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)
Cohorts A and C: Overall Response Rate (ORR) — Up to 2.9 years 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.
Trial sites (51)
Facility
City
Region
Status
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
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.
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