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

Primary Purpose

Hematological Malignancies

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Talquetamab
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 focused on measuring Multiple Myeloma

Eligibility Criteria

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

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, and 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

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: T cell redirection therapy within 3 months
  • Vaccinated with live, attenuated vaccine within 4 weeks or as recommended by the product manufacturer prior to the first dose, during treatment, or within 100 days of the last dose of talquetamab
  • 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)

Sites / Locations

  • University of Alabama BirminghamRecruiting
  • University of Arkansas for Medical SciencesRecruiting
  • City of HopeRecruiting
  • Emory University - Winship Cancer InstituteRecruiting
  • University of ChicagoRecruiting
  • Norton Cancer InstituteRecruiting
  • University of Michigan Health SystemRecruiting
  • Washington University School of MedicineRecruiting
  • NYU Langone HealthRecruiting
  • Mount Sinai Medical CenterRecruiting
  • University of Rochester Medical CenterRecruiting
  • Providence Portland Medical CenterRecruiting
  • Sarah Cannon Research InstituteRecruiting
  • UCL - Saint LucRecruiting
  • UZ AntwerpenRecruiting
  • UZ LeuvenRecruiting
  • CHU de Liège - Domaine Universitaire du Sart TilmanRecruiting
  • Peking University Third HospitalRecruiting
  • Sun Yat-Sen University Cancer CenterRecruiting
  • First affiliated Hospital of Zhejiang UniversityRecruiting
  • First Affiliated Hospital, SooChow UniversityRecruiting
  • Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical ScienceRecruiting
  • First Affiliated Hospital of Xi'an Jiaotong University School of MedicineRecruiting
  • CHU Henri MondorRecruiting
  • CHU de Montpellier, Hopital Saint-EloiRecruiting
  • C.H.U. Hotel Dieu - FranceRecruiting
  • CHU de Bordeaux - Hospital Haut-LevequeRecruiting
  • Centre hospitalier Lyon-SudRecruiting
  • Pôle IUC Oncopole CHURecruiting
  • Charite Campus Benjamin FranklinRecruiting
  • Universitaetsklinikum HeidelbergRecruiting
  • Universitaetsklinikum Muenster
  • Universitätsklinikum WürzburgRecruiting
  • Rambam Medical CenterRecruiting
  • Carmel Medical CenterRecruiting
  • Hadassah Medical CenterRecruiting
  • Sheba Medical CenterRecruiting
  • Tel Aviv Sourasky Medical CenterRecruiting
  • Kameda General HospitalRecruiting
  • Fukuoka University HospitalRecruiting
  • Ogaki Municipal HospitalRecruiting
  • Teine Keijinkai HospitalRecruiting
  • Kobe City Medical Center General HospitalRecruiting
  • Dokkyo Medical University Saitama Medical CenterRecruiting
  • Kumamoto University HospitalRecruiting
  • Kurashiki Central HospitalRecruiting
  • National Hospital Organization Matsumoto Medical CenterRecruiting
  • National Hospital Organization Okayama Medical CenterRecruiting
  • Japanese Red Cross Osaka HospitalRecruiting
  • Hiroshima West Medical CenterRecruiting
  • Iwate Medical University HospitalRecruiting
  • Chonnam National University Hwasun HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Asan Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • The Catholic University of Korea Seoul St. Mary's HospitalRecruiting
  • VU Medisch CentrumRecruiting
  • UMCU
  • Uniwersyteckie Centrum KliniczneRecruiting
  • Narodowy Instytut Onkologii im.Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz. w Gliwicach
  • Uniwersytecki Szpital Kliniczny w PoznaniuRecruiting
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut BadawczyRecruiting
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we WroclawiuRecruiting
  • Hosp. Univ. Germans Trias I PujolRecruiting
  • Hosp. Univ. Vall D HebronRecruiting
  • Inst. Cat. Doncologia-H Duran I ReynalsRecruiting
  • Hosp. Univ. Fund. Jimenez Diaz
  • Hosp. Univ. 12 de OctubreRecruiting
  • Hosp. Univ. Virgen de La ArrixacaRecruiting
  • Clinica Univ. de NavarraRecruiting
  • Hosp. Quiron Madrid PozueloRecruiting
  • Hosp. Clinico Univ. de SalamancaRecruiting
  • Hosp. Univ. Marques de ValdecillaRecruiting
  • Hosp. Virgen Del RocioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Part 3: Cohort A (Talquetamab)

Part 3: Cohort B (Talquetamab)

Part 3: Cohort C (Talquetamab)

Arm Description

Cohort A will enroll participants with multiple myeloma who have previously received greater than or equal to (>=) 3 prior lines of therapy and have not been exposed to T cell redirection therapies. Participants will receive talquetamab subcutaneously (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.

Cohort B will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy and have been exposed to T cell redirection therapies. Participants will receive talquetamab subcutaneously (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.

Cohort C will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy and have not been exposed to T cell redirection therapies. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Stringent Complete Response (sCR) Rate
sCR rate is defined as the percentage of patients who achieve sCR according to IMWG response criteria.
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.
Progression-Free Survival (PFS)
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)
OS is defined as the time from the date of first dose of study drug to the date of the participant's death.
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.
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.
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.
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.
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.
Serum Concentration of Talquetamab
Serum samples will be analyzed to determine concentrations of talquetamab.
Number of Participants with Talquetamab Antibodies
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)
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)
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)
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).
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.

Full Information

First Posted
November 16, 2020
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04634552
Brief Title
A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
Official Title
A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D 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
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
July 7, 2022 (Actual)
Study Completion Date
April 13, 2026 (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
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).
Detailed Description
Multiple myeloma is a malignant plasma cell disorder characterized by osteolytic lesions, increased susceptibility to infections, hypercalcemia, and renal failure. Talquetamab is a humanized immunoglobulin G4 proline, alanine, alanine (IgG4PAA) bispecific antibody designed to target G protein-coupled receptor family C group 5-member D (GPRC5D) and the CD3 molecule found on T lymphocytes (T cell). This study consists 3 periods: screening phase (up to 28 days), treatment phase (start of study drug administration and continues until the completion of the end of treatment [EOT (30 days (+ 7 days)] visit); and a post-treatment follow-up phase (until the end of study unless the participant has died, is lost to follow up or has withdrawn consent). Total duration of study is up to 2 years (after the last participant receives their first dose). Safety, pharmacokinetics (PK), laboratory tests, and questionnaire will be assessed at specified time points during this study. Participants safety and study conduct will be monitored throughout the study. The corresponding study (NCT03399799) is the Phase 1 part of the study and TALMMY1001- Part 3 is the Phase 2 part of the study.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 3: Cohort A (Talquetamab)
Arm Type
Experimental
Arm Description
Cohort A will enroll participants with multiple myeloma who have previously received greater than or equal to (>=) 3 prior lines of therapy and have not been exposed to T cell redirection therapies. Participants will receive talquetamab subcutaneously (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.
Arm Title
Part 3: Cohort B (Talquetamab)
Arm Type
Experimental
Arm Description
Cohort B will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy and have been exposed to T cell redirection therapies. Participants will receive talquetamab subcutaneously (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.
Arm Title
Part 3: Cohort C (Talquetamab)
Arm Type
Experimental
Arm Description
Cohort C will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy and have not been exposed to T cell redirection therapies. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study.
Intervention Type
Drug
Intervention Name(s)
Talquetamab
Other Intervention Name(s)
JNJ-64407564
Intervention Description
Talquetamab will be administered SC until disease progression.
Primary Outcome Measure Information:
Title
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 years and 10 months
Secondary Outcome Measure Information:
Title
Duration of Response (DOR)
Description
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
Title
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 years and 10 months
Title
Complete Response (CR) or Better Rate
Description
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
Title
Stringent Complete Response (sCR) Rate
Description
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
Title
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 years and 10 months
Title
Progression-Free Survival (PFS)
Description
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
Title
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 years and 10 months
Title
Minimal Residual Disease (MRD) Negative Rate
Description
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
Title
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 years and 10 months
Title
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, 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
Title
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 years and 10 months
Title
Number of Participants with Abnormalities in Clinical Laboratory Values
Description
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
Title
Serum Concentration of Talquetamab
Description
Serum samples will be analyzed to determine concentrations of talquetamab.
Time Frame
Up to 2 years and 10 months
Title
Number of Participants with Talquetamab Antibodies
Description
Antibodies to talquetamab will be assessed to evaluate potential immunogenicity.
Time Frame
Up to 2 years and 10 months
Title
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 years and 10 months
Title
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 years and 10 months
Title
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 years and 10 months
Title
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 or other high-risk molecular subtypes.
Time Frame
Up to 2 years and 10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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, and 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 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: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
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 Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory University - Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
UCL - Saint Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU de Liège - Domaine Universitaire du Sart Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Name
Sun Yat-Sen University Cancer Center
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Name
First affiliated Hospital of Zhejiang University
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Name
First Affiliated Hospital, SooChow University
City
Su Zhou
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Name
Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
City
Tianjin
ZIP/Postal Code
300320
Country
China
Individual Site Status
Recruiting
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University School of Medicine
City
Xi'an
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Name
CHU Henri Mondor
City
Creteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Montpellier, Hopital Saint-Eloi
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Name
C.H.U. Hotel Dieu - France
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Bordeaux - Hospital Haut-Leveque
City
Pessac cedex
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Name
Centre hospitalier Lyon-Sud
City
Pierre Benite cedex
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Name
Pôle IUC Oncopole CHU
City
Toulouse cedex 9
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Charite Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Muenster
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Completed
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Individual Site Status
Recruiting
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Recruiting
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Name
Kameda General Hospital
City
Chiba
ZIP/Postal Code
296-8602
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukuoka University Hospital
City
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ogaki Municipal Hospital
City
Gifu
ZIP/Postal Code
503-8502
Country
Japan
Individual Site Status
Recruiting
Facility Name
Teine Keijinkai Hospital
City
Hokkaido
ZIP/Postal Code
006-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kobe City Medical Center General Hospital
City
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Individual Site Status
Recruiting
Facility Name
Dokkyo Medical University Saitama Medical Center
City
Koshigaya
ZIP/Postal Code
343-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kurashiki Central Hospital
City
Kurashiki
ZIP/Postal Code
710-8602
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Matsumoto Medical Center
City
Matsumoto
ZIP/Postal Code
399-8701
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Okayama Medical Center
City
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Individual Site Status
Recruiting
Facility Name
Japanese Red Cross Osaka Hospital
City
Osaka
ZIP/Postal Code
543-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hiroshima West Medical Center
City
Otake
ZIP/Postal Code
739-0696
Country
Japan
Individual Site Status
Recruiting
Facility Name
Iwate Medical University Hospital
City
Shiwa-gun
ZIP/Postal Code
028-3695
Country
Japan
Individual Site Status
Recruiting
Facility Name
Chonnam National University Hwasun Hospital
City
Jeollanam-do
ZIP/Postal Code
58128
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
VU Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
UMCU
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Individual Site Status
Completed
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Recruiting
Facility Name
Narodowy Instytut Onkologii im.Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz. w Gliwicach
City
Gliwice
ZIP/Postal Code
44102
Country
Poland
Individual Site Status
Completed
Facility Name
Uniwersytecki Szpital Kliniczny w Poznaniu
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Individual Site Status
Recruiting
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
City
Wroclaw
ZIP/Postal Code
52-007
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Germans Trias I Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Vall D Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Inst. Cat. Doncologia-H Duran I Reynals
City
Barcelona
ZIP/Postal Code
8908
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Fund. Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Completed
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Virgen de La Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Univ. de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Quiron Madrid Pozuelo
City
Pozuelo de Alarcon
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinico Univ. de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting

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
Links:
URL
https://clinicaltrials.gov/ct2/show/NCT03399799
Description
Dose Escalation Study of JNJ-64407564 in Participants With Relapsed or Refractory Multiple Myeloma

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

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