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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT05050097




Registration number
NCT05050097
Ethics application status
Date submitted
10/09/2021
Date registered
20/09/2021
Date last updated
20/09/2021

Titles & IDs
Public title
A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
Scientific title
A Multi-arm Phase 1b Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
Secondary ID [1] 0 0
2020-004502-55
Secondary ID [2] 0 0
CR108946
Universal Trial Number (UTN)
Trial acronym
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 - Carfilzomib
Treatment: Drugs - Daratumumab SC
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Pomalidomide

Experimental: Treatment Regimen A: Talquetamab + Carfilzomib - Participants assigned to Treatment regimen A will receive talquetamab subcutaneously (SC) in combination with carfilzomib as an intravenous (IV) infusion.

Experimental: Treatment Regimen B: Talquetamab + Daratumumab + Carfilzomib - Participants assigned to Treatment regimen B will receive talquetamab SC in combination with daratumumab SC and carfilzomib as an IV infusion.

Experimental: Treatment Regimen C: Talquetamab + Lenalidomide - Participants assigned to Treatment regimen C will receive talquetamab SC in combination with lenalidomide orally.

Experimental: Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide - Participants assigned to Treatment regimen D will receive talquetamab SC in combination with daratumumab SC and lenalidomide orally.

Experimental: Treatment Regimen E: Talquetamab + Pomalidomide - Participants assigned to Treatment regimen E will receive talquetamab SC in combination with pomalidomide orally.


Treatment: Drugs: Talquetamab
Talquetamab will be administered subcutaneously.

Treatment: Drugs: Carfilzomib
Carfilzomib will be administered as an IV infusion.

Treatment: Drugs: Daratumumab SC
Daratumumab will be administered subcutaneously.

Treatment: Drugs: Lenalidomide
Lenalidomide will be self-administered orally.

Treatment: Drugs: Pomalidomide
Pomalidomide will be self-administered orally.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability - An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Timepoint [1] 0 0
Up to 1 year and 10 months
Primary outcome [2] 0 0
Number of Participants with AEs by Severity - 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 AE.
Timepoint [2] 0 0
Up to 1 year and 10 months
Primary outcome [3] 0 0
Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters - Number of participants with clinically significant abnormalities in laboratory parameters such as hematology and serum chemistry will be reported.
Timepoint [3] 0 0
Up to 1 year and 6 months
Primary outcome [4] 0 0
Number of Participants with Dose Limiting Toxicity (DLT) - Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity of grade 3 or higher, clinical laboratory abnormalities, or hematologic toxicity.
Timepoint [4] 0 0
Up to 49 days
Secondary outcome [1] 0 0
Overall Response Rate (ORR) - ORR is defined as the percentage of participants who achieve partial response (PR) or better according to the International Myeloma Working Group (IMWG) 2016 criteria. Response to treatment will be evaluated by the investigator based on IMWG criteria.
Timepoint [1] 0 0
Up to 1 year and 10 months
Secondary outcome [2] 0 0
Very Good Partial Response (VGPR) or Better Response Rate - VGPR or better response rate is defined as the percentage of participants who achieve a VGPR or better response (stringent complete response [sCR] + complete response [CR] +VGPR) according to the IMWG 2016 criteria.
Timepoint [2] 0 0
Up to 1 year and 10 months
Secondary outcome [3] 0 0
Complete Response (CR) or Better Response Rate - CR or better response rate is defined as the percentage of participants who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria.
Timepoint [3] 0 0
Up to 1 year and 10 months
Secondary outcome [4] 0 0
Stringent Complete Response (sCR) - sCR rate is defined as the percentage of participants who achieve an sCR according to the IMWG 2016 criteria.
Timepoint [4] 0 0
Up to 1 year and 10 months
Secondary outcome [5] 0 0
Duration of Response - Duration of response is defined as time 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 2016 criteria, or death due to disease progression, whichever occurs first.
Timepoint [5] 0 0
Up to 1 year and 10 months
Secondary outcome [6] 0 0
Time to Response - Time to response is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participant has met all criteria for PR or better.
Timepoint [6] 0 0
Up to 1 year and 10 months
Secondary outcome [7] 0 0
Serum Concentration of Talquetamab - Serum samples will be analyzed to determine concentrations of talquetamab.
Timepoint [7] 0 0
Up to 1 year and 10 months
Secondary outcome [8] 0 0
Serum Concentration of Daratumumab - Serum samples will be analyzed to determine concentrations of daratumumab for treatment regimens B and D.
Timepoint [8] 0 0
Up to 1 year and 10 months
Secondary outcome [9] 0 0
Number of Participants with Anti-Drug Antibodies to Talquetamab - Number of participants with anti-drug antibodies to talquetamab will be reported.
Timepoint [9] 0 0
Up to 1 year and 10 months
Secondary outcome [10] 0 0
Number of Participants with Anti-Drug Antibodies to Daratumumab - Number of participants with anti-drug antibodies to daratumumab will be reported for treatment regimens B and D.
Timepoint [10] 0 0
Up to 1 year and 10 months
Secondary outcome [11] 0 0
Number of Participants with Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20) - Number of participants with anti-drug antibodies to rHuPH20 will be reported.
Timepoint [11] 0 0
Up to 1 year and 10 months

Eligibility
Key inclusion criteria
- Have documented initial diagnosis of multiple myeloma according to International
Myeloma Working Group (IMWG) diagnostic criteria

- Have measurable disease at screening as defined by at least 1 of the following: a.
Serum monoclonal protein (M-protein) level greater than or equal to (>=) 1.0 gram per
deciliter (g/dL); or b. Urine M-protein level >= 200 milligrams (mg)/24 hours; or c.
Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >=10
milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio

- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
at screening and immediately before the start of study treatment administration

- A woman of childbearing potential must have a negative highly sensitive serum beta
human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative
urine or serum pregnancy test within 24 hours before the start of study treatment
administration

- Be willing and able to adhere to the lifestyle restrictions specified in the protocol,
including adherence to the applicable immunomodulatory drug (IMiD) global Pregnancy
Prevention Plan (PPP) or local PPP/Risk Evaluation and Mitigation Strategy (REMS)
program
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Live, attenuated vaccine within 4 weeks 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

- History of stroke or seizure within 6 months prior to the first dose of study
treatment

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
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St. Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [2] 0 0
Alfred Health - Melbourne
Recruitment hospital [3] 0 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
4215 - Southport
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
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
United States of America
State/province [14] 0 0
Wisconsin
Country [15] 0 0
Belgium
State/province [15] 0 0
Brussel
Country [16] 0 0
Belgium
State/province [16] 0 0
Edegem
Country [17] 0 0
Belgium
State/province [17] 0 0
Gent
Country [18] 0 0
Belgium
State/province [18] 0 0
Leuven
Country [19] 0 0
France
State/province [19] 0 0
Lyon Cedex 8
Country [20] 0 0
France
State/province [20] 0 0
Nantes Cedex 1
Country [21] 0 0
France
State/province [21] 0 0
Pessac cedex
Country [22] 0 0
France
State/province [22] 0 0
Rennes
Country [23] 0 0
France
State/province [23] 0 0
TOULOUSE Cedex 9
Country [24] 0 0
Netherlands
State/province [24] 0 0
Amsterdam
Country [25] 0 0
Netherlands
State/province [25] 0 0
Groningen
Country [26] 0 0
Netherlands
State/province [26] 0 0
Maastricht
Country [27] 0 0
Netherlands
State/province [27] 0 0
Utrecht

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to characterize the safety and tolerability of talquetamab when
administered in different combination regimens and to identify the safe dose(s) of
talquetamab combination regimens.
Trial website
https://clinicaltrials.gov/show/NCT05050097
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
JNJ.CT@sylogent.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT05050097