Multiple Myeloma Clinical Trial

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

Summary

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

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Full Description

Study record NCT03145181 is Phase 1 part of this study and study record NCT04557098 is Phase 2 part of this study.

View Eligibility Criteria

Eligibility Criteria

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, Cohort C and Cohort D: 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
Cohorts A and D: received at least 3 prior MM treatment lines of therapy. Prior therapy must include an IMiD, PI, and 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

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

192

Study ID:

NCT04557098

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 81 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35294, United States
Mayo Clinic Cancer Center-Scottsdale
Phoenix Arizona, 85054, United States
City of Hope
Duarte California, 91010, United States
University of California, San Francisco
San Francisco California, 94143, United States
Stanford University Medical Center
Stanford California, 94305, United States
Yale University
New Haven Connecticut, 06510, United States
Mayo Clinic in Florida
Jacksonville Florida, 32224, United States
Winship Cancer Institute Emory University
Atlanta Georgia, 30322, United States
University of Kansas
Westwood Kansas, 66205, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States
Mayo Clinic Cancer Center
Rochester New York, 55905, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
The Ohio State University Wexner Medical Center - James Cancer Hospital
Columbus Ohio, 43210, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15232, United States
Vanderbilt - Ingram Cancer Center
Nashville Tennessee, 37212, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
Medical College Of Wisconsin
Milwaukee Wisconsin, 53226, United States
Universitair Ziekenhuis Gent - UZ GENT
Gent , 9000, Belgium
Universitaire Ziekenhuizen Leuven
Leuven , 3000, Belgium
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
University Health Network (UHN) Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
McGill University Health Centre
Montreal Quebec, H4A 3, Canada
Peking University First Hospital
Beijing , 10003, China
The second Xiangya Hospital of Central South University
ChangSha , 41000, China
West China Hospital, Si Chuan University
Chengdu , 61004, China
Fujian Medical University Union Hospital
Fuzhou , 35000, China
Sun Yat -Sen University Cancer Center
Guangzhou , 51006, China
First affiliated Hospital of Zhejiang University
Hangzhou , 31000, China
Shanghai Changzheng Hospital
Shanghai , 20000, China
Shengjing Hospital of China Medical University
Shenyang , 11000, China
Peking University Shenzhen Hospital
Shenzhen , 51803, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin , 30060, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou , 32500, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an , 71000, China
Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez
Lille Cedex , 59000, France
C.H.U. Hotel Dieu - France
Nantes , 44093, France
Centre Hospitalier Lyon Sud
Pierre Benite , 69495, France
CHRU Hôpital Jean Bernard
Poitiers , 86021, France
Pôle IUC Oncopole CHU
Toulouse cedex 9 , 31059, France
CHRU Hôpital Bretonneau
Tours , 37044, France
Universitätsklinikum Carl-Gustav-Carus Dresden
Dresden , 01307, Germany
Universitaetsklinikum Hamburg Eppendorf
Hamburg , 20246, Germany
Universitaetsklinikum Heidelberg
Heidelberg , 69120, Germany
Universitaetsklinikum Koeln
Koeln , 50937, Germany
Universitatsklinikum Leipzig
Leipzig , 04103, Germany
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
Tübingen , 72076, Germany
Universitätsklinikum Würzburg
Würzburg , 97080, Germany
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo , 24127, Italy
Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi
Bologna , 40138, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano , 20133, Italy
A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette
Turin , 10126, Italy
VU Medisch Centrum
Amsterdam , 1081 , Netherlands
Universitair Medisch Centrum Groningen
Groningen , 9713 , Netherlands
Erasmus MC
Rotterdam , 3075 , Netherlands
Hosp. Univ. Germans Trias I Pujol
Badalona , 08916, Spain
Hosp. Clinic I Provincial de Barcelona
Barcelona , 08036, Spain
Hosp. Univ. 12 de Octubre
Madrid , 28041, Spain
Clinica Univ. de Navarra
Pamplona , 31008, Spain
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcon , 28223, Spain
Hosp. Clinico Univ. de Salamanca
Salamanca , 37007, Spain
Hosp. Univ. Marques de Valdecilla
Santander , 39008, Spain
Sahlgrenska University Hospital
Göteborg , 413 4, Sweden
Skane University Hospital
Lund , 221 8, Sweden
Haematology Centre, R 51
Stockholm , SE-14, Sweden
University College Hospital
London , NW1 2, United Kingdom
King's College Hospital
London , SE5 9, United Kingdom
The Christie Nhs Foundation Trust
Manchester , M20 4, United Kingdom
Newcastle Freeman Hospital
Newcastle Upon Tyne , NE7 7, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford , OX3 7, United Kingdom
University Hospital Southampton
Sothampton , SO16 , United Kingdom
Royal Marsden Hospital
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

192

Study ID:

NCT04557098

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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