search
Back to results

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

Primary Purpose

Hematological Malignancies

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Teclistamab
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematological Malignancies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, Cohort C and Cohort D: 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
  • Cohorts A and D: received at least 3 prior MM treatment lines of therapy. Prior therapy must include an IMiD, PI, and 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

Sites / Locations

  • University of Alabama at Birmingham
  • City of Hope
  • University of California, San Francisco
  • Stanford University Medical Center
  • Winship Cancer Institute Emory University
  • Barbara Ann Karmanos Cancer Institute
  • Icahn School of Medicine at Mount Sinai
  • Memorial Sloan-Kettering Cancer Center
  • Levine Cancer Institute
  • University of Pennsylvania
  • Universitair Ziekenhuis Gent - UZ GENT
  • Universitaire Ziekenhuizen Leuven
  • Tom Baker Cancer Centre
  • Cross Cancer Institute
  • University Health Network (UHN) Princess Margaret Cancer Centre
  • McGill University Health Centre
  • Peking University First Hospital
  • West China Hospital, Si Chuan University
  • Sun Yat -Sen University Cancer Center
  • First affiliated Hospital of Zhejiang University
  • Shanghai Changzheng Hospital
  • Shengjing Hospital of China Medical University
  • Tianjin Medical University Cancer Institute and Hospital
  • The Second Affiliated Hospital of Xi'an Jiaotong University
  • Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez
  • C.H.U. Hotel Dieu - France
  • Centre Hospitalier Lyon Sud
  • CHRU Hôpital Jean Bernard
  • Pôle IUC Oncopole CHU
  • CHRU Hôpital Bretonneau
  • Universitaetsklinikum Heidelberg
  • Universitaetsklinikum Leipzig
  • Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
  • Universitätsklinikum Würzburg
  • Azienda Ospedaliera Papa Giovanni XXIII
  • Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • VU Medisch Centrum
  • Hosp. Univ. Germans Trias I Pujol
  • Hosp. Clinic I Provincial de Barcelona
  • Hosp. Univ. 12 de Octubre
  • Clinica Univ. de Navarra
  • Hosp. Quiron Madrid Pozuelo
  • Hosp. Clinico Univ. de Salamanca
  • Hosp. Univ. Marques de Valdecilla
  • Sahlgrenska University Hospital
  • Skane University Hospital
  • Haematology Centre, R 51
  • University College Hospital
  • University Hospital Southampton
  • Royal Marsden Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Part 3: Teclistamab

Arm Description

Participants will receive teclistamab subcutaneously (SC) at recommended Phase 2 dose (RP2D) (Cohort A and Cohort C) and will receive alternative dosing schedule of teclistamab (Cohort D).

Outcomes

Primary Outcome Measures

Cohorts A and C: 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.
Cohort D: 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.
Cohort D: 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 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.
Cohort D: 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.
Cohort D: Number of Participants with Laboratory Abnormalities in Clinical Laboratory Values
Number of participants with laboratory abnormalities in clinical laboratory values (such as hemoglobin, platelets) will be reported.
Cohort D: Serum Concentration of Teclistamab
Serum concentrations of teclistamab will be reported.

Secondary Outcome Measures

Cohorts A and C: Duration of Response (DOR)
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.
Cohorts A and C: 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.
Cohorts A and C: Cohorts A and C: Complete Response (CR) or Better Rate
CR or better rate is defined as the percentage of patients who achieve a complete response (CR) or better according to IMWG response criteria.
Cohorts A and C: Stringent Complete Response (sCR) Rate
sCR rate is defined as the percentage of patients who achieve a stringent complete response (sCR) according to IMWG response criteria.
Cohorts A and C: 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.
Cohorts A and C: Progression-free Survival (PFS)
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.
Cohorts A and C: 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.
Cohorts A and C: Minimal Residual Disease (MRD) Negative Rate
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
Cohorts A and C: 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.
Cohorts A and C: 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 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.
Cohorts A and C: 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.
Cohorts A and C: Number of Participants with Laboratory Abnormalities in Clinical Laboratory Values
Number of participants with laboratory abnormalities in clinical laboratory values (such as hemoglobin, platelets) will be reported.
Cohorts A and C: Serum Concentration of Teclistamab
Serum concentrations of teclistamab will be reported.
Cohorts A and C: Number of Participants with Teclistamab Antibodies
Antibodies to teclistamab will be assessed to evaluate potential immunogenicity.
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)
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.
Cohorts A and C: 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.
Cohorts A and C: 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).
Cohorts A and C: 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 (del17p, t(4;14), t(14;16), or other high-risk molecular subtypes).

Full Information

First Posted
September 17, 2020
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT04557098
Brief Title
A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
Acronym
MajesTEC-1
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 17, 2020 (Actual)
Primary Completion Date
March 13, 2025 (Anticipated)
Study Completion Date
May 27, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D).
Detailed Description
Study record NCT03145181 is Phase 1 part of this study and study record NCT04557098 is Phase 2 part of this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Malignancies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 3: Teclistamab
Arm Type
Experimental
Arm Description
Participants will receive teclistamab subcutaneously (SC) at recommended Phase 2 dose (RP2D) (Cohort A and Cohort C) and will receive alternative dosing schedule of teclistamab (Cohort D).
Intervention Type
Drug
Intervention Name(s)
Teclistamab
Other Intervention Name(s)
JNJ-64007957
Intervention Description
Teclistamab will be administered SC.
Primary Outcome Measure Information:
Title
Cohorts A and C: Overall Response Rate (ORR)
Description
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 2.9 years
Title
Cohort D: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Description
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 2.9 years
Title
Cohort D: Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
Description
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.
Time Frame
Up to 2.9 years
Title
Cohort D: Number of Participants with AEs by Severity
Description
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 2.9 years
Title
Cohort D: Number of Participants with Laboratory Abnormalities in Clinical Laboratory Values
Description
Number of participants with laboratory abnormalities in clinical laboratory values (such as hemoglobin, platelets) will be reported.
Time Frame
Up to 2.9 years
Title
Cohort D: Serum Concentration of Teclistamab
Description
Serum concentrations of teclistamab will be reported.
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
Cohorts A and C: Duration of Response (DOR)
Description
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.
Time Frame
Up to 2.9 years
Title
Cohorts A and C: Very Good Partial Response (VGPR) or Better Rate
Description
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 2.9 years
Title
Cohorts A and C: Cohorts A and C: Complete Response (CR) or Better Rate
Description
CR or better rate is defined as the percentage of patients who achieve a complete response (CR) or better according to IMWG response criteria.
Time Frame
Up to 2.9 years
Title
Cohorts A and C: Stringent Complete Response (sCR) Rate
Description
sCR rate is defined as the percentage of patients who achieve a stringent complete response (sCR) according to IMWG response criteria.
Time Frame
Up to 2.9 years
Title
Cohorts A and C: Time to Response (TTR)
Description
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 2.9 years
Title
Cohorts A and C: Progression-free Survival (PFS)
Description
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.
Time Frame
Up to 2.9 years
Title
Cohorts A and C: Overall Survival (OS)
Description
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 2.9 years
Title
Cohorts A and C: Minimal Residual Disease (MRD) Negative Rate
Description
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
Time Frame
Up to 2.9 years
Title
Cohorts A and C: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Description
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 2.9 years
Title
Cohorts A and C: Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
Description
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.
Time Frame
Up to 2.9 years
Title
Cohorts A and C: Number of Participants with AEs by Severity
Description
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 2.9 years
Title
Cohorts A and C: Number of Participants with Laboratory Abnormalities in Clinical Laboratory Values
Description
Number of participants with laboratory abnormalities in clinical laboratory values (such as hemoglobin, platelets) will be reported.
Time Frame
Up to 2.9 years
Title
Cohorts A and C: Serum Concentration of Teclistamab
Description
Serum concentrations of teclistamab will be reported.
Time Frame
Up to 3 months
Title
Cohorts A and C: Number of Participants with Teclistamab Antibodies
Description
Antibodies to teclistamab will be assessed to evaluate potential immunogenicity.
Time Frame
Up to 2.9 years
Title
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)
Description
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 2.9 years
Title
Cohorts A and C: Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L)
Description
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 2.9 years
Title
Cohorts A and C: Change from Baseline in HRQoL as Assessed by Patient Global Impression of Severity (PGIS)
Description
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 2.9 years
Title
Cohorts A and C: Overall Response Rate (ORR) in Participants with High-risk Molecular Features
Description
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).
Time Frame
Up to 2.9 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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, Cohort C and Cohort D: 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 Cohorts A and D: received at least 3 prior MM treatment lines of therapy. Prior therapy must include an IMiD, PI, and 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5623
Country
United States
Facility Name
Winship Cancer Institute Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Universitair Ziekenhuis Gent - UZ GENT
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitaire Ziekenhuizen Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
University Health Network (UHN) Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
West China Hospital, Si Chuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Sun Yat -Sen University Cancer Center
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Facility Name
First affiliated Hospital of Zhejiang University
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
ZIP/Postal Code
200003
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
ZIP/Postal Code
110004
Country
China
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
ZIP/Postal Code
30060
Country
China
Facility Name
The Second Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
ZIP/Postal Code
710004
Country
China
Facility Name
Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez
City
Lille Cedex
ZIP/Postal Code
59000
Country
France
Facility Name
C.H.U. Hotel Dieu - France
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
CHRU Hôpital Jean Bernard
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Pôle IUC Oncopole CHU
City
Toulouse cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
CHRU Hôpital Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Universitaetsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitaetsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Azienda Ospedaliera Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
VU Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Hosp. Univ. Germans Trias I Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hosp. Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Clinica Univ. de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hosp. Quiron Madrid Pozuelo
City
Pozuelo de Alarcon
ZIP/Postal Code
28223
Country
Spain
Facility Name
Hosp. Clinico Univ. de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hosp. Univ. Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Sahlgrenska University Hospital
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Skane University Hospital
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Haematology Centre, R 51
City
Stockholm
ZIP/Postal Code
SE-141 86
Country
Sweden
Facility Name
University College Hospital
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
University Hospital Southampton
City
Sothampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency
Citations:
PubMed Identifier
35661166
Citation
Moreau P, Garfall AL, van de Donk NWCJ, Nahi H, San-Miguel JF, Oriol A, Nooka AK, Martin T, Rosinol L, Chari A, Karlin L, Benboubker L, Mateos MV, Bahlis N, Popat R, Besemer B, Martinez-Lopez J, Sidana S, Delforge M, Pei L, Trancucci D, Verona R, Girgis S, Lin SXW, Olyslager Y, Jaffe M, Uhlar C, Stephenson T, Van Rampelbergh R, Banerjee A, Goldberg JD, Kobos R, Krishnan A, Usmani SZ. Teclistamab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2022 Aug 11;387(6):495-505. doi: 10.1056/NEJMoa2203478. Epub 2022 Jun 5.
Results Reference
derived
Links:
URL
https://clinicaltrials.gov/ct2/show/NCT03145181
Description
Dose Escalation Study of JNJ-64007957, a Humanized BCMA CD3 DuoBody® Antibody, in Participants With Relapsed or Refractory Multiple Myeloma

Learn more about this trial

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

We'll reach out to this number within 24 hrs