A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-...
Last Updated   April 25, 2024 - 21:04
OVERVIEW
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Gender
all -
Age
years -
Phase
phase 3The drug or treatment is given to large groups of people to confirm its effectiveness, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. -
Sites
sites -
Status
Recruiting
SUMMARY
The purpose of this study is to compare the effectiveness of either talquetamab plus pomalidomide (Tal-P) or talquetamab plus teclistamab (Tal-Tec) with elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd).
CONDITIONS
- Relapsed or Refractory Multiple Myeloma
ELIGIBILITY
Inclusion Criteria:
* Documented multiple myeloma as defined by the criteria below: (a) multiple myeloma diagnosis according to the international myeloma working group (IMWG) diagnostic criteria (b) measurable disease at screening as assessed by central laboratory, defined by any of the following: (i) serum M-protein level greater than or equal to (>=) 0.5 gram per deciliter (g/dL); or (ii) urine M-protein level >= 200 milligram (mg) per 24 hours; or (iii) light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin (Ig) free light chain (FLC) >= 10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
* Relapsed or refractory disease as defined below: a) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease (PD) by IMWG criteria greater than (>) 60 days after cessation of treatment. b) Refractory disease is defined as less than (<) 25 percent (%) reduction in M-protein or confirmed PD by IMWG criteria during previous treatment or less than or equal to (<=) 60 days after cessation of treatment
* Documented evidence of PD or failure to achieve a minimal response to the last line of therapy 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
* A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6months after the last dose of study treatment
Exclusion Criteria:
* Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients
* Stroke, transient ischemic attack, or seizure within 6 months prior to signing informed consent form (ICF)
* Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment
* A maximum cumulative dose of corticosteroids of >=140 mg of prednisone or equivalent within 14-day period before the first dose of study drug
* Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required
DETAILS
LOCATIONS
Country (18) | City or Province (84) | Status |
United Kingdom | Cardiff, CRF University Hospital of Wales |
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United Kingdom | Plymouth University Hospitals Plymouth NHS Trust |
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Sweden | Lund Skanes universitetssjukhus |
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Sweden | Uppsala Akademiska Sjukhuset |
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Sweden | Varberg Varberg Hospital |
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Spain | Asturias, AS Hosp. de Cabuenes |
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Spain | Burgos, BU Hosp. Univ. de Burgos |
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Spain | Cáceres Hosp. San Pedro de Alcantara |
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Spain | Granada, GD Hosp. Univ. Virgen de Las Nieves |
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Spain | Lugo, LG Hosp. Univ. Lucus Augusti |
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Spain | Madrid, MD Hosp. Univ. La Paz |
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Spain | Palma de Mallorca, IB Hosp. Univ. Son Espases |
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Spain | Pamplona Clinica Univ. de Navarra |
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Spain | Salamanca, SL Hosp. Clinico Univ. de Salamanca |
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Spain | San Sebastian Hosp. Univ. Donostia |
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Spain | Santiago de Compostela Hosp. Clinico Univ. de Santiago |
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South Korea | Busan Dong-A University Hospital |
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South Korea | Busan Pusan National University Hospital |
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South Korea | Jeollanam-do, 46 Chonnam National University Hwasun Hospital |
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South Korea | Seoul Samsung Medical Center |
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South Korea | Seoul Seoul National University Hospital |
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South Korea | Seoul The Catholic University of Korea Seoul St. Mary's Hospital |
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South Korea | Ulsan Ulsan University Hospital |
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Poland | Brzozow Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza |
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Poland | Kielce Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach |
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Poland | Lublin Centrum Onkologii Ziemii Lubelskiej |
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Poland | Szczecin Uniwersytecki Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie |
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Poland | Wroclaw Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu |
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Netherlands | Almere, FL Flevoziekenhuis |
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Netherlands | Den Haag Haga ziekenhuis |
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Netherlands | Eindhoven Catharinaziekenhuis |
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Netherlands | Nieuwegein, UT St. Antonius Ziekenhuis Nieuwegein |
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Netherlands | Zwolle, OV Isala Kliniek |
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Japan | Bunkyo Ku, 13 Juntendo University Hospital |
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Japan | Kanazawa Kanazawa University Hospital |
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Japan | Kyoto University Hospital Kyoto Prefectural University of Medicine |
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Japan | Niigata, 15 Niigata Cancer Center Hospital |
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Japan | Shiwa-gun, 03 Iwate Medical University Hospital |
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Japan | Suita-City, 27 Osaka University Hospital |
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Japan | Tottori, 31 Tottori University Hospital |
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Japan | Yokohama City, 14 Kanagawa Cancer Center |
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Italy | Alessandria Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria |
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Italy | Brindisi oncologia medica - Oncology |
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Italy | Legnano Asst Ovest Milanese - Ospedale Di Legnano |
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Italy | Pavia Fondazione IRCCS Policlinico San Matteo |
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Italy | Pescara Presidio Ospedaliero Pescara |
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Italy | Ravenna Ospedale S. Maria Delle Croci |
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Israel | Be'er Ya'akov Shamir Medical Center (Assaf Harofeh) |
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Israel | Haifa, H Carmel Medical Center |
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Israel | Petah-Tikva Rabin Medical center - Petah-Tikva |
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Israel | Ramat Gan Sheba Medical Center |
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Israel | Tel Aviv-Yafo Tel Aviv Sourasky Medical Center |
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India | Pune, MH Deenanath Mangeshkar Hospital and Research Centre |
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Germany | Augsburg Klinikum Augsburg |
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Germany | Halle (Saale), ST Universitaetsklinikum Halle (Saale) |
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Germany | München Klinikum rechts der Isar der TU Muenchen |
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Germany | Tuebingen, BW Universitaetsklinikum Tuebingen |
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France | Limoges CHU de Limoges Hopital Dupuytren |
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France | Marseille Institut Paoli Calmettes |
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France | Nantes CHU Nantes |
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France | Pessac Cedex CHU de Bordeaux - Hospital Haut-Leveque |
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France | Pierre-Benite CHU Lyon Sud |
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France | TOURS Cedex 01 CHRU Tours Hopital Bretonneau |
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France | Toulouse Cedex 9 Institut Universitaire du Cancer Toulouse Oncopole |
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Denmark | Aarhus Aarhus University Hospital |
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Denmark | Odense C Odense University Hospital |
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Denmark | Vejle Vejle Hospital |
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Czechia | Brno - Bohunice Fakultni nemocnice Brno |
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Czechia | Hradec Kralove Fakultni nemocnice Hradec Kralove |
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Czechia | Ostrava Fakultni nemocnice Ostrava |
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China | Beijing, 11 Peking University People s Hospital |
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Canada | Hamilton, ON Juravinski Cancer Centre |
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Canada | Montreal, QC CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont |
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Canada | Toronto, ON University Health Network (UHN) Princess Margaret Cancer Centre |
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Belgium | Charleroi, WHT Grand Hopital de Charleroi, site Notre Dame |
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Belgium | Genk, VLI Ziekenhuis Oost-Limburg |
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Belgium | Gent Ghent University Hospital |
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Belgium | Sint-Niklaas AZ Nikolaas - Campus Sint-Niklaas Moerland |
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Australia | Adelaide, SA Royal Adelaide Hospital |
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Australia | Box Hill, VIC Box Hill Hospital |
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Australia | Darlinghurst, NSW St. Vincent's Hospital |
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Australia | Fitzroy, VIC St. Vincent's Hospital Melbourne |
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Australia | Southport, QLD Gold Coast University Hospital |
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Australia | Wollongong, NSW Wollongong Hospital |
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