra
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València
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Sweden
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Uppsala
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Aberdeen
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Birmingham
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Colchester
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Liverpool
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London
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Middlesborough
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Norwich
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Staffordshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
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?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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.janssen.com/clinical-trials/transparency


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/NCT05572515