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A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment (MonumenTAL-3)

Primary Purpose

Relapsed or Refractory Multiple Myeloma

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Talquetamab
Daratumumab
Pomalidomide
Dexamethasone
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 multiple myeloma as defined: a) Multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria and b) Measurable disease at screening as defined by any of the following: i) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL) (central laboratory); ii) Urine M-protein level >= 200 milligram (mg)/24 hours (central laboratory); iii) Light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin free light chain >= 10 milligram per deciliter (mg/dL) (central laboratory), and abnormal serum immunoglobulin kappa lambda free light chain ratio
  • Relapsed or refractory disease as defined: a) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease by IMWG criteria greater than (>) 60 days after cessation of treatment; b) Refractory disease is defined as less than (<) 25 percent (%) reduction in monoclonal paraprotein (M-protein) or confirmed progressive disease by IMWG criteria during previous treatment or less than or equal to (=<) 60 days after cessation of treatment
  • Received at least 1 prior line of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide. Participants who have received only 1 prior line of antimyeloma therapy must be considered lenalidomide-refractory (that is, have demonstrated progressive disease by IMWG criteria on or within 60 days of completion of lenalidomide-containing regimen). Participants who have received >=2 prior lines of antimyeloma therapy must be considered lenalidomide exposed
  • Documented evidence of progressive disease based on investigator's determination of response by the 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 immediately prior to the start of administration of study treatment

Exclusion Criteria:

  • Contraindications or life-threatening allergies, hypersensitivity, or intolerance to study drug excipients
  • Disease is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody as defined per IMWG consensus guidelines (progression during treatment or within 60 days of completing therapy with an anti-CD38 monoclonal antibody)
  • A maximum cumulative dose of corticosteroids to >=140 milligrams (mg) of prednisone or equivalent within 14-day period before the first dose of study drug
  • Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required
  • Plasma cell leukemia at the time of screening, Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS syndrome), or primary amyloid light chain amyloidosis

Sites / Locations

  • The University of Arizona Cancer CenterRecruiting
  • University of Arkansas for Medical SciencesRecruiting
  • Norwalk Hospital-oncologyRecruiting
  • MedStar Georgetown University HospitalRecruiting
  • George Washington UniversityRecruiting
  • Memorial Healthcare SystemRecruiting
  • University of Miami Health SystemRecruiting
  • University Of IllinoisRecruiting
  • University of KansasRecruiting
  • Tulane University Hospital & ClinicsRecruiting
  • Ochsner Health SystemRecruiting
  • Johns Hopkins UniversityRecruiting
  • Massachusetts GeneralRecruiting
  • Boston University Medical CenterRecruiting
  • University of Massachusetts Medical SchoolRecruiting
  • University of Michigan Health SystemRecruiting
  • University Of MinnesotaRecruiting
  • University of Mississippi Medical CenterRecruiting
  • Washington University School of MedicineRecruiting
  • Rutgers Cancer Institute of New JerseyRecruiting
  • NYU Langone HealthRecruiting
  • SUNY Upstate Medical UniversityRecruiting
  • University of North CarolinaRecruiting
  • Levine Cancer Institute, Carolinas HealthCare SystemRecruiting
  • Wake Forest Baptist Medical CenterRecruiting
  • University Hospitals Cleveland Medical CenterRecruiting
  • The Ohio State University Wexner Medical Center - James Cancer HospitalRecruiting
  • OhioHealthRecruiting
  • Thomas Jefferson UniversityRecruiting
  • Baptist Cancer CenterRecruiting
  • Houston Methodist HospitalRecruiting
  • MD Anderson Cancer CenterRecruiting
  • Huntsman Cancer InstituteRecruiting
  • University of VirginiaRecruiting
  • Virginia Commonwealth University - Massey Cancer CenterRecruiting
  • Fred Hutchinson Cancer Research CenterRecruiting
  • UZ BrusselRecruiting
  • UZARecruiting
  • Virga Jessa ZiekenhuisRecruiting
  • CHC MontLegiaRecruiting
  • Clinique Saint PierreRecruiting
  • UCL Mont GodinneRecruiting
  • Fundacao Pio XIIRecruiting
  • Santa Casa de Misericordia de Belo HorizonteRecruiting
  • Hospitais Integradaos da Gavea S/A - DF StarRecruiting
  • Fundacao Universidade de Caxias do SulRecruiting
  • Liga Paranaense de Combate ao CancerRecruiting
  • Liga Norte Riograndense Contra O CancerRecruiting
  • Irmandade Santa Casa de Misericordia de Porto AlegreRecruiting
  • Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRPRecruiting
  • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)Recruiting
  • Hospital Sao RafaelRecruiting
  • Hospital PaulistanoRecruiting
  • Fundacao Antonio Prudente - A.C. Camargo Cancer CenterRecruiting
  • Sociedade Beneficente de Senhoras - Hospital Sírio LibanêsRecruiting
  • Real e Benemérita Associação Portuguesa de BeneficênciaRecruiting
  • Clinica Sao GermanoRecruiting
  • Instituto D'Or de Pesquisa e Ensino (IDOR)Recruiting
  • Peking Union Medical College HospitalRecruiting
  • Beijing Chaoyang HospitalRecruiting
  • Peking University First HospitalRecruiting
  • The First Hospital of Jilin UniversityRecruiting
  • The second Xiangya Hospital of Central South UniversityRecruiting
  • Sichuan Academy of Medical Science Sichuan Provincial People's HospitalRecruiting
  • Fujian Medical University Union HospitalRecruiting
  • Sun Yat-Sen University Cancer CenterRecruiting
  • Guangdong Provincial People's HospitalRecruiting
  • The First Affiliated Hospital, Zhejiang University College of MedicineRecruiting
  • Nanjing Drum Tower HospitalRecruiting
  • Tongji Hospital of Tongji UniversityRecruiting
  • Shanghai Fourth People's HospitalRecruiting
  • Peking University Shenzhen HospitalRecruiting
  • First Affiliated Hospital, SooChow UniversityRecruiting
  • Tianjin cancer hospitalRecruiting
  • Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical ScienceRecruiting
  • Tongji Hospital, Tongji Medical College of HUSTRecruiting
  • Henan Cancer HospitalRecruiting
  • Fakultni nemocnice BrnoRecruiting
  • Fakultni nemocnice Hradec KraloveRecruiting
  • Fakultní nemocnice OlomoucRecruiting
  • Fakultni nemocnice OstravaRecruiting
  • Fakultni nemocnice Kralovske VinohradyRecruiting
  • Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologieRecruiting
  • APHP - Hopital Henri MondorRecruiting
  • CHU DijonRecruiting
  • Centre Leon BérardRecruiting
  • CHU de Montpellier - Hopital Saint-EloiRecruiting
  • CHU de Nantes hotel-DieuRecruiting
  • CHU HOPITAL DE L'ARCHET - HematologyRecruiting
  • CHU Hopital Saint AntoineRecruiting
  • CHRU - Hôpital du Haut Lévêque - Centre François MagendieRecruiting
  • Institut Universitaire du cancer de Toulouse-OncopoleRecruiting
  • Charite Campus Benjamin FranklinRecruiting
  • Asklepios Klinik AltonaRecruiting
  • Universitaetsklinikum HeidelbergRecruiting
  • Universitaetsklinikum KoelntRecruiting
  • Universitaetsklinikum LeipzigRecruiting
  • Universitätsmedizin der Johannes Gutenberg UniversitätRecruiting
  • Universitaetsklinikum WuerzburgRecruiting
  • Alexandra General Hospital of AthensRecruiting
  • 'G. Papanikolaou' Hospital of ThessalonikiRecruiting
  • Anticancer Hospital of Thessaloniki 'Theageneio'Recruiting
  • Ha'Emek Medical CenterRecruiting
  • Bnai Zion Medical CenterRecruiting
  • Rambam Medical CenterRecruiting
  • Carmel Medical CenterRecruiting
  • Shaare Zedek Medical CenterRecruiting
  • Galilee Medical CenterRecruiting
  • Beilinson medical centerRecruiting
  • Sheba Medical CenterRecruiting
  • Ziv Medical CenterRecruiting
  • Sourasky (Ichilov) Medical CenterRecruiting
  • A.O. Universitaria Ospedali Riuniti di AnconaRecruiting
  • Policlinico di BariRecruiting
  • Azienda Ospedaliera Policlinico S. Orsola-MalpighiRecruiting
  • Azienda Ospedaliera Spedali Civili di BresciaRecruiting
  • PO G.Rodolico, AOU Policlinico-Vittorio Emanuele CataniaRecruiting
  • Fondazione IRCCS Istituto Nazionale dei TumoriRecruiting
  • ASST Grande Ospedale Metropolitano NiguardaRecruiting
  • Ospedale Villa Sofia-CervelloRecruiting
  • Fondazione IRCCS Policlinico San MatteoRecruiting
  • Arcispedale Santa Maria Nuova - IRCCSRecruiting
  • Presidio Ospedaliero Santo Spirito in SassiaRecruiting
  • IRCCS Ospedale Casa Sollievo della SofferenzaRecruiting
  • A.O.U. Città della Salute e della ScienzaRecruiting
  • Chiba Cancer CenterRecruiting
  • Fukuoka University HospitalRecruiting
  • Ogaki Municipal HospitalRecruiting
  • Gunma University HospitalRecruiting
  • Kansai Medical University HospitalRecruiting
  • Japanese Red Cross Society Himeji HospitalRecruiting
  • Hyogo Medical University HospitalRecruiting
  • Shonan Kamakura General HospitalRecruiting
  • National Cancer Center Hospital EastRecruiting
  • Dokkyo Medical University Saitama Medical CenterRecruiting
  • Kumamoto University HospitalRecruiting
  • Kyoto Kuramaguchi Medical CenterRecruiting
  • National Hospital Organization Matsumoto Medical CenterRecruiting
  • Niigata Cancer Center HospitalRecruiting
  • Hiroshima West Medical CenterRecruiting
  • Hokkaido University HospitalRecruiting
  • Tohoku University HospitalRecruiting
  • Iwate Medical University HospitalRecruiting
  • Osaka University HospitalRecruiting
  • The Cancer Institute Hospital of JFCRRecruiting
  • Dong-A University HospitalRecruiting
  • National Cancer CenterRecruiting
  • Gachon University Gil Medical CenterRecruiting
  • Chonnam National University Hwasun HospitalRecruiting
  • Jeonbuk National University HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Asan Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • The Catholic University of Korea Seoul St. Mary's HospitalRecruiting
  • Albert Schweitzer ziekenhuis-lokatie DordwijkRecruiting
  • Maxima Medisch CentrumRecruiting
  • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. MarkiewiczaRecruiting
  • Uniwersyteckie Centrum KliniczneRecruiting
  • Pratia Onkologia KatowiceRecruiting
  • Swietokrzyskie Centrum Onkologii SPZOZ w KielcachRecruiting
  • Szpital Uniwersytecki w KrakowieRecruiting
  • Centrum Onkologii Ziemi Lubelskiej im. św. Jana z DukliRecruiting
  • SP ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie, Oddział HematologiiRecruiting
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut BadawczyRecruiting
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we WroclawiuRecruiting
  • Hosp. Univ. Germans Trias I PujolRecruiting
  • Hosp. de La Santa Creu I Sant PauRecruiting
  • Hosp. Univ. Vall D HebronRecruiting
  • Hosp. Clinic I Provincial de BarcelonaRecruiting
  • Hosp. Univ. Virgen de La ArrixacaRecruiting
  • Hosp. de Jerez de La FronteraRecruiting
  • Hosp. de LeonRecruiting
  • Hosp. Univ. de La PrincesaRecruiting
  • Hosp. Univ. 12 de OctubreRecruiting
  • Hosp. Univ. Hm SanchinarroRecruiting
  • Hosp. Virgen de La VictoriaRecruiting
  • Clinica Univ. de NavarraRecruiting
  • Hosp. Clinico Univ. de SalamancaRecruiting
  • Hosp. Univ. de CanariasRecruiting
  • Hosp. Univ. Dr. PesetRecruiting
  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
  • Kaohsiung Chang Gung Memorial HospitalRecruiting
  • China Medical University HospitalRecruiting
  • National Cheng Kung University HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Hematology UnitRecruiting
  • Ankara University Medical FacultyRecruiting
  • Medipol Mega University HospitalRecruiting
  • Istanbul University Istanbul Medical Faculty
  • Istanbul University Cerrahpasa Medical FacultyRecruiting
  • Dokuz Eylul University Medical FacultyRecruiting
  • On Dokuz Mayıs University Medical FacultyRecruiting
  • Blackpool Victoria HospitalRecruiting
  • Ninewells Hospital & Medical SchoolRecruiting
  • Imperial College HealthcareRecruiting
  • Newcastle Freeman HospitalRecruiting
  • Nottingham City HospitalRecruiting
  • University Hospitals Plymouth NHS TrustRecruiting
  • New Cross HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm A: Talquetamab Subcutaneous (SC) in Combination With Daratumumab SC and Pomalidomide (Tal-DP)

Arm B: Daratumumab in Combination With Pomalidomide and Dexamethasone (DPd)

Arm C: Talquetamab SC in Combination With Daratumumab SC (Tal-D)

Arm Description

Participants will receive talquetamab and daratumumab as SC injections; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.

Participants will receive daratumumab as SC injection; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.

Participants will receive talquetamab and daratumumab as SC injection; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)
PFS is defined as time from the date of randomization to the first documentation of disease progression, or death due to any cause, whichever is reported first.

Secondary Outcome Measures

Overall Response (Partial Response [PR] or Better)
Overall response (PR or better) is defined as percentage of participants who have a PR or better per International Myeloma Working Group (IMWG) criteria.
Very Good Partial Response (VGPR) or Better Rate
VGPR or better rate is defined as the percentage of participants who achieve a VGPR or better according to IMWG response criteria.
Complete Response (CR) or Better Rate
CR or better rate is defined as the percentage of participants who achieve CR or better according to IMWG response criteria.
Overall Minimal Residual Disease (MRD) Negative CR
MRD-negative CR is defined as proportion of participants with CR or stringent CR who achieve MRD negativity at a threshold of 10^-5 at any timepoint after the first dose of study drug and before disease progression or start of subsequent antimyeloma therapy.
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of the participant's death.
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.
Time to Next Therapy (TTNT)
TTNT is defined as the time from randomization to the start of subsequent antimyeloma treatment.
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Number of Participants with AEs by Severity
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).
Serum Concentrations of Talquetamab
Serum concentrations of talquetamab will be reported.
Serum Concentrations of Daratumumab
Serum concentrations of daratumumab will be reported.
Number of Participants with Presence of Anti-Drug Antibodies (ADAs) to Talquetamab
Number of participants with presence ADAs to talquetamab will be reported.
Number of Participants With Presence of Anti-Drug Antibodies (ADAs) to Daratumumab
Number of participants with presence of ADAs to daratumumab will be reported.
Time to Worsening in Symptoms, Functioning, and Overall Health-Related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q)
The MySIm-Q is a disease-specific PRO assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC-QLQ-C30).
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by PROMIS Short Form Version 2.0 -Physical Functioning 8c
The Patient-reported Outcomes Measurement Information System (PROMIS) Short Form Version 2.0 -Physical Function 8c is an 8-item fixed--length short form derived from the PROMIS Physical Function item bank.
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30
Time to worsening in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 will be reported.
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by PRO-CTCAE
The National Cancer Institute's (NCI) PRO-CTCAE is an item library of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability.
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
The EQ-5D-5L is a generic measure of health status. For purposes of this study, the EQ-5D-5L will be used to generate utility scores for use in cost-effectiveness analyses.
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by Patient Global Impression - Severity (PGI-S)
The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and PROMIS SF PF 8c in this population.
Change From Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q)
The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30.
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by PROMIS Short Form Version 2.0 -Physical Functioning 8c
The Patient-reported Outcomes Measurement Information System (PROMIS) Short Form Version 2.0 -Physical Function 8c is an 8-item fixed-length short form derived from the PROMIS Physical Function item bank.
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30
Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 will be reported.
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by PRO-CTCAE
The National Cancer Institute's (NCI) PRO-CTCAE is an item library of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability.
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
The EQ-5D-5L is a generic measure of health status. For purposes of this study, the EQ-5D-5L will be used to generate utility scores for use in cost-effectiveness analyses.
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by Patient Global Impression - Severity (PGI-S)
The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and PROMIS SF PF 8c in this population.

Full Information

First Posted
June 22, 2022
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05455320
Brief Title
A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment
Acronym
MonumenTAL-3
Official Title
A Phase 3 Randomized Study Comparing Talquetamab SC in Combination With Daratumumab SC and Pomalidomide (Tal-DP) or Talquetamab SC in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 1 Prior Line of Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2022 (Actual)
Primary Completion Date
February 6, 2026 (Anticipated)
Study Completion Date
April 6, 2029 (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 the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with pomalidomide and dexamethasone (DPd).
Detailed Description
Overall rationale of the study is that combination treatments of talquetamab, daratumumab, pomalidomide and dexamethasone may lead to enhanced clinical responses in treatment of relapsed or refractory multiple myeloma through multiple mechanisms of action. The study is divided into 3 phases: screening, treatment (until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first), and posttreatment follow-up (until death, withdrawal of consent, loss to follow-up, or end of the study, whichever occurs first). Efficacy, safety (physical examinations, neurologic examinations, Eastern Cooperative Oncology Group [ECOG] performance status, clinical laboratory tests, vital signs, and AE monitoring), pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points. Total duration of study will be up to 6 years 6 months.

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
810 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Talquetamab Subcutaneous (SC) in Combination With Daratumumab SC and Pomalidomide (Tal-DP)
Arm Type
Experimental
Arm Description
Participants will receive talquetamab and daratumumab as SC injections; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
Arm Title
Arm B: Daratumumab in Combination With Pomalidomide and Dexamethasone (DPd)
Arm Type
Experimental
Arm Description
Participants will receive daratumumab as SC injection; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
Arm Title
Arm C: Talquetamab SC in Combination With Daratumumab SC (Tal-D)
Arm Type
Experimental
Arm Description
Participants will receive talquetamab and daratumumab as SC injection; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
Intervention Type
Drug
Intervention Name(s)
Talquetamab
Other Intervention Name(s)
JNJ-64407564
Intervention Description
Talquetamab will be administered subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Daratumumab
Intervention Description
Daratumumab will be administered subcutaneously.
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.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
PFS is defined as time from the date of randomization to the first documentation of disease progression, or death due to any cause, whichever is reported first.
Time Frame
Up to 6 years 6 months
Secondary Outcome Measure Information:
Title
Overall Response (Partial Response [PR] or Better)
Description
Overall response (PR or better) is defined as percentage of participants who have a PR or better per International Myeloma Working Group (IMWG) criteria.
Time Frame
Up to 6 years 6 months
Title
Very Good Partial Response (VGPR) or Better Rate
Description
VGPR or better rate is defined as the percentage of participants who achieve a VGPR or better according to IMWG response criteria.
Time Frame
Up to 6 years 6 months
Title
Complete Response (CR) or Better Rate
Description
CR or better rate is defined as the percentage of participants who achieve CR or better according to IMWG response criteria.
Time Frame
Up to 6 years 6 months
Title
Overall Minimal Residual Disease (MRD) Negative CR
Description
MRD-negative CR is defined as proportion of participants with CR or stringent CR who achieve MRD negativity at a threshold of 10^-5 at any timepoint after the first dose of study drug and before disease progression or start of subsequent antimyeloma therapy.
Time Frame
Up to 6 years 6 months
Title
Overall Survival (OS)
Description
OS is defined as the time from the date of randomization to the date of the participant's death.
Time Frame
Up to 6 years 6 months
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 6 years 6 months
Title
Time to Next Therapy (TTNT)
Description
TTNT is defined as the time from randomization to the start of subsequent antimyeloma treatment.
Time Frame
Up to 6 years 6 months
Title
Number of Participants with Adverse Events (AEs)
Description
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Time Frame
Up to 6 years 6 months
Title
Number of Participants with AEs by Severity
Description
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).
Time Frame
Up to 6 years 6 months
Title
Serum Concentrations of Talquetamab
Description
Serum concentrations of talquetamab will be reported.
Time Frame
Up to 6 years 6 months
Title
Serum Concentrations of Daratumumab
Description
Serum concentrations of daratumumab will be reported.
Time Frame
Up to 6 years 6 months
Title
Number of Participants with Presence of Anti-Drug Antibodies (ADAs) to Talquetamab
Description
Number of participants with presence ADAs to talquetamab will be reported.
Time Frame
Up to 6 years 6 months
Title
Number of Participants With Presence of Anti-Drug Antibodies (ADAs) to Daratumumab
Description
Number of participants with presence of ADAs to daratumumab will be reported.
Time Frame
Up to 6 years 6 months
Title
Time to Worsening in Symptoms, Functioning, and Overall Health-Related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q)
Description
The MySIm-Q is a disease-specific PRO assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC-QLQ-C30).
Time Frame
Up to 6 years 6 months
Title
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by PROMIS Short Form Version 2.0 -Physical Functioning 8c
Description
The Patient-reported Outcomes Measurement Information System (PROMIS) Short Form Version 2.0 -Physical Function 8c is an 8-item fixed--length short form derived from the PROMIS Physical Function item bank.
Time Frame
Up to 6 years 6 months
Title
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30
Description
Time to worsening in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 will be reported.
Time Frame
Up to 6 years 6 months
Title
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by PRO-CTCAE
Description
The National Cancer Institute's (NCI) PRO-CTCAE is an item library of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability.
Time Frame
Up to 6 years 6 months
Title
Time to Worsening in Symptoms, Functioning, and 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. For purposes of this study, the EQ-5D-5L will be used to generate utility scores for use in cost-effectiveness analyses.
Time Frame
Up to 6 years 6 months
Title
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by Patient Global Impression - Severity (PGI-S)
Description
The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and PROMIS SF PF 8c in this population.
Time Frame
Up to 6 years 6 months
Title
Change From Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q)
Description
The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30.
Time Frame
Baseline up to 6 years 6 months
Title
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by PROMIS Short Form Version 2.0 -Physical Functioning 8c
Description
The Patient-reported Outcomes Measurement Information System (PROMIS) Short Form Version 2.0 -Physical Function 8c is an 8-item fixed-length short form derived from the PROMIS Physical Function item bank.
Time Frame
Baseline up to 6 years 6 months
Title
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30
Description
Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 will be reported.
Time Frame
Baseline up to 6 years 6 months
Title
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by PRO-CTCAE
Description
The National Cancer Institute's (NCI) PRO-CTCAE is an item library of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability.
Time Frame
Baseline up to 6 years 6 months
Title
Change from Baseline in Symptoms, Functioning, and 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. For purposes of this study, the EQ-5D-5L will be used to generate utility scores for use in cost-effectiveness analyses.
Time Frame
Baseline up to 6 years 6 months
Title
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by Patient Global Impression - Severity (PGI-S)
Description
The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and PROMIS SF PF 8c in this population.
Time Frame
Baseline up to 6 years 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented multiple myeloma as defined: a) Multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria and b) Measurable disease at screening as defined by any of the following: i) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL) (central laboratory); ii) Urine M-protein level >= 200 milligram (mg) per 24 hours (central laboratory); iii) Light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin free light chain >= 10 milligram per deciliter (mg/dL) (central laboratory), and abnormal serum immunoglobulin kappa lambda free light chain ratio Received at least 1 prior line of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide. Participants who have received only 1 prior line of antimyeloma therapy must be considered lenalidomide-refractory (that is, have demonstrated progressive disease by IMWG criteria on or within 60 days of completion of lenalidomide-containing regimen). Participants who have received >=2 prior lines of antimyeloma therapy must be considered lenalidomide exposed Documented evidence of progressive disease based on investigator's determination of response by the 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 immediately prior to the start of administration of study treatment Exclusion Criteria: Contraindications or life-threatening allergies, hypersensitivity, or intolerance to study drug excipients Disease is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody as defined per IMWG consensus guidelines (progression during treatment or within 60 days of completing therapy with an anti-CD38 monoclonal antibody) A maximum cumulative dose of corticosteroids to >=140 milligrams (mg) of prednisone or equivalent within 14-day period before the first dose of study drug Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required Plasma cell leukemia (per IMWG criteria) at the time of screening, Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS syndrome), or primary amyloid light chain amyloidosis
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
First Name & Middle Initial & Last Name or Official Title & Degree
Mel McMahon
Phone
888-850-0650
Email
mel@sparkcures.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
The University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Name
Norwalk Hospital-oncology
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06850
Country
United States
Individual Site Status
Recruiting
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Name
George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Healthcare System
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Miami Health System
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Name
University Of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kansas
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
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
Ochsner Health System
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121-2429
Country
United States
Individual Site Status
Recruiting
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting
Facility Name
Massachusetts General
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
University Of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1032
Country
United States
Individual Site Status
Recruiting
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Individual Site Status
Recruiting
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Recruiting
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Name
Levine Cancer Institute, Carolinas HealthCare System
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
The Ohio State University Wexner Medical Center - James Cancer Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Name
OhioHealth
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-4215
Country
United States
Individual Site Status
Recruiting
Facility Name
Baptist Cancer Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Individual Site Status
Recruiting
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Commonwealth University - Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Individual Site Status
Recruiting
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Name
UZ Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZA
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Virga Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHC MontLegia
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Clinique Saint Pierre
City
Ottignies
ZIP/Postal Code
1340
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UCL Mont Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Fundacao Pio XII
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Santa Casa de Misericordia de Belo Horizonte
City
Belo Horizonte
ZIP/Postal Code
30150-221
Country
Brazil
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
Fundacao Universidade de Caxias do Sul
City
Caxias do Sul
ZIP/Postal Code
95070 560
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Liga Paranaense de Combate ao Cancer
City
Curitiba
ZIP/Postal Code
81520-060
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
Irmandade Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90050-170
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP
City
Ribeirão Preto
ZIP/Postal Code
14051-140
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
Hospital Paulistano
City
Sao Paulo
ZIP/Postal Code
01323-000
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
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
City
São Paulo
ZIP/Postal Code
01308-901
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
Clinica Sao Germano
City
São Paulo
ZIP/Postal Code
01455-010
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto D'Or de Pesquisa e Ensino (IDOR)
City
São Paulo
ZIP/Postal Code
4501000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100006
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Chaoyang Hospital
City
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
The second Xiangya Hospital of Central South University
City
ChangSha
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Name
Sichuan Academy of Medical Science Sichuan Provincial People's Hospital
City
Chengdu
ZIP/Postal Code
610072
Country
China
Individual Site Status
Recruiting
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
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
Guangdong Provincial People's Hospital
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital, Zhejiang University College of Medicine
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Name
Tongji Hospital of Tongji University
City
Shanghai
ZIP/Postal Code
200065
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai Fourth People's Hospital
City
Shanghai
ZIP/Postal Code
200434
Country
China
Individual Site Status
Recruiting
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
ZIP/Postal Code
518036
Country
China
Individual Site Status
Recruiting
Facility Name
First Affiliated Hospital, SooChow University
City
Su Zhou
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin cancer hospital
City
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Name
Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
City
Tianjin
ZIP/Postal Code
300320
Country
China
Individual Site Status
Recruiting
Facility Name
Tongji Hospital, Tongji Medical College of HUST
City
Wuhan
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Cancer Hospital
City
Zhengzhou
ZIP/Postal Code
450008
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 Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultní nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
779 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
Fakultni nemocnice Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Individual Site Status
Recruiting
Facility Name
APHP - Hopital Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Dijon
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Leon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Montpellier - Hopital Saint-Eloi
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Nantes hotel-Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
CHU HOPITAL DE L'ARCHET - Hematology
City
Nice N/a
ZIP/Postal Code
06202
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Hopital Saint Antoine
City
Paris Cedex 12
ZIP/Postal Code
75571
Country
France
Individual Site Status
Recruiting
Facility Name
CHRU - Hôpital du Haut Lévêque - Centre François Magendie
City
Pessac
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Universitaire du cancer de Toulouse-Oncopole
City
TOULOUSE Cedex 9
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Charite Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Name
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
Universitaetsklinikum Koelnt
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsmedizin der Johannes Gutenberg Universität
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Wuerzburg
City
Wuerzburg
ZIP/Postal Code
97080
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
'G. Papanikolaou' Hospital of Thessaloniki
City
Thessalonikis
ZIP/Postal Code
570 10
Country
Greece
Individual Site Status
Recruiting
Facility Name
Anticancer Hospital of Thessaloniki 'Theageneio'
City
Thessaloniki
ZIP/Postal Code
546 39
Country
Greece
Individual Site Status
Recruiting
Facility Name
Ha'Emek Medical Center
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Individual Site Status
Recruiting
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Individual Site Status
Recruiting
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Individual Site Status
Recruiting
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Individual Site Status
Recruiting
Facility Name
Galilee Medical Center
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Beilinson 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
Ziv Medical Center
City
Safed
ZIP/Postal Code
13100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Sourasky (Ichilov) Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Name
A.O. Universitaria Ospedali Riuniti di Ancona
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Policlinico di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Policlinico S. Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Name
PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
City
Catania
ZIP/Postal Code
95123
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
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Villa Sofia-Cervello
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
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
Presidio Ospedaliero Santo Spirito in Sassia
City
Roma
ZIP/Postal Code
00193
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Ospedale Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.O.U. Città della Salute e della Scienza
City
Torino
ZIP/Postal Code
10126
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
Fukuoka University Hospital
City
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ogaki Municipal Hospital
City
Gifu
ZIP/Postal Code
503-8502
Country
Japan
Individual Site Status
Recruiting
Facility Name
Gunma University Hospital
City
Gunma
ZIP/Postal Code
371-0034
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
Japanese Red Cross Society Himeji Hospital
City
Hyogo
ZIP/Postal Code
670-8540
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hyogo Medical University Hospital
City
Hyôgo
ZIP/Postal Code
663-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shonan Kamakura General Hospital
City
Kamakura-shi
ZIP/Postal Code
247-8533
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital East
City
Kashiwa
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Name
Dokkyo Medical University Saitama Medical Center
City
Koshigaya
ZIP/Postal Code
343-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kyoto Kuramaguchi Medical Center
City
Kyoto
ZIP/Postal Code
603-8151
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Matsumoto Medical Center
City
Matsumoto
ZIP/Postal Code
399-8701
Country
Japan
Individual Site Status
Recruiting
Facility Name
Niigata Cancer Center Hospital
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hiroshima West Medical Center
City
Otake
ZIP/Postal Code
739-0696
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hokkaido University Hospital
City
Sapporo-shi
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tohoku University Hospital
City
Sendai
ZIP/Postal Code
980-8574
Country
Japan
Individual Site Status
Recruiting
Facility Name
Iwate Medical University Hospital
City
Shiwa-gun
ZIP/Postal Code
028-3695
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka University Hospital
City
Suita-shi
ZIP/Postal Code
565-0871
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
Dong-A University Hospital
City
Busan
ZIP/Postal Code
602-812
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
National Cancer Center
City
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chonnam National University Hwasun Hospital
City
Jeollanam-do
ZIP/Postal Code
58128
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Jeonbuk National University Hospital
City
Jeonju-si
ZIP/Postal Code
54907
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Albert Schweitzer ziekenhuis-lokatie Dordwijk
City
Dordrecht
ZIP/Postal Code
3318 AT
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Maxima Medisch Centrum
City
Eindhoven
ZIP/Postal Code
5631 BM
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
City
Brzozow
ZIP/Postal Code
36-200
Country
Poland
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
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
City
Kielce
ZIP/Postal Code
25-734
Country
Poland
Individual Site Status
Recruiting
Facility Name
Szpital Uniwersytecki w Krakowie
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
City
Lublin
ZIP/Postal Code
20090
Country
Poland
Individual Site Status
Recruiting
Facility Name
SP ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie, Oddział Hematologii
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Individual Site Status
Recruiting
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
City
Wroclaw
ZIP/Postal Code
52-007
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Germans Trias I Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. de La Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Vall D Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Virgen de La Arrixaca
City
El Palmar, Murcia
ZIP/Postal Code
30120
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. de Leon
City
Leon
ZIP/Postal Code
24071
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Hm Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Virgen de La Victoria
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Univ. de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinico Univ. de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. de Canarias
City
San Cristóbal de La Laguna
ZIP/Postal Code
38320
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Dr. Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Individual Site Status
Recruiting
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Hematology Unit
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ankara University Medical Faculty
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Medipol Mega University Hospital
City
Istabul
ZIP/Postal Code
34214
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Istanbul University Istanbul Medical Faculty
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Suspended
Facility Name
Istanbul University Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34153
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Dokuz Eylul University Medical Faculty
City
Izmir
ZIP/Postal Code
35330
Country
Turkey
Individual Site Status
Recruiting
Facility Name
On Dokuz Mayıs University Medical Faculty
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Blackpool Victoria Hospital
City
Blackpool
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Ninewells Hospital & Medical School
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Imperial College Healthcare
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Newcastle Freeman Hospital
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Nottingham City Hospital
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University Hospitals Plymouth NHS Trust
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
New Cross Hospital
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
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
Links:
URL
https://sparkcures.com/trial/1328/nct05455320?utm_source=ctgov&utm_medium=organic&utm_campaign=monumental3
Description
Click here to learn more about the 64407564MMY3002 (MonumenTAL-3) trial

Learn more about this trial

A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment

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