A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

JRCT ID: jRCT2031210621

Registered date:19/02/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hematological Malignancies
• Date of first enrollment: 05/07/2022
• Target sample size: 320
• Countries of recruitment: Belgium,Japan,China,Japan,Germany,Japan,Spain,Japan,France,Japan,Israel,Japan,Korea,Japan,Netherlands,Japan,Poland,Japan,UnitedStates OfAmerica,Japan
• Study type: Interventional
• Intervention(s): Talquetamab:Talquetamab will be administered SC at a recommended Phase 2 dose (RP2D) selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study until disease progression.

Outcome(s)

• Primary Outcome: Overall Response Rate (ORR):Up to 2 years and 10 months:ORR is defined as the proportion of participants who have a partial response (PR) or better according to the international myeloma working group (IMWG) criteria.

Secondary Outcome

-Duration of Response (DOR):Up to 2 years and 10 months:DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG criteria, or death due to PD, whichever occurs first.
-Very Good Partial Response (VGPR) or Better Rate:Up to 2 years and 10 months:VGPR or better rate is defined as the percentage of patients who achieve a VGPR or better according to IMWG response criteria.
-Complete Response (CR) or Better Rate:Up to 2 years and 10 months:CR or better rate is defined as the percentage of patients who achieve CR or better according to IMWG response criteria.
-Stringent Complete Response (sCR) Rate:Up to 2 years and 10 months:sCR rate is defined as the percentage of patients who achieve sCR according to IMWG response criteria.
-Time to Response (TTR):Up to 2 years and 10 months:TTR 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.
-Progression-Free Survival (PFS):Up to 2 years and 10 months:PFS is defined as time from date of first dose of study drug to date of first documented PD, per IMWG criteria, or death due to any cause, whichever occurs first.
-Overall Survival (OS):Up to 2 years and 10 months:OS is defined as the time from the date of first dose of study drug to the date of the participants death.
-Minimal Residual Disease (MRD) Negative Rate:Up to 2 years and 10 months:MRD negativity rate is measured only for participants who achieve at least a CR but is reported based on all treated similar to the other response data.
-Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability:Up to 2 years and 10 months: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.
-Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability:Up to 2 years and 10 months:An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
-Number of Participants with AEs by Severity:Up to 2 years and 10 months:Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). 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.
-Number of Participants with Abnormalities in Clinical Laboratory Values:Up to 2 years and 10 months:Number of participants with abnormalities in clinical laboratory values (such as hematology, serum chemistry and coagulation) will be reported.
-Serum Concentration of Talquetamab:Up to 2 years and 10 months:Serum samples will be analyzed to determine concentrations of talquetamab.
-Number of Participants with Talquetamab Antibodies:Up to 2 years and 10 months:Antibodies to talquetamab will be assessed to evaluate potential immunogenicity.
-Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC QLQ-C30):Baseline up to 2 years and 10 months:The EORTC- QLQ-Core-30 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The recall period is 1 week (`past week`) and responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.
-Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L):Baseline up to 2 years and 10 months:The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating `health today` with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores for the 5 separate questions are categorical and cannot be analyzed as cardinal numbers.
-Change from Baseline in HRQoL as Assessed by Patient Global Impression of Severity (PGIS):Baseline up to 2 years and 10 months:The PGIS is a single item that assesses severity of the participants health state, on a 5-point verbal rating scale. Score ranges from 1 (None) to 5 (Very Severe).
-Overall Response Rate (ORR) in Participants with High-risk Molecular Features:Up to 2 years and 10 months:ORR in participants with high risk is defined as the overall response rate among the high risk molecular subgroups or other high-risk molecular subtypes.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria
- Part 3: Measurable disease cohort A, cohort B, cohort C: multiple myeloma must be measurable by central laboratory assessment
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (beta human chorionic gonadotropin [hCG]) or urine
- Willing and able to adhere to the prohibitions and restrictions specified in this protocol

Exclude criteria

- Part 3 only: Cohort A and cohort C only: exposed to a CAR-T or T cell redirection therapy at any time. Cohort B: T cell redirection therapy within 3 months
- Participants who received or plan to receive any live, attenuated vaccine within 4 weeks prior to the first dose, during treatment, or within 4 weeks of the last dose of talquetamab. Non-live or non-replicating vaccines approved or authorized for emergency use (example, COVID-19) by local health authorities are allowed
- Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
- Received a cumulative dose of corticosteroids equivalent to >= 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)
- Stroke or seizure within 6 months prior to signing the informed consent form (ICF)

Related Information

• Primary Sponsor: Fujikawa Ei
• Secondary ID(s): NCT04634552