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

Phase 2RecruitingNCT04634552

Janssen Research & Development, LLC510 enrolled

Overview

The purpose of this study is to evaluate the efficacy and safety of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

510

Conditions

Hematological Malignancies

Interventions

TalquetamabDRUG

Talquetamab will be administered SC until disease progression.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion 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 and cohort D: multiple myeloma must be measurable by central laboratory assessment; Cohort E: Multiple myeloma must be measurable by local 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 Exclusion 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, Cohort D and Cohort E: T cell redirection therapy within 3 months * 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)

Locations (78)

Outcomes

Primary Outcomes

Overall Response Rate (ORR)

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.

Time frame: Up to 2 years and 10 months

Secondary Outcomes

Duration of Response (DOR)

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.

Time frame: Up to 2 years and 10 months

Very Good Partial Response (VGPR) or Better Rate

VGPR or better rate is defined as the percentage of patients who achieve a VGPR or better according to IMWG response criteria.

Time frame: Up to 2 years and 10 months

Complete Response (CR) or Better Rate

CR or better rate is defined as the percentage of patients who achieve CR or better according to IMWG response criteria.

Time frame: Up to 2 years and 10 months

Stringent Complete Response (sCR) Rate

sCR rate is defined as the percentage of patients who achieve sCR according to IMWG response criteria.

Time frame: Up to 2 years and 10 months

Time to Response (TTR)

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.

Time frame: Up to 2 years and 10 months

Progression-Free Survival (PFS)

Central Contacts

Study Contact

CONTACT

844-434-4210 Participate-In-This-Study1@its.jnj.com

Data from ClinicalTrials.gov

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University of Alabama Birmingham

Birmingham, Alabama, United States

RECRUITING

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

RECRUITING

City of Hope

Duarte, California, United States

COMPLETED

Memorial Healthcare System

Hollywood, Florida, United States

RECRUITING

Emory University Winship Cancer Institute

Atlanta, Georgia, United States

RECRUITING

University of Chicago

Chicago, Illinois, United States

COMPLETED

Norton Cancer Institute

Louisville, Kentucky, United States

RECRUITING

University of Michigan Health System

Ann Arbor, Michigan, United States

RECRUITING

Washington University School Of Medicine

St Louis, Missouri, United States

RECRUITING

NYU Langone Health

New York, New York, United States

ACTIVE_NOT_RECRUITING

...and 68 more locations

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.

Time frame: Up to 2 years and 10 months

Overall Survival (OS)

OS is defined as the time from the date of first dose of study drug to the date of the participant's death.

Time frame: Up to 2 years and 10 months

Minimal Residual Disease (MRD) Negative Rate

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.

Time frame: Up to 2 years and 10 months

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.

Time frame: Up to 2 years and 10 months

Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability

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.

Time frame: Up to 2 years and 10 months

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). 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.

Time frame: Up to 2 years and 10 months

Number of Participants with Abnormalities in Clinical Laboratory Values

Number of participants with abnormalities in clinical laboratory values (such as hematology, serum chemistry and coagulation) will be reported.

Time frame: Up to 2 years and 10 months

Serum Concentration of Talquetamab

Serum samples will be analyzed to determine concentrations of talquetamab.

Time frame: Up to 2 years and 10 months

Number of Participants with Talquetamab Antibodies

Antibodies to talquetamab will be assessed to evaluate potential immunogenicity.

Time frame: Up to 2 years and 10 months

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)

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.

Time frame: Baseline up to 2 years and 10 months

Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L)

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.

Time frame: Baseline up to 2 years and 10 months

Change from Baseline in HRQoL as Assessed by Patient Global Impression of Severity (PGIS)

The PGIS is a single item that assesses severity of the participant's health state, on a 5-point verbal rating scale. Score ranges from 1 (None) to 5 (Very Severe).

Time frame: Baseline up to 2 years and 10 months

Overall Response Rate (ORR) in Participants with High-risk Molecular Features

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.

Time frame: Up to 2 years and 10 months