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

Want to learn how to participate in this trial?

OVERVIEW

  • Gender
    all
  • Age
    18+ years
  • Phase
    phase 3
    The 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
    84 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

Locations in:
United Kingdom, Sweden, Spain, South Korea, Poland, Netherlands, Japan, Italy, Israel, India, Germany, France, Denmark, Czechia, China, Canada, Belgium, Australia
Country (18) City or Province (84) Status
United Kingdom Cardiff, CRF University Hospital of Wales
RECRUITING
United Kingdom Plymouth University Hospitals Plymouth NHS Trust
RECRUITING
Sweden Lund Skanes universitetssjukhus
RECRUITING
Sweden Uppsala Akademiska Sjukhuset
RECRUITING
Sweden Varberg Varberg Hospital
RECRUITING
Spain Asturias, AS Hosp. de Cabuenes
RECRUITING
Spain Burgos, BU Hosp. Univ. de Burgos
RECRUITING
Spain Cáceres Hosp. San Pedro de Alcantara
RECRUITING
Spain Granada, GD Hosp. Univ. Virgen de Las Nieves
RECRUITING
Spain Lugo, LG Hosp. Univ. Lucus Augusti
RECRUITING
Spain Madrid, MD Hosp. Univ. La Paz
RECRUITING
Spain Palma de Mallorca, IB Hosp. Univ. Son Espases
RECRUITING
Spain Pamplona Clinica Univ. de Navarra
RECRUITING
Spain Salamanca, SL Hosp. Clinico Univ. de Salamanca
RECRUITING
Spain San Sebastian Hosp. Univ. Donostia
RECRUITING
Spain Santiago de Compostela Hosp. Clinico Univ. de Santiago
RECRUITING
South Korea Busan Dong-A University Hospital
RECRUITING
South Korea Busan Pusan National University Hospital
RECRUITING
South Korea Jeollanam-do, 46 Chonnam National University Hwasun Hospital
RECRUITING
South Korea Seoul Samsung Medical Center
RECRUITING
South Korea Seoul Seoul National University Hospital
RECRUITING
South Korea Seoul The Catholic University of Korea Seoul St. Mary's Hospital
RECRUITING
South Korea Ulsan Ulsan University Hospital
RECRUITING
Poland Brzozow Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
RECRUITING
Poland Kielce Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
RECRUITING
Poland Lublin Centrum Onkologii Ziemii Lubelskiej
RECRUITING
Poland Szczecin Uniwersytecki Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie
RECRUITING
Poland Wroclaw Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
RECRUITING
Netherlands Almere, FL Flevoziekenhuis
RECRUITING
Netherlands Den Haag Haga ziekenhuis
RECRUITING
Netherlands Eindhoven Catharinaziekenhuis
RECRUITING
Netherlands Nieuwegein, UT St. Antonius Ziekenhuis Nieuwegein
RECRUITING
Netherlands Zwolle, OV Isala Kliniek
RECRUITING
Japan Bunkyo Ku, 13 Juntendo University Hospital
RECRUITING
Japan Kanazawa Kanazawa University Hospital
RECRUITING
Japan Kyoto University Hospital Kyoto Prefectural University of Medicine
RECRUITING
Japan Niigata, 15 Niigata Cancer Center Hospital
RECRUITING
Japan Shiwa-gun, 03 Iwate Medical University Hospital
RECRUITING
Japan Suita-City, 27 Osaka University Hospital
RECRUITING
Japan Tottori, 31 Tottori University Hospital
RECRUITING
Japan Yokohama City, 14 Kanagawa Cancer Center
RECRUITING
Italy Alessandria Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria
RECRUITING
Italy Brindisi oncologia medica - Oncology
RECRUITING
Italy Legnano Asst Ovest Milanese - Ospedale Di Legnano
RECRUITING
Italy Pavia Fondazione IRCCS Policlinico San Matteo
RECRUITING
Italy Pescara Presidio Ospedaliero Pescara
RECRUITING
Italy Ravenna Ospedale S. Maria Delle Croci
RECRUITING
Israel Be'er Ya'akov Shamir Medical Center (Assaf Harofeh)
RECRUITING
Israel Haifa, H Carmel Medical Center
RECRUITING
Israel Petah-Tikva Rabin Medical center - Petah-Tikva
RECRUITING
Israel Ramat Gan Sheba Medical Center
RECRUITING
Israel Tel Aviv-Yafo Tel Aviv Sourasky Medical Center
RECRUITING
India Pune, MH Deenanath Mangeshkar Hospital and Research Centre
RECRUITING
Germany Augsburg Klinikum Augsburg
RECRUITING
Germany Halle (Saale), ST Universitaetsklinikum Halle (Saale)
RECRUITING
Germany München Klinikum rechts der Isar der TU Muenchen
RECRUITING
Germany Tuebingen, BW Universitaetsklinikum Tuebingen
RECRUITING
France Limoges CHU de Limoges Hopital Dupuytren
RECRUITING
France Marseille Institut Paoli Calmettes
RECRUITING
France Nantes CHU Nantes
RECRUITING
France Pessac Cedex CHU de Bordeaux - Hospital Haut-Leveque
RECRUITING
France Pierre-Benite CHU Lyon Sud
RECRUITING
France TOURS Cedex 01 CHRU Tours Hopital Bretonneau
RECRUITING
France Toulouse Cedex 9 Institut Universitaire du Cancer Toulouse Oncopole
RECRUITING
Denmark Aarhus Aarhus University Hospital
RECRUITING
Denmark Odense C Odense University Hospital
RECRUITING
Denmark Vejle Vejle Hospital
RECRUITING
Czechia Brno - Bohunice Fakultni nemocnice Brno
RECRUITING
Czechia Hradec Kralove Fakultni nemocnice Hradec Kralove
RECRUITING
Czechia Ostrava Fakultni nemocnice Ostrava
RECRUITING
China Beijing, 11 Peking University People s Hospital
RECRUITING
Canada Hamilton, ON Juravinski Cancer Centre
RECRUITING
Canada Montreal, QC CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont
RECRUITING
Canada Toronto, ON University Health Network (UHN) Princess Margaret Cancer Centre
RECRUITING
Belgium Charleroi, WHT Grand Hopital de Charleroi, site Notre Dame
RECRUITING
Belgium Genk, VLI Ziekenhuis Oost-Limburg
RECRUITING
Belgium Gent Ghent University Hospital
RECRUITING
Belgium Sint-Niklaas AZ Nikolaas - Campus Sint-Niklaas Moerland
RECRUITING
Australia Adelaide, SA Royal Adelaide Hospital
RECRUITING
Australia Box Hill, VIC Box Hill Hospital
RECRUITING
Australia Darlinghurst, NSW St. Vincent's Hospital
RECRUITING
Australia Fitzroy, VIC St. Vincent's Hospital Melbourne
RECRUITING
Australia Southport, QLD Gold Coast University Hospital
RECRUITING
Australia Wollongong, NSW Wollongong Hospital
RECRUITING
x
50

Indicates 50+ sites in this region: click to zoom in.

10

Indicates 10+ sites in this region: click to zoom in.

5

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

View Map Legend