A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma (NCT04557098) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
United States194 participantsStarted 2020-09-17
Plain-language summary
The purpose of this study is to evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, with…