A Study of Teclistamab in Japanese Participants With Relapsed or Refractory Multiple Myeloma

June 4, 2026 updated by: Janssen Pharmaceutical K.K.

A Phase 1/2 Study of JNJ-64007957, a Humanized BCMA * CD3 Bispecific Antibody in Japanese Patients With Relapsed or Refractory Multiple Myeloma

The purpose of the study is to evaluate the safety and tolerability in Japanese participants with relapsed or refractory multiple myeloma (RRMM) at the recommended Phase 2 dose (RP2D) identified in Study 64007957MMY1001 (NCT03145181) in Phase 1 part and to evaluate the efficacy of teclistamab at RP2D for Japanese participants in Phase 2 part.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Japan
      • Chiba, Japan, 296-8602
        • Kameda Medical Center
      • Gifu, Japan, 503-8502
        • Ogaki Municipal Hospital
      • Higashiibaraki-gun, Japan, 311-3193
        • National Hospital Organization Mito Medical Center
      • Kobe, Japan, 650 0047
        • Kobe City Medical Center General Hospital
      • Kumamoto, Japan, 860-0008
        • National Hospital Organization Kumamoto Medical Center
      • Kurume, Japan, 830-0011
        • Kurume University Hospital
      • Kyoto, Japan, 603-8151
        • Kyoto Kuramaguchi Medical Center
      • Matsumoto, Japan, 399-8701
        • National Hospital Organization Matsumoto Medical Center
      • Nagoya, Japan, 467 8602
        • Nagoya City University Hospital
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital
      • Okayama, Japan, 701-1192
        • National Hospital Organization Okayama Medical Center
      • Osaka, Japan, 543-8555
        • Japanese Red Cross Osaka Hospital
      • Osaka, Japan, 541 8567
        • Osaka International Cancer Institute
      • Shibuya City, Japan, 150-8935
        • Japanese Red Cross Medical Center
      • Ōtake, Japan, 739-0696
        • National Hospital Organization Hiroshima-Nishi Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Documented diagnosis of multiple myeloma (MM) according to International Myeloma Working Group (IMWG) diagnostic criteria
  • Participant must have measurable disease defined by any of the following: Serum M-protein level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); Urine M-protein level >= 200 milligrams per 24 hours (mg/24 hours); or Light chain MM, for participants without measurable disease in the serum or urine: serum Ig-free light chain (FLC) >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa-lambda FLC ratio; or if central laboratory assessments are not available, relevant local laboratory measurements must exceed the minimum required level by at least 25 percent (%)
  • Participant must be relapsed or refractory to established therapies with known clinical benefit in relapsed/refractory MM or be intolerant to established MM therapies and a candidate for teclistamab treatment in the opinion of the treating physician. Prior lines of therapy must include a proteasome inhibitors (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody in any order during the course of treatment. Participants who could not tolerate PI, immunomodulatory drugs, or anti-CD38 antibody are allowed
  • Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 at screening and immediately before the start of study treatment administration
  • Woman of childbearing potential must have a negative pregnancy test at screening and within 24 hours prior to the first dose of study treatment using highly sensitive pregnancy test either serum (beta-human chorionic gonadotropin [beta-hCG]) or urine

Exclusion criteria:

  • Prior treatment with any B cell maturation antigen (BCMA)-targeted therapy
  • Toxicities from previous anticancer therapies that have not resolved to baseline levels or to less than or equal to (<=) Grade 1 except for alopecia or peripheral neuropathy
  • Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within the 14-day period before the first step-up dose of study treatment (does not include pretreatment medication)
  • Stem cell transplantation: An allogeneic stem cell transplant within 6 months. Participants who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease; Received an autologous stem cell transplant less than or equal (<=) 12 weeks before the first step-up dose of study treatment
  • Central nervous system involvement or clinical signs of meningeal involvement of MM. If either is suspected, whole brain magnetic resonance imaging (MRI) and lumbar cytology are required during screening

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?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Japanese Participants with Relapsed or Refractory Multiple Myeloma (MM)
Japanese participants will receive Teclistamab subcutaneously (SC) at four dose levels. Cohort 1 will receive Teclistamab at Dose 1 and 2 (step-up doses) prior to first treatment dose on Day 1 followed by Dose 3 weekly (that is, on Days 1,8, and 15 of a 21-day cycle). Cohort 2 will receive Teclistamab at Dose 1 and 4 (step up doses) prior to first treatment dose on Day 1 followed by Dose 5 weekly. Cohort 3 will receive Teclistamab at Dose 1, 4, and 5 (step up doses) prior to first treatment dose on Day 1 followed by Dose 6 weekly. Cohort 4 will receive Teclistamab at Dose 1, 4, and 5 (step up doses) prior to first treatment dose on Day 1 followed by Dose 7 weekly for (2 cycles), then biweekly (cycle 3 to 6) on Days 1 and 15 and monthly (cycle 7) on Day 1 of 1 28-day cycle. In Phase 2 , participants will receive Teclistamab SC at Dose 1 and 4 (step up doses) up to 8 days prior to first treatment dose on Day 1 followed by Dose 5 on Days 1,8,15, and 22 of a 28-day cycle.
Drug: Teclistamab
Teclistamab will be administered subcutaneously.
Other Names:
  • JNJ-64007957

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Phase 1: Number of Participants with Adverse Events (AE)
Time Frame: Up to 1 year and 5 months
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.
Up to 1 year and 5 months
Phase 1: Number of Participants with Serious Adverse Events (SAE)
Time Frame: Up to 1 year and 5 months
A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
Up to 1 year and 5 months
Phase 1: Number of Participants with Dose Limiting Toxicity (DLT)
Time Frame: Up to 28 days
Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Up to 28 days
Phase 2: Overall response rate (ORR)
Time Frame: Up to 1 year and 5 months
ORR is defined as the percentage of participants who have a partial response (PR) or better according to the 2016 International Myeloma Working Group (IMWG) response criteria.
Up to 1 year and 5 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Phase 1 and Phase 2: Serum Concentration of Teclistamab
Time Frame: Up to 1 year and 5 months
Serum concentration of Teclistamab will be assessed.
Up to 1 year and 5 months
Phase 1: Systemic Cytokine Concentrations
Time Frame: Up to 1 year and 5 months
Cytokines concentration will be measured for biomarker assessment.
Up to 1 year and 5 months
Phase 1 and Phase 2: Number of Participants with Anti-teclistamab Antibodies
Time Frame: Up to 1 year and 5 months
Number of participants with anti-teclistamab antibodies will be assessed.
Up to 1 year and 5 months
Phase 1: Objective Response Rate
Time Frame: Up to 1 year and 5 months
Objective response will be defined as partial response (PR) or better as defined by the 2016 IMWG response criteria in multiple myeloma (MM).
Up to 1 year and 5 months
Phase 1 and Phase 2: Duration of Response (DOR)
Time Frame: Up to 1 year and 5 months
DOR is defined as the duration 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 2016 IMWG criteria, or death.
Up to 1 year and 5 months
Phase 1 and Phase 2: Time to Response (TTR)
Time Frame: Up to 1 year and 5 months
TTR is defined as the time between date of first dose of study treatment and the first efficacy evaluation that the participant has met all criteria for PR or better.
Up to 1 year and 5 months
Phase 2: Very Good Partial Response (VGPR) or Better Response Rate (Stringent Complete Response [sCR]+ Complete Response [CR]+VGPR)
Time Frame: Up to 1 year and 5 months
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 2016 IMWG response criteria.
Up to 1 year and 5 months
Phase 2: Complete Response (CR) or Better Response Rate
Time Frame: Up to 1 year and 5 months
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.
Up to 1 year and 5 months
Phase 2: Stringent Complete Response (sCR) Rate
Time Frame: Up to 1 year and 5 months
sCR rate is defined as the percentage of participants who achieve an sCR according to the IMWG 2016 criteria.
Up to 1 year and 5 months
Phase 2: Progression-free Survival (PFS)
Time Frame: Up to 1 year and 5 months
PFS is defined as the time from the date of first dose of study drug to the date of first documented disease progression, as defined in the 2016 IMWG response criteria, or death due to any cause, whichever occurs first.
Up to 1 year and 5 months
Phase 2: Overall survival (OS)
Time Frame: Up to 1 year and 5 months
OS is defined as the time from the date of first dose of study drug to the date of the participant's death. If the participant is alive or the vital status is unknown, then the participant's data will be censored at the date the participant was last known to be alive.
Up to 1 year and 5 months
Phase 2: Minimal Residual Disease (MRD)-negative Rate
Time Frame: Up to 1 year and 5 months
MRD-negative rate is defined as the percentage of participants who achieved MRD-negative status to a threshold of 10^-5 at any timepoint after initial dose of teclistamab and before disease progression or starting subsequent therapy.
Up to 1 year and 5 months
Phase 2: Number of Participants with AEs
Time Frame: Up to 1 year and 5 months
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.
Up to 1 year and 5 months
Phase 2: Number of Participants with AEs by Severity
Time Frame: Up to 1 year and 5 months
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), which will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. 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.
Up to 1 year and 5 months
Phase 2: Number of Participants with SAEs
Time Frame: Up to 1 year and 5 months
A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
Up to 1 year and 5 months
Phase 2: Number of Participants with SAEs by Severity
Time Frame: Up to 1 year and 5 months
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), which will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. 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.
Up to 1 year and 5 months
Phase 2: Number of Participants with Abnormalities in Clinical Laboratory Test Values
Time Frame: Up to 1 year and 5 months
Number of participants with abnormalities in clinical laboratory test values of hematology, serum chemistry, and coagulation will be reported.
Up to 1 year and 5 months
Phase 2: Number of Participants with Abnormalities in Clinical Laboratory Test Values by Severity
Time Frame: Up to 1 year and 5 months
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), which will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. 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.
Up to 1 year and 5 months
Phase 2: Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score
Time Frame: Up to 1 year and 5 months
Change from baseline in EORTC- QLQ-C30 score will be reported. The EORTC- QLQ-C30 Version 3 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 item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.
Up to 1 year and 5 months
Phase 2: Change from Baseline in EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L) Scale
Time Frame: Up to 1 year and 5 months
Change from baseline in EQ-5D-5L scale will be reported. The EQ-5D-5L is a generic measure of health status. 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).
Up to 1 year and 5 months
Phase 2: Change from Baseline in Patient Global Impression of Severity (PGIS) Scale
Time Frame: Up to 1 year and 5 months
Change from baseline in PGIS scale will be reported. The PGIS is a single item that assesses severity of the participant's health state, on a 5-point verbal rating scale (1: None, 2: Mild, 3: Moderate, 4: Severe, 5: Very Severe) at the time of completing the PRO measure. Higher score indicate greater severity.
Up to 1 year and 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Pharmaceutical K.K.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Pharmaceutical K.K., Japan Clinical trials, Janssen Pharmaceutical K.K.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 13, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 13, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108949
  • 64007957MMY1002 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hematologic Malignancies

Clinical Trials on Teclistamab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings