Share
Save
A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
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).
Study details:
Multiple myeloma is a malignant plasma cell disorder characterized by production of monoclonal proteins (M proteins), which are comprised of pathologic immunoglobulins (Ig) or fragments of such, which have subsequently lost their normal function. Rationale for combining talquetamab and teclistamab is the targeting of multiple proteins on the surface of multiple myeloma cells resulting in cell lysis. This study consists of 3 periods: screening phase (up to 28 days), treatment phase (start of study drug administration and continues until the completion of the end of treatment \[EOT\] visit); and a post-treatment follow-up phase (after end of treatment and up to 16 weeks after last dose of study drug(s) for each participant).
End of study is defined as 2 years after the last participant has received his or her initial dose of the treatment combination. Total duration of study is Approximately 5 years. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points during this study.
Participants safety and study conduct will be monitored throughout the study.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2020-12-15
Primary completion: 2025-06-27
Study completion finish: 2025-08-29
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT04586426
Intervention or treatment
DRUG: Talquetamab
DRUG: Teclistamab
DRUG: Daratumumab
Conditions
- • Multiple Myeloma
Find a site
Closest Location:
St Vincents Hospital Melbourne
Research sites nearby
Select from list below to view details:
St Vincents Hospital Melbourne
Fitzroy, Not Specified, Australia
Royal Perth Hospital
Perth, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Part 1: Dose Escalation
| DRUG: Talquetamab
|
EXPERIMENTAL: Part 2: Dose Expansion
| DRUG: Talquetamab
|
EXPERIMENTAL: Part 3: Phase 2
| DRUG: Talquetamab
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Part 1: Number of Participants with Dose Limiting Toxicity (DLT) | 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. | Approximately 5 years |
| Part 1: Severity of DLT as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) | 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. | Approximately 5 years |
| Part 2: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability | 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. | Approximately 5 years |
| Part 2: Number of Participants with Adverse Events and SAEs 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 adverse event. | Approximately 5 years |
| Part 3: Overall Response Rate (ORR) | ORR is defined as the percentage of participants who have a partial response (PR) or better according Independent Review Committees (IRC). | Approximately 5 years |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Parts 1, 2 and 3: Serum Concentration of Talquetamab | Serum samples will be analyzed to determine concentrations of talquetamab using a validated, specific, and sensitive immunoassay method. | Approximately 5 years |
| Parts 1, 2 and 3: Serum Concentration of Teclistamab | Serum samples will be analyzed to determine concentrations of teclistamab using a validated, specific, and sensitive immunoassay method. | Approximately 5 years |
| Part 1 and Part 2: Serum Concentration of Daratumumab | Serum samples will be analyzed to determine concentrations of daratumumab using a validated, specific, and sensitive immunoassay method. | Approximately 5 years |
| Parts 1, 2 and 3: Number of Participants with Anti-Drug Antibodies to Talquetamab | Number of participants with anti-drug antibodies to talquetamab will be assessed. | Approximately 5 years |
| Parts 1, 2 and 3: Number of Participants with Anti-Drug Antibodies to Teclistamab | Number of participants with anti-drug antibodies to teclistamab will be assessed. | Approximately 5 years |
| Part 1 and Part 2: Number of Participants with Anti-Drug Antibodies to Daratumumab | Number of participants with anti-drug antibodies to daratumumab will be assessed. | Approximately 5 years |
| Part 1 and Part 2: Overall Response Rate (ORR) | 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. | Approximately 5 years |
| Parts 1, 2 and 3: Very Good Partial Response (VGPR) or Better Response Rate | 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. | Approximately 5 years |
| Parts 1, 2 and 3: Complete Response (CR) or Better Response Rate | 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. | Approximately 5 years |
| Part 1, 2 and 3: Stringent Complete Response (sCR) Rate | sCR rate is defined as the percentage of participants who achieve a sCR according to the IMWG criteria. | Approximately 5 years |
| Parts 1, 2 and 3: Duration of Response (DOR) | 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. | Approximately 5 years |
| Parts 1, 2 and 3: Time to Response | 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. | Approximately 5 years |
| Part 3: Progression free Survival (PFS) | 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. | Approximately 5 years |
| Part 3: Overall Survival (OS) | OS is measured from the date of first dose to the date of the participant's death. | Approximately 5 years |
| Part 3: Number of Participants with Adverse Events | 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. | Approximately 5 years |
| Part 3: Number of Participants with Adverse Events 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 adverse event. | Approximately 5 years |
Frequently Asked Questions
Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol
No questions submitted. Be the first to ask a question!