Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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/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
Query!
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
Query!
Secondary ID [1]
0
0
2019-004124-38
Query!
Secondary ID [2]
0
0
CR108901
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
RedirecTT-1
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Other cancer types
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Part 1: Number of Participants with Dose Limiting Toxicity (DLT)
Query!
Assessment method [1]
0
0
The dose limiting toxicities are based on drug related adverse events and defined as any of the following events: hematological or non-hematological toxicity of grade 3 or higher.
Query!
Timepoint [1]
0
0
Approximately 5 years
Query!
Primary outcome [2]
0
0
Part 1: Severity of DLT as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Query!
Assessment method [2]
0
0
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.
Query!
Timepoint [2]
0
0
Approximately 5 years
Query!
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
Query!
Assessment method [3]
0
0
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product, is medically important.
Query!
Timepoint [3]
0
0
Approximately 5 years
Query!
Primary outcome [4]
0
0
Part 2: Number of Participants with Adverse Events and SAEs by Severity
Query!
Assessment method [4]
0
0
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.
Query!
Timepoint [4]
0
0
Approximately 5 years
Query!
Primary outcome [5]
0
0
Part 3: Overall Response Rate (ORR)
Query!
Assessment method [5]
0
0
ORR is defined as the percentage of participants who have a partial response (PR) or better according Independent Review Committees (IRC).
Query!
Timepoint [5]
0
0
Approximately 5 years
Query!
Secondary outcome [1]
0
0
Parts 1, 2 and 3: Serum Concentration of Talquetamab
Query!
Assessment method [1]
0
0
Serum samples will be analyzed to determine concentrations of talquetamab using a validated, specific, and sensitive immunoassay method.
Query!
Timepoint [1]
0
0
Approximately 5 years
Query!
Secondary outcome [2]
0
0
Parts 1, 2 and 3: Serum Concentration of Teclistamab
Query!
Assessment method [2]
0
0
Serum samples will be analyzed to determine concentrations of teclistamab using a validated, specific, and sensitive immunoassay method.
Query!
Timepoint [2]
0
0
Approximately 5 years
Query!
Secondary outcome [3]
0
0
Part 1 and Part 2: Serum Concentration of Daratumumab
Query!
Assessment method [3]
0
0
Serum samples will be analyzed to determine concentrations of daratumumab using a validated, specific, and sensitive immunoassay method.
Query!
Timepoint [3]
0
0
Approximately 5 years
Query!
Secondary outcome [4]
0
0
Parts 1, 2 and 3: Number of Participants with Anti-Drug Antibodies to Talquetamab
Query!
Assessment method [4]
0
0
Number of participants with anti-drug antibodies to talquetamab will be assessed.
Query!
Timepoint [4]
0
0
Approximately 5 years
Query!
Secondary outcome [5]
0
0
Parts 1, 2 and 3: Number of Participants with Anti-Drug Antibodies to Teclistamab
Query!
Assessment method [5]
0
0
Number of participants with anti-drug antibodies to teclistamab will be assessed.
Query!
Timepoint [5]
0
0
Approximately 5 years
Query!
Secondary outcome [6]
0
0
Part 1 and Part 2: Number of Participants with Anti-Drug Antibodies to Daratumumab
Query!
Assessment method [6]
0
0
Number of participants with anti-drug antibodies to daratumumab will be assessed.
Query!
Timepoint [6]
0
0
Approximately 5 years
Query!
Secondary outcome [7]
0
0
Part 1 and Part 2: Overall Response Rate (ORR)
Query!
Assessment method [7]
0
0
ORR is defined as the percentage of participants who have a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria.
Query!
Timepoint [7]
0
0
Approximately 5 years
Query!
Secondary outcome [8]
0
0
Parts 1, 2 and 3: Very Good Partial Response (VGPR) or Better Response Rate
Query!
Assessment method [8]
0
0
VGPR or better response rate (sCR+CR+VGPR) is defined as the percentage of participants who achieve a VGPR or better response according to the IMWG criteria.
Query!
Timepoint [8]
0
0
Approximately 5 years
Query!
Secondary outcome [9]
0
0
Parts 1, 2 and 3: Complete Response (CR) or Better Response Rate
Query!
Assessment method [9]
0
0
CR or better response rate (sCR+CR) is defined as the percentage of participants who achieve a CR or better response according to the IMWG criteria.
Query!
Timepoint [9]
0
0
Approximately 5 years
Query!
Secondary outcome [10]
0
0
Part 1, 2 and 3: Stringent Complete Response (sCR) Rate
Query!
Assessment method [10]
0
0
sCR rate is defined as the percentage of participants who achieve a sCR according to the IMWG criteria.
Query!
Timepoint [10]
0
0
Approximately 5 years
Query!
Secondary outcome [11]
0
0
Parts 1, 2 and 3: Duration of Response (DOR)
Query!
Assessment method [11]
0
0
DOR will be calculated among responders (with PR or better) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria.
Query!
Timepoint [11]
0
0
Approximately 5 years
Query!
Secondary outcome [12]
0
0
Parts 1, 2 and 3: Time to Response
Query!
Assessment method [12]
0
0
Time to response is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better.
Query!
Timepoint [12]
0
0
Approximately 5 years
Query!
Secondary outcome [13]
0
0
Part 3: Progression free Survival (PFS)
Query!
Assessment method [13]
0
0
PFS is defined as the time from the date of first dose to the date of first documented disease progression, as defined in the IMWG criteria, or death due to any cause, whichever occurs first.
Query!
Timepoint [13]
0
0
Approximately 5 years
Query!
Secondary outcome [14]
0
0
Part 3: Overall Survival (OS)
Query!
Assessment method [14]
0
0
OS is measured from the date of first dose to the date of the participant's death.
Query!
Timepoint [14]
0
0
Approximately 5 years
Query!
Secondary outcome [15]
0
0
Part 3: Number of Participants with Adverse Events
Query!
Assessment method [15]
0
0
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
Query!
Timepoint [15]
0
0
Approximately 5 years
Query!
Secondary outcome [16]
0
0
Part 3: Number of Participants with Adverse Events by Severity
Query!
Assessment method [16]
0
0
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.
Query!
Timepoint [16]
0
0
Approximately 5 years
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Other
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
15/12/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
29/08/2025
Query!
Actual
Query!
Sample size
Target
208
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
St Vincents Hospital Melbourne - Fitzroy
Query!
Recruitment hospital [2]
0
0
Royal Perth Hospital - Perth
Query!
Recruitment postcode(s) [1]
0
0
3065 - Fitzroy
Query!
Recruitment postcode(s) [2]
0
0
6000 - Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Minnesota
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Missouri
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
New York
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
North Carolina
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Ohio
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Oregon
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Texas
Query!
Country [12]
0
0
Canada
Query!
State/province [12]
0
0
Alberta
Query!
Country [13]
0
0
Canada
Query!
State/province [13]
0
0
Ontario
Query!
Country [14]
0
0
Canada
Query!
State/province [14]
0
0
Quebec
Query!
Country [15]
0
0
Israel
Query!
State/province [15]
0
0
Jerusalem
Query!
Country [16]
0
0
Israel
Query!
State/province [16]
0
0
Ramat Gan
Query!
Country [17]
0
0
Israel
Query!
State/province [17]
0
0
Tel-Aviv
Query!
Country [18]
0
0
Japan
Query!
State/province [18]
0
0
Kanazawa
Query!
Country [19]
0
0
Japan
Query!
State/province [19]
0
0
Nagoya
Query!
Country [20]
0
0
Japan
Query!
State/province [20]
0
0
Osaka
Query!
Country [21]
0
0
Japan
Query!
State/province [21]
0
0
Sendai shi
Query!
Country [22]
0
0
Japan
Query!
State/province [22]
0
0
Shibuya
Query!
Country [23]
0
0
Korea, Republic of
Query!
State/province [23]
0
0
Seoul
Query!
Country [24]
0
0
Spain
Query!
State/province [24]
0
0
Badalona
Query!
Country [25]
0
0
Spain
Query!
State/province [25]
0
0
Barcelona
Query!
Country [26]
0
0
Spain
Query!
State/province [26]
0
0
L Hospitalet De Llobregat
Query!
Country [27]
0
0
Spain
Query!
State/province [27]
0
0
Madrid
Query!
Country [28]
0
0
Spain
Query!
State/province [28]
0
0
Pamplona
Query!
Country [29]
0
0
Spain
Query!
State/province [29]
0
0
Salamanca
Query!
Country [30]
0
0
Spain
Query!
State/province [30]
0
0
Santander
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Janssen Research & Development, LLC
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to identify the recommended Phase 2 regimen(s) (RP2R\[s\]) and schedule for the study treatment (Part 1), to characterize the safety of the RP2R(s) for the study treatment (Part 2) and to evaluate the anticancer activity of talquetamab + teclistamab in participants with relapsed or refractory multiple myeloma and extramedullary disease (EMD) (Part 3).
Query!
Trial website
https://clinicaltrials.gov/study/NCT04586426
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Janssen Research & Development, LLC Clinical Trial
Query!
Address
0
0
Janssen Research & Development, LLC
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Study Contact
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
844-434-4210
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
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
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency
Query!
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