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Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant (MagnetisMM-7)

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Elranatamab
Lenalidomide
Lenalidomide
Elranatamab
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring BCMA, Multiple Myeloma, Newly diagnosed, Elranatamab, Targeted T-cell, MagnetisMM, MM7, Phase 3, B-cell Maturation Antigen, monoclonal antibody, Stem cell transplant, Autologous stem cell transplant (ASCT), Hematologic disease, Minimum residual disease, Lenalidomide

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of MM as defined according to IMWG criteria (Rajkumar, 2014) with measurable disease at diagnosis History of induction therapy for newly diagnosed MM, followed by high dose therapy and autologous stem cell transplant. Randomization must occur within 120 days from the stem cell transplant. For participants who receive consolidation therapy after ASCT, randomization must occur within 60 days of consolidation and within 7 months from ASCT.
  • Partial Response or better according to IMWG criteria at the time of randomization
  • MRD positive (≥10^-5) at screening by central laboratory NGS test (ClonoSEQ assay) Must have an archival bone marrow aspirate sample(s) that identified the dominant malignant (index) clone that is used to track MRD status. This sample sample should preferably be collected before induction treatment (eg, at diagnosis) or before transplant.
  • ECOG performance status ≤1
  • Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1
  • Not pregnant and willing to use contraception

Exclusion Criteria:

  • Plasma cell leukemia
  • Amyloidosis, Waldenström's macroglobulinemia
  • POEMS syndrome
  • Known active CNS involvement or clinical signs of myelomatous meningeal involvement
  • Previous MM maintenance treatment
  • Prior treatment with BCMA targeted therapy
  • Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
  • Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, and known HIV or AIDS-related illness
  • Previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)

Sites / Locations

  • Ronald Reagan UCLA Medical CenterRecruiting
  • UCLA Hematology/Oncology - Westwood (Building 200 Suite 120)Recruiting
  • OhioHealth Arthur G.H. Bing, MD, Cancer CenterRecruiting
  • OhioHealth Research InstituteRecruiting
  • OhioHealth Riverside Methodist Hospital
  • OhioHealth Riverside Methodist HospitalRecruiting
  • Pindara Private HospitalRecruiting
  • QScan Radiology ClinicsRecruiting
  • Princess Alexandra HospitalRecruiting
  • Epworth HealthcareRecruiting
  • Precision HaematologyRecruiting
  • St Vincent's Hospital (Melbourne)Recruiting
  • Slade PharmacyRecruiting
  • Universitaetsklinikum Allgemeines Krankenhaus WienRecruiting
  • Hanusch-KrankenhausRecruiting
  • Medizinische Universität WienRecruiting
  • Grand Hôpital de Charleroi
  • Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site GodRecruiting
  • ZNA MiddelheimRecruiting
  • Zna CadixRecruiting
  • ZNA StuivenbergRecruiting
  • Zna CadixRecruiting
  • ZNA StuivenbergRecruiting
  • UZ BrusselRecruiting
  • Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial SalvadorRecruiting
  • Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E PesquisaRecruiting
  • Centro de Pesquisa Clínica - Área AdministrativaRecruiting
  • Hospital Mae de DeusRecruiting
  • Ambulatório de QT ConvênioRecruiting
  • Hospital Amaral CarvalhoRecruiting
  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USRecruiting
  • BP - A Beneficencia Portuguesa de São PauloRecruiting
  • Fundação Doutor Amaral CarvalhoRecruiting
  • Américas Medical CityRecruiting
  • Instituto de Educação, Pesquisa e Gestão em SaúdeRecruiting
  • ESHO Empresa de Serviços Hospitalares S.A/ Hospital Samaritano de HigienópolisRecruiting
  • HU UNIFESP / SPDM - Hospital São PauloRecruiting
  • Universidade Federal de Sao PauloRecruiting
  • Hospital Japonês Santa CruzRecruiting
  • Clínica Médica São Germano S/S LtdaRecruiting
  • Tom Baker Cancer CenterRecruiting
  • Dr. Everett Chalmers Regional HospitalRecruiting
  • Saint John Regional HospitalRecruiting
  • Hamilton Health Sciences CorporationRecruiting
  • Princess Margaret Cancer CentreRecruiting
  • Centre Integre Universitaire de la Santé et de Services Sociaux de l'Est-de-l'ile-de-Montreal,Recruiting
  • McGill University Health CentreRecruiting
  • Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSRecruiting
  • Sun Yat-sen University Cancer Center
  • Tongji Hospital; Tongji Medical college; Huazhong University of Science and Technonogy
  • Institute of hematology&blood disease hospital
  • The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
  • Shanghai Fourth People's Hospital
  • Fakultní nemocnice Brno BohuniceRecruiting
  • Fakultni nemocnice Hradec KraloveRecruiting
  • Fakultni nemocnice OstravaRecruiting
  • Fakultni nemocnice OlomoucRecruiting
  • Vseobecna fakultni nemocnice v PrazeRecruiting
  • Oulun yliopistollinen sairaalaRecruiting
  • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)Recruiting
  • Turku University HospitalRecruiting
  • Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSERecruiting
  • Hopital Claude Huriez - CHU de Lille
  • Centre Hospitalier Universitaire de PoitiersRecruiting
  • Hopital Claude Huriez - CHU de LilleRecruiting
  • Hôpital Saint AntoineRecruiting
  • Hopital Lyon SudRecruiting
  • Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
  • Hôpital Saint Antoine
  • Universitätsklinikum WürzburgRecruiting
  • Universitaetsklinikum KoelnRecruiting
  • Universitaetsklinikum Schleswig-Holstein Campus KielRecruiting
  • Charite Universitätsmedizin Berlin Campus Benjamin FranklinRecruiting
  • Charite Universitätsmedizin Berlin Campus Benjamin Franklin
  • Klinikum Chemnitz gGMbHRecruiting
  • Universitätsklinikum EssenRecruiting
  • Klinikum rechts der Isar der Technischen Universität MünchenRecruiting
  • Evangelismos General Hospital of AthensRecruiting
  • Alexandra General Hospital of AthensRecruiting
  • Theageneio Cancer Hospital of ThessalonikiRecruiting
  • Evangelismos HospitalRecruiting
  • University Hospital of IoanninaRecruiting
  • Somogy Megyei Kaposi Mór Oktató KórházRecruiting
  • Semmelweis EgyetemRecruiting
  • Dél-Pesti CentrumkórházRecruiting
  • Debreceni Egyetem Klinikai KozpontRecruiting
  • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András OktatókórháRecruiting
  • Artemis hospitalRecruiting
  • Medanta-The MedicityRecruiting
  • Fortis Memorial Research InstituteRecruiting
  • Christian Medical College VelloreRecruiting
  • Himalayan Institute Hospital Trust UniversityRecruiting
  • Tata Medical CenterRecruiting
  • Rajiv Gandhi Cancer Institute And Research CentreRecruiting
  • Soroka Medical Center
  • Sheba Medical CenterRecruiting
  • Rambam Health Care CampusRecruiting
  • Tel-Aviv Sourasky Medical Center Dana-Dwek Children's HospitalRecruiting
  • Hadassah Medical CenterRecruiting
  • Hadassah Mount Scopus Medical CenterRecruiting
  • Shaare Zedek Medical CenterRecruiting
  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"Recruiting
  • Fondazione Policlinico Universitario Agostino GemelliRecruiting
  • Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoRecruiting
  • Policlinico "G. Rodolico"Recruiting
  • Azienda Ospedaliero Universitaria SeneseRecruiting
  • Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle ScotteRecruiting
  • Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. SalesiRecruiting
  • IRCCS - AOU di BolognaRecruiting
  • AOU Policlinico Umberto IRecruiting
  • Nagoya City University HospitalRecruiting
  • Gunma University HospitalRecruiting
  • Iwate Medical University HospitalRecruiting
  • University Hospital,Kyoto Prefectural University of MedicineRecruiting
  • Tohoku University HospitalRecruiting
  • Hamamatsu University HospitalRecruiting
  • Shizuoka Cancer CenterRecruiting
  • National Hospital Organization Kumamoto Medical CenterRecruiting
  • University Hospital,Kyoto Prefectural University of MedicineRecruiting
  • National Hospital Organization Okayama Medical CenterRecruiting
  • Osaka Metropolitan University HospitalRecruiting
  • Japanese Red Cross Medical CenterRecruiting
  • Yamagata University HospitalRecruiting
  • Gachon University Gil Medical CenterRecruiting
  • Chonnam National University Hwasun HospitalRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Pusan National University HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Samsung Medical CenterRecruiting
  • The Catholic Univ. of Korea Seoul St. Mary's Hospital(Seoul St. Mary's Hospital)Recruiting
  • The Catholic Univ. of Korea Seoul St. Mary's HospitalRecruiting
  • Kyungpook National UniversityRecruiting
  • Kyungpook National University HospitalRecruiting
  • HagaZiekenhuisRecruiting
  • Maastricht Universitair Medisch Centrum
  • IsalaRecruiting
  • Haukeland UniversitetssjukehusRecruiting
  • Oslo Universitetssykehus UllevålRecruiting
  • Stavanger UniversitetssykehusRecruiting
  • Centrum Medyczne Pratia PoznańRecruiting
  • Uniwersyteckie Centrum Kliniczne,Recruiting
  • Uniwersytecki Szpital Kliniczny w PoznaniuRecruiting
  • Uniwersyteckie Centrum Kliniczne WUM Centralny Szpital KlinicznyRecruiting
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut BadawczyRecruiting
  • Klinika Hematologii, Nowotworow Krwi i Transplantacji SzpikuRecruiting
  • Pratia Onkologia KatowiceRecruiting
  • Complejo Hospitalario Universitario de SantiagoRecruiting
  • Hospital Universitari Vall d'HebronRecruiting
  • Institut Català d'Oncologia - L'HospitaletRecruiting
  • Hospital Universitari Mutua TerrassaRecruiting
  • Institut Catala d' Oncologia. Hospital Germans Trias i PujolRecruiting
  • Hospital Universitari Mutua TerrassaRecruiting
  • Hospital Universitario de SalamancaRecruiting
  • Hospital Clínic de BarcelonaRecruiting
  • Clinica Universidad de NavarraRecruiting
  • Hospital Universitario Quironsalud MadridRecruiting
  • Clinica Universidad de Navarra
  • Institut Catala Oncologia - Hospital Universitari de Girona Dr Josep TruetaRecruiting
  • Hospital La PrincesaRecruiting
  • Hospital General Universitario Gregorio MarañonRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospital Universitario HM SanchinarroRecruiting
  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de SalamancaRecruiting
  • Hospital Universitari i Politecnic La FeRecruiting
  • Helsingborgs LasarettRecruiting
  • Karolinska Universitetssjukhuset HuddingeRecruiting
  • Södra Älvsborgs Sjukhus BoråsRecruiting
  • Falu LasarettRecruiting
  • Universitetssjukhuset ÖrebroRecruiting
  • Universitetssjukhuset i LinköpingRecruiting
  • China Medical University HospitalRecruiting
  • Taichung Veterans General HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting
  • Chang Gung Medical Foundation-Linkou BranchRecruiting
  • Medipol Mega Universite HastanesiRecruiting
  • Sisli Florence Nightingale HastanesiRecruiting
  • Ege Universitesi HastanesiRecruiting
  • Dokuz Eylul Universitesi HastanesiRecruiting
  • Ankara Universitesi Tip Fakultesi HastanesiRecruiting
  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma HastanesiRecruiting
  • Gazi UniversitesiRecruiting
  • Akdeniz Universitesi HastanesiRecruiting
  • Aydın Adnan Menderes Universitesi HastanesiRecruiting
  • Erciyes Universitesi Tıp Fakultesi HastaneleriRecruiting
  • Özel Anadolu Sağlık MerkeziRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Experimental

Arm Label

Arm A - Part 1

Arm B - Part 1

Arm B - Part 2

Arm C - Part 2

Arm Description

Elranatamab

Lenalidomide

Lenalidomide

Elranatamab

Outcomes

Primary Outcome Measures

Progression Free Survival
Progression Free Survival assessed by Blinded Independent Central review per IMWG response criteria

Secondary Outcome Measures

Overall Survival
Defined as the time from randomization until death due to any cause
Minimal Residual Disease negativity rate
Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing
Sustained MRD negativity rate
Sustained Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing
Progression Free Survival
Progression Free Survival by investigator per IMWG response criteria
Overall minimal residual disease negativity rate
Minimal residual disease negativity rate per IMWG criteria
Duration of minimal residual disease negativity
Minimal residual disease negativity per IMWG criteria
Sustained minimal residual disease negativity rate
Minimal residual disease negativity per IMWG criteria that has lasted a minimum of 12 months
Complete response rate
Complete response rate by blinded independent central review and by investigator per IMWG criteria
Duration of complete response
Duration of complete response by blinded independent central review and by investigator per IMWG criteria
Frequency of adverse events
Adverse event as characterized by type, frequency, severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5, seriousness and relationship to the study intervention
Frequency of laboratory abnormalities
Pre-dose concentrations of elranatamab
Pharmacokinetics of elranatamab (trough concentrations of elranatamab)
Post-dose concentrations of elranatamab
Pharmacokinetics of elranatamab (Post-dose serum concentrations of elranatamab)"
Incidence and titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab
Immunogenicity of elranatamab
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30
Higher scores on the functional scales represent higher levels of functioning. Higher scores on the global health status/quality of life scale represent higher health status/quality of life. Higher scores on symptom scales/items represent a greater presence of symptoms
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20
Higher scores on the functioning subscales (body image, future perspective) represent higher levels of functioning, whereas higher scores on the symptom subscales (disease symptoms, side effects) represent a greater presence of symptoms
Progression Free Survival 2
Progression Free Survival to the date of second objective disease progression by investigator per IMWG response criteria

Full Information

First Posted
March 18, 2022
Last Updated
October 10, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05317416
Brief Title
Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant
Acronym
MagnetisMM-7
Official Title
A RANDOMIZED, 2-ARM, PHASE 3 STUDY OF ELRANATAMAB (PF-06863135) VERSUS LENALIDOMIDE IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA AFTER UNDERGOING AUTOLOGOUS STEM-CELL TRANSPLANTATION
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2022 (Actual)
Primary Completion Date
August 4, 2027 (Anticipated)
Study Completion Date
October 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years
Detailed Description
Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
BCMA, Multiple Myeloma, Newly diagnosed, Elranatamab, Targeted T-cell, MagnetisMM, MM7, Phase 3, B-cell Maturation Antigen, monoclonal antibody, Stem cell transplant, Autologous stem cell transplant (ASCT), Hematologic disease, Minimum residual disease, Lenalidomide

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Arm A - Part 1
Arm Type
Experimental
Arm Description
Elranatamab
Arm Title
Arm B - Part 1
Arm Type
Active Comparator
Arm Description
Lenalidomide
Arm Title
Arm B - Part 2
Arm Type
Active Comparator
Arm Description
Lenalidomide
Arm Title
Arm C - Part 2
Arm Type
Experimental
Arm Description
Elranatamab
Intervention Type
Drug
Intervention Name(s)
Elranatamab
Intervention Description
BCMA-CD3 bispecific antibody
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
Immunomodulatory drug
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
Immunomodulatory drug
Intervention Type
Drug
Intervention Name(s)
Elranatamab
Intervention Description
BCMA-CD3 bispecific antibody
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
Progression Free Survival assessed by Blinded Independent Central review per IMWG response criteria
Time Frame
Assessed for up to approximately 5 years
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Defined as the time from randomization until death due to any cause
Time Frame
Assessed for up to approximately 5 years
Title
Minimal Residual Disease negativity rate
Description
Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing
Time Frame
12 months after randomization
Title
Sustained MRD negativity rate
Description
Sustained Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing
Time Frame
24 months after randomization
Title
Progression Free Survival
Description
Progression Free Survival by investigator per IMWG response criteria
Time Frame
Assessed for up to approximately 5 years
Title
Overall minimal residual disease negativity rate
Description
Minimal residual disease negativity rate per IMWG criteria
Time Frame
Assessed for up to approximately 5 years
Title
Duration of minimal residual disease negativity
Description
Minimal residual disease negativity per IMWG criteria
Time Frame
Assessed for up to approximately 5 years
Title
Sustained minimal residual disease negativity rate
Description
Minimal residual disease negativity per IMWG criteria that has lasted a minimum of 12 months
Time Frame
Assessed for up to approximately 5 years
Title
Complete response rate
Description
Complete response rate by blinded independent central review and by investigator per IMWG criteria
Time Frame
Assessed for up to approximately 5 years
Title
Duration of complete response
Description
Duration of complete response by blinded independent central review and by investigator per IMWG criteria
Time Frame
Assessed for up to approximately 5 years
Title
Frequency of adverse events
Description
Adverse event as characterized by type, frequency, severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5, seriousness and relationship to the study intervention
Time Frame
Up to 90 days after last dose
Title
Frequency of laboratory abnormalities
Time Frame
Assessed for up to approximately 5 years
Title
Pre-dose concentrations of elranatamab
Description
Pharmacokinetics of elranatamab (trough concentrations of elranatamab)
Time Frame
Assessed for up to approximately 5 years
Title
Post-dose concentrations of elranatamab
Description
Pharmacokinetics of elranatamab (Post-dose serum concentrations of elranatamab)"
Time Frame
Assessed for up to approximately 5 years
Title
Incidence and titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab
Description
Immunogenicity of elranatamab
Time Frame
Assessed for up to approximately 5 years
Title
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30
Description
Higher scores on the functional scales represent higher levels of functioning. Higher scores on the global health status/quality of life scale represent higher health status/quality of life. Higher scores on symptom scales/items represent a greater presence of symptoms
Time Frame
Assessed for up to approximately 5 years
Title
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20
Description
Higher scores on the functioning subscales (body image, future perspective) represent higher levels of functioning, whereas higher scores on the symptom subscales (disease symptoms, side effects) represent a greater presence of symptoms
Time Frame
Assessed for up to approximately 5 years
Title
Progression Free Survival 2
Description
Progression Free Survival to the date of second objective disease progression by investigator per IMWG response criteria
Time Frame
Assessed for up to approximately 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of MM as defined according to IMWG criteria (Rajkumar, 2014) with measurable disease at diagnosis Part 1 patients must be MRD positive, Part 2 patients can be MRD negative or MRD positive History of induction therapy for newly diagnosed MM, followed by high dose therapy and autologous stem cell transplant. Randomization must occur within 120 days from the stem cell transplant. For participants who receive consolidation therapy after ASCT, randomization must occur within 60 days of consolidation and within 7 months from ASCT. Partial Response or better according to IMWG criteria at the time of randomization Must have an archival bone marrow aspirate sample(s) to identify the dominant malignant (index) clone by central laboratory NGS test (ClonoSEQ assay) that is used to track MRD status. This sample should preferably be collected before induction treatment (eg, at diagnosis) or before transplant. ECOG performance status ≤1 Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1 Not pregnant and willing to use contraception Exclusion Criteria: Plasma cell leukemia Amyloidosis, Waldenström's macroglobulinemia POEMS syndrome Known active CNS involvement or clinical signs of myelomatous meningeal involvement Previous MM maintenance treatment Prior treatment with BCMA targeted therapy Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, and known HIV or AIDS-related illness Previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Name
UCLA Hematology/Oncology - Westwood (Building 200 Suite 120)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Name
OhioHealth Arthur G.H. Bing, MD, Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Name
OhioHealth Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Name
OhioHealth Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
OhioHealth Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Name
Pindara Private Hospital
City
Benowa
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Individual Site Status
Recruiting
Facility Name
QScan Radiology Clinics
City
Clayfield
State/Province
Queensland
ZIP/Postal Code
4011
Country
Australia
Individual Site Status
Recruiting
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Name
Epworth Healthcare
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Recruiting
Facility Name
Precision Haematology
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Recruiting
Facility Name
St Vincent's Hospital (Melbourne)
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Recruiting
Facility Name
Slade Pharmacy
City
Richmond
ZIP/Postal Code
3121
Country
Australia
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Allgemeines Krankenhaus Wien
City
Vienna
State/Province
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
Hanusch-Krankenhaus
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Name
Medizinische Universität Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
Grand Hôpital de Charleroi
City
Charleroi
State/Province
Hainaut
ZIP/Postal Code
6000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site God
City
Yvoir
State/Province
Namur
ZIP/Postal Code
5530
Country
Belgium
Individual Site Status
Recruiting
Facility Name
ZNA Middelheim
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Zna Cadix
City
Antwerpen
ZIP/Postal Code
2030
Country
Belgium
Individual Site Status
Recruiting
Facility Name
ZNA Stuivenberg
City
Antwerpen
ZIP/Postal Code
2030
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Zna Cadix
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Individual Site Status
Recruiting
Facility Name
ZNA Stuivenberg
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador
City
Salvador,
State/Province
Bahia
ZIP/Postal Code
41253-190
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90110-270
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Centro de Pesquisa Clínica - Área Administrativa
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90850-170
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Mae de Deus
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90880-480
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Ambulatório de QT Convênio
City
Jaú
State/Province
SÃO Paulo
ZIP/Postal Code
17210-120
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Amaral Carvalho
City
Jaú
State/Province
SÃO Paulo
ZIP/Postal Code
17210-120
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (US
City
Ribeirão Preto
State/Province
SÃO Paulo
ZIP/Postal Code
14051-140
Country
Brazil
Individual Site Status
Recruiting
Facility Name
BP - A Beneficencia Portuguesa de São Paulo
City
Sao Paulo
State/Province
SÃO Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fundação Doutor Amaral Carvalho
City
Jaú
ZIP/Postal Code
17210-080
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Américas Medical City
City
Rio de Janeiro
ZIP/Postal Code
22775-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto de Educação, Pesquisa e Gestão em Saúde
City
Rio de Janeiro
ZIP/Postal Code
22775001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
ESHO Empresa de Serviços Hospitalares S.A/ Hospital Samaritano de Higienópolis
City
São Paulo
ZIP/Postal Code
01232-010
Country
Brazil
Individual Site Status
Recruiting
Facility Name
HU UNIFESP / SPDM - Hospital São Paulo
City
São Paulo
ZIP/Postal Code
04024-002
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Universidade Federal de Sao Paulo
City
São Paulo
ZIP/Postal Code
04024-002
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Japonês Santa Cruz
City
São Paulo
ZIP/Postal Code
04122-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Clínica Médica São Germano S/S Ltda
City
São Paulo
ZIP/Postal Code
04537-080
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Tom Baker Cancer Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N4N2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Dr. Everett Chalmers Regional Hospital
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 5N5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Hamilton Health Sciences Corporation
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 8E7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centre Integre Universitaire de la Santé et de Services Sociaux de l'Est-de-l'ile-de-Montreal,
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUS
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Tongji Hospital; Tongji Medical college; Huazhong University of Science and Technonogy
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Institute of hematology&blood disease hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai Fourth People's Hospital
City
Shanghai
ZIP/Postal Code
200434
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Fakultní nemocnice Brno Bohunice
City
Brno
State/Province
Brno-město
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
State/Province
Hradec Králové
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava-Poruba
State/Province
Moravskoslezský KRAJ
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Oulun yliopistollinen sairaala
City
Oulu
State/Province
Pohjois-pohjanmaa
ZIP/Postal Code
90220
Country
Finland
Individual Site Status
Recruiting
Facility Name
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00029
Country
Finland
Individual Site Status
Recruiting
Facility Name
Turku University Hospital
City
Turku
State/Province
Varsinais-suomi
ZIP/Postal Code
20520
Country
Finland
Individual Site Status
Recruiting
Facility Name
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
City
Toulouse
State/Province
Haute-garonne
ZIP/Postal Code
31100
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Claude Huriez - CHU de Lille
City
Lille
State/Province
Nord
ZIP/Postal Code
59000
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Centre Hospitalier Universitaire de Poitiers
City
Poitiers
State/Province
Vienne
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Claude Huriez - CHU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Saint Antoine
City
Paris Cedex 12
ZIP/Postal Code
75571
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
City
Tours
ZIP/Postal Code
37032
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hôpital Saint Antoine
City
Paris
State/Province
Île-de-france
ZIP/Postal Code
75571
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Koeln
City
Köln
State/Province
Nordrhein-westfalen
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Schleswig-Holstein Campus Kiel
City
Kiel
State/Province
Schleswig-holstein
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Name
Charite Universitätsmedizin Berlin Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Individual Site Status
Recruiting
Facility Name
Charite Universitätsmedizin Berlin Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Klinikum Chemnitz gGMbH
City
Chemnitz
ZIP/Postal Code
09116
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum rechts der Isar der Technischen Universität München
City
München
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Name
Evangelismos General Hospital of Athens
City
Athens
State/Province
Attikí
ZIP/Postal Code
106 76
Country
Greece
Individual Site Status
Recruiting
Facility Name
Alexandra General Hospital of Athens
City
Athens
State/Province
Attikí
ZIP/Postal Code
115 28
Country
Greece
Individual Site Status
Recruiting
Facility Name
Theageneio Cancer Hospital of Thessaloniki
City
Thessaloniki
State/Province
Kentrikí Makedonía
ZIP/Postal Code
546 39
Country
Greece
Individual Site Status
Recruiting
Facility Name
Evangelismos Hospital
City
Athens
ZIP/Postal Code
10676
Country
Greece
Individual Site Status
Recruiting
Facility Name
University Hospital of Ioannina
City
Ioannina
State/Province
Ípeiros
ZIP/Postal Code
455 00
Country
Greece
Individual Site Status
Recruiting
Facility Name
Somogy Megyei Kaposi Mór Oktató Kórház
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Dél-Pesti Centrumkórház
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórhá
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Artemis hospital
City
Gurugram
State/Province
Haryana
ZIP/Postal Code
122001
Country
India
Individual Site Status
Recruiting
Facility Name
Medanta-The Medicity
City
Gurugram
State/Province
Haryana
ZIP/Postal Code
122001
Country
India
Individual Site Status
Recruiting
Facility Name
Fortis Memorial Research Institute
City
Gurugram
State/Province
Haryana
ZIP/Postal Code
122002
Country
India
Individual Site Status
Recruiting
Facility Name
Christian Medical College Vellore
City
Ranipet
State/Province
Tamil NADU
ZIP/Postal Code
632517
Country
India
Individual Site Status
Recruiting
Facility Name
Himalayan Institute Hospital Trust University
City
Dehradun
State/Province
Uttarakhand
ZIP/Postal Code
248140
Country
India
Individual Site Status
Recruiting
Facility Name
Tata Medical Center
City
Kolkata
State/Province
WEST Bengal
ZIP/Postal Code
700160
Country
India
Individual Site Status
Recruiting
Facility Name
Rajiv Gandhi Cancer Institute And Research Centre
City
Delhi
ZIP/Postal Code
110085
Country
India
Individual Site Status
Recruiting
Facility Name
Soroka Medical Center
City
Be'er Sheva
State/Province
Hadarom
ZIP/Postal Code
8410101
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Sheba Medical Center
City
Ramat Gan
State/Province
Hamerkaz
ZIP/Postal Code
5262100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rambam Health Care Campus
City
Haifa
State/Province
Hatsafon
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Tel-Aviv Sourasky Medical Center Dana-Dwek Children's Hospital
City
Tel Aviv
State/Province
Tell Abīb
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah Medical Center
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah Mount Scopus Medical Center
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
9124001
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
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
City
Meldola
State/Province
Emilia-romagna
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Name
Policlinico "G. Rodolico"
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Senese
City
Siena
State/Province
Toscana
ZIP/Postal Code
53100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte
City
Siena
State/Province
Toscana
ZIP/Postal Code
53100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS - AOU di Bologna
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
AOU Policlinico Umberto I
City
Roma
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Name
Nagoya City University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Individual Site Status
Recruiting
Facility Name
Gunma University Hospital
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Iwate Medical University Hospital
City
Yahaba-cho, Shiwa-gun
State/Province
Iwate
ZIP/Postal Code
028-3695
Country
Japan
Individual Site Status
Recruiting
Facility Name
University Hospital,Kyoto Prefectural University of Medicine
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tohoku University Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hamamatsu University Hospital
City
Hamamatsu-shi
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shizuoka Cancer Center
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Kumamoto Medical Center
City
Kumamoto
ZIP/Postal Code
860-0008
Country
Japan
Individual Site Status
Recruiting
Facility Name
University Hospital,Kyoto Prefectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Okayama Medical Center
City
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka Metropolitan University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Individual Site Status
Recruiting
Facility Name
Japanese Red Cross Medical Center
City
Tokyo
ZIP/Postal Code
150-8935
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yamagata University Hospital
City
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Individual Site Status
Recruiting
Facility Name
Gachon University Gil Medical Center
City
Namdong-gu
State/Province
Incheon-gwangyeoksi [incheon]
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun Gun
State/Province
Jeonranamdo
ZIP/Postal Code
58128
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Kyǒnggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Pusan National University Hospital
City
Busan
State/Province
Pusan-kwangyǒkshi
ZIP/Postal Code
49241
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Seoul-teukbyeolsi [seoul]
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Seoul-teukbyeolsi [seoul]
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic Univ. of Korea Seoul St. Mary's Hospital(Seoul St. Mary's Hospital)
City
Seoul
State/Province
Seoul-teukbyeolsi [seoul]
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic Univ. of Korea Seoul St. Mary's Hospital
City
Seoul
State/Province
Seoul-teukbyeolsi [seoul]
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kyungpook National University
City
Daegu
State/Province
Taegu-kwangyǒkshi
ZIP/Postal Code
41944
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kyungpook National University Hospital
City
Jung-gu
State/Province
Taegu-kwangyǒkshi
ZIP/Postal Code
41944
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
HagaZiekenhuis
City
Den Haag
State/Province
Zuid-holland
ZIP/Postal Code
2545 AA
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Maastricht Universitair Medisch Centrum
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Isala
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Haukeland Universitetssjukehus
City
Bergen
State/Province
Hordaland
ZIP/Postal Code
5021
Country
Norway
Individual Site Status
Recruiting
Facility Name
Oslo Universitetssykehus Ullevål
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Individual Site Status
Recruiting
Facility Name
Stavanger Universitetssykehus
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Pratia Poznań
City
Skorzewo
State/Province
Wielkopolskie
ZIP/Postal Code
60-185
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
Uniwersytecki Szpital Kliniczny w Poznaniu
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersyteckie Centrum Kliniczne WUM Centralny Szpital Kliniczny
City
Warszawa
ZIP/Postal Code
02-097
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
Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Individual Site Status
Recruiting
Facility Name
Pratia Onkologia Katowice
City
Katowice
State/Province
Śląskie
ZIP/Postal Code
40-519
Country
Poland
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalario Universitario de Santiago
City
Santiago de Compostela
State/Province
A Coruna
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
State/Province
Barcelona [barcelona]
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Institut Català d'Oncologia - L'Hospitalet
City
L'Hospitalet Del Llobregat
State/Province
Barcelona [barcelona]
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Mutua Terrassa
City
Terrassa
State/Province
Barcelona [barcelona]
ZIP/Postal Code
08221
Country
Spain
Individual Site Status
Recruiting
Facility Name
Institut Catala d' Oncologia. Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Mutua Terrassa
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08221
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
State/Province
Castilla Y LEÓN
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
State/Province
Catalunya [cataluña]
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Universidad de Navarra
City
Madrid
State/Province
Madrid, Comunidad DE
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Quironsalud Madrid
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Institut Catala Oncologia - Hospital Universitari de Girona Dr Josep Trueta
City
Gerona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario HM Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari i Politecnic La Fe
City
València
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Helsingborgs Lasarett
City
Helsingborg
State/Province
Skåne LÄN [se-12]
ZIP/Postal Code
251 87
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Karolinska Universitetssjukhuset Huddinge
City
Stockholm
State/Province
Stockholms LÄN [se-01]
ZIP/Postal Code
141 86
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Södra Älvsborgs Sjukhus Borås
City
Borås
State/Province
Västra Götalands LÄN [se-14]
ZIP/Postal Code
501 82
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Falu Lasarett
City
Falun
ZIP/Postal Code
791 31
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Universitetssjukhuset Örebro
City
Örebro
State/Province
Örebro LÄN [se-18]
ZIP/Postal Code
701 85
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Universitetssjukhuset i Linköping
City
Linköping
State/Province
Östergötlands LÄN [se-05]
ZIP/Postal Code
581 85
Country
Sweden
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang Gung Medical Foundation-Linkou Branch
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Medipol Mega Universite Hastanesi
City
İstanbul
State/Province
İ̇stanbul
ZIP/Postal Code
34214
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Sisli Florence Nightingale Hastanesi
City
İstanbul
State/Province
İ̇stanbul
ZIP/Postal Code
34381
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ege Universitesi Hastanesi
City
Izmir
State/Province
İ̇zmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Dokuz Eylul Universitesi Hastanesi
City
İzmir
State/Province
İ̇zmir
ZIP/Postal Code
35340
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ankara Universitesi Tip Fakultesi Hastanesi
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Gazi Universitesi
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Akdeniz Universitesi Hastanesi
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Aydın Adnan Menderes Universitesi Hastanesi
City
Aydin
ZIP/Postal Code
09100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Erciyes Universitesi Tıp Fakultesi Hastaneleri
City
Kayseri
ZIP/Postal Code
38030
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Özel Anadolu Sağlık Merkezi
City
Kocaeli
ZIP/Postal Code
41400
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C1071007
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant

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