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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04586426




Registration number
NCT04586426
Ethics application status
Date submitted
12/10/2020
Date registered
14/10/2020

Titles & IDs
Public title
A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
Scientific title
A Phase 1b/2 Dose Escalation and Expansion Study of the Combination of the Bispecific T Cell Redirection Antibodies Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
Secondary ID [1] 0 0
2019-004124-38
Secondary ID [2] 0 0
CR108901
Universal Trial Number (UTN)
Trial acronym
RedirecTT-1
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 - Talquetamab
Treatment: Drugs - Teclistamab
Treatment: Drugs - Daratumumab

Experimental: Part 1: Dose Escalation - Participants will receive tec+tal with or without daratumumab in 28-day cycles following initial step-up doses.

Experimental: Part 2: Dose Expansion - Participants will receive treatment doses (combination of tal+tec and dara+tal+tec regimens) which will be determined by the recommended Phase 2 regimen (s) (RP2R\[s\]) of the study treatment identified in Part 1.

Experimental: Part 3: Phase 2 - Participants will receive teclistamab + talquetamab combination therapy, at the RP2R selected from Part 1 and Part 2.


Treatment: Drugs: Talquetamab
Talquetamab will be administered by subcutaneous (SC) injection.

Treatment: Drugs: Teclistamab
Teclistamab will be administered by SC injection.

Treatment: Drugs: Daratumumab
Daratumumab will be administered by SC injection.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Number of Participants with Dose Limiting Toxicity (DLT)
Timepoint [1] 0 0
Approximately 5 years
Primary outcome [2] 0 0
Part 1: Severity of DLT as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Timepoint [2] 0 0
Approximately 5 years
Primary outcome [3] 0 0
Part 2: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
Timepoint [3] 0 0
Approximately 5 years
Primary outcome [4] 0 0
Part 2: Number of Participants with Adverse Events and SAEs by Severity
Timepoint [4] 0 0
Approximately 5 years
Primary outcome [5] 0 0
Part 3: Overall Response Rate (ORR)
Timepoint [5] 0 0
Approximately 5 years
Secondary outcome [1] 0 0
Parts 1, 2 and 3: Serum Concentration of Talquetamab
Timepoint [1] 0 0
Approximately 5 years
Secondary outcome [2] 0 0
Parts 1, 2 and 3: Serum Concentration of Teclistamab
Timepoint [2] 0 0
Approximately 5 years
Secondary outcome [3] 0 0
Part 1 and Part 2: Serum Concentration of Daratumumab
Timepoint [3] 0 0
Approximately 5 years
Secondary outcome [4] 0 0
Parts 1, 2 and 3: Number of Participants with Anti-Drug Antibodies to Talquetamab
Timepoint [4] 0 0
Approximately 5 years
Secondary outcome [5] 0 0
Parts 1, 2 and 3: Number of Participants with Anti-Drug Antibodies to Teclistamab
Timepoint [5] 0 0
Approximately 5 years
Secondary outcome [6] 0 0
Part 1 and Part 2: Number of Participants with Anti-Drug Antibodies to Daratumumab
Timepoint [6] 0 0
Approximately 5 years
Secondary outcome [7] 0 0
Part 1 and Part 2: Overall Response Rate (ORR)
Timepoint [7] 0 0
Approximately 5 years
Secondary outcome [8] 0 0
Parts 1, 2 and 3: Very Good Partial Response (VGPR) or Better Response Rate
Timepoint [8] 0 0
Approximately 5 years
Secondary outcome [9] 0 0
Parts 1, 2 and 3: Complete Response (CR) or Better Response Rate
Timepoint [9] 0 0
Approximately 5 years
Secondary outcome [10] 0 0
Part 1, 2 and 3: Stringent Complete Response (sCR) Rate
Timepoint [10] 0 0
Approximately 5 years
Secondary outcome [11] 0 0
Parts 1, 2 and 3: Duration of Response (DOR)
Timepoint [11] 0 0
Approximately 5 years
Secondary outcome [12] 0 0
Parts 1, 2 and 3: Time to Response
Timepoint [12] 0 0
Approximately 5 years
Secondary outcome [13] 0 0
Part 3: Progression free Survival (PFS)
Timepoint [13] 0 0
Approximately 5 years
Secondary outcome [14] 0 0
Part 3: Overall Survival (OS)
Timepoint [14] 0 0
Approximately 5 years
Secondary outcome [15] 0 0
Part 3: Number of Participants with Adverse Events
Timepoint [15] 0 0
Approximately 5 years
Secondary outcome [16] 0 0
Part 3: Number of Participants with Adverse Events by Severity
Timepoint [16] 0 0
Approximately 5 years

Eligibility
Key inclusion criteria
* Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
* Part 1 and 2: Participant could not tolerate or has disease that is relapsed or refractory to established therapies, including the last line of therapy. Part 3: (a) Relapsed or refractory disease, and exposed to a PI, IMiD, and an anti-CD38 mAb; (b) Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen
* Part 1 and Part 2: Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 at screening and immediately before the start of study drug administration. Part 3: ECOG performance status grade of 0, 1, or 2 at screening and immediately before the start of study drug administration
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* All Parts: Targeted therapy, epigenetic therapy, or treatment with an investigational treatment or an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less. Part 3: prior BCMA targeted bispecific antibody therapy; prior GPRC5D targeted therapy
* All Parts: Allogeneic stem cell transplant within 6 months before the first dose of study treatment.
* All Parts: Central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma.
* All Parts: Active plasma cell leukemia (greater than [>]2.0*10^9/L plasma cells by standard differential), Waldenstro¨m's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M- protein, and skin changes), or primary amyloid light chain amyloidosis

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
15/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/08/2025
Actual
Sample size
Target
228
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [2] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
6000 - Perth
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
Arkansas
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
Minnesota
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 York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Canada
State/province [12] 0 0
Alberta
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
Israel
State/province [15] 0 0
Jerusalem
Country [16] 0 0
Israel
State/province [16] 0 0
Ramat Gan
Country [17] 0 0
Israel
State/province [17] 0 0
Tel-Aviv
Country [18] 0 0
Japan
State/province [18] 0 0
Kanazawa
Country [19] 0 0
Japan
State/province [19] 0 0
Nagoya
Country [20] 0 0
Japan
State/province [20] 0 0
Osaka
Country [21] 0 0
Japan
State/province [21] 0 0
Sendai shi
Country [22] 0 0
Japan
State/province [22] 0 0
Shibuya
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Seoul
Country [24] 0 0
Spain
State/province [24] 0 0
Badalona
Country [25] 0 0
Spain
State/province [25] 0 0
Barcelona
Country [26] 0 0
Spain
State/province [26] 0 0
L Hospitalet De Llobregat
Country [27] 0 0
Spain
State/province [27] 0 0
Madrid
Country [28] 0 0
Spain
State/province [28] 0 0
Pamplona
Country [29] 0 0
Spain
State/province [29] 0 0
Salamanca
Country [30] 0 0
Spain
State/province [30] 0 0
Santander

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
Participate-In-This-Study@its.jnj.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?
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/NCT04586426