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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05317416
Other study ID # C1071007
Secondary ID 2021-006052-14Ma
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 25, 2022
Est. completion date October 31, 2029

Study information

Verified date May 2024
Source Pfizer
Contact Pfizer CT.gov Call Center
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 760
Est. completion date October 31, 2029
Est. primary completion date August 4, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Elranatamab
BCMA-CD3 bispecific antibody
Lenalidomide
Immunomodulatory drug
Lenalidomide
Immunomodulatory drug
Elranatamab
BCMA-CD3 bispecific antibody

Locations

Country Name City State
Australia Pindara Private Hospital Benowa Queensland
Australia QScan Radiology Clinics Clayfield Queensland
Australia Epworth Healthcare East Melbourne Victoria
Australia Precision Haematology East Melbourne Victoria
Australia St Vincent's Hospital (Melbourne) Fitzroy Victoria
Australia Slade Pharmacy Richmond
Australia Princess Alexandra Hospital Woolloongabba Queensland
Austria Hanusch-Krankenhaus Vienna
Austria Medizinische Universität Wien Vienna Wien
Austria Medizinische Universität Wien Wien
Belgium Institut Jules Bordet Anderlecht Bruxelles-capitale, Région DE
Belgium Zna Cadix Antwerpen
Belgium Zna Cadix Antwerpen
Belgium ZNA Middelheim Antwerpen
Belgium ZNA Stuivenberg Antwerpen
Belgium ZNA Stuivenberg Antwerpen
Belgium UZ Brussel Brussel
Belgium Grand Hôpital de Charleroi Charleroi Hainaut
Belgium Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi Yvoir Namur
Brazil Ambulatório de QT Convênio Jaú SÃO Paulo
Brazil Fundação Doutor Amaral Carvalho Jaú
Brazil Hospital Amaral Carvalho Jaú SÃO Paulo
Brazil Centro de Pesquisa Clínica - Área Administrativa Porto Alegre RIO Grande DO SUL
Brazil Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa Porto Alegre RIO Grande DO SUL
Brazil Hospital Mae de Deus Porto Alegre RIO Grande DO SUL
Brazil Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP Ribeirão Preto SÃO Paulo
Brazil Américas Medical City Rio de Janeiro
Brazil Instituto de Educação, Pesquisa e Gestão em Saúde Rio de Janeiro
Brazil Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador Salvador, Bahia
Brazil BP - A Beneficencia Portuguesa de São Paulo Sao Paulo SÃO Paulo
Brazil Clínica Médica São Germano S/S Ltda São Paulo
Brazil ESHO Empresa de Serviços Hospitalares S.A/ Hospital Samaritano de Higienópolis São Paulo
Brazil Hospital Japonês Santa Cruz São Paulo
Brazil HU UNIFESP / SPDM - Hospital São Paulo São Paulo
Brazil Universidade Federal de Sao Paulo São Paulo
Brazil Clínica Médica São Germano LTDA SP SÃO Paulo
Canada Tom Baker Cancer Center Calgary Alberta
Canada Dr. Everett Chalmers Regional Hospital Fredericton New Brunswick
Canada Hamilton Health Sciences Corporation Hamilton Ontario
Canada Centre Integre Universitaire de la Santé et de Services Sociaux de l'Est-de-l'ile-de-Montreal, Montreal Quebec
Canada Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSS Montreal Quebec
Canada McGill University Health Centre Montreal Quebec
Canada Saint John Regional Hospital Saint John New Brunswick
Canada Princess Margaret Cancer Centre Toronto Ontario
Canada Windsor Regional Hospital Cancer Program Windsor Ontario
China Sun Yat-sen University Cancer Center Guangzhou Guangdong
China Shanghai Fourth People's Hospital Shanghai
China Institute of hematology&blood disease hospital Tianjin Tianjin
China The First Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang
China Tongji Hospital; Tongji Medical college; Huazhong University of Science and Technonogy Wuhan Hubei
Czechia Fakultní nemocnice Brno Bohunice Brno Brno-mesto
Czechia Fakultni nemocnice Hradec Kralove Hradec Kralove Hradec Králové
Czechia Fakultni nemocnice Olomouc Olomouc
Czechia Fakultni nemocnice Ostrava Ostrava Moravskoslezský KRAJ
Czechia Fakultni nemocnice Ostrava Ostrava-Poruba Moravskoslezský KRAJ
Czechia Vseobecna fakultni nemocnice v Praze Praha 2
Finland Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) Helsinki Uusimaa
Finland Oulun yliopistollinen sairaala Oulu Pohjois-pohjanmaa
Finland Turku University Hospital Turku Varsinais-suomi
France Chu Grenoble Alpes La Tronche
France Hopital Claude Huriez - CHU de Lille Lille
France Hopital Claude Huriez - CHU de Lille Lille Nord
France Hôpital Saint Antoine Paris Île-de-france
France Pitie Salpetriere University Hospital Paris Orne
France Hôpital Saint Antoine Paris Cedex 12
France Hopital Lyon Sud Pierre Benite
France Centre Hospitalier Universitaire de Poitiers Poitiers Vienne
France Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE Toulouse Haute-garonne
France Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau Tours
France Gustave Roussy Villejuif Val-de-marne
Germany Charite Universitätsmedizin Berlin Campus Benjamin Franklin Berlin
Germany Charite Universitätsmedizin Berlin Campus Benjamin Franklin Berlin
Germany Klinikum Chemnitz gGMbH Chemnitz
Germany Universitätsklinikum Essen Essen
Germany Universitaetsklinikum Schleswig-Holstein Campus Kiel Kiel Schleswig-holstein
Germany Universitaetsklinikum Koeln Köln Nordrhein-westfalen
Germany Universitätsklinikum Leipzig Leipzig Sachsen
Germany Universitätsmedizin Johannes Gutenberg Universität Mainz Mainz Rheinland-pfalz
Germany Klinikum rechts der Isar der Technischen Universität München München
Germany Universitätsklinikum Würzburg Würzburg Bayern
Greece Alexandra General Hospital of Athens Athens Attikí
Greece Evangelismos General Hospital of Athens Athens Attikí
Greece Evangelismos Hospital Athens
Greece University Hospital of Ioannina Ioannina Ípeiros
Greece Theageneio Cancer Hospital of Thessaloniki Thessaloniki Kentrikí Makedonía
Hungary Dél-Pesti Centrumkórház Budapest
Hungary Semmelweis University Budapest
Hungary Debreceni Egyetem Klinikai Kozpont Debrecen
Hungary Somogy Megyei Kaposi Mór Oktató Kórház Kaposvár Somogy
Hungary Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház Nyíregyháza
India Himalayan Institute Hospital Trust University Dehradun Uttarakhand
India Rajiv Gandhi Cancer Institute And Research Centre Delhi
India Artemis hospital Gurugram Haryana
India Fortis Memorial Research Institute Gurugram Haryana
India Medanta-The Medicity Gurugram Haryana
India Tata Medical Center Kolkata WEST Bengal
India Christian Medical College Vellore Ranipet Tamil NADU
Israel Soroka Medical Center Be'er Sheva Hadarom
Israel Rambam Health Care Campus Haifa Hatsafon
Israel Hadassah Medical Center Jerusalem Yerushalayim
Israel Hadassah Mount Scopus Medical Center Jerusalem Yerushalayim
Israel Shaare Zedek Medical Center Jerusalem
Israel Shaare Zedek Medical Center Jerusalem
Israel Shaare Zedek Medical Center Jerusalem Yerushalayim
Israel Rabin Medical Center Petah-Tikva Hamerkaz
Israel Sheba Medical Center Ramat Gan Hamerkaz
Israel Tel-Aviv Sourasky Medical Center Dana-Dwek Children's Hospital Tel Aviv Tell Abib
Italy Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi Ancona
Italy IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola Bologna
Italy Policlinico "G. Rodolico" Catania Sicilia
Italy IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" Meldola Emilia-romagna
Italy Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano Lombardia
Italy AOU Policlinico Umberto I Roma
Italy Fondazione Policlinico Universitario Agostino Gemelli Roma Lazio
Italy Azienda Ospedaliero Universitaria Senese Siena Toscana
Italy Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte Siena Toscana
Japan Hamamatsu University Hospital Hamamatsu-shi Shizuoka
Japan National Hospital Organization Kumamoto Medical Center Kumamoto
Japan University Hospital,Kyoto Prefectural University of Medicine Kyoto
Japan University Hospital,Kyoto Prefectural University of Medicine Kyoto-shi Kyoto
Japan Gunma University Hospital Maebashi Gunma
Japan Nagoya City University Hospital Nagoya Aichi
Japan National Hospital Organization Okayama Medical Center Okayama
Japan Osaka Metropolitan University Hospital Osaka
Japan Tohoku University Hospital Sendai Miyagi
Japan Shizuoka Cancer Center Sunto-gun Shizuoka
Japan Japanese Red Cross Medical Center Tokyo
Japan Iwate Medical University Hospital Yahaba-cho, Shiwa-gun Iwate
Japan Yamagata University Hospital Yamagata
Korea, Republic of Pusan National University Hospital Busan Pusan-kwangyokshi
Korea, Republic of Kyungpook National University Daegu Taegu-kwangyokshi
Korea, Republic of Chonnam National University Hwasun Hospital Hwasun Gun Jeonranamdo
Korea, Republic of Kyungpook National University Hospital Jung-gu Taegu-kwangyokshi
Korea, Republic of Gachon University Gil Medical Center Namdong-gu Incheon-gwangyeoksi [incheon]
Korea, Republic of Seoul National University Bundang Hospital Seongnam Kyonggi-do
Korea, Republic of Samsung Medical Center Seoul Seoul-teukbyeolsi [seoul]
Korea, Republic of Seoul National University Hospital Seoul Seoul-teukbyeolsi [seoul]
Korea, Republic of The Catholic Univ. of Korea Seoul St. Mary's Hospital Seoul Seoul-teukbyeolsi [seoul]
Korea, Republic of The Catholic Univ. of Korea Seoul St. Mary's Hospital(Seoul St. Mary's Hospital) Seoul Seoul-teukbyeolsi [seoul]
Netherlands HagaZiekenhuis Den Haag Zuid-holland
Netherlands Maastricht Universitair Medisch Centrum Maastricht
Netherlands Isala Zwolle
Norway Haukeland Universitetssjukehus Bergen Hordaland
Norway Oslo Universitetssykehus Ullevål Oslo
Norway Stavanger Universitetssykehus Stavanger
Poland Uniwersyteckie Centrum Kliniczne, Gdansk
Poland Pratia Onkologia Katowice Katowice Slaskie
Poland Uniwersytecki Szpital Kliniczny w Poznaniu Poznan
Poland Centrum Medyczne Pratia Poznan Skorzewo Wielkopolskie
Poland Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy Warszawa
Poland Uniwersyteckie Centrum Kliniczne WUM Centralny Szpital Kliniczny Warszawa
Poland Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku Wroclaw
Spain Institut Catala d' Oncologia. Hospital Germans Trias i Pujol Badalona Barcelona
Spain Hospital Clínic de Barcelona Barcelona Catalunya [cataluña]
Spain Hospital Universitari Vall d'Hebron Barcelona Barcelona [barcelona]
Spain Institut Catala Oncologia - Hospital Universitari de Girona Dr Josep Trueta Gerona
Spain Institut Català d'Oncologia - L'Hospitalet L'Hospitalet Del Llobregat Barcelona [barcelona]
Spain Clinica Universidad de Navarra Madrid Madrid, Comunidad DE
Spain Hospital General Universitario Gregorio Marañon Madrid
Spain Hospital La Princesa Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario HM Sanchinarro Madrid
Spain Clinica Universidad de Navarra Pamplona Navarra
Spain Hospital Universitario Quironsalud Madrid Pozuelo de Alarcon Madrid
Spain Hospital Universitario de Salamanca Salamanca Castilla Y LEÓN
Spain Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca Salamanca
Spain Complejo Hospitalario Universitario de Santiago Santiago de Compostela A Coruna
Spain Hospital Universitari Mutua Terrassa Terrassa Barcelona [barcelona]
Spain Hospital Universitari Mutua Terrassa Terrassa Barcelona
Spain Hospital Universitari i Politecnic La Fe València
Sweden Södra Älvsborgs Sjukhus Borås Borås Västra Götalands LÄN [se-14]
Sweden Falu Lasarett Falun
Sweden Helsingborgs Lasarett Helsingborg Skåne LÄN [se-12]
Sweden Universitetssjukhuset i Linköping Linköping Östergötlands LÄN [se-05]
Sweden Universitetssjukhuset Örebro Örebro Örebro LÄN [se-18]
Sweden Karolinska Universitetssjukhuset Huddinge Stockholm Stockholms LÄN [se-01]
Taiwan China Medical University Hospital Taichung
Taiwan Taichung Veterans General Hospital Taichung
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei
Taiwan Chang Gung Medical Foundation-Linkou Branch Taoyuan
Turkey Ankara Universitesi Tip Fakultesi Hastanesi Ankara
Turkey Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi Ankara
Turkey Gazi Universitesi Ankara
Turkey Akdeniz Universitesi Hastanesi Antalya
Turkey Aydin Adnan Menderes Universitesi Hastanesi Aydin
Turkey Medipol Mega Universite Hastanesi Istanbul I?stanbul
Turkey Sisli Florence Nightingale Hastanesi Istanbul I?stanbul
Turkey Dokuz Eylul Universitesi Hastanesi Izmir I?zmir
Turkey Dokuz Eylul Universitesi Hastanesi Izmir I?zmir
Turkey Ege Universitesi Hastanesi Izmir I?zmir
Turkey Erciyes Universitesi Tip Fakultesi Hastaneleri Kayseri
Turkey Özel Anadolu Saglik Merkezi Kocaeli
United Kingdom The Beatson West of Scotland Cancer Centre Glasgow
United States University of Michigan Ann Arbor Michigan
United States Emory University Hospital Atlanta Georgia
United States Emory University Hospital Midtown Atlanta Georgia
United States Investigational Drug Service, Emory University Clinic Atlanta Georgia
United States Winship Cancer Institute, Emory University Atlanta Georgia
United States Cleveland Clinic Cleveland Ohio
United States OhioHealth Arthur G.H. Bing, MD, Cancer Center Columbus Ohio
United States OhioHealth Research Institute Columbus Ohio
United States OhioHealth Riverside Methodist Hospital Columbus Ohio
United States OhioHealth Riverside Methodist Hospital Columbus Ohio
United States Baylor University Medical Center Dallas Texas
United States Banner Gateway Medical Center Gilbert Arizona
United States Banner MD Anderson Cancer Center Gilbert Arizona
United States University Of Mississippi Medical Center Jackson Mississippi
United States University of Mississippi Medical Center Jackson Mississippi
United States Ronald Reagan UCLA Medical Center Los Angeles California
United States UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) Los Angeles California
United States Alliance for Multispecialty Research, LLC Merriam Kansas
United States Miami Cancer Institute at Baptist Health, Inc. Miami Florida
United States Baylor Scott & White Medical Center - Temple Temple Texas
United States Georgetown University Medical Center Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Czechia,  Finland,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Norway,  Poland,  Spain,  Sweden,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free Survival Progression Free Survival assessed by Blinded Independent Central review per IMWG response criteria Assessed for up to approximately 5 years
Secondary Overall Survival Defined as the time from randomization until death due to any cause Assessed for up to approximately 5 years
Secondary Minimal Residual Disease negativity rate Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing 12 months after randomization
Secondary Sustained MRD negativity rate Sustained Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing 24 months after randomization
Secondary Progression Free Survival Progression Free Survival by investigator per IMWG response criteria Assessed for up to approximately 5 years
Secondary Overall minimal residual disease negativity rate Minimal residual disease negativity rate per IMWG criteria Assessed for up to approximately 5 years
Secondary Duration of minimal residual disease negativity Minimal residual disease negativity per IMWG criteria Assessed for up to approximately 5 years
Secondary Sustained minimal residual disease negativity rate Minimal residual disease negativity per IMWG criteria that has lasted a minimum of 12 months Assessed for up to approximately 5 years
Secondary Complete response rate Complete response rate by blinded independent central review and by investigator per IMWG criteria Assessed for up to approximately 5 years
Secondary Duration of complete response Duration of complete response by blinded independent central review and by investigator per IMWG criteria Assessed for up to approximately 5 years
Secondary 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 Up to 90 days after last dose
Secondary Frequency of laboratory abnormalities Assessed for up to approximately 5 years
Secondary Pre-dose concentrations of elranatamab Pharmacokinetics of elranatamab (trough concentrations of elranatamab) Assessed for up to approximately 5 years
Secondary Post-dose concentrations of elranatamab Pharmacokinetics of elranatamab (Post-dose serum concentrations of elranatamab)" Assessed for up to approximately 5 years
Secondary Incidence and titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab Immunogenicity of elranatamab Assessed for up to approximately 5 years
Secondary 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 Assessed for up to approximately 5 years
Secondary 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 Assessed for up to approximately 5 years
Secondary Progression Free Survival 2 Progression Free Survival to the date of second objective disease progression by investigator per IMWG response criteria Assessed for up to approximately 5 years
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