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My Saved Trials

A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma (MonumenTAL-1)

Last Updated   March 5, 2025

Want to learn how to participate in this trial?

CR108920

OVERVIEW

  • Sexes Eligible for Study
    all
  • Age
    18+ years
  • Phase
    phase 2
    2
  • Sites
    78 Sites
  • Status
    Recruiting

SUMMARY

The purpose of this study is to evaluate the efficacy and safety of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).

CONDITIONS

  • Hematological Malignancies

ELIGIBILITY


Inclusion Criteria:

* Documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria
* Part 3: Measurable disease cohort A, cohort B, cohort C, and cohort D: multiple myeloma must be measurable by central laboratory assessment
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
* Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (beta human chorionic gonadotropin [hCG]) or urine
* Willing and able to adhere to the prohibitions and restrictions specified in this protocol


Exclusion Criteria:

* Part 3 only: Cohort A and Cohort C only: exposed to a CAR-T or T cell redirection therapy at any time. Cohort B and Cohort D: T cell redirection therapy within 3 months
* Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
* Received a cumulative dose of corticosteroids equivalent to >= 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)
* Stroke or seizure within 6 months prior to signing the informed consent form (ICF)


Inclusion Criteria:

* Documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria
* Part 3: Measurable disease cohort A, cohort B, cohort C, and cohort D: multiple myeloma must be measurable by central laboratory as

More...

DETAILS

LOCATIONS

Locations in:
United States, Belgium, China, France, Germany, Israel, Japan, South Korea, Netherlands, Poland, Spain
Country (11) City or Province (78) Status
United States Birmingham University of Alabama Birmingham
RECRUITING
United States Little Rock University of Arkansas for Medical Sciences
RECRUITING
United States Duarte City of Hope
COMPLETED
United States Chicago University of Chicago
RECRUITING
United States Louisville Norton Cancer Institute
RECRUITING
United States Ann Arbor University of Michigan Health System
RECRUITING
United States Saint Louis Washington University School Of Medicine
RECRUITING
United States New York NYU Langone Health
RECRUITING
United States New York Mount Sinai Medical Center
RECRUITING
United States Rochester University of Rochester Medical Center
RECRUITING
United States Portland Providence Portland Medical Center
RECRUITING
United States Nashville Tennessee Oncology
RECRUITING
Belgium Brussels UCL - Saint Luc
RECRUITING
Belgium Edegem UZ Antwerpen
RECRUITING
Belgium Leuven UZ Leuven
RECRUITING
Belgium Liège CHU de Liège - Domaine Universitaire du Sart Tilman
RECRUITING
China Beijing Peking University Third Hospital
RECRUITING
China Guangzhou Sun Yat-Sen University Cancer Center
RECRUITING
China Hangzhou The 1St Affiliated Hospital of Medical College Zhejiang University
ACTIVE_NOT_RECRUITING
China Hangzhou The 1St Affiliated Hospital of Medical College Zhejiang University
RECRUITING
China Su Zhou First Affiliated Hospital SooChow University
RECRUITING
China Tianjin Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
RECRUITING
China XI An Shi The First Affiliated Hospital of Xian Jiaotong University
RECRUITING
China Xi'an The Second Affiliated Hospital of Xi'an Jiaotong University
COMPLETED
France Creteil CHU Henri Mondor
RECRUITING
France Montpellier CHU de Montpellier Hopital Saint Eloi
RECRUITING
France Nantes C.H.U. Hotel Dieu - France
RECRUITING
France Pessac cedex CHU de Bordeaux - Hospital Haut-Leveque
RECRUITING
France Pierre Benite cedex Centre hospitalier Lyon-Sud
RECRUITING
France Toulouse cedex 9 Pôle IUC Oncopole CHU
RECRUITING
Germany Berlin Charite Campus Benjamin Franklin
RECRUITING
Germany Heidelberg Universitaetsklinikum Heidelberg
RECRUITING
Germany Muenster Universitaetsklinikum Muenster
COMPLETED
Germany Wuerzburg Universitatsklinikum Wurzburg
RECRUITING
Israel Haifa Rambam Medical Center
RECRUITING
Israel Haifa Carmel Medical Center
RECRUITING
Israel Jerusalem Hadassah Medical Center
RECRUITING
Israel Ramat Gan Sheba Medical Center
RECRUITING
Israel Tel Aviv Tel Aviv Sourasky Medical Center
RECRUITING
Japan Fukuoka Fukuoka University Hospital
ACTIVE_NOT_RECRUITING
Japan Gifu Ogaki Municipal Hospital
ACTIVE_NOT_RECRUITING
Japan Kobe City Kobe City Medical Center General Hospital
ACTIVE_NOT_RECRUITING
Japan Kumamoto Kumamoto University Hospital
ACTIVE_NOT_RECRUITING
Japan Kurashiki Kurashiki Central Hospital
ACTIVE_NOT_RECRUITING
Japan Matsumoto National Hospital Organization Matsumoto Medical Center
ACTIVE_NOT_RECRUITING
Japan Okayama National Hospital Organization Okayama Medical Center
ACTIVE_NOT_RECRUITING
Japan Shiwa-gun Iwate Medical University Hospital
ACTIVE_NOT_RECRUITING
South Korea Jeollanam-do Chonnam National University Hwasun Hospital
RECRUITING
South Korea Seoul Severance Hospital Yonsei University Health System
COMPLETED
South Korea Seoul Asan Medical Center
COMPLETED
South Korea Seoul Samsung Medical Center
COMPLETED
South Korea Seoul The Catholic University of Korea Seoul St Marys Hospital
RECRUITING
Netherlands Amsterdam VU Medisch Centrum
RECRUITING
Netherlands Utrecht UMCU
COMPLETED
Poland Poznan Uniwersytecki Szpital Kliniczny w Poznaniu
ACTIVE_NOT_RECRUITING
Poland Warszawa Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
ACTIVE_NOT_RECRUITING
Spain Badalona Hosp. Univ. Germans Trias I Pujol
COMPLETED
Spain Madrid Hosp Univ Fund Jimenez Diaz
COMPLETED
United States Hollywood Memorial Healthcare System
RECRUITING
United States Atlanta Emory University Winship Cancer Institute
RECRUITING
Japan Chiba Kameda Medical Center
RECRUITING
Japan Hokkaido Teine Keijinkai Hospital
COMPLETED
Japan Koshigaya Dokkyo Medical University Saitama Medical Center
RECRUITING
Japan Osaka Japanese Red Cross Osaka Hospital
ACTIVE_NOT_RECRUITING
Japan Otake National Hospital Organization Hiroshima-Nishi Medical Center
RECRUITING
South Korea Seoul Seoul National University Hospital
COMPLETED
Poland Gdansk Uniwersyteckie Centrum Kliniczne
ACTIVE_NOT_RECRUITING
Poland Gliwice Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
COMPLETED
Poland Wroclaw Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
ACTIVE_NOT_RECRUITING
Spain Barcelona Hosp Univ Vall D Hebron
RECRUITING
Spain Barcelona Inst. Cat. Doncologia-H Duran I Reynals
RECRUITING
Spain Madrid Hosp. Univ. 12 de Octubre
RECRUITING
Spain Murcia Hosp. Univ. Virgen de La Arrixaca
RECRUITING
Spain Pamplona Clinica Univ. de Navarra
RECRUITING
Spain Pozuelo de Alarcon Hosp. Quiron Madrid Pozuelo
RECRUITING
Spain Salamanca Hosp Clinico Univ de Salamanca
RECRUITING
Spain Santander Hosp. Univ. Marques de Valdecilla
RECRUITING
Spain Sevilla Hosp. Virgen Del Rocio
RECRUITING
Show More
Geo Locations

33.52066, -86.80249

34.74648, -92.28959

34.13945, -117.97729

41.85003, -87.65005

38.25424, -85.75941

42.27756, -83.74088

38.62727, -90.19789

40.71427, -74.00597

40.71427, -74.00597

43.15478, -77.61556

45.52345, -122.67621

36.16589, -86.78444

50.85045, 4.34878

51.15662, 4.44504

50.87959, 4.70093

50.63373, 5.56749

39.9075, 116.39723

23.11667, 113.25

30.29365, 120.16142

30.29365, 120.16142

31.2982999, 120.643

39.14222, 117.17667

34.2075699, 108.94631

34.25833, 108.92861

48.78333, 2.46667

43.61092, 3.87723

47.21725, -1.55336

44.81011, -0.64129

45.7009, 4.82511

43.60426, 1.44367

52.52437, 13.41053

49.40768, 8.69079

51.96236, 7.62571

49.79391, 9.95121

32.81841, 34.9885

32.81841, 34.9885

31.76904, 35.21633

32.08227, 34.81065

32.08088, 34.78057

33.6, 130.41667

35.42291, 136.76039

34.6913, 135.183

32.80589, 130.69182

34.58333, 133.76667

36.23333, 137.96667

34.65, 133.93333

33.23058, 133.24871

35.056264, 127.0025403

37.566, 126.9784

37.566, 126.9784

37.566, 126.9784

37.566, 126.9784

52.37403, 4.88969

52.09083, 5.12222

52.40692, 16.92993

52.22977, 21.01178

41.45004, 2.24741

40.4165, -3.70256

26.0112, -80.14949

33.749, -84.38798

35.6, 140.11667

43.41104, 142.88878

35.89035, 139.78916

34.69374, 135.50218

34.20752, 132.22062

37.566, 126.9784

54.35205, 18.64637

50.29761, 18.67658

51.1, 17.03333

41.38879, 2.15899

41.38879, 2.15899

40.4165, -3.70256

37.98704, -1.13004

42.81687, -1.64323

40.43293, -3.81338

40.96882, -5.66388

43.46472, -3.80444

37.38283, -5.97317

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50

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10

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5

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

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