A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma (MonumenTAL-1)
Last Updated April 24, 2024 - 21:08
OVERVIEW
-
Gender
all -
Age
years -
Phase
phase 2The drug or treatment is given to a larger group of people to see if it is effective and to better understand its safety. -
Sites
sites -
Status
Recruiting
SUMMARY
Multiple myeloma is a malignant plasma cell disorder characterized by osteolytic lesions, increased susceptibility to infections, hypercalcemia, and renal failure. Talquetamab is a humanized immunoglobulin G4 proline, alanine, alanine (IgG4PAA) bispecific antibody designed to target G protein-coupled receptor family C group 5-member D (GPRC5D) and the CD3 molecule found on T lymphocytes (T cell). This study consists of 3 periods: screening phase (up to 28 days), treatment phase (start of study drug administration and continues until the completion of the end of treatment [EOT (30 days (+ 7 days)] visit); and a post-treatment follow-up phase (until the end of study unless the participant has died, is lost to follow up or has withdrawn consent). Total duration of study is up to 2 years (after the last participant receives their first dose). Safety, pharmacokinetics (PK), laboratory tests, and questionnaire will be assessed at specified time points during this study. Participants safety and study conduct will be monitored throughout the study. The corresponding study (NCT03399799) is the Phase 1 part of the study and TALMMY1001- Part 3 is the Phase 2 part of the study.
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)
DETAILS
Multiple myeloma is a malignant plasma cell disorder characterized by osteolytic lesions, increased susceptibility to infections, hypercalcemia, and renal failure. Talquetamab is a humanized immunoglobulin G4 proline, alanine, alanine (IgG4PAA) bispecific antibody designed to target G protein-coupled receptor family C group 5-member D (GPRC5D) and the CD3 molecule found on T lymphocytes (T cell). This study consists of 3 periods: screening phase (up to 28 days), treatment phase (start of study drug administration and continues until the completion of the end of treatment \[EOT (30 days (+ 7 days)\] visit); and a post-treatment follow-up phase (until the end of study unless the participant has died, is lost to follow up or has withdrawn consent). Total duration of study is up to 2 years (after the last participant receives their first dose). Safety, pharmacokinetics (PK), laboratory tests, and questionnaire will be assessed at specified time points during this study. Participants safety and study conduct will be monitored throughout the study. The corresponding study (NCT03399799) is the Phase 1 part of the study and TALMMY1001- Part 3 is the Phase 2 part of the study.
LOCATIONS
| Country (11) | City or Province (77) | Status |
| United States | Ann Arbor, MI University of Michigan Health System |
RECRUITING
|
| United States | Atlanta, GA Emory University - Winship Cancer Institute |
RECRUITING
|
| United States | Birmingham, AL University of Alabama Birmingham |
RECRUITING
|
| United States | Chicago, IL University of Chicago |
RECRUITING
|
| United States | Duarte, CA City of Hope |
COMPLETED
|
| United States | Little Rock, AR University of Arkansas for Medical Sciences |
RECRUITING
|
| United States | Louisville, KY Norton Cancer Institute |
RECRUITING
|
| United States | Nashville, TN Tennessee Oncology |
RECRUITING
|
| United States | New York, NY Mount Sinai Medical Center |
RECRUITING
|
| United States | New York, NY NYU Langone Health |
RECRUITING
|
| United States | Portland, OR Providence Portland Medical Center |
RECRUITING
|
| United States | Rochester, NY University of Rochester Medical Center |
RECRUITING
|
| United States | Saint Louis, MO Washington University School of Medicine |
RECRUITING
|
| Spain | Badalona, BA Hosp. Univ. Germans Trias I Pujol |
RECRUITING
|
| Spain | Barcelona, BA Hosp. Univ. Vall D Hebron |
RECRUITING
|
| Spain | Barcelona, BA Inst. Cat. Doncologia-H Duran I Reynals |
RECRUITING
|
| Spain | Madrid, MD Hosp. Univ. 12 de Octubre |
RECRUITING
|
| Spain | Madrid, MD Hosp. Univ. Fund. Jimenez Diaz |
COMPLETED
|
| Spain | Murcia, MU Hosp. Univ. Virgen de La Arrixaca |
RECRUITING
|
| Spain | Pamplona Clinica Univ. de Navarra |
RECRUITING
|
| Spain | Pozuelo de Alarcon, MD Hosp. Quiron Madrid Pozuelo |
RECRUITING
|
| Spain | Salamanca, SL Hosp. Clinico Univ. de Salamanca |
RECRUITING
|
| Spain | Santander, CT Hosp. Univ. Marques de Valdecilla |
RECRUITING
|
| Spain | Sevilla Hosp. Virgen Del Rocio |
RECRUITING
|
| South Korea | Jeollanam-do, 46 Chonnam National University Hwasun Hospital |
RECRUITING
|
| South Korea | Seoul Asan Medical Center |
COMPLETED
|
| South Korea | Seoul Samsung Medical Center |
COMPLETED
|
| South Korea | Seoul Seoul National University Hospital |
RECRUITING
|
| South Korea | Seoul Severance Hospital, Yonsei University Health System |
COMPLETED
|
| South Korea | Seoul The Catholic University of Korea Seoul St. Mary's Hospital |
RECRUITING
|
| Poland | Gdansk Uniwersyteckie Centrum Kliniczne |
ACTIVE_NOT_RECRUITING
|
| Poland | Gliwice Narodowy Instytut Onkologii im.Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz. w Gliwicach |
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
|
| Poland | Wroclaw Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu |
ACTIVE_NOT_RECRUITING
|
| Netherlands | Amsterdam VU Medisch Centrum |
RECRUITING
|
| Netherlands | Utrecht, UT UMCU |
COMPLETED
|
| Japan | Chiba Kameda General Hospital |
ACTIVE_NOT_RECRUITING
|
| Japan | Fukuoka Fukuoka University Hospital |
ACTIVE_NOT_RECRUITING
|
| Japan | Gifu Ogaki Municipal Hospital |
ACTIVE_NOT_RECRUITING
|
| Japan | Hokkaido, 01 Teine Keijinkai Hospital |
ACTIVE_NOT_RECRUITING
|
| Japan | Hyogo, 28 Kobe City Medical Center General Hospital |
ACTIVE_NOT_RECRUITING
|
| Japan | Koshigaya, 11 Dokkyo Medical University Saitama Medical Center |
ACTIVE_NOT_RECRUITING
|
| Japan | Kumamoto, 43 Kumamoto University Hospital |
ACTIVE_NOT_RECRUITING
|
| Japan | Kurashiki, 33 Kurashiki Central Hospital |
ACTIVE_NOT_RECRUITING
|
| Japan | Matsumoto, 20 National Hospital Organization Matsumoto Medical Center |
ACTIVE_NOT_RECRUITING
|
| Japan | Okayama, 33 National Hospital Organization Okayama Medical Center |
ACTIVE_NOT_RECRUITING
|
| Japan | Osaka, 27 Japanese Red Cross Osaka Hospital |
ACTIVE_NOT_RECRUITING
|
| Japan | Otake Hiroshima West Medical Center |
ACTIVE_NOT_RECRUITING
|
| Japan | Shiwa-gun, 03 Iwate Medical University Hospital |
ACTIVE_NOT_RECRUITING
|
| Israel | Haifa, H Carmel Medical Center |
RECRUITING
|
| Israel | Haifa, H Rambam 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
|
| Germany | Berlin, BE Charite Campus Benjamin Franklin |
RECRUITING
|
| Germany | Heidelberg, BW Universitaetsklinikum Heidelberg |
RECRUITING
|
| Germany | Muenster Universitaetsklinikum Muenster |
COMPLETED
|
| Germany | Wuerzburg Universitatsklinikum Wurzburg |
RECRUITING
|
| 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
|
| China | Beijing, 11 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 |
RECRUITING
|
| China | Hangzhou The 1St Affiliated Hospital of Medical College Zhejiang University |
ACTIVE_NOT_RECRUITING
|
| China | Su Zhou First Affiliated Hospital SooChow University |
RECRUITING
|
| China | Tianjin, 12 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
|
| Belgium | Brussels, BRU 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
|
Indicates 50+ sites in this region: click to zoom in.
Indicates 10+ sites in this region: click to zoom in.
Indicates < 10 sites in this region: click to zoom in.
Corresponds to individual site.