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A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-3)

Primary Purpose

Multiple Myeloma

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

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

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

Inclusion Criteria:

  • Documented multiple myeloma as defined by the criteria: a. multiple myeloma diagnosis according to the 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 gram per deciliter (g/dL); or 2) urine M-protein level >=200 milligrams (mg)/24 hours; or 3) serum immunoglobulin free light chain >=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
  • Received 1 to 3 prior line(s) of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide; a. participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory. Stable disease or progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion
  • Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen
  • Have an eastern cooperative oncology group (ECOG) performance status score of 0, 1, or 2 at screening and prior to the start of administration of study treatment
  • Have clinical laboratory values within the specified range

Exclusion Criteria:

  • Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients. Additional exclusion criteria pertaining to specific study drugs include:

    1. A participant is not eligible to receive daratumumab subcutaneous (SC) in combination with pomalidomide and dexamethasone (DPd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide, 2) Disease that is considered refractory to pomalidomide per IMWG,
    2. A participant is not eligible to receive daratumumab SC in combination with bortezomib and dexamethasone (DVd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to bortezomib, 2) Grade 1 peripheral neuropathy with pain or Grade >= 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, 3) Disease that is considered refractory to bortezomib per IMWG, 4) Received a strong cytochromes P450 (CYP3A4) inducer within 5 half-lives prior to randomization
  • Received any prior B cell maturation antigen (BCMA)-directed therapy
  • Has disease that is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody per IMWG
  • Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within 14 days before randomization
  • Received a live, attenuated vaccine within 4 weeks before randomization
  • Plasma cell leukemia at the time of screening, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary amyloid light chain amyloidosis

Sites / Locations

  • University of Alabama Birmingham
  • City of Hope
  • Stanford University Medical Center
  • Yale University
  • Emory University - Winship Cancer Institute
  • Tufts Medical Center
  • Henry Ford Hospital
  • Ascension Providence Hospital
  • Cleveland Clinic
  • West Penn Hospital
  • University of Pittsburgh Medical Center
  • Medical University of South Carolina
  • Baptist Cancer Center
  • Vanderbilt - Ingram Cancer Center
  • University of Texas Southwestern Medical Center
  • Huntsman Cancer Institute
  • Seattle Cancer Care Alliance
  • University of Wisconsin Carbone Cancer Center
  • Hospital Aleman
  • Hospital Italiano de Buenos Aires
  • Hospital Privado - Centro Medico de Cordoba
  • ZNA Cadix
  • AZ St.-Jan Brugge-Oostende AV
  • UZ Gent
  • Hopital de Jolimont
  • Az Groeninge
  • UZ Leuven
  • Algemeen Ziekenhuis Delta
  • Hospitais Integradaos da Gavea S/A - DF Star
  • Liga Paranaense de Combate ao Cancer
  • Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN
  • Liga Norte Riograndense Contra O Cancer
  • Irmandade Santa Casa de Misericordia de Porto Alegre
  • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
  • Hospital Sao Rafael
  • Hospital Paulistano
  • Clinica Sao Germano
  • Real e Benemérita Associação Portuguesa de Beneficência
  • Instituto D'Or de Pesquisa e Ensino (IDOR)
  • Tom Baker Cancer Centre
  • Cross Cancer Institute
  • BC Cancer Agency - Vancouver BC
  • QEII Health Sciences
  • Princess Margaret Cancer Centre University Health Network
  • Peking University First Hospital
  • Peking University People's Hospital
  • Peking University Third Hospital
  • The First Hospital of Jilin University
  • The Third Xiangya Hospital of Central Sourth University
  • Beijing Chaoyang Hospital
  • West China Hospital, Sichuan University
  • Fujian Meidical University Union Hospital
  • Sun Yat-Sen University Cancer Center
  • First affiliated Hospital of Zhejiang University
  • Zhongda Hospital,Southeast University
  • First Affiliated Hospital of Guangxi Medical University
  • Shanghai Zhongshan Hospital
  • Shengjing Hospital of China Medical University
  • Peking University Shenzhen Hospital
  • Tianjin Medical University General Hospital
  • Tianjin Medical University Cancer Institute and Hospital
  • The Second Affiliated Hospital of Xi'an Jiaotong University
  • The Affiliated Hospital of Xuzhou Medical University
  • Henan Cancer Hospital
  • Aalborg University Hospital
  • Aarhus University Hospital
  • Rigshospitalet
  • Odense Universitets Hospital
  • Vejle Hospital
  • CHU Henri Mondor
  • CHRU de Lille - Hopital Claude Huriez
  • CHU de Limoges, Hopital Dupuytren
  • C.H.U. Hotel Dieu - France
  • Centre hospitalier Lyon-Sud
  • CHU De Poitiers
  • Institut de Cancerologie Strasbourg Europe (ICANS)
  • Pôle IUC Oncopole CHU
  • CHRU Hôpital Bretonneau
  • Universitätsklinikum Carl-Gustav-Carus Dresden
  • Heinrich-Heine -Universitaet Duesseldorf
  • Evang. Krankenhaus Essen-Mitte gGmbH
  • Universitatsklinikum Freiburg
  • Universitaetsklinikum Hamburg Eppendorf
  • St. Barbara-Klinik Hamm GmbH
  • Universitaetsklinikum Heidelberg
  • Universitaetsklinikum Schleswig-Holstein Campus Kiel
  • Universitaetsklinikum Leipzig
  • Universitaetsklinikum Tuebingen
  • Alexandra General Hospital of Athens
  • Anticancer Hospital of Thessaloniki 'Theageneio'
  • G.Papanikolaou
  • U.O. Ematologia con Trapianto- AOU Policlinico di Bari
  • ASST Papa Giovanni XXIII - Bergamo
  • Policlinico Sant'Orsola Malpighi
  • Azienda Ospedaliera Universitaria Careggi
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • IRCCS Policlinico San Matteo, Università degli studi di Pavi
  • Università di Roma 'La Sapienza' - Ospedale Umberto 1°
  • A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette
  • Fukuoka University Hospital
  • Ogaki Municipal Hospital
  • National Hospital Organization Mito Medical Center
  • The Hospital of Hyogo College of Medicine
  • Tokai University Hospital
  • Shonan Kamakura General Hospital
  • National Cancer Center Hospital East
  • Dokkyo Medical University Saitama Medical Center
  • Kumamoto University Hospital
  • Kurume University Hospital
  • National Hospital Organization Matsumoto Medical Center
  • Nagoya City University Hospital
  • National Hospital Organization Okayama Medical Center
  • National Hospital Organization Hiroshima-Nishi Medical Center
  • Hokkaido University Hospital
  • National Hospital Organization Sendai Medical Center
  • Tohoku University Hospital
  • Japanese Red Cross Medical Center
  • Iwate Medical University Hospital
  • Kyungpook National University Hospital
  • Gachon University Gil Medical Center
  • Chonnam National University Hwasun Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Samsung Medical Center
  • The Catholic University of Korea Seoul St. Mary's Hospital
  • VU Medisch Centrum
  • Universitair Medisch Centrum Groningen
  • Sint Antonius Ziekenhuis - Afd.Interne - INT
  • Radboudumc
  • Isala Kliniek
  • Klinika Hematologii i Transplantologii, UCK
  • Pratia Onkologia Katowice
  • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
  • Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
  • Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
  • S.P. Botkin Moscow City Clinical Hospital
  • Clinical Research Institute of Hematology and Transfusiology
  • Inst. Cat. Doncologia-H Duran I Reynals
  • Hosp. Univ. Vall D Hebron
  • Hosp. de Cabuenes
  • Hosp. Univ. de Gran Canaria Dr. Negrin
  • Hosp. Gral. Univ. Gregorio Maranon
  • Hosp. Univ. Ramon Y Cajal
  • Hosp. Univ. 12 de Octubre
  • Hosp. Univ. Son Espases
  • Clinica Univ. de Navarra
  • Hosp. Quiron Madrid Pozuelo
  • Hosp. Clinico Univ. de Salamanca
  • Hosp. Univ. Marques de Valdecilla
  • Hosp. Clinico Univ. de Santiago
  • Hosp. Virgen Del Rocio
  • Hosp. Univ. I Politecni La Fe
  • Falu Lasarett
  • Sahlgrenska University Hospital
  • Helsingborgs lasarett
  • Sunderby Sjukhus
  • Skanes universitetssjukhus
  • Norrlands Universitetssjukhus
  • Akademiska Sjukhuset
  • China Medical University Hospital
  • National Cheng Kung University Hospital
  • Chang Gung Memorial Hospital
  • Ankara University Medical Faculty
  • Ondokuz Mayis University
  • Medipol University Hospital
  • Dokuz Eylul University Medical Faculty
  • Blackpool Teaching Hospitals NHS Foundation Trust
  • Ninewells Hospital & Medical School
  • Kings College Hospital
  • Oxford University Hospitals NHS Foundation Trust
  • University Hospitals Plymouth NHS Trust
  • Royal Marsden Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A: Teclistamab-daratumumab (Tec-Dara)

Arm B: DPd or DVd

Arm Description

Participants will receive teclistamab and daratumumab by subcutaneous (SC) injection. Step-up doses of teclistamab will be given prior to the first full dose.

Participants will be randomized either to daratumumab, pomalidomide, dexamethasone (DPd) treatment to receive daratumumab SC injection; pomalidomide orally; dexamethasone orally or intravenously, or to Daratumumab, Bortezomib, Dexamethasone (DVd) treatment to receive daratumumab SC injection; bortezomib SC injection, and dexamethasone orally or intravenously.

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) 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 per IMWG criteria.
Very Good Partial Response (VGPR) or Better
VGPR or better is defined as participants who achieve a VGPR or better response per IMWG criteria.
Complete Response (CR) or Better
CR or better is defined as participants who achieve a CR or better response per IMWG criteria.
Minimal Residual Disease (MRD)-negativity
MRD-negativity is defined as participants who achieve MRD negativity at a threshold of 10^-5 at any timepoint after the date of randomization and before disease progression or start of subsequent antimyeloma therapy.
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 measured from the date of randomization to the date of the participant's death.
Time to Next Treatment (TTNT)
TTNT is defined as the interval time from randomization to the start of subsequent antimyeloma treatment.
Duration of Response
Duration of response 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 according to the IMWG response criteria, or death due to any cause, whichever occurs first.
Number of Participants with Adverse Events (AEs) by Severity
Number of participants with AEs by Severity will be reported.
Serum Concentration of Teclistamab
Serum samples will be analyzed to determine concentrations of teclistamab using a validated, specific, and sensitive method.
Number of Participants with Anti-drug Antibodies (ADAs) to Teclistamab and Daratumumab
Number of participants with ADAs to teclistamab and daratumumab will be reported.
Time to Worsening of Symptoms
Time to worsening is measured as the interval from the date of randomization to the start date of meaningful change.
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)
The EORTC-QLQ-C30 Version 3 includes 30 items in 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 responses are reported using a verbal and numeric rating scales. 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
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 Measurement Information System Short Form v2.0 - Physical Function 8c (PROMIS PF 8c)
The PROMIS-SD is used to assess self-reported perceptions of sleep quality, sleep depth and restoration associated with sleep. The 8-item short form will be used in this study, in which responses are scored 1 to 5 for each item. Higher overall score indicates more sleep disturbance.
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 )
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)
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).
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Patient Global Impression - Severity (PGI-S)
The PGIS contains 2 questions on how the participant would currently rate severity of symptoms and impacts with a 7-day recall period. The response options are presented as a 5-point verbal rating scale from 1="none" to 5="very severe."
PFS in Participants with High-risk Molecular Features
PFS in participants with high-risk molecular features will be reported.
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 8, 2021
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05083169
Brief Title
A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma
Acronym
MajesTEC-3
Official Title
A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants 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
October 14, 2021 (Actual)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
October 1, 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 compare the efficacy of teclistamab daratumumab (Tec-Dara) with daratumumab subcutaneously (SC) in combination with pomalidomide and dexamethasone (DPd) or daratumumab SC in combination with bortezomib and dexamethasone (DVd).
Detailed Description
Teclistamab is a novel B-cell maturation antigen (BCMA) bispecific antibody that is being evaluated to treat participants with multiple myeloma, an incurable malignant plasma cell disorder. The primary hypothesis of this study is that Tec-Dara will significantly improve progression free survival (PFS) compared with investigator's choice of DPd/DVd in participants with relapsed refractory multiple myeloma. Approximately 560 participants will be randomly assigned in a 1:1 ratio to receive either Tec-Dara (Arm A) or investigator's choice of DPd/DVd (Arm B). The study will be conducted in 3 phases: Screening Phase, Treatment Phase, and Follow-up Phase. Participants will be treated until disease progression, unacceptable toxicity, or other reasons to discontinue the study. Disease evaluation will occur every cycle. Safety will be assessed throughout the study. Efficacy will be assessed using International Myeloma Working Group (IMWG) criteria. The overall duration of the study will be approximately 5 years.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Arm A: Teclistamab-daratumumab (Tec-Dara)
Arm Type
Experimental
Arm Description
Participants will receive teclistamab and daratumumab by subcutaneous (SC) injection. Step-up doses of teclistamab will be given prior to the first full dose.
Arm Title
Arm B: DPd or DVd
Arm Type
Experimental
Arm Description
Participants will be randomized either to daratumumab, pomalidomide, dexamethasone (DPd) treatment to receive daratumumab SC injection; pomalidomide orally; dexamethasone orally or intravenously, or to Daratumumab, Bortezomib, Dexamethasone (DVd) treatment to receive daratumumab SC injection; bortezomib SC injection, and dexamethasone orally or intravenously.
Intervention Type
Drug
Intervention Name(s)
Daratumumab
Intervention Description
Daratumumab will be administered SC injection.
Intervention Type
Drug
Intervention Name(s)
Pomalidomide
Intervention Description
Pomalidomide will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone will be administered orally or intravenously.
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Intervention Description
Bortezomib will be administered SC injection.
Intervention Type
Drug
Intervention Name(s)
Teclistamab
Other Intervention Name(s)
JNJ-64007957
Intervention Description
Teclistamab will be administered SC injection.
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) criteria, or death due to any cause, whichever occurs first.
Time Frame
Up to 5 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 per IMWG criteria.
Time Frame
Up to 5 years
Title
Very Good Partial Response (VGPR) or Better
Description
VGPR or better is defined as participants who achieve a VGPR or better response per IMWG criteria.
Time Frame
Up to 5 years
Title
Complete Response (CR) or Better
Description
CR or better is defined as participants who achieve a CR or better response per IMWG criteria.
Time Frame
Up to 5 years
Title
Minimal Residual Disease (MRD)-negativity
Description
MRD-negativity is defined as participants who achieve MRD negativity at a threshold of 10^-5 at any timepoint after the date of randomization and before disease progression or start of subsequent antimyeloma therapy.
Time Frame
Up to 5 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 5 years
Title
Overall Survival (OS)
Description
OS is measured from the date of randomization to the date of the participant's death.
Time Frame
Up to 5 years
Title
Time to Next Treatment (TTNT)
Description
TTNT is defined as the interval time from randomization to the start of subsequent antimyeloma treatment.
Time Frame
Up to 5 years
Title
Duration of Response
Description
Duration of response 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 according to the IMWG response criteria, or death due to any cause, whichever occurs first.
Time Frame
Up to 5 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 5 years
Title
Serum Concentration of Teclistamab
Description
Serum samples will be analyzed to determine concentrations of teclistamab using a validated, specific, and sensitive method.
Time Frame
Up to 5 years
Title
Number of Participants with Anti-drug Antibodies (ADAs) to Teclistamab and Daratumumab
Description
Number of participants with ADAs to teclistamab and daratumumab will be reported.
Time Frame
Up to 5 years
Title
Time to Worsening of Symptoms
Description
Time to worsening is measured as the interval from the date of randomization to the start date of meaningful change.
Time Frame
Up to 5 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
The EORTC-QLQ-C30 Version 3 includes 30 items in 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 responses are reported using a verbal and numeric rating scales. 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 5 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
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 5 years
Title
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Patient-reported Outcomes Measurement Information System Short Form v2.0 - Physical Function 8c (PROMIS PF 8c)
Description
The PROMIS-SD is used to assess self-reported perceptions of sleep quality, sleep depth and restoration associated with sleep. The 8-item short form will be used in this study, in which responses are scored 1 to 5 for each item. Higher overall score indicates more sleep disturbance.
Time Frame
Baseline up to 5 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
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
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 5 years
Title
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Patient Global Impression - Severity (PGI-S)
Description
The PGIS contains 2 questions on how the participant would currently rate severity of symptoms and impacts with a 7-day recall period. The response options are presented as a 5-point verbal rating scale from 1="none" to 5="very severe."
Time Frame
Baseline up to 5 years
Title
PFS in Participants with High-risk Molecular Features
Description
PFS in participants with high-risk molecular features will be reported.
Time Frame
Up to 5 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 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented multiple myeloma as defined by the criteria: a. multiple myeloma diagnosis according to the 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 gram per deciliter (g/dL); or 2) urine M-protein level >=200 milligrams (mg)/24 hours; or 3) serum immunoglobulin free light chain >=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio Received 1 to 3 prior line(s) of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide; a. participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory. Stable disease or progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen Have an eastern cooperative oncology group (ECOG) performance status score of 0, 1, or 2 at screening and prior to the start of administration of study treatment Have clinical laboratory values within the specified range Exclusion Criteria: Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients. Additional exclusion criteria pertaining to specific study drugs include: A participant is not eligible to receive daratumumab subcutaneous (SC) in combination with pomalidomide and dexamethasone (DPd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide, 2) Disease that is considered refractory to pomalidomide per IMWG, A participant is not eligible to receive daratumumab SC in combination with bortezomib and dexamethasone (DVd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to bortezomib, 2) Grade 1 peripheral neuropathy with pain or Grade >= 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, 3) Disease that is considered refractory to bortezomib per IMWG, 4) Received a strong cytochromes P450 (CYP3A4) inducer within 5 half-lives prior to randomization Received any prior B cell maturation antigen (BCMA)-directed therapy Has disease that is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody per IMWG Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within 14 days before randomization Received a live, attenuated vaccine within 4 weeks before randomization Plasma cell leukemia at the time of screening, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary amyloid light chain amyloidosis
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
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5623
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Emory University - Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Ascension Providence Hospital
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
West Penn Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-8900
Country
United States
Facility Name
Baptist Cancer Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Vanderbilt - Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Hospital Aleman
City
Buenos Aires
ZIP/Postal Code
C1118AAT
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
C1199ABB
Country
Argentina
Facility Name
Hospital Privado - Centro Medico de Cordoba
City
Cordoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Facility Name
ZNA Cadix
City
Antwerpen
ZIP/Postal Code
2030
Country
Belgium
Facility Name
AZ St.-Jan Brugge-Oostende AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Hopital de Jolimont
City
Haine-saint-paul, LA Louviere
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Az Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Algemeen Ziekenhuis Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Hospitais Integradaos da Gavea S/A - DF Star
City
Brasilia
ZIP/Postal Code
70390-140
Country
Brazil
Facility Name
Liga Paranaense de Combate ao Cancer
City
Curitiba
ZIP/Postal Code
81520-060
Country
Brazil
Facility Name
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN
City
Florianopolis
ZIP/Postal Code
88034-000
Country
Brazil
Facility Name
Liga Norte Riograndense Contra O Cancer
City
Natal
ZIP/Postal Code
59062-000
Country
Brazil
Facility Name
Irmandade Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90050-170
Country
Brazil
Facility Name
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
City
Rio de Janeiro
ZIP/Postal Code
22775-001
Country
Brazil
Facility Name
Hospital Sao Rafael
City
Salvador
ZIP/Postal Code
41253-190
Country
Brazil
Facility Name
Hospital Paulistano
City
Sao Paulo
ZIP/Postal Code
01323-000
Country
Brazil
Facility Name
Clinica Sao Germano
City
Sao Paulo
ZIP/Postal Code
01455-010
Country
Brazil
Facility Name
Real e Benemérita Associação Portuguesa de Beneficência
City
São Paulo
ZIP/Postal Code
01323-900
Country
Brazil
Facility Name
Instituto D'Or de Pesquisa e Ensino (IDOR)
City
São Paulo
ZIP/Postal Code
4501000
Country
Brazil
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
BC Cancer Agency - Vancouver BC
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
QEII Health Sciences
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Princess Margaret Cancer Centre University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X6
Country
Canada
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
The Third Xiangya Hospital of Central Sourth University
City
Changshashi
ZIP/Postal Code
410013
Country
China
Facility Name
Beijing Chaoyang Hospital
City
Chaoyang District
ZIP/Postal Code
100020
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Fujian Meidical University Union Hospital
City
Fuzhou
ZIP/Postal Code
350001
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
Zhongda Hospital,Southeast University
City
Nanjing
ZIP/Postal Code
210009
Country
China
Facility Name
First Affiliated Hospital of Guangxi Medical University
City
Nanning
ZIP/Postal Code
530021
Country
China
Facility Name
Shanghai Zhongshan Hospital
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
ZIP/Postal Code
110022
Country
China
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
ZIP/Postal Code
518036
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300011
Country
China
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
The Second Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
ZIP/Postal Code
710004
Country
China
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
ZIP/Postal Code
221000
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
DK-9000
Country
Denmark
Facility Name
Aarhus University Hospital
City
Aarhus N
ZIP/Postal Code
DK-8200
Country
Denmark
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Odense Universitets Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Vejle Hospital
City
Vejle
ZIP/Postal Code
DK-7100
Country
Denmark
Facility Name
CHU Henri Mondor
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
CHRU de Lille - Hopital Claude Huriez
City
LILLE Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
CHU de Limoges, Hopital Dupuytren
City
Limoges
ZIP/Postal Code
87042
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 cedex
ZIP/Postal Code
69495
Country
France
Facility Name
CHU De Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Institut de Cancerologie Strasbourg Europe (ICANS)
City
Strasbourg
ZIP/Postal Code
67200
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
Universitätsklinikum Carl-Gustav-Carus Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Heinrich-Heine -Universitaet Duesseldorf
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Evang. Krankenhaus Essen-Mitte gGmbH
City
Essen
ZIP/Postal Code
45239
Country
Germany
Facility Name
Universitatsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitaetsklinikum Hamburg Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
St. Barbara-Klinik Hamm GmbH
City
Hamm
ZIP/Postal Code
59073
Country
Germany
Facility Name
Universitaetsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitaetsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Alexandra General Hospital of Athens
City
Athens Attica
ZIP/Postal Code
115 28
Country
Greece
Facility Name
Anticancer Hospital of Thessaloniki 'Theageneio'
City
Thessaloniki
ZIP/Postal Code
546 39
Country
Greece
Facility Name
G.Papanikolaou
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
U.O. Ematologia con Trapianto- AOU Policlinico di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
ASST Papa Giovanni XXIII - Bergamo
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Policlinico Sant'Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
IRCCS Policlinico San Matteo, Università degli studi di Pavi
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Università di Roma 'La Sapienza' - Ospedale Umberto 1°
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette
City
Turin
ZIP/Postal Code
10126
Country
Italy
Facility Name
Fukuoka University Hospital
City
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Ogaki Municipal Hospital
City
Gifu
ZIP/Postal Code
503-8502
Country
Japan
Facility Name
National Hospital Organization Mito Medical Center
City
Higashiibaraki-gun
ZIP/Postal Code
311-3193
Country
Japan
Facility Name
The Hospital of Hyogo College of Medicine
City
Hyôgo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Tokai University Hospital
City
Isehara
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Shonan Kamakura General Hospital
City
Kamakura-shi
ZIP/Postal Code
247-8533
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Dokkyo Medical University Saitama Medical Center
City
Koshigaya
ZIP/Postal Code
343-8555
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Kurume University Hospital
City
Kurume
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
National Hospital Organization Matsumoto Medical Center
City
Matsumoto
ZIP/Postal Code
399-8701
Country
Japan
Facility Name
Nagoya City University Hospital
City
Nagoya
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
National Hospital Organization Okayama Medical Center
City
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Facility Name
National Hospital Organization Hiroshima-Nishi Medical Center
City
Otake
ZIP/Postal Code
739-0696
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo-shi
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
National Hospital Organization Sendai Medical Center
City
Sendai-City
ZIP/Postal Code
983-8520
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Japanese Red Cross Medical Center
City
Shibuya-ku
ZIP/Postal Code
150-8935
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Shiwa-gun
ZIP/Postal Code
028-3695
Country
Japan
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Jeollanam-do
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
VU Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Sint Antonius Ziekenhuis - Afd.Interne - INT
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Radboudumc
City
Nijmegen
ZIP/Postal Code
6525GA
Country
Netherlands
Facility Name
Isala Kliniek
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
Klinika Hematologii i Transplantologii, UCK
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Pratia Onkologia Katowice
City
Katowice
ZIP/Postal Code
40-519
Country
Poland
Facility Name
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
City
Kielce
ZIP/Postal Code
25-734
Country
Poland
Facility Name
Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu
City
Wałbrzych
ZIP/Postal Code
58-309
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Facility Name
S.P. Botkin Moscow City Clinical Hospital
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Clinical Research Institute of Hematology and Transfusiology
City
St-Petersburg
ZIP/Postal Code
191024
Country
Russian Federation
Facility Name
Inst. Cat. Doncologia-H Duran I Reynals
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hosp. Univ. Vall D Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hosp. de Cabuenes
City
Gijón
ZIP/Postal Code
33394
Country
Spain
Facility Name
Hosp. Univ. de Gran Canaria Dr. Negrin
City
Las Palmas de Gran Canaria
ZIP/Postal Code
35010
Country
Spain
Facility Name
Hosp. Gral. Univ. Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hosp. Univ. Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hosp. Univ. Son Espases
City
Palma
ZIP/Postal Code
7120
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
Hosp. Clinico Univ. de Santiago
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hosp. Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hosp. Univ. I Politecni La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Falu Lasarett
City
Falun
ZIP/Postal Code
791 82
Country
Sweden
Facility Name
Sahlgrenska University Hospital
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Helsingborgs lasarett
City
Helsingborg
ZIP/Postal Code
25187
Country
Sweden
Facility Name
Sunderby Sjukhus
City
Luleå
ZIP/Postal Code
971 80
Country
Sweden
Facility Name
Skanes universitetssjukhus
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Norrlands Universitetssjukhus
City
Umea
ZIP/Postal Code
901 85
Country
Sweden
Facility Name
Akademiska Sjukhuset
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Ankara University Medical Faculty
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Facility Name
Ondokuz Mayis University
City
Atakum
ZIP/Postal Code
55280
Country
Turkey
Facility Name
Medipol University Hospital
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Facility Name
Dokuz Eylul University Medical Faculty
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Blackpool Teaching Hospitals NHS Foundation Trust
City
Blackpool
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Facility Name
Ninewells Hospital & Medical School
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Foundation Trust
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
University Hospitals Plymouth NHS Trust
City
Plymouth
ZIP/Postal Code
PL6 8DH
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 and 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 of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma

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