Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04722146




Registration number
NCT04722146
Ethics application status
Date submitted
20/01/2021
Date registered
25/01/2021

Titles & IDs
Public title
A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma
Scientific title
A Multi-arm Phase 1b Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma
Secondary ID [1] 0 0
2020-004404-33
Secondary ID [2] 0 0
CR108927
Universal Trial Number (UTN)
Trial acronym
MajesTEC-2
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 - Daratumumab
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Bortezomib
Treatment: Drugs - Nirogacestat

Experimental: Treatment Regimen A: Teclistamab + Daratumumab + Pomalidomide - Participants will receive teclistamab plus daratumumab plus pomalidomide.

Experimental: Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (21-day Cycles) - Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 21-day cycles.

Experimental: Treatment Regimen C: Teclistamab + Nirogacestat - Participants will receive teclistamab plus nirogacestat.

Experimental: Treatment Regimen D: Teclistamab + Lenalidomide - Participants will receive teclistamab plus lenalidomide.

Experimental: Treatment Regimen E: Teclistamab + Daratumumab + Lenalidomide - Participants will receive teclistamab plus daratumumab plus lenalidomide.

Experimental: Treatment Regimen F: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (28-day Cycles) - Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 28-day cycles.


Treatment: Drugs: Teclistamab
Participants will receive teclistamab.

Treatment: Drugs: Daratumumab
Participants will receive daratumumab.

Treatment: Drugs: Pomalidomide
Participants will receive pomalidomide.

Treatment: Drugs: Lenalidomide
Participants will receive lenalidomide.

Treatment: Drugs: Bortezomib
Participants will receive bortezomib.

Treatment: Drugs: Nirogacestat
Participants will receive nirogacestat.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Incidence of Adverse Events (AEs)
Timepoint [1] 0 0
Up to 2 year and 5 months
Primary outcome [2] 0 0
Number of Participants with AEs by Severity
Timepoint [2] 0 0
Up to 2 year and 5 months
Primary outcome [3] 0 0
Number of Participants with Abnormalities in Laboratory Values
Timepoint [3] 0 0
Up to 2 year and 5 months
Primary outcome [4] 0 0
Number of Participants with Dose-Limiting Toxicity (DLT)
Timepoint [4] 0 0
Up to Cycle 2 Day 21 (each cycle is of 28 days for Treatment Regimen A and 21 days for Treatment Regimen B)
Secondary outcome [1] 0 0
Overall Response Rate (ORR)
Timepoint [1] 0 0
Up to 2 year and 5 months
Secondary outcome [2] 0 0
Very Good Partial Response (VGPR) or Better Response Rate
Timepoint [2] 0 0
Up to 2 year and 5 months
Secondary outcome [3] 0 0
Complete Response (CR) or Better Response Rate
Timepoint [3] 0 0
Up to 2 year and 5 months
Secondary outcome [4] 0 0
Stringent Complete Response (sCR) Rate
Timepoint [4] 0 0
Up to 2 year and 5 months
Secondary outcome [5] 0 0
Duration of Response
Timepoint [5] 0 0
Up to 2 year and 5 months
Secondary outcome [6] 0 0
Time to Response
Timepoint [6] 0 0
Up to 2 year and 5 months
Secondary outcome [7] 0 0
Serum Concentrations of Teclistamab
Timepoint [7] 0 0
Up to 2 year and 5 months
Secondary outcome [8] 0 0
Serum Concentrations of Daratumumab
Timepoint [8] 0 0
Up to 2 year and 5 months
Secondary outcome [9] 0 0
Serum Concentrations of Nirogacestat
Timepoint [9] 0 0
Up to 2 year and 5 months
Secondary outcome [10] 0 0
Number of Participants with Presence of Anti-Drug Antibodies to Teclistamab
Timepoint [10] 0 0
Up to 2 year and 5 months
Secondary outcome [11] 0 0
Number of Participants with Presence of Anti-Drug Antibodies to Daratumumab
Timepoint [11] 0 0
Up to 2 year and 5 months
Secondary outcome [12] 0 0
Number of Participants with Presence of Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20)
Timepoint [12] 0 0
Up to 2 year and 5 months

Eligibility
Key inclusion criteria
* Have documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria
* Meet treatment regimen-specific requirements as follows: Treatment Regimen A (teclistamab [tec]-daratumumab [dara]-pomalidomide [pom]) only: Participant has relapsed or refractory multiple myeloma and has received 1 to 3 prior lines of therapy, including exposure to a proteasome inhibitor (PI) and lenalidomide; Treatment Regimen B (tec-dara-lenalidomide [len]-bortezomib [bor]) only: Participant has newly diagnosed or relapsed/refractory multiple myeloma and is naive to treatment with lenalidomide; Treatment Regimen C (tec-nirogacestat [niro]) only: Participant has relapsed or refractory multiple myeloma and has 1) received 3 or more prior lines of therapy or 2) is double refractory to a PI and an immunomodulatory drug (IMiD) and triple exposed to a PI, an IMiD, and an anti-cluster of differentiation (CD)38 monoclonal antibody (mAb); Treatment Regimen D (tec-len) only: Participant has multiple myeloma and has received greater than or equal to (>=) 2 prior lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb; Treatment Regimen E (tec-dara-len) only: Participant has newly diagnosed multiple myeloma or if previously treated has received 1 to 3 prior lines of therapy, including exposure to a PI and an IMiD; Treatment Regimen F (tec-dara-len-bor) only: Participant has newly diagnosed multiple myeloma
* Have measurable disease at screening as defined by at least one of the following: serum M-protein level >= 1.0 gram/deciliter (g/dL); or urine M-protein level >= 200 milligrams (mg)/24 hours; or light chain multiple myeloma: serum immunoglobulin (Ig) free light chain (FLC) >= 10 milligram/deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
* A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin [hCG]) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration and must agree to further serum or urine pregnancy tests during the study
* A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 100 days after the last dose of study treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior treatment with any therapy that targets B-cell maturation antigen (BCMA): This exclusion does not apply to Treatment Regimen C
* Live, attenuated vaccine within 30 days before the first dose of study treatment
* Received a cumulative dose of corticosteroids equivalent to >= 140 mg of prednisone within the 14-day period before the start of study treatment administration
* Active central nervous system (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
* Known to be seropositive for human immunodeficiency virus

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
24/02/2025
Actual
Sample size
Target
Accrual to date
Final
140
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [2] 0 0
Alfred Health - Melbourne
Recruitment hospital [3] 0 0
Calvary Mater Newcastle Hospital - Waratah
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
2298 - Waratah
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
United States of America
State/province [13] 0 0
Wisconsin
Country [14] 0 0
Belgium
State/province [14] 0 0
Edegem
Country [15] 0 0
Belgium
State/province [15] 0 0
Gent
Country [16] 0 0
France
State/province [16] 0 0
Lyon Cedex 8
Country [17] 0 0
France
State/province [17] 0 0
Nantes Cedex 1
Country [18] 0 0
France
State/province [18] 0 0
Pessac cedex
Country [19] 0 0
France
State/province [19] 0 0
Rennes
Country [20] 0 0
France
State/province [20] 0 0
TOULOUSE Cedex 9
Country [21] 0 0
United Kingdom
State/province [21] 0 0
London
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Manchester
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Surrey

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 and Development, LLC Clinical Trial
Address 0 0
Janssen Research and Development LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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/NCT04722146