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A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-9)

Primary Purpose

Relapsed or Refractory Multiple Myeloma

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Teclistamab
Pomalidomide
Bortezomib
Dexamethasone
Carfilzomib
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed or Refractory Multiple Myeloma

Eligibility Criteria

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

Inclusion Criteria:

  • Documented diagnosis of multiple myeloma as defined by the criteria below: (a)Multiple myeloma diagnosis according to International Myeloma Working Group (IMWG) diagnostic criteria (b) Measurable disease at screening as defined by any of the following: (1) Serum M-protein level greater than or equal to (>=)0.5 grams per deciliter (g/dL) (central laboratory); or (2) Urine M-protein level >=200 milligrams (mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain >=10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio
  • Received 1 to 3 prior lines of antimyeloma therapy including a minimum of 2 consecutive cycles of an anti- cluster of differentiation 38 (CD38) monoclonal antibody at the approved dosing regimen in any prior line and 2 consecutive cycles of lenalidomide in any prior line
  • Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by International myeloma working group (IMWG) criteria
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
  • A female participant must agree not to be pregnant, breast-feeding, or plan to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
  • Must be willing and able to adhere to the lifestyle restrictions specified in this protocol

Exclusion Criteria:

  • Received any prior B cell maturation antigen (BCMA)-directed therapy
  • A participant is not eligible to receive PVd as control therapy if any of the following are present: (1) Received prior pomalidomide therapy, (2) Does not meet criteria for bortezomib retreatment (3) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide or bortezomib, (4) Grade 1 peripheral neuropathy with pain or Grade greater than or equal to (>=) 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, (5) Received a strong cytochrome P (CYP) 3A4 inducer within 5 half-lives prior to randomization; A participant is not eligible to receive Kd as control therapy if any of the following are present:(1) Received prior carfilzomib therapy, (2) Uncontrolled hypertension, defined as an average systolic blood pressure greater than (>)159 millimeters of mercury (mmHg) or diastolic blood pressure >99 mmHg despite optimal treatment (3) Grade 2 peripheral neuropathy with pain or Grade >=3 peripheral neuropathy as defined by NCI-CTCAE Version 5.0, (4) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to carfilzomib (intolerance defined as prior therapy discontinued due to any adverse event [AE] related to carfilzomib)
  • Central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma.
  • Received a live, attenuated vaccine within 4 weeks before randomization
  • Plasma cell leukemia at the time of screening, Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein (POEMS) syndrome and skin changes, or primary amyloid light chain amyloidosis
  • Received a maximum cumulative dose of corticosteroids of >=140 mg of prednisone or equivalent within 14 days prior to randomization

Sites / Locations

  • MemorialCare Long Beach Medical CenterRecruiting
  • University of California, IrvineRecruiting
  • PIH Health HospitalRecruiting
  • Cleveland Clinic FloridaRecruiting
  • Tulane University Hospital & ClinicsRecruiting
  • Saint Luke's Hospital - Saint Luke's Cancer SpecialistsRecruiting
  • St. Vincent's Hospital MelbourneRecruiting
  • Box Hill HospitalRecruiting
  • Fiona Stanley HospitalRecruiting
  • Sir Charles Gairdner HospitalRecruiting
  • Algemeen Ziekenhuis KlinaRecruiting
  • JolimontRecruiting
  • Az GroeningeRecruiting
  • Universitair Ziekenhuis GasthuisbergRecruiting
  • Hospitais Integradaos da Gavea S/A - DF StarRecruiting
  • Instituto Joinvilense de Hematologia e Oncologia Ltda-Centro de Hematologia e OncologiaRecruiting
  • Liga Norte Riograndense Contra O CancerRecruiting
  • Complexo Hospitalar de NiteróiRecruiting
  • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)Recruiting
  • Hospital Sao RafaelRecruiting
  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de BaseRecruiting
  • Sociedade Beneficente de Senhoras - Hospital Sírio LibanêsRecruiting
  • Fundacao Antonio Prudente - A.C. Camargo Cancer CenterRecruiting
  • Instituto D'Or de Pesquisa e Ensino (IDOR)Recruiting
  • Real e Benemérita Associação Portuguesa de BeneficênciaRecruiting
  • Hospital Alemao Oswaldo CruzRecruiting
  • Clinica Sao GermanoRecruiting
  • Lakeridge Health OshawaRecruiting
  • Beijing Chaoyang HospitalRecruiting
  • The First Bethune Hospital of Jilin UniversityRecruiting
  • The Third Xiangya Hospital, Central South UniversityRecruiting
  • Sichuan Provincial People's HospitalRecruiting
  • Chongqing University Cancer HospitalRecruiting
  • Fujian Meidical University Union HospitalRecruiting
  • Sun Yat -Sen University Cancer CenterRecruiting
  • First affiliated Hospital of Zhejiang UniversityRecruiting
  • Harbin medical university cancer hospitalRecruiting
  • The First Affiliated Hospital of NanChang UniversityRecruiting
  • First Affiliated Hospital of Guangxi Medical UniversityRecruiting
  • Shengjing Hospital of China Medical UniversityRecruiting
  • Shenzhen 2nd People's HospitalRecruiting
  • Institute of Hematology & Blood Diseases HospitalRecruiting
  • The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
  • Wuhan Union HospitalRecruiting
  • Wuxi People's HospitalRecruiting
  • Fakultni nemocnice BrnoRecruiting
  • Fakultni nemocnice OstravaRecruiting
  • Vseobecna fakultni nemocnice v PrazeRecruiting
  • Aalborg University HospitalRecruiting
  • RigshospitaletRecruiting
  • Regionshospitalet GodstrupRecruiting
  • Vejle SygehusRecruiting
  • CHU Amiens - Hopital SudRecruiting
  • Hôpital Côte de NacreRecruiting
  • CHU GrenobleRecruiting
  • Centre Hospitalier du MansRecruiting
  • CHU de Montpellier, Hopital Saint-EloiRecruiting
  • CHU NantesRecruiting
  • Hopital de la Pitie SalpetriereRecruiting
  • Hôpital Necker Enfants MaladesRecruiting
  • Institut Universitaire du Cancer Toulouse OncopoleRecruiting
  • CHU de Nancy - Hôpital de BraboisRecruiting
  • Carl-Thiem-Klinikum Cottbus gGmbHRecruiting
  • Universitätsklinikum Carl Gustav Carus DresdenRecruiting
  • Universitätsmedizin GreifswaldRecruiting
  • Asklepios Klinik AltonaRecruiting
  • Universitaetsklinikum HeidelbergRecruiting
  • Heinrich-Braun-Klinikum gGmbHRecruiting
  • Alexandra General Hospital of AthensRecruiting
  • Agios Andreas General Hospital of PatraRecruiting
  • 'G. Papanikolaou' Hospital of ThessalonikiRecruiting
  • Bnai Zion Medical Center
  • Carmel Medical CenterRecruiting
  • Rabin Medical CenterRecruiting
  • Sheba Medical CenterRecruiting
  • Tel-Aviv Sourasky Medical CenterRecruiting
  • A.O.U Sant'Orsola-MalpighiRecruiting
  • Fondazione IRCCS Istituto Nazionale dei TumoriRecruiting
  • Azienda Ospedaliero Universitaria Policlinico Paolo GiacconeRecruiting
  • Arcispedale Santa Maria Nuova - IRCCSRecruiting
  • Campus Bio-Medico di RomaRecruiting
  • A.O. Universitaria Senese- Ospedale Santa Maria alle ScotteRecruiting
  • A.O.U. Citta della Salute e della Scienza di Torino - Presidio MolinetteRecruiting
  • ASUI Santa Maria della Misericordia di UdineRecruiting
  • Ospedale di Circolo e Fondazione MacchiRecruiting
  • Chiba Cancer CenterRecruiting
  • Ogaki Municipal HospitalRecruiting
  • Kansai Medical University HospitalRecruiting
  • Hitachi General HospitalRecruiting
  • Saitama Medical University HospitalRecruiting
  • Kameda General HospitalRecruiting
  • Kurashiki Central HospitalRecruiting
  • Matsuyama Red Cross HospitalRecruiting
  • JRC Nagasaki Genbaku HospitalRecruiting
  • Niigata University Medical & Dental HospitalRecruiting
  • National Hospital Organization Okayama Medical CenterRecruiting
  • Osaka Metropolitan University HospitalRecruiting
  • Hokkaido University HospitalRecruiting
  • Juntendo University HospitalRecruiting
  • The Cancer Institute Hospital of JFCRRecruiting
  • Yamanashi Prefectural Central HospitalRecruiting
  • Hospital Pulau PinangRecruiting
  • Hospital Queen ElizabethRecruiting
  • University Malaya Medical CentreRecruiting
  • Subang Jaya Medical CentreRecruiting
  • Meander Medisch CentrumRecruiting
  • VUMC AmsterdamRecruiting
  • Universitair Medisch Centrum GroningenRecruiting
  • UMC UtrechtRecruiting
  • Uniwersyteckie Centrum KliniczneRecruiting
  • Pratia Onkologia KatowiceRecruiting
  • Samodzielny Publiczny Szpital Kliniczny nr 1 w LublinieRecruiting
  • Hosp. Garcia de OrtaRecruiting
  • Champalimaud Foundation Champalimaud CentreRecruiting
  • Instituto Portugues de OncologiaRecruiting
  • Institut Catala d'Oncologia L'HospitaletRecruiting
  • Hosp. de Jerez de La FronteraRecruiting
  • Hosp. Univ. Infanta LeonorRecruiting
  • Hosp. Univ. Ramon Y CajalRecruiting
  • Hosp. Gral. Univ. J.M. Morales MeseguerRecruiting
  • Hospital Universitario Central de AsturiasRecruiting
  • Hosp. Son LlatzerRecruiting
  • Hosp. MonteceloRecruiting
  • Hospital Universitari i Politecnic La FeRecruiting
  • Falu Lasarett Medicinkliniken FalunRecruiting
  • Helsingborgs lasarettRecruiting
  • Akademiska SjukhusetRecruiting
  • Antalya Training And Research HospitalRecruiting
  • Ondokuz Mayis UniversityRecruiting
  • Medipol University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Teclistamab

Pomalidomide, Bortezomib and Dexamethasone (PVd) or Carfilzomib and Dexamethasone (Kd)

Arm Description

Participants will receive teclistamab monotherapy.

Participants will receive either PVd or Kd based on principal investigator's choice.

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)
PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the International myeloma working group (IMWG) 2016 response criteria, or death due to any cause, whichever occurs first.

Secondary Outcome Measures

Overall Response (Partial Response [PR] or Better)
Overall response (PR or better) is defined as participants who have a PR or better prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 criteria.
Very Good Partial Response (VGPR) or Better Response
VGPR or better (Stringent Complete Response [sCR]+Complete Response [CR]+VGPR) is defined as participants who achieve a VGPR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 criteria.
Complete Response (CR) or Better Response
CR or better response is defined as participants who achieve a CR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 criteria.
Duration of Response (DOR)
DOR is defined as the time interval between the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG 2016 response criteria or death due to any cause, whichever occurs first.
Time to Next Treatment (TTNT)
TTNT is defined as the time from randomization to the start of subsequent antimyeloma treatment.
Progression-free Survival on Next-line Therapy (PFS2)
PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as progressive disease as assessed by investigator on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first.
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of the participant's death due to any cause.
Number of Participants with Adverse Events (AEs) by Severity
Number of participants with AEs by Severity will be reported.
Number of Participants with Serious Adverse Events (SAEs) by Severity
Number of participants with SAEs by Severity will be reported.
Number of Participants with Abnormal Laboratory Results
Number of participants with abnormal laboratory results (such as hematology and chemistry) will be reported.
Serum Concentrations of Teclistamab
Serum concentrations of teclistamab will be reported.
Number of Participants with Anti-drug Antibodies (ADAs) to Teclistamab
Number of participants with ADAs to teclistamab will be reported.
Change from Baseline in Symptoms, Functioning, and Overall Health-related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30)
Change from baseline in symptoms, functioning, and overall HRQoL assessed by EORTC QLQ-C30 score version 3 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 high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Score
Change from baseline in symptoms, functioning, and overall HRQoL assessed by MySIm-Q will be reported. The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30. It includes 17 items resulting in a symptom subscale and an impact subscale. The recall period is the "past 7 days", and responses are reported on a 5-point verbal rating scale.
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Change from baseline in symptoms, functioning, and overall HRQoL assessed by PRO-CTCAE will be reported. The National Cancer Institute's (NCI's) PRO-CTCAE is an item library of common adverse events experienced by people with cancer that are appropriate for self-reporting of treatment tolerability. Each symptom selected for inclusion can be rated by up to 3 attributes characterizing the presence/frequency, severity, and/or interference of the AEs. It ranges from 0 to 4 with higher scores indicating higher frequency or greater severity/impact.
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
Change from baseline in symptoms, functioning, and overall HRQoL assessed by EQ-5D-5L will be reported. 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).
Time to Worsening in Symptoms, Functioning, and Overall HRQoL
Time to worsening in symptoms, functioning, and overall HRQoL will be measured as the interval from the date of randomization to the start date of meaningful change.
PFS in Participants in High-risk Molecular Features
PFS in participants in high-risk molecular features will be reported. PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the IMWG 2016 response criteria, or death due to any cause, whichever occurs first.
Depth of Response in Participants in High-risk Molecular Features
Depth of response in participants in high-risk molecular features will be reported.

Full Information

First Posted
October 5, 2022
Last Updated
September 12, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05572515
Brief Title
A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma
Acronym
MajesTEC-9
Official Title
A Phase 3 Randomized Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2023 (Actual)
Primary Completion Date
August 14, 2025 (Anticipated)
Study Completion Date
August 31, 2031 (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 compare the efficacy of teclistamab with PVd/Kd.
Detailed Description
Multiple myeloma is an incurable, malignant, plasma cell disorder. Teclistamab (JNJ-64007957) is a full-size, Immunoglobulin G (IgG) 4 proline, alanine, and alanine (PAA) bispecific antibody that targets the cluster of differentiation (CD3) receptor expressed on the surface of T cells and B cell maturation antigen (BCMA). With its dual binding sites, teclistamab is able to draw CD3 positive T cells in close proximity to BCMA positive cells, resulting in T-cell activation and subsequent lysis of BCMA positive cells. Pomalidomide is a third-generation immunomodulatory imide drug (IMiD) that exerts potent, direct tumoricidal and immune-enhancing effects and Carfilzomib is a second-generation proteasome inhibitor that inhibits proteasome which results in disruption of protein turnover and induces apoptosis. The primary hypothesis of this study is that teclistamab monotherapy (Arm A) will significantly improve progression free survival (PFS) compared with investigator's choice of PVd or Kd (Arm B) in participants with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and lenalidomide. The study will include a screening phase, treatment phase, and follow-up phase. Safety will be assessed by physical examinations, neurologic examinations, eastern cooperative oncology group (ECOG) performance status, clinical laboratory tests, vital signs, and AE monitoring. The overall duration of the study will be up to 9 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
590 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Teclistamab
Arm Type
Experimental
Arm Description
Participants will receive teclistamab monotherapy.
Arm Title
Pomalidomide, Bortezomib and Dexamethasone (PVd) or Carfilzomib and Dexamethasone (Kd)
Arm Type
Experimental
Arm Description
Participants will receive either PVd or Kd based on principal investigator's choice.
Intervention Type
Drug
Intervention Name(s)
Teclistamab
Other Intervention Name(s)
JNJ-64007957
Intervention Description
Teclistamab will be administered subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Pomalidomide
Intervention Description
Pomalidomide will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Intervention Description
Bortezomib will be administered subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone will be administered orally in PVd and intravenously or orally in Kd.
Intervention Type
Drug
Intervention Name(s)
Carfilzomib
Intervention Description
Carfilzomib will be administered intravenously.
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the International myeloma working group (IMWG) 2016 response criteria, or death due to any cause, whichever occurs first.
Time Frame
Up to 9 years
Secondary Outcome Measure Information:
Title
Overall Response (Partial Response [PR] or Better)
Description
Overall response (PR or better) is defined as participants who have a PR or better prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 criteria.
Time Frame
Up to 9 years
Title
Very Good Partial Response (VGPR) or Better Response
Description
VGPR or better (Stringent Complete Response [sCR]+Complete Response [CR]+VGPR) is defined as participants who achieve a VGPR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 criteria.
Time Frame
Up to 9 years
Title
Complete Response (CR) or Better Response
Description
CR or better response is defined as participants who achieve a CR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 criteria.
Time Frame
Up to 9 years
Title
Duration of Response (DOR)
Description
DOR is defined as the time interval between the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG 2016 response criteria or death due to any cause, whichever occurs first.
Time Frame
Up to 9 years
Title
Time to Next Treatment (TTNT)
Description
TTNT is defined as the time from randomization to the start of subsequent antimyeloma treatment.
Time Frame
Up to 9 years
Title
Progression-free Survival on Next-line Therapy (PFS2)
Description
PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as progressive disease as assessed by investigator on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first.
Time Frame
Up to 9 years
Title
Overall Survival (OS)
Description
OS is defined as the time from the date of randomization to the date of the participant's death due to any cause.
Time Frame
Up to 9 years
Title
Number of Participants with Adverse Events (AEs) by Severity
Description
Number of participants with AEs by Severity will be reported.
Time Frame
Up to 9 years
Title
Number of Participants with Serious Adverse Events (SAEs) by Severity
Description
Number of participants with SAEs by Severity will be reported.
Time Frame
Up to 9 years
Title
Number of Participants with Abnormal Laboratory Results
Description
Number of participants with abnormal laboratory results (such as hematology and chemistry) will be reported.
Time Frame
Up to 9 years
Title
Serum Concentrations of Teclistamab
Description
Serum concentrations of teclistamab will be reported.
Time Frame
Up to 9 years
Title
Number of Participants with Anti-drug Antibodies (ADAs) to Teclistamab
Description
Number of participants with ADAs to teclistamab will be reported.
Time Frame
Up to 9 years
Title
Change from Baseline in Symptoms, Functioning, and Overall Health-related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30)
Description
Change from baseline in symptoms, functioning, and overall HRQoL assessed by EORTC QLQ-C30 score version 3 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 high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Time Frame
Baseline up to 9 years
Title
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Score
Description
Change from baseline in symptoms, functioning, and overall HRQoL assessed by MySIm-Q will be reported. The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30. It includes 17 items resulting in a symptom subscale and an impact subscale. The recall period is the "past 7 days", and responses are reported on a 5-point verbal rating scale.
Time Frame
Baseline up to 9 years
Title
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Description
Change from baseline in symptoms, functioning, and overall HRQoL assessed by PRO-CTCAE will be reported. The National Cancer Institute's (NCI's) PRO-CTCAE is an item library of common adverse events experienced by people with cancer that are appropriate for self-reporting of treatment tolerability. Each symptom selected for inclusion can be rated by up to 3 attributes characterizing the presence/frequency, severity, and/or interference of the AEs. It ranges from 0 to 4 with higher scores indicating higher frequency or greater severity/impact.
Time Frame
Baseline up to 6 months
Title
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
Description
Change from baseline in symptoms, functioning, and overall HRQoL assessed by EQ-5D-5L will be reported. 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).
Time Frame
Baseline up to 9 years
Title
Time to Worsening in Symptoms, Functioning, and Overall HRQoL
Description
Time to worsening in symptoms, functioning, and overall HRQoL will be measured as the interval from the date of randomization to the start date of meaningful change.
Time Frame
Up to 9 years
Title
PFS in Participants in High-risk Molecular Features
Description
PFS in participants in high-risk molecular features will be reported. PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the IMWG 2016 response criteria, or death due to any cause, whichever occurs first.
Time Frame
Up to 9 years
Title
Depth of Response in Participants in High-risk Molecular Features
Description
Depth of response in participants in high-risk molecular features will be reported.
Time Frame
Up to 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 as defined by the criteria below: (a)Multiple myeloma diagnosis according to International Myeloma Working Group (IMWG) diagnostic criteria (b) Measurable disease at screening as defined by any of the following: (1) Serum M-protein level greater than or equal to (>=)0.5 grams per deciliter (g/dL) (central laboratory); or (2) Urine M-protein level >=200 milligrams (mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain >=10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio Received 1 to 3 prior lines of antimyeloma therapy including a minimum of 2 consecutive cycles of an anti- cluster of differentiation 38 (CD38) monoclonal antibody at the approved dosing regimen in any prior line and 2 consecutive cycles of lenalidomide in any prior line Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by International myeloma working group (IMWG) criteria Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2 A female participant must agree not to be pregnant, breast-feeding, or plan to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment Must be willing and able to adhere to the lifestyle restrictions specified in this protocol Exclusion Criteria: Received any prior B cell maturation antigen (BCMA)-directed therapy A participant is not eligible to receive PVd as control therapy if any of the following are present: (1) Received prior pomalidomide therapy, (2) Does not meet criteria for bortezomib retreatment (3) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide or bortezomib, (4) Grade 1 peripheral neuropathy with pain or Grade greater than or equal to (>=) 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, (5) Received a strong cytochrome P (CYP) 3A4 inducer within 5 half-lives prior to randomization; A participant is not eligible to receive Kd as control therapy if any of the following are present:(1) Received prior carfilzomib therapy, (2) Uncontrolled hypertension, defined as an average systolic blood pressure greater than (>)159 millimeters of mercury (mmHg) or diastolic blood pressure >99 mmHg despite optimal treatment (3) Grade 2 peripheral neuropathy with pain or Grade >=3 peripheral neuropathy as defined by NCI-CTCAE Version 5.0, (4) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to carfilzomib (intolerance defined as prior therapy discontinued due to any adverse event [AE] related to carfilzomib) Central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma. Received a live, attenuated vaccine within 4 weeks before randomization Plasma cell leukemia at the time of screening, Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein (POEMS) syndrome and skin changes, or primary amyloid light chain amyloidosis Received a maximum cumulative dose of corticosteroids of >=140 mg of prednisone or equivalent within 14 days prior to randomization
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
MemorialCare Long Beach Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
PIH Health Hospital
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Individual Site Status
Recruiting
Facility Name
Tulane University Hospital & Clinics
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Name
Saint Luke's Hospital - Saint Luke's Cancer Specialists
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Vincent's Hospital Melbourne
City
Fitzroy
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Recruiting
Facility Name
Box Hill Hospital
City
Melbourne
ZIP/Postal Code
3128
Country
Australia
Individual Site Status
Recruiting
Facility Name
Fiona Stanley Hospital
City
Murdoch
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Recruiting
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Name
Algemeen Ziekenhuis Klina
City
Brasschaat
ZIP/Postal Code
2930
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Jolimont
City
Haine-St-Paul
ZIP/Postal Code
7100
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Az Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Hospitais Integradaos da Gavea S/A - DF Star
City
Brasilia
ZIP/Postal Code
70390-140
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto Joinvilense de Hematologia e Oncologia Ltda-Centro de Hematologia e Oncologia
City
Joinville
ZIP/Postal Code
89201-260
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Liga Norte Riograndense Contra O Cancer
City
Natal
ZIP/Postal Code
59062-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Complexo Hospitalar de Niterói
City
Niteroi
ZIP/Postal Code
24020-073
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
City
Rio de Janeiro
ZIP/Postal Code
22775-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Sao Rafael
City
Salvador
ZIP/Postal Code
41253-190
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
City
Sao Jose do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
City
Sao Paulo
ZIP/Postal Code
01308-901
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fundacao Antonio Prudente - A.C. Camargo Cancer Center
City
Sao Paulo
ZIP/Postal Code
01509900
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto D'Or de Pesquisa e Ensino (IDOR)
City
Sao Paulo
ZIP/Postal Code
04501-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Real e Benemérita Associação Portuguesa de Beneficência
City
São Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Alemao Oswaldo Cruz
City
São Paulo
ZIP/Postal Code
01323-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Clinica Sao Germano
City
São Paulo
ZIP/Postal Code
01455-010
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Lakeridge Health Oshawa
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G2B9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Beijing Chaoyang Hospital
City
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Name
The First Bethune Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
The Third Xiangya Hospital, Central South University
City
Changsha
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Name
Sichuan Provincial People's Hospital
City
Chengdu
ZIP/Postal Code
610032
Country
China
Individual Site Status
Recruiting
Facility Name
Chongqing University Cancer Hospital
City
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Recruiting
Facility Name
Fujian Meidical University Union Hospital
City
Fu Zhou
ZIP/Postal Code
350001
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
Harbin medical university cancer hospital
City
Harbin
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of NanChang University
City
Nanchang
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
First Affiliated Hospital of Guangxi Medical University
City
Nanning
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
ZIP/Postal Code
110055
Country
China
Individual Site Status
Recruiting
Facility Name
Shenzhen 2nd People's Hospital
City
Shenzhen
ZIP/Postal Code
518025
Country
China
Individual Site Status
Recruiting
Facility Name
Institute of Hematology & Blood Diseases Hospital
City
Tian Jin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Name
Wuhan Union Hospital
City
Wuhan
ZIP/Postal Code
430023
Country
China
Individual Site Status
Recruiting
Facility Name
Wuxi People's Hospital
City
Wuxi
ZIP/Postal Code
214023
Country
China
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava - Poruba
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Regionshospitalet Godstrup
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Vejle Sygehus
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
CHU Amiens - Hopital Sud
City
AMIENS cedex 1
ZIP/Postal Code
80000
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Côte de Nacre
City
Caen cedex 9
ZIP/Postal Code
14003
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Grenoble
City
Grenoble
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier du Mans
City
Le Mans
ZIP/Postal Code
72000
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Montpellier, Hopital Saint-Eloi
City
Montpellier
ZIP/Postal Code
34090
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Nantes
City
Nantes Cedex 1
ZIP/Postal Code
44000
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital de la Pitie Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Necker Enfants Malades
City
Paris
ZIP/Postal Code
75743
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Universitaire du Cancer Toulouse Oncopole
City
Toulouse
ZIP/Postal Code
31100
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Nancy - Hôpital de Brabois
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France
Individual Site Status
Recruiting
Facility Name
Carl-Thiem-Klinikum Cottbus gGmbH
City
Cottbus
ZIP/Postal Code
03048
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Carl Gustav Carus Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsmedizin Greifswald
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Individual Site Status
Recruiting
Facility Name
Asklepios Klinik Altona
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Heinrich-Braun-Klinikum gGmbH
City
Zwickau
ZIP/Postal Code
08060
Country
Germany
Individual Site Status
Recruiting
Facility Name
Alexandra General Hospital of Athens
City
Athens Attica
ZIP/Postal Code
115 28
Country
Greece
Individual Site Status
Recruiting
Facility Name
Agios Andreas General Hospital of Patra
City
Patra
ZIP/Postal Code
263 35
Country
Greece
Individual Site Status
Recruiting
Facility Name
'G. Papanikolaou' Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
570 10
Country
Greece
Individual Site Status
Recruiting
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Individual Site Status
Suspended
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
49100
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-Yafo
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Name
A.O.U Sant'Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Individual Site Status
Recruiting
Facility Name
Arcispedale Santa Maria Nuova - IRCCS
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Campus Bio-Medico di Roma
City
Roma
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.O. Universitaria Senese- Ospedale Santa Maria alle Scotte
City
Siena
ZIP/Postal Code
53100
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette
City
Turin
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASUI Santa Maria della Misericordia di Udine
City
Udine
ZIP/Postal Code
33100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale di Circolo e Fondazione Macchi
City
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Chiba Cancer Center
City
Chiba
ZIP/Postal Code
260-8717
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
Kansai Medical University Hospital
City
Hirakata
ZIP/Postal Code
573-1191
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hitachi General Hospital
City
Hitachi
ZIP/Postal Code
317-0077
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saitama Medical University Hospital
City
Iruma-gun
ZIP/Postal Code
350-0495
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kameda General Hospital
City
Kamogawa City
ZIP/Postal Code
296-8602
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
Matsuyama Red Cross Hospital
City
Matsuyama
ZIP/Postal Code
790-8524
Country
Japan
Individual Site Status
Recruiting
Facility Name
JRC Nagasaki Genbaku Hospital
City
Nagasaki-Shi
ZIP/Postal Code
852-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Niigata University Medical & Dental Hospital
City
Niigata
ZIP/Postal Code
951-8520
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
Osaka Metropolitan University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hokkaido University Hospital
City
Sapporo
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Name
Juntendo University Hospital
City
Tokyo
ZIP/Postal Code
113-0033
Country
Japan
Individual Site Status
Recruiting
Facility Name
The Cancer Institute Hospital of JFCR
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yamanashi Prefectural Central Hospital
City
Yamanashi
ZIP/Postal Code
400-8506
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hospital Pulau Pinang
City
Georgetown
ZIP/Postal Code
10450
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Queen Elizabeth
City
Kota Kinabalu
ZIP/Postal Code
88200
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Subang Jaya Medical Centre
City
Subang Jaya
ZIP/Postal Code
47500
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Meander Medisch Centrum
City
Amersfoort
ZIP/Postal Code
3813 TZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
VUMC Amsterdam
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Recruiting
Facility Name
Pratia Onkologia Katowice
City
Katowice
ZIP/Postal Code
40-519
Country
Poland
Individual Site Status
Recruiting
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hosp. Garcia de Orta
City
Almada
ZIP/Postal Code
2805-267
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Champalimaud Foundation Champalimaud Centre
City
Lisbon
ZIP/Postal Code
1400-038
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Instituto Portugues de Oncologia
City
Porto
ZIP/Postal Code
4200072
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Institut Catala d'Oncologia L'Hospitalet
City
Hospitalet de Llobregat
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. de Jerez de La Frontera
City
Jerez de la Frontera
ZIP/Postal Code
11407
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Gral. Univ. J.M. Morales Meseguer
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Son Llatzer
City
Palma de Mallorca
ZIP/Postal Code
07198
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Montecelo
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari i Politecnic La Fe
City
València
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Falu Lasarett Medicinkliniken Falun
City
Falun
ZIP/Postal Code
791 82
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Helsingborgs lasarett
City
Helsingborg
ZIP/Postal Code
25287
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Akademiska Sjukhuset
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Antalya Training And Research Hospital
City
Antalya
ZIP/Postal Code
07100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ondokuz Mayis University
City
Atakum
ZIP/Postal Code
55280
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Medipol University Hospital
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
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/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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma

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