Talketamabitutkimus potilailla, joilla on uusiutunut tai refraktiivinen multippeli myelooma (MonumenTAL-1)
Vaihe 1/2, ensimmäinen ihmisessä, avoin, annoksen eskalaatiotutkimus talketamabista, humanisoidusta GPRC5D x CD3 -bispesifisestä vasta-aineesta, potilailla, joilla on uusiutunut tai refraktaarinen multippeli myelooma
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).
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Vaihe 2
Laajennettu käyttöoikeus
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Study Contact
- Puhelinnumero: 844-434-4210
- Sähköposti: Participate-In-This-Study1@its.jnj.com
Opiskelupaikat
-
-
-
Amsterdam, Alankomaat, 1081 HV
- Valmis
- VU Medisch Centrum
-
Utrecht, Alankomaat, 3584 CX
- Valmis
- UMCU
-
-
-
-
-
Edegem, Belgia, 2650
- Valmis
- UZ Antwerpen
-
Leuven, Belgia, 3000
- Aktiivinen, ei rekrytointi
- UZ Leuven
-
Liège, Belgia, 4000
- Aktiivinen, ei rekrytointi
- CHU de Liège - Domaine Universitaire du Sart Tilman
-
Woluwe-Saint-Lambert, Belgia, 1200
- Valmis
- UCL - Saint Luc
-
-
-
-
-
Badalona, Espanja, 08916
- Valmis
- Hosp. Univ. Germans Trias I Pujol
-
Barcelona, Espanja, 8908
- Aktiivinen, ei rekrytointi
- Inst. Cat. Doncologia-H Duran I Reynals
-
Barcelona, Espanja, 08035
- Rekrytointi
- Hosp Univ Vall D Hebron
-
Madrid, Espanja, 28041
- Valmis
- Hosp. Univ. 12 de Octubre
-
Madrid, Espanja, 28040
- Valmis
- Hosp Univ Fund Jimenez Diaz
-
Murcia, Espanja, 30120
- Aktiivinen, ei rekrytointi
- Hosp. Univ. Virgen de La Arrixaca
-
Pamplona, Espanja, 31008
- Rekrytointi
- Clinica Univ. de Navarra
-
Pozuelo de Alarcón, Espanja, 28223
- Valmis
- Hosp. Quiron Madrid Pozuelo
-
Salamanca, Espanja, 37007
- Rekrytointi
- Hosp Clinico Univ de Salamanca
-
Santander, Espanja, 39008
- Rekrytointi
- Hosp. Univ. Marques de Valdecilla
-
Seville, Espanja, 41013
- Rekrytointi
- Hosp. Virgen Del Rocio
-
-
-
-
-
Jeollanam-do, Etelä -Korea, 58128
- Valmis
- Chonnam National University Hwasun Hospital
-
Seoul, Etelä -Korea, 06351
- Valmis
- Samsung Medical Center
-
Seoul, Etelä -Korea, 05505
- Valmis
- Asan Medical Center
-
Seoul, Etelä -Korea, 03080
- Valmis
- Seoul National University Hospital
-
Seoul, Etelä -Korea, 03722
- Valmis
- Severance Hospital Yonsei University Health System
-
Seoul, Etelä -Korea, 06591
- Valmis
- The Catholic University of Korea Seoul St Marys Hospital
-
-
-
-
-
Haifa, Israel, 31096
- Aktiivinen, ei rekrytointi
- Rambam Medical Center
-
Haifa, Israel, 3436212
- Aktiivinen, ei rekrytointi
- Carmel Medical Center
-
Jerusalem, Israel, 91120
- Aktiivinen, ei rekrytointi
- Hadassah Medical Center
-
Ramat Gan, Israel, 52621
- Aktiivinen, ei rekrytointi
- Sheba Medical Center
-
Tel Aviv, Israel, 64239
- Aktiivinen, ei rekrytointi
- Tel Aviv Sourasky Medical Center
-
-
-
-
-
Chiba, Japani, 296-8602
- Valmis
- Kameda Medical Center
-
Fukuoka, Japani, 814-0180
- Valmis
- Fukuoka University Hospital
-
Gifu, Japani, 503-8502
- Valmis
- Ogaki Municipal Hospital
-
Hokkaido, Japani, 006-8555
- Valmis
- Teine Keijinkai Hospital
-
Kobe, Japani, 650 0047
- Valmis
- Kobe City Medical Center General Hospital
-
Koshigaya, Japani, 343-8555
- Valmis
- Dokkyo Medical University Saitama Medical Center
-
Kumamoto, Japani, 860-8556
- Valmis
- Kumamoto University Hospital
-
Kurashiki, Japani, 710-8602
- Valmis
- Kurashiki Central Hospital
-
Matsumoto, Japani, 399-8701
- Valmis
- National Hospital Organization Matsumoto Medical Center
-
Okayama, Japani, 701-1192
- Valmis
- National Hospital Organization Okayama Medical Center
-
Osaka, Japani, 543 8555
- Valmis
- Japanese Red Cross Osaka Hospital
-
Shiwa-gun, Japani, 028-3695
- Valmis
- Iwate Medical University Hospital
-
Ōtake, Japani, 739-0696
- Aktiivinen, ei rekrytointi
- National Hospital Organization Hiroshima-Nishi Medical Center
-
-
-
-
-
Beijing, Kiina, 100191
- Valmis
- Peking University Third Hospital
-
Guangzhou, Kiina, 510060
- Aktiivinen, ei rekrytointi
- Sun Yat Sen University Cancer Center
-
Hangzhou, Kiina, 310003
- Aktiivinen, ei rekrytointi
- The 1St Affiliated Hospital of Medical College Zhejiang University
-
Hangzhou, Kiina, 310003
- Aktiivinen, ei rekrytointi
- The 1st Affiliated Hospital Of Medical College Zhejiang University 1
-
Suzhou, Kiina, 215006
- Aktiivinen, ei rekrytointi
- First Affiliated Hospital SooChow University
-
Tianjin, Kiina, 300320
- Aktiivinen, ei rekrytointi
- Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
-
Xi'an, Kiina, 710004
- Valmis
- The Second Affiliated Hospital of Xi'an Jiaotong University
-
Xi'an, Kiina, 710063
- Valmis
- The First Affiliated Hospital of Xian Jiaotong University
-
-
-
-
-
Gdansk, Puola, 80 214
- Aktiivinen, ei rekrytointi
- Uniwersyteckie Centrum Kliniczne
-
Gliwice, Puola, 44102
- Valmis
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
-
Poznan, Puola, 60-569
- Aktiivinen, ei rekrytointi
- Uniwersytecki Szpital Kliniczny w Poznaniu
-
Warsaw, Puola, 02-781
- Valmis
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
-
Wroclaw, Puola, 50 367
- Aktiivinen, ei rekrytointi
- Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
-
-
-
-
-
Créteil, Ranska, 94000
- Aktiivinen, ei rekrytointi
- CHU Henri Mondor
-
Lyon, Ranska, 69002
- Aktiivinen, ei rekrytointi
- Hospices Civils de Lyon HCL
-
Montpellier, Ranska, 34295
- Aktiivinen, ei rekrytointi
- CHU de Montpellier Hopital Saint Eloi
-
Nantes, Ranska, 44093
- Aktiivinen, ei rekrytointi
- C.H.U. Hotel Dieu - France
-
Pessac, Ranska, 33604
- Aktiivinen, ei rekrytointi
- CHU de Bordeaux - Hospital Haut-Leveque
-
Toulouse, Ranska, 31059
- Aktiivinen, ei rekrytointi
- Pôle IUC Oncopole CHU
-
-
-
-
-
Berlin, Saksa, 12203
- Aktiivinen, ei rekrytointi
- Charite Campus Benjamin Franklin
-
Heidelberg, Saksa, 69120
- Aktiivinen, ei rekrytointi
- Universitaetsklinikum Heidelberg
-
Münster, Saksa, 48149
- Valmis
- Universitaetsklinikum Muenster
-
Würzburg, Saksa, 97080
- Aktiivinen, ei rekrytointi
- Universitatsklinikum Wurzburg
-
-
-
-
Alabama
-
Birmingham, Alabama, Yhdysvallat, 35294
- Rekrytointi
- University of Alabama Birmingham
-
-
Arkansas
-
Little Rock, Arkansas, Yhdysvallat, 72205
- Rekrytointi
- University of Arkansas for Medical Sciences
-
-
California
-
Duarte, California, Yhdysvallat, 91010
- Valmis
- City of Hope
-
-
Florida
-
Hollywood, Florida, Yhdysvallat, 33021
- Rekrytointi
- Memorial Healthcare System
-
-
Georgia
-
Atlanta, Georgia, Yhdysvallat, 30322
- Rekrytointi
- Emory University Winship Cancer Institute
-
-
Illinois
-
Chicago, Illinois, Yhdysvallat, 60637
- Valmis
- University of Chicago
-
-
Kentucky
-
Louisville, Kentucky, Yhdysvallat, 40207
- Rekrytointi
- Norton Cancer Institute
-
-
Michigan
-
Ann Arbor, Michigan, Yhdysvallat, 48109
- Rekrytointi
- University of Michigan Health System
-
-
Missouri
-
St Louis, Missouri, Yhdysvallat, 63110
- Rekrytointi
- Washington University School Of Medicine
-
-
New York
-
New York, New York, Yhdysvallat, 10023
- Rekrytointi
- Mount Sinai Medical Center
-
New York, New York, Yhdysvallat, 10016
- Aktiivinen, ei rekrytointi
- NYU Langone Health
-
Rochester, New York, Yhdysvallat, 14642
- Rekrytointi
- University of Rochester Medical Center
-
-
Oregon
-
Portland, Oregon, Yhdysvallat, 97213
- Valmis
- Providence Portland Medical Center
-
-
Tennessee
-
Nashville, Tennessee, Yhdysvallat, 37203
- Valmis
- Tennessee Oncology
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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; Cohort E: Multiple myeloma must be measurable by local 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, Cohort D and Cohort E: 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)
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Part 3: Cohort A (Talquetamab)
Cohort A will enroll participants with multiple myeloma who have previously received greater than or equal to (>=) 3 prior lines of therapy and have not been exposed to T cell redirection therapies. Participants will receive talquetamab subcutaneously (SC) at a recommended Phase 2 dose (RP2D) selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. All participants (ongoing and those who are in follow-up) will transition to open-label extension (OLE) phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the long-term extension (LTE) and will continue to receive study treatment. |
Talquetamab will be administered SC until disease progression.
Muut nimet:
|
|
Kokeellinen: Part 3: Cohort B (Talquetamab)
Cohort B will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy and have been exposed to T cell redirection therapies. Participants will receive talquetamab subcutaneously (SC) at a recommended Phase 2 dose (RP2D) selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. All participants (ongoing and those who are in follow-up) will transition to OLE phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment. |
Talquetamab will be administered SC until disease progression.
Muut nimet:
|
|
Kokeellinen: Part 3: Cohort C (Talquetamab)
Cohort C will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy and have not been exposed to T cell redirection therapies. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. All participants (ongoing and those who are in follow-up) will transition to OLE phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment. |
Talquetamab will be administered SC until disease progression.
Muut nimet:
|
|
Kokeellinen: Part 3: Cohort D (Talquetamab)
Cohort D will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. Participants in this cohort will receive tocilizumab prophylaxis for cytokine release syndrome (CRS) including all outpatient dosing. Participants will transition to OLE upon communication by the sponsor. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment. |
Talquetamab will be administered SC until disease progression.
Muut nimet:
|
|
Kokeellinen: Part 3: Cohort E (Talquetamab)
Cohort E will enroll participants with multiple myeloma who have previously received at least 1 proteasome inhibitor (PI), 1 immunomodulatory imide drug (IMiD), and 1 anti-cluster of differentiation 38 (CD38) monoclonal antibody. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. Participants will receive tocilizumab prophylaxis for CRS with consolidated priming dose schedules as well as possible transition to outpatient priming dosing transition to OLE upon communication by the sponsor. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment. |
Talquetamab will be administered SC until disease progression.
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Overall Response Rate (ORR)
Aikaikkuna: Up to 2 years and 10 months
|
ORR is defined as the proportion of participants who have a partial response (PR) or better according to the international myeloma working group (IMWG) criteria. |
Up to 2 years and 10 months
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Duration of Response (DOR)
Aikaikkuna: Up to 2 years and 10 months
|
DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG criteria, or death due to PD, whichever occurs first. |
Up to 2 years and 10 months
|
|
Very Good Partial Response (VGPR) or Better Rate
Aikaikkuna: Up to 2 years and 10 months
|
VGPR or better rate is defined as the percentage of patients who achieve a VGPR or better according to IMWG response criteria. |
Up to 2 years and 10 months
|
|
Complete Response (CR) or Better Rate
Aikaikkuna: Up to 2 years and 10 months
|
CR or better rate is defined as the percentage of patients who achieve CR or better according to IMWG response criteria. |
Up to 2 years and 10 months
|
|
Stringent Complete Response (sCR) Rate
Aikaikkuna: Up to 2 years and 10 months
|
sCR rate is defined as the percentage of patients who achieve sCR according to IMWG response criteria. |
Up to 2 years and 10 months
|
|
Time to Response (TTR)
Aikaikkuna: Up to 2 years and 10 months
|
TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better. |
Up to 2 years and 10 months
|
|
Progression-Free Survival (PFS)
Aikaikkuna: Up to 2 years and 10 months
|
PFS is defined as time from date of first dose of study drug to date of first documented PD, per IMWG criteria, or death due to any cause, whichever occurs first. |
Up to 2 years and 10 months
|
|
Overall Survival (OS)
Aikaikkuna: Up to 2 years and 10 months
|
OS is defined as the time from the date of first dose of study drug to the date of the participant's death. |
Up to 2 years and 10 months
|
|
Minimal Residual Disease (MRD) Negative Rate
Aikaikkuna: Up to 2 years and 10 months
|
MRD negativity rate is measured only for participants who achieve at least a CR but is reported based on all treated similar to the other response data. |
Up to 2 years and 10 months
|
|
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Aikaikkuna: Up to 2 years and 10 months
|
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. |
Up to 2 years and 10 months
|
|
Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
Aikaikkuna: Up to 2 years and 10 months
|
An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. |
Up to 2 years and 10 months
|
|
Number of Participants with AEs by Severity
Aikaikkuna: Up to 2 years and 10 months
|
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event. |
Up to 2 years and 10 months
|
|
Number of Participants with Abnormalities in Clinical Laboratory Values
Aikaikkuna: Up to 2 years and 10 months
|
Number of participants with abnormalities in clinical laboratory values (such as hematology, serum chemistry and coagulation) will be reported. |
Up to 2 years and 10 months
|
|
Serum Concentration of Talquetamab
Aikaikkuna: Up to 2 years and 10 months
|
Serum samples will be analyzed to determine concentrations of talquetamab. |
Up to 2 years and 10 months
|
|
Number of Participants with Talquetamab Antibodies
Aikaikkuna: Up to 2 years and 10 months
|
Antibodies to talquetamab will be assessed to evaluate potential immunogenicity. |
Up to 2 years and 10 months
|
|
Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC QLQ-C30)
Aikaikkuna: Baseline up to 2 years and 10 months
|
The EORTC- QLQ-Core-30 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The recall period is 1 week ("past week") and responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms. |
Baseline up to 2 years and 10 months
|
|
Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L)
Aikaikkuna: Baseline up to 2 years and 10 months
|
The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores for the 5 separate questions are categorical and cannot be analyzed as cardinal numbers. |
Baseline up to 2 years and 10 months
|
|
Change from Baseline in HRQoL as Assessed by Patient Global Impression of Severity (PGIS)
Aikaikkuna: Baseline up to 2 years and 10 months
|
The PGIS is a single item that assesses severity of the participant's health state, on a 5-point verbal rating scale. Score ranges from 1 (None) to 5 (Very Severe). |
Baseline up to 2 years and 10 months
|
|
Overall Response Rate (ORR) in Participants with High-risk Molecular Features
Aikaikkuna: Up to 2 years and 10 months
|
ORR in participants with high risk is defined as the overall response rate among the high risk molecular subgroups or other high-risk molecular subtypes. |
Up to 2 years and 10 months
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- Einsele H, Moreau P, Bahlis N, Bhutani M, Vincent L, Karlin L, Perrot A, Goldschmidt H, van de Donk NWCJ, Ocio EM, Martinez-Lopez J, Rodriguez-Otero P, Dytfeld D, Diels J, Strulev V, Haddad I, Renaud T, Ammann E, Cabrieto J, Perualila N, Gan R, Zhang Y, Parekh T, Albrecht C, Weisel K, Mateos MV. Comparative Efficacy of Talquetamab vs. Current Treatments in the LocoMMotion and MoMMent Studies in Patients with Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma. Adv Ther. 2024 Apr;41(4):1576-1593. doi: 10.1007/s12325-024-02797-x. Epub 2024 Feb 24.
- Schinke C, Touzeau C, Oriol A, Mateos MV, Stevens D, Rasche L, Qin X, Kato K, Bathija S, Katz EG, Gries KS, Campagna M, Masterson T, Hilder BW, Tolbert J, Renaud T, Heuck C, Tomlinson C, Moreau P, San-Miguel J, Rodriguez-Otero P, Chari A. Talquetamab improves patient-reported symptoms and health-related quality of life in relapsed or refractory multiple myeloma: Results from the phase 1/2 MonumenTAL-1 study. Cancer. 2025 Jul 15;131(14):e35927. doi: 10.1002/cncr.35927.
- Chari A, Touzeau C, Schinke C, Minnema MC, Berdeja JG, Oriol A, van de Donk NWCJ, Rodriguez-Otero P, Morillo D, Martinez-Chamorro C, Mateos MV, Costa LJ, Caers J, Rasche L, Krishnan A, Ye JC, Karlin L, Lipe B, Vishwamitra D, Skerget S, Verona R, Ma X, Qin X, Ludlage H, Campagna M, Masterson T, Hilder B, Tolbert J, Renaud T, Goldberg JD, Kane C, Heuck C, San-Miguel J, Moreau P. Safety and activity of talquetamab in patients with relapsed or refractory multiple myeloma (MonumenTAL-1): a multicentre, open-label, phase 1-2 study. Lancet Haematol. 2025 Apr;12(4):e269-e281. doi: 10.1016/S2352-3026(24)00385-5. Epub 2025 Mar 13.
- van de Donk NWCJ, Chari A, Martin T, Krishnan A, Rasche L, Ye JC, Popat R, Lipe B, Rodriguez C, Schinke C, Skerget S, Vishwamitra D, Verona R, Gong J, Singh I, Campagna M, Masterson T, Hilder B, Tolbert J, Renaud T, Smit MD, Heuck C, Mateos MV. Characterization and Management of Cytokine Release Syndrome From the MonumenTAL-1 Study of Talquetamab in Patients With Relapsed/Refractory Multiple Myeloma. Cancer Med. 2025 Oct;14(19):e71276. doi: 10.1002/cam4.71276.
- Schinke C, Rodriguez-Otero P, van de Donk NWCJ, Lipe B, Lavi N, Rasche L, Parekh S, Van Oekelen O, Vishwamitra D, Skerget S, Cortes-Selva D, Verona R, Hilder B, Masterson T, Campagna M, Khedkar S, Renaud T, Tolbert J, Kane C, Gray KS, Saber I, Heuck C, Chari A. Infections and parameters of humoral immunity with talquetamab in relapsed/refractory multiple myeloma in MonumenTAL-1. Blood Adv. 2025 Nov 25;9(22):5752-5762. doi: 10.1182/bloodadvances.2025016613.
- Catamero D, Ray C, Purcell K, Leahey S, Esler E, Rogers S, Hefner K, O'Rourke L, Gray K, Tolbert J, Renaud T, Patel S, Hannemann L, Shenoy S. Nursing Considerations for the Clinical Management of Adverse Events Associated with Talquetamab in Patients with Relapsed or Refractory Multiple Myeloma. Semin Oncol Nurs. 2024 Oct;40(5):151712. doi: 10.1016/j.soncn.2024.151712. Epub 2024 Aug 17.
- Einsele H, Moreau P, Bahlis N, Bhutani M, Vincent L, Karlin L, Perrot A, Goldschmidt H, van de Donk NWCJ, Ocio EM, Martinez Lopez J, Rodriguez-Otero P, Dytfeld D, Jakubowiak A, Schinke C, Besemer B, Anguille S, Manier S, Rasche L, Teipel R, Scheid C, Pawlyn C, Cavo M, Diels J, Ghilotti F, Lau BW, Renaud T, Orel O, Ong F, Ramos DF, Ammann E, Parekh T, Albrecht C, Weisel K, Mateos MV. Comparative Efficacy of Talquetamab vs. Real-World Physician's Choice of Treatment in Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma: Updated Analyses of MonumenTAL-1 vs. LocoMMotion/MoMMent. Adv Ther. 2026 Jan;43(1):333-355. doi: 10.1007/s12325-025-03409-y. Epub 2025 Nov 28.
- Ito S, Kuroda Y, Sunami K, Matsue K, Imada K, Tamura H, Fujikawa E, Yamazaki H, Takamoto M, Pei L, Qin X, Masterson TJ, Campagna M, Vreys V, Lau BW, Takamatsu Y. Talquetamab in Japanese patients with relapsed/refractory multiple myeloma in the MonumenTAL-1 study. Int J Hematol. 2026 Apr;123(4):580-592. doi: 10.1007/s12185-025-04134-6. Epub 2025 Dec 17.
- Rasche L, Schinke C, Touzeau C, Minnema MC, van de Donk N, Rodriguez-Otero P, Mateos MV, Ye JC, Tomlinson C, Vishwamitra D, Singh I, Qin X, Campagna M, Masterson T, Vreys V, Lau BW, Tolbert J, Renaud T, Heuck C, Chari A. Talquetamab in patients with relapsed/refractory multiple myeloma: 3-year follow-up of the phase 1/2 MonumenTAL-1 study. Blood. 2026 Aug 6:blood.2025031994. doi: 10.1182/blood.2025031994. Online ahead of print.
- Schinke C, Touzeau C, Oriol A, Mateos MV, Stevens D, Rasche L, Moreau P, San-Miguel J, Rodriguez-Otero P, Kato K, Bathija S, Katz EG, Masterson T, Tomlinson C, Chari A. A plain language summary describing how talquetamab affects the way people with multiple myeloma feel and function in the MonumenTAL-1 study. Future Oncol. 2026 Jun;22(14):1651-1668. doi: 10.1080/14796694.2026.2669331. Epub 2026 Jun 16.
- Chari A, Touzeau C, Berdeja JG, Oriol A, van de Donk NW, Rodriguez-Otero P, Morillo D, Martinez-Chamorro C, Mateos MV, Costa LJ, Caers J, Rasche L, Krishnan A, Ye JC, Karlin L, Lipe B, Masterton T, Tolbert J, Renaud T, Kane C, Heuck C, Moreau P. Talquetamab for people living with relapsed/ refractory multiple myeloma: plain language summary of the MonumenTAL-1 study. Future Oncol. 2026 Aug 30:1-20. doi: 10.1080/14796694.2026.2709901. Online ahead of print.
- Schinke C, Rodriguez-Otero P, van de Donk NWCJ, Lipe B, Lavi N, Rasche L, Cortes-Selva D, Masterson T, Khedkar S, Tolbert J, Kane C, Saber I, Heuck C, Chari A. Infections in MonumenTAL-1: a plain language summary of talquetamab treatment for relapsed/refractory multiple myeloma. Future Oncol. 2026 Sep 28:1-16. doi: 10.1080/14796694.2026.2722559. Online ahead of print.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Verisuonisairaudet
- Sydän-ja verisuonitaudit
- Neoplasmat sivustoittain
- Neoplasmat
- Immuunijärjestelmän sairaudet
- Neoplasmat histologisen tyypin mukaan
- Hematologiset sairaudet
- Lymfoproliferatiiviset häiriöt
- Immunoproliferatiiviset häiriöt
- Neoplasmat, plasmasolut
- Hemostaattiset häiriöt
- Paraproteinemiat
- Veren proteiinien häiriöt
- Hemorragiset häiriöt
- Hemic- ja imusuutteet
- Hematologiset kasvaimet
- Multippeli myelooma
- talquetamab
Muut tutkimustunnusnumerot
- CR108920
- 2017-002400-26 (EudraCT-numero)
- TALMMY1001-PT3 (Muu tunniste: Janssen Research & Development, LLC)
- 2017 (Yhdysvaltain NIH-apuraha/sopimus)
- 2023-504581-29-00 (Rekisterin tunniste: EUCT number)
- 2023 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .