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).
Full Description
Study record NCT03145181 is Phase 1 part of this study and study record NCT04557098 is Phase 2 part of this study.
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
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There are 51 Locations for this study
Birmingham Alabama, 35294, United States
Duarte California, 91010, United States
San Francisco California, 94143, United States
Stanford California, 94305, United States
Atlanta Georgia, 30322, United States
Detroit Michigan, 48201, United States
New York New York, 10029, United States
New York New York, 10065, United States
Charlotte North Carolina, 28204, United States
Philadelphia Pennsylvania, 19104, United States
Gent , 9000, Belgium
Leuven , 3000, Belgium
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H4A 3, Canada
Beijing , 10003, China
Chengdu , 61004, China
Guangzhou , 51006, China
Hangzhou , 31000, China
Shanghai , 20000, China
Shenyang , 11000, China
Tianjin , 30060, China
Xi'an , 71000, China
Lille Cedex , 59000, France
Nantes , 44093, France
Pierre Benite , 69495, France
Poitiers , 86021, France
Toulouse cedex 9 , 31059, France
Tours , 37044, France
Heidelberg , 69120, Germany
Leipzig , 04103, Germany
Tübingen , 72076, Germany
Würzburg , 97080, Germany
Bergamo , 24127, Italy
Bologna , 40138, Italy
Milano , 20133, Italy
Amsterdam , 1081 , Netherlands
Badalona , 08916, Spain
Barcelona , 08036, Spain
Madrid , 28041, Spain
Pamplona , 31008, Spain
Pozuelo de Alarcon , 28223, Spain
Salamanca , 37007, Spain
Santander , 39008, Spain
Göteborg , 413 4, Sweden
Lund , 221 8, Sweden
Stockholm , SE-14, Sweden
London , NW1 2, United Kingdom
Sothampton , SO16 , United Kingdom
Sutton , SM2 5, United Kingdom
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