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Clinical Trials in the UK / NCT04557098
Active, not recruiting Phase 2

A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT04557098 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 2
Started
2020-09-17
Last updated
2026-07-31

Condition(s) studied

Hematological Malignancies

Investigational drug(s) / intervention(s)

Teclistamab

Teclistamab: Teclistamab will be administered SC.

Study summary

The purpose of this study is to evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: - * Documented diagnosis of multiple myeloma according to IMWG diagnostic criteria * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 * Measurable disease: Cohort A and Cohort C: Multiple myeloma must be measurable by central laboratory assessment * A female participant of childbearing potential must have a negative pregnancy test at screening * Willing and able to adhere to the prohibitions and restrictions specified in this protocol * Cohort A: received at least \>=3 prior lines of therapy and previously received a PI, an IMiD and an anti-CD38 monoclonal antibody; Cohort C: received \>= 3 prior lines of therapy that included a PI, an IMiD, an anti-CD38 monoclonal antibody, and an anti-B cell maturation antigen (BCMA) treatment (with CART-T cells or an antibody drug conjugate (ADC) Exclusion Criteria: * Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light-chain amyloidosis * The following medical conditions: Pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency virus (HIV) infection, hepatitis B or C infection, stroke or seizure less than or equal to (\<=) 6 m, autoimmune disease, uncontrolled systemic infection, cardiac conditions (Myocardial Infarction \<= 6 m, stage III-IV congestive heart failure, etc) * Received any therapy that is targeted to BCMA, with the exception of Cohort C in Part 3 * Prior antitumor therapy, within 21 days (PI or radiotherapy within 14 days, IMiDs within 7 days, Gene modified adoptive cell therapy within 3 months) prior to first dose of study drug * Toxicities from previous anticancer therapies that have not resolved to baseline or to \<= grade 1 (except for alopecia or peripheral neuropathy) * Received a cumulative dose of corticosteroids equivalent to \>=140 mg of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication) * Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma (MM) * Myelodysplastic syndrome or active malignancies other than relapsed/refractory multiple myeloma with exceptions are: 1) Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured 2) Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured. 3) Noninvasive cervical cancer treated within the last 24 months that is considered completely cured. 4) Localized prostate cancer (N0M0) 5) Breast cancer: Adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence. 6) Malignancy that is considered cured with minimal risk of recurrence * Prior allogenic stem cell transplant \<=6 months * Prior autologous stem cell transplant \<=12 weeks * Live, attenuated vaccine within 4 weeks prior to the first dose of teclistamab

Primary outcome measure(s)

Trial sites (51)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama
City of Hope Duarte California
University of California San Francisco San Francisco California
Stanford University Medical Center Stanford California
Winship Cancer Institute Emory University Atlanta Georgia
Barbara Ann Karmanos Cancer Institute Detroit Michigan
Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects New York New York
Memorial Sloan-Kettering Cancer Center New York New York
Levine Cancer Institute Charlotte North Carolina
University of Pennsylvania Philadelphia Pennsylvania
Universitair Ziekenhuis Gent - UZ GENT Ghent Belgium
Universitaire Ziekenhuizen Leuven Leuven Belgium
Arthur J E Child Comprehensive Cancer Centre Calgary Alberta
Cross Cancer Institute Edmonton Alberta
University Health Network UHN Princess Margaret Cancer Centre Toronto Ontario
McGill University Health Centre Montreal Quebec
Peking University First Hospital Beijing China
West China Hospital Si Chuan University Chengdu China
Sun Yat -Sen University Cancer Center Guangzhou China
First affiliated Hospital of Zhejiang University Hangzhou China
Shanghai Changzheng Hospital Shanghai China
Shengjing Hospital Of China Medical University Shenyang China
Tianjin Medical University Cancer Institute and Hospital Tianjin China
The Second Affiliated Hospital of Xi'an Jiaotong University Xi'an China
Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez Lille France
Centre Hospitalier Lyon Sud Lyon France
C.H.U. Hotel Dieu - France Nantes France
CHU Poitiers - Hopital la Miletrie Poitiers France
Pôle IUC Oncopole CHU Toulouse France
CHRU Hôpital Bretonneau Tours France
Universitaetsklinikum Heidelberg Heidelberg Germany
Universitaetsklinikum Leipzig Leipzig Germany
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II, Tübingen Germany
Universitatsklinikum Wurzburg Würzburg Germany
Azienda Ospedaliera Papa Giovanni XXIII Bergamo Italy
Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi Bologna Italy
Fondazione IRCCS Istituto Nazionale dei Tumori Milan Italy
VU Medisch Centrum Amsterdam Netherlands
Hosp. Univ. Germans Trias I Pujol Badalona Spain
Hosp Clinic de Barcelona Barcelona Spain

+ 11 more sites — see the full list on the official registry below.

More Janssen Research & Development, LLC trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04557098 on ClinicalTrials.gov ↗ ← All trials in the UK