MajesTEC-3: 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

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05083169
Collaborator
(none)
560
Enrollment
141
Locations
2
Arms
62.1
Anticipated Duration (Months)
4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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 IMWG criteria. The overall duration of the study will be up to 5 years and 2 months after the last participant is randomized.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
560 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 19, 2021
Anticipated Primary Completion Date :
Jul 7, 2024
Anticipated Study Completion Date :
Dec 23, 2026

Arms and Interventions

ArmIntervention/Treatment
Experimental: Arm A: Teclistamab-daratumumab (Tec-Dara)

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

Drug: Daratumumab
Daratumumab will be administered SC injection.

Drug: Teclistamab
Teclistamab will be administered SC injection.
Other Names:
  • JNJ-64007957
  • Experimental: Arm B:Daratumumab, Pomalidomide, Dexamethasone (DPd) or Daratumumab, Bortezomib, Dexamethasone (DVd)

    In DPd treatment (28-day cycle), participants will receive daratumumab SC 1800mg weekly on Cycles 1 and 2, every 2 weeks on Cycles 3 to 6, every 4 weeks on Cycle 7 and beyond; oral pomalidomide 4 mg on Days 1 to 21 of every 28-day cycle, dexamethasone 40 mg (less than or equal to [<=] 75 years) or 20 mg (greater than [>] 75 years) orally or intravenously (IV) weekly on every cycle. In DVd treatment (21-day cycle from Cycles 1 to 8 and 28-day cycle from Cycle 9 and beyond), daratumumab SC injection 1800 mg weekly on Cycles 1 to 3 and on Day 1 (Cycle 4 and beyond); bortezomib 1.3 milligrams per meter square (mg/m^2) on Days 1, 4, 8 and 11 (Cycles 1 to 8), and dexamethasone 20 mg on Days 1, 2, 4, 5, 8, 9, 11 and 12 (Cycles 1 to 8).

    Drug: Daratumumab
    Daratumumab will be administered SC injection.

    Drug: Pomalidomide
    Pomalidomide will be administered orally.

    Drug: Dexamethasone
    Dexamethasone will be administered orally or IV.

    Drug: Bortezomib
    Bortezomib will be administered SC injection.

    Outcome Measures

    Primary Outcome Measures

    1. Progression Free Survival (PFS) [Up to 5 years and 2 months]

      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

    1. Overall Response (Partial Response [PR] or Better) [Up to 5 years and 2 months]

      Overall response (PR or better) is defined as participants who have a PR or better per IMWG criteria.

    2. Very Good Partial Response (VGPR) or Better [Up to 5 years and 2 months]

      VGPR or better is defined as participants who achieve a VGPR or better response per IMWG criteria.

    3. Complete Response (CR) or Better [Up to 5 years and 2 months]

      CR or better is defined as participants who achieve a CR or better response per IMWG criteria.

    4. Minimal Residual Disease (MRD)-negativity [Up to 5 years and 2 months]

      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.

    5. Progression Free Survival on Next-line Therapy (PFS2) [Up to 5 years and 2 months]

      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.

    6. Overall Survival (OS) [Up to 5 years and 2 months]

      OS is measured from the date of randomization to the date of the participant's death.

    7. Time to Next Treatment (TTNT) [Up to 5 years and 2 months]

      TTNT is defined as the interval time from randomization to the start of subsequent antimyeloma treatment.

    8. Number of Participants with Adverse Events (AEs) by Severity [Up to 5 years and 2 months]

      Number of participants with AEs by Severity will be reported.

    9. Serum Concentration of Teclistamab [Up to 5 years and 2 months]

      Serum samples will be analyzed to determine concentrations of teclistamab using a validated, specific, and sensitive method.

    10. Number of Participants with Anti-drug Antibodies (ADAs) to Teclistamab and Daratumumab [Up to 5 years and 2 months]

      Number of participants with ADAs to teclistamab and daratumumab will be reported.

    11. Time to Worsening of Symptoms [Up to 5 years and 2 months]

      Time to worsening is measured as the interval from the date of randomization to the start date of meaningful change.

    12. 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) [Baseline up to 5 years and 2 months]

      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.

    13. Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Score [Baseline up to 5 years and 2 months]

      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.

    14. 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) [Baseline up to 5 years and 2 months]

      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.

    15. 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 ) [Baseline up to 6 months]

      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.

    16. Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L) [Baseline up to 5 years and 2 months]

      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).

    17. Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Patient Global Impression - Severity (PGI-S) [Baseline up to 5 years and 2 months]

      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."

    18. PFS in Participants with High-risk Molecular Features [Up to 5 years and 2 months]

      PFS in participants with high-risk molecular features will be reported.

    19. Depth of Response in Participants in High-risk Molecular Features [Up to 5 years and 2 months]

      Depth of response in participants in high-risk molecular features will be reported.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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. 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 immediately 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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1University of Alabama at BirminghamBirminghamAlabamaUnited States35294
    2City of HopeDuarteCaliforniaUnited States91010
    3Stanford University Medical CenterStanfordCaliforniaUnited States94305-5623
    4Yale UniversityNew HavenConnecticutUnited States06510
    5Grady Memorial HospitalAtlantaGeorgiaUnited States30303
    6Henry Ford Health SystemsDetroitMichiganUnited States48202
    7Mayo Clinic Cancer CenterRochesterMinnesotaUnited States55905
    8Hackensack University Medical CenterHackensackNew JerseyUnited States07601
    9Cleveland ClinicClevelandOhioUnited States44195
    10University of Pittsburgh Medical CenterPittsburghPennsylvaniaUnited States15232
    11Medical University of South CarolinaCharlestonSouth CarolinaUnited States29425-8900
    12Baptist Cancer CenterMemphisTennesseeUnited States38120
    13Vanderbilt - Ingram Cancer CenterNashvilleTennesseeUnited States37212
    14University of Texas Southwestern Medical CenterDallasTexasUnited States75390
    15Huntsman Cancer InstituteSalt Lake CityUtahUnited States84112
    16Seattle Cancer Care AllianceSeattleWashingtonUnited States98109
    17University of Wisconsin Carbone Cancer CenterMadisonWisconsinUnited States53792
    18Medical College Of WisconsinMilwaukeeWisconsinUnited States53226
    19Hospital AlemanBuenos AiresArgentinaC1118AAT
    20Hospital Italiano de Buenos AiresBuenos AiresArgentinaC1199ABB
    21Hospital Privado - Centro Medico de CordobaCordobaArgentinaX5016KEH
    22ZNA StuivenbergAntwerpenBelgium2060
    23AZ St.-Jan Brugge-Oostende AVBruggeBelgium8000
    24UZ GentGentBelgium9000
    25Hopital de JolimontHaine-saint-paul, LA LouviereBelgium7100
    26Az GroeningeKortrijkBelgium8500
    27UZ LeuvenLeuvenBelgium3000
    28Algemeen Ziekenhuis DeltaRoeselareBelgium8800
    29DF StarBrasiliaBrazil70390-140
    30Liga Norte Riograndense Contra O CancerNatalBrazil59062-000
    31NTC Santa Casa Porto AlegrePorto AlegreBrazil90050-170
    32Instituto COI de Pesquisa, Educacao e GestaoRio de JaneiroBrazil22793-080
    33Hospital Sao RafaelSalvadorBrazil41253-190
    34Hospital PaulistanoSão PauloBrazil01321-001
    35Hospital Beneficencia PortuguesaSão PauloBrazil01323-010
    36Clinica Sao GermanoSão PauloBrazil01455-010
    37Tom Baker Cancer CentreCalgaryAlbertaCanadaT2N 4N2
    38Cross Cancer InstituteEdmontonAlbertaCanadaT6G 1Z2
    39BC Cancer Agency - Vancouver BCVancouverBritish ColumbiaCanadaV5Z 4E6
    40Qwii Health SciencesHalifaxNova ScotiaCanadaB3H 2Y9
    41Princess Margaret Cancer Centre University Health NetworkTorontoOntarioCanadaM5G 1X6
    42McGill University Health CentreMontrealQuebecCanadaH4A 3J1
    43CHU de QuébecQuebecCanadaG1R 2J6
    44Peking University People's HospitalBeijingChina100044
    45West China Hospital, Sichuan UniversityChengduChina610041
    46First affiliated Hospital of Zhejiang UniversityHangzhouChina310003
    47Shanghai Changzheng HospitalShanghaiChina200003
    48Wuhan Union HospitalWuhanChina430022
    49The Second Affiliated Hospital of Xi'an Jiaotong UniversityXi'anChina710004
    50Aalborg University HospitalAalborgDenmarkDK-9000
    51Aarhus University HospitalAarhus NDenmarkDK-8200
    52RigshospitaletCopenhagenDenmark2100
    53Odense Universitets HospitalOdenseDenmark5000
    54Vejle HospitalVejleDenmarkDK-7100
    55CHU Henri MondorCreteilFrance94000
    56CHRU de Lille - Hôpital Claude HuriezLILLE CedexFrance59037
    57CHU de Limoges, Hopital DupuytrenLimogesFrance87042
    58C.H.U. Hotel Dieu - FranceNantesFrance44093
    59Centre hospitalier Lyon-SudPierre Benite cedexFrance69495
    60CHU De PoitiersPoitiersFrance86021
    61Institut de Cancérologie Strasbourg Europe (ICANS)StrasbourgFrance67200
    62Pôle IUC Oncopole CHUToulouse cedex 9France31059
    63CHRU Hôpital BretonneauToursFrance37044
    64Universitätsklinikum Carl-Gustav-Carus DresdenDresdenGermany01307
    65Heinrich-Heine -Universitaet DuesseldorfDuesseldorfGermany40225
    66Universitatsklinikum FreiburgFreiburgGermany79106
    67Universitaetsklinikum Hamburg EppendorfHamburgGermany20246
    68St. Barbara-Klinik Hamm GmbHHammGermany59075
    69Universitaetsklinikum HeidelbergHeidelbergGermany69120
    70Universitaetsklinikum Schleswig-Holstein Campus KielKielGermany24105
    71Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,TübingenGermany72076
    72Alexandra General Hospital of AthensAthens AtticaGreece115 28
    73University of Athens - Evaggelismos Hospital (Evangelismos Hospital)AthensGreece106 76
    74Anticancer Hospital of Thessaloniki 'Theageneio'ThessalonikiGreece546 39
    75G.PapanikolaouThessalonikiGreece57010
    76U.O. Ematologia con Trapianto- AOU Policlinico di BariBariItaly70124
    77ASST Papa Giovanni XXIII - BergamoBergamoItaly24127
    78Policlinico Sant'Orsola MalpighiBolognaItaly40138
    79Azienda Ospedaliera Universitaria CareggiFirenzeItaly50134
    80Università di Roma 'La Sapienza' - Ospedale Umberto 1°RomaItaly00161
    81A.O.U. Citta della Salute e della Scienza di Torino - Presidio MolinetteTurinItaly10126
    82Kyungpook National University HospitalDaeguKorea, Republic of41944
    83Chonnam National University Hwasun HospitalHwasun GunKorea, Republic of58128
    84Gachon University Gil Medical CenterIncheonKorea, Republic of21565
    85Seoul National University HospitalSeoulKorea, Republic of03080
    86Severance Hospital, Yonsei University Health SystemSeoulKorea, Republic of03722
    87Samsung Medical CenterSeoulKorea, Republic of06351
    88The Catholic University of Korea, Seoul St. Mary's HospitalSeoulKorea, Republic of06591
    89VU Medisch CentrumAmsterdamNetherlands1081 HV
    90Universitair Medisch Centrum GroningenGroningenNetherlands9713 GZ
    91Sint Antonius Ziekenhuis - Afd.Interne - INTNieuwegeinNetherlands3435 CM
    92RadboudumcNijmegenNetherlands6525GA
    93Isala KliniekZwolleNetherlands8025 AB
    94S.P. Botkin Moscow City Clinical HospitalMoscowRussian Federation125284
    95Saint-Petersburg State Pavlov UniversitySaint-PetersburgRussian Federation197022
    96Samara State Medical UniveristySamaraRussian Federation443079
    97Samara Region Clinical HospitalSamaraRussian Federation443095
    98Clinical Research Institute of Hematology and TransfusiologySt-PetersburgRussian Federation191024
    99St.-Petersburg City Clinical Hospital nr 31St. PetersburgRussian Federation197110
    100Federal Center of Heart, Blood and EndocrinologySt.-PetersburgRussian Federation197341
    101Inst. Cat. Doncologia-H Duran I ReynalsBarcelonaSpain08908
    102Hosp. Univ. Vall D HebronBarcelonaSpain8035
    103Hosp. de CabuenesGijónSpain33394
    104Hosp. Univ. de Gran Canaria Dr. NegrinLas Palmas de Gran CanariaSpain35010
    105Hosp. Gral. Univ. Gregorio MarañonMadridSpain28007
    106Hosp. Univ. Ramon Y CajalMadridSpain28034
    107Hosp. Univ. 12 de OctubreMadridSpain28041
    108Hosp. Univ. Son EspasesPalmaSpain7120
    109Clinica Univ. de NavarraPamplonaSpain31008
    110Hosp. Quiron Madrid PozueloPozuelo de AlarconSpain28223
    111Hosp. Clinico Univ. de SalamancaSalamancaSpain37007
    112Hosp. Univ. Marques de ValdecillaSantanderSpain39008
    113Hosp. Clinico Univ. de SantiagoSantiago de CompostelaSpain15706
    114Hosp. Virgen Del RocioSevillaSpain41013
    115Hosp. Univ. I Politecni La FeValenciaSpain46026
    116Falu LasarettFalunSweden791 82
    117Sahlgrenska University HospitalGöteborgSweden413 45
    118Helsingborgs lasarettHelsingborgSweden25187
    119Skanes universitetssjukhusLundSweden221 85
    120Universitetssjukhuset ÖrebroOrebroSweden703 62
    121Karolinska Universitetssjukhuset, HuddingeStockholmSweden141 86
    122Sunderby SjukhusSunderbynSweden954 42
    123Norrlands UniversitetssjukhusUmeaSweden901 85
    124Akademiska SjukhusetUppsalaSweden751 85
    125China Medical University HospitalTaichungTaiwan40447
    126National Cheng Kung University HospitalTainanTaiwan704
    127Chang Gung Memorial HospitalTaoyuanTaiwan333
    128National Cancer Institute, Dept. of chemotherapy of hemoblastosisKievUkraine03022
    129State Institution 'National Scientific Center for Radiation Medicine of NAMS of Ukraine'KievUkraine03115
    130Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'KyivUkraine02091
    131Institute of Blood Pathology and Transfusion Medicine of AMS of UkraineLvivUkraine79044
    132Mykolaiv Regional Clinical HospitalMykolaivUkraine54000
    133Municipal Enterprise 'Poltava Reg. Clinical Hospital N.A. Sklifosovsky of The Poltava Reg. Council'PoltavaUkraine36011
    134Blackpool Teaching Hospitals NHS Foundation TrustBlackpoolUnited KingdomFY3 8NR
    135Ninewells Hospital & Medical SchoolDundeeUnited KingdomDD1 9SY
    136St James University HospitalLeedsUnited KingdomLS9 7TF
    137University College HospitalLondonUnited KingdomNW1 2BU
    138Kings College HospitalLondonUnited KingdomSE5 9RS
    139Oxford University Hospitals NHS Foundation TrustOxfordUnited KingdomOX3 7LE
    140University Hospitals Plymouth NHS TrustPlymouthUnited KingdomPL6 8DH
    141Royal Marsden HospitalSuttonUnited KingdomSM2 5PT

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT05083169
    Other Study ID Numbers:
    • CR109049
    • 2020-004742-11
    • 64007957MMY3001
    First Posted:
    Oct 19, 2021
    Last Update Posted:
    Dec 3, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 3, 2021