A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-1)

June 4, 2026 updated by: Janssen Research & Development, LLC

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Study record NCT03145181 is Phase 1 part of this study and study record NCT04557098 is Phase 2 part of this study.

Study Type

Interventional

Enrollment (Actual)

194

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Universitair Ziekenhuis Gent - UZ GENT
      • Leuven, Belgium, 3000
        • Universitaire Ziekenhuizen Leuven
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Arthur J E Child Comprehensive Cancer Centre
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network UHN Princess Margaret Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre
  • China
      • Beijing, China, 100034
        • Peking University First Hospital
      • Chengdu, China, 610041
        • West China Hospital Si Chuan University
      • Guangzhou, China, 510060
        • Sun Yat -Sen University Cancer Center
      • Hangzhou, China, 310003
        • First Affiliated Hospital of Zhejiang University
      • Shanghai, China, 200003
        • Shanghai Changzheng Hospital
      • Shenyang, China, 110134
        • Shengjing Hospital of China Medical University
      • Tianjin, China, 30060
        • Tianjin Medical University Cancer Institute and Hospital
      • Xi'an, China, 710004
        • The Second Affiliated Hospital of Xi'an Jiaotong University
  • France
      • Lille, France, 59000
        • Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez
      • Lyon, France, 69002
        • Centre Hospitalier Lyon Sud
      • Nantes, France, 44093
        • C.H.U. Hotel Dieu - France
      • Poitiers, France, 86000
        • CHU Poitiers - Hôpital la Milétrie
      • Toulouse, France, 31059
        • Pôle IUC Oncopole CHU
      • Tours, France, 37044
        • CHRU Hôpital Bretonneau
  • Germany
      • Heidelberg, Germany, 69120
        • Universitaetsklinikum Heidelberg
      • Leipzig, Germany, 04103
        • Universitaetsklinikum Leipzig
      • Tübingen, Germany, 72076
        • Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
      • Würzburg, Germany, 97080
        • Universitätsklinikum Würzburg
  • Italy
      • Bergamo, Italy, 24127
        • Azienda Ospedaliera Papa Giovanni XXIII
      • Bologna, Italy, 40138
        • Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi
      • Milan, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • VU Medisch Centrum
  • Spain
      • Badalona, Spain, 08916
        • Hosp. Univ. Germans Trias I Pujol
      • Barcelona, Spain, 08036
        • Hosp Clinic de Barcelona
      • Madrid, Spain, 28041
        • Hosp. Univ. 12 de Octubre
      • Pamplona, Spain, 31008
        • Clinica Univ. de Navarra
      • Pozuelo de Alarcón, Spain, 28223
        • Hosp. Quiron Madrid Pozuelo
      • Salamanca, Spain, 37007
        • Hosp Clinico Univ de Salamanca
      • Santander, Spain, 39008
        • Hosp. Univ. Marques de Valdecilla
  • Sweden
      • Gothenburg, Sweden, 413 45
        • Sahlgrenska University Hospital
      • Lund, Sweden, 221 85
        • Skåne University Hospital
      • Stockholm, Sweden, SE-141 86
        • Haematology Centre, R 51
  • United Kingdom
      • London, United Kingdom, NW1 2PG
        • University College Hospital
      • Sothampton, United Kingdom, SO16 6YD
        • University Hospital Southampton
      • Sutton, United Kingdom, SM2 5PT
        • Royal Marsden Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • California
      • Duarte, California, United States, 91010
        • City of Hope
      • San Francisco, California, United States, 94143
        • University of California San Francisco
      • Stanford, California, United States, 94305-5623
        • Stanford University Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute Emory University
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Barbara Ann Karmanos Cancer Institute
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: -

  • Documented diagnosis of multiple myeloma according to IMWG diagnostic criteria
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  • Measurable disease: Cohort A and Cohort C: Multiple myeloma must be measurable by central laboratory assessment
  • A female participant of childbearing potential must have a negative pregnancy test at screening
  • Willing and able to adhere to the prohibitions and restrictions specified in this protocol
  • Cohort A: received at least >=3 prior lines of therapy and previously received a PI, an IMiD and an anti-CD38 monoclonal antibody; Cohort C: received >= 3 prior lines of therapy that included a PI, an IMiD, an anti-CD38 monoclonal antibody, and an anti-B cell maturation antigen (BCMA) treatment (with CART-T cells or an antibody drug conjugate (ADC)

Exclusion Criteria:

  • Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light-chain amyloidosis
  • The following medical conditions: Pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency virus (HIV) infection, hepatitis B or C infection, stroke or seizure less than or equal to (<=) 6 m, autoimmune disease, uncontrolled systemic infection, cardiac conditions (Myocardial Infarction <= 6 m, stage III-IV congestive heart failure, etc)
  • Received any therapy that is targeted to BCMA, with the exception of Cohort C in Part 3
  • Prior antitumor therapy, within 21 days (PI or radiotherapy within 14 days, IMiDs within 7 days, Gene modified adoptive cell therapy within 3 months) prior to first dose of study drug
  • Toxicities from previous anticancer therapies that have not resolved to baseline or 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 dose of study drug (does not include pretreatment medication)
  • Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma (MM)
  • Myelodysplastic syndrome or active malignancies other than relapsed/refractory multiple myeloma with exceptions are: 1) Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured 2) Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured. 3) Noninvasive cervical cancer treated within the last 24 months that is considered completely cured. 4) Localized prostate cancer (N0M0) 5) Breast cancer: Adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence. 6) Malignancy that is considered cured with minimal risk of recurrence
  • Prior allogenic stem cell transplant <=6 months
  • Prior autologous stem cell transplant <=12 weeks
  • Live, attenuated vaccine within 4 weeks prior to the first dose of teclistamab

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 3: Teclistamab
Participants will receive teclistamab subcutaneously (SC) at recommended Phase 2 dose (RP2D) in Cohort A and Cohort C.
Drug: Teclistamab
Teclistamab will be administered SC.
Other Names:
  • JNJ-64007957

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohorts A and C: Overall Response Rate (ORR)
Time Frame: Up to 2.9 years
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.
Up to 2.9 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohorts A and C: Duration of Response (DOR)
Time Frame: Up to 2.9 years
DOR will be calculated among responders (with a PR or better response) 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, or death due to PD, whichever occurs first.
Up to 2.9 years
Cohorts A and C: Very Good Partial Response (VGPR) or Better Rate
Time Frame: Up to 2.9 years
VGPR or better rate is defined as the percentage of patients who achieve a VGPR or better according to IMWG response criteria.
Up to 2.9 years
Cohorts A and C: Cohorts A and C: Complete Response (CR) or Better Rate
Time Frame: Up to 2.9 years
CR or better rate is defined as the percentage of patients who achieve a complete response (CR) or better according to IMWG response criteria.
Up to 2.9 years
Cohorts A and C: Stringent Complete Response (sCR) Rate
Time Frame: Up to 2.9 years
sCR rate is defined as the percentage of patients who achieve a stringent complete response (sCR) according to IMWG response criteria.
Up to 2.9 years
Cohorts A and C: Time to Response (TTR)
Time Frame: Up to 2.9 years
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.
Up to 2.9 years
Cohorts A and C: Progression-free Survival (PFS)
Time Frame: Up to 2.9 years
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 IMWG criteria, or death due to any cause, whichever occurs first.
Up to 2.9 years
Cohorts A and C: Overall Survival (OS)
Time Frame: Up to 2.9 years
OS is defined as the time from the date of first dose of study drug to the date of the participant's death.
Up to 2.9 years
Cohorts A and C: Minimal Residual Disease (MRD) Negative Rate
Time Frame: Up to 2.9 years
MRD-negative rate is defined as the proportion 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 2.9 years
Cohorts A and C: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Time Frame: Up to 2.9 years
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.
Up to 2.9 years
Cohorts A and C: Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
Time Frame: Up to 2.9 years
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 experience, 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.
Up to 2.9 years
Cohorts A and C: Number of Participants with AEs by Severity
Time Frame: Up to 2.9 years
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.
Up to 2.9 years
Cohorts A and C: Number of Participants with Laboratory Abnormalities in Clinical Laboratory Values
Time Frame: Up to 2.9 years
Number of participants with laboratory abnormalities in clinical laboratory values (such as hemoglobin, platelets) will be reported.
Up to 2.9 years
Cohorts A and C: Serum Concentration of Teclistamab
Time Frame: Up to 3 months
Serum concentrations of teclistamab will be reported.
Up to 3 months
Cohorts A and C: Number of Participants with Teclistamab Antibodies
Time Frame: Up to 2.9 years
Antibodies to teclistamab will be assessed to evaluate potential immunogenicity.
Up to 2.9 years
Cohorts A and C: 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)
Time Frame: Baseline, up to 2.9 years
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.
Baseline, up to 2.9 years
Cohorts A and C: Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L)
Time Frame: Baseline, up to 2.9 years
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.
Baseline, up to 2.9 years
Cohorts A and C: Change from Baseline in HRQoL as Assessed by Patient Global Impression of Severity (PGIS)
Time Frame: Baseline, up to 2.9 years
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).
Baseline, up to 2.9 years
Cohorts A and C: Overall Response Rate (ORR) in Participants with High-risk Molecular Features
Time Frame: Up to 2.9 years
ORR in participants with high risk is defined as the overall response rate among the high-risk molecular subgroups (del17p, t(4;14), t(14;16), or other high-risk molecular subtypes).
Up to 2.9 years

Collaborators and Investigators

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

Sponsor

Janssen Research & Development, LLC

Investigators

  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

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

Helpful Links

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)

September 17, 2020

Primary Completion (Actual)

November 9, 2021

Study Completion (Estimated)

May 28, 2027

Study Registration Dates

First Submitted

September 17, 2020

First Submitted That Met QC Criteria

September 17, 2020

First Posted (Actual)

September 21, 2020

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR108859
  • 2016-002122-36 (EudraCT Number)
  • TECLIMMY1001-P3 (Other Identifier: Janssen Research & Development, LLC)
  • 2023-503438-40-00 (Registry Identifier: EUCT number)

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/clinicaltrials/ 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

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.

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