Clinical trial NCT04634552: A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
Official title: A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hematological Malignancies
Keywords: Multiple Myeloma
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2020-11-18
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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)

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to 2 years and 10 months
Secondary outcomes:
measure: Duration of Response (DOR)
timeFrame: Up to 2 years and 10 months
measure: Very Good Partial Response (VGPR) or Better Rate
timeFrame: Up to 2 years and 10 months
measure: Complete Response (CR) or Better Rate
timeFrame: Up to 2 years and 10 months
measure: Stringent Complete Response (sCR) Rate
timeFrame: Up to 2 years and 10 months
measure: Time to Response (TTR)
timeFrame: Up to 2 years and 10 months
measure: Progression-Free Survival (PFS)
timeFrame: Up to 2 years and 10 months
measure: Overall Survival (OS)
timeFrame: Up to 2 years and 10 months
measure: Minimal Residual Disease (MRD) Negative Rate
timeFrame: Up to 2 years and 10 months
measure: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
timeFrame: Up to 2 years and 10 months
measure: Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
timeFrame: Up to 2 years and 10 months
measure: Number of Participants with AEs by Severity
timeFrame: Up to 2 years and 10 months
measure: Number of Participants with Abnormalities in Clinical Laboratory Values
timeFrame: Up to 2 years and 10 months
measure: Serum Concentration of Talquetamab
timeFrame: Up to 2 years and 10 months
measure: Number of Participants with Talquetamab Antibodies
timeFrame: Up to 2 years and 10 months
measure: 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)
timeFrame: Baseline up to 2 years and 10 months
measure: Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L)
timeFrame: Baseline up to 2 years and 10 months
measure: Change from Baseline in HRQoL as Assessed by Patient Global Impression of Severity (PGIS)
timeFrame: Baseline up to 2 years and 10 months
measure: Overall Response Rate (ORR) in Participants with High-risk Molecular Features
timeFrame: Up to 2 years and 10 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Duarte
country: United States
facility: City of Hope
state: California
city: Hollywood
country: United States
facility: Memorial Healthcare System
state: Florida
city: Atlanta
country: United States
facility: Emory University Winship Cancer Institute
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School Of Medicine
state: Missouri
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Brussels
country: Belgium
facility: UCL - Saint Luc
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHU de Liège - Domaine Universitaire du Sart Tilman
city: Beijing
country: China
facility: Peking University Third Hospital
city: Guangzhou
country: China
facility: Sun Yat Sen University Cancer Center
city: Hangzhou
country: China
facility: The 1St Affiliated Hospital of Medical College Zhejiang University
city: Su Zhou
country: China
facility: First Affiliated Hospital SooChow University
city: Tianjin
country: China
facility: Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
city: XI An Shi
country: China
facility: The First Affiliated Hospital of Xian Jiaotong University
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
city: Creteil
country: France
facility: CHU Henri Mondor
city: Montpellier
country: France
facility: CHU de Montpellier Hopital Saint Eloi
city: Nantes
country: France
facility: C.H.U. Hotel Dieu - France
city: Pessac cedex
country: France
facility: CHU de Bordeaux - Hospital Haut-Leveque
city: Pierre Benite cedex
country: France
facility: Centre hospitalier Lyon-Sud
city: Toulouse cedex 9
country: France
facility: Pôle IUC Oncopole CHU
city: Berlin
country: Germany
facility: Charite Campus Benjamin Franklin
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Wuerzburg
country: Germany
facility: Universitatsklinikum Wurzburg
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Chiba
country: Japan
facility: Kameda Medical Center
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Gifu
country: Japan
facility: Ogaki Municipal Hospital
city: Hokkaido
country: Japan
facility: Teine Keijinkai Hospital
city: Kobe City
country: Japan
facility: Kobe City Medical Center General Hospital
city: Koshigaya
country: Japan
facility: Dokkyo Medical University Saitama Medical Center
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital
city: Matsumoto
country: Japan
facility: National Hospital Organization Matsumoto Medical Center
city: Okayama
country: Japan
facility: National Hospital Organization Okayama Medical Center
city: Osaka
country: Japan
facility: Japanese Red Cross Osaka Hospital
city: Otake
country: Japan
facility: National Hospital Organization Hiroshima-Nishi Medical Center
city: Shiwa-gun
country: Japan
facility: Iwate Medical University Hospital
city: Jeollanam-do
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Marys Hospital
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum
city: Utrecht
country: Netherlands
facility: UMCU
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Gliwice
country: Poland
facility: Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
city: Poznan
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Poznaniu
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
city: Badalona
country: Spain
facility: Hosp. Univ. Germans Trias I Pujol
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Barcelona
country: Spain
facility: Inst. Cat. Doncologia-H Duran I Reynals
city: Madrid
country: Spain
facility: Hosp Univ Fund Jimenez Diaz
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Murcia
country: Spain
facility: Hosp. Univ. Virgen de La Arrixaca
city: Pamplona
country: Spain
facility: Clinica Univ. de Navarra
city: Pozuelo de Alarcon
country: Spain
facility: Hosp. Quiron Madrid Pozuelo
city: Salamanca
country: Spain
facility: Hosp Clinico Univ de Salamanca
city: Santander
country: Spain
facility: Hosp. Univ. Marques de Valdecilla
city: Sevilla
country: Spain
facility: Hosp. Virgen Del Rocio
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: