Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma (NCT05972135) | Clinical Trial Compass
RecruitingPhase 2
Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma
United States100 participantsStarted 2023-10-23
Plain-language summary
This is a phase II study to evaluate the outpatient administration of Teclistamab or Talquetamab in Multiple Myeloma patients
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:
* Be ≥18 years of age (or the higher legal age in the jurisdiction in which the study is taking place) at the time of informed consent
* Has documented diagnosis of MM according to the IMWG diagnostic criteria (Rajkumar 2011).
* Teclistamab or Talquetamab + Tocilizumab: has received 2 or more prior MM therapies including a PI, IMiD and CD38 antibody.
* Teclistamab + Oral Dexamethasone: has received 1 or more prior MM therapies including a PI, IMiD and/or CD38 antibody.
* Teclistamab or Talquetamab + Tocilizumab: has an ECOG performance status (Oken 1982) of 0 to 1.
Teclistamab + Oral Dexamethasone: has an ECOG performance status (Oken 1982) of 0 to 2.
* Measurable disease at screening, as assessed by local laboratory, defined by any of the following:
* Serum M-protein level ≥0.5 g/dL; or
* Urine M-protein level ≥200 mg/24 hours; or
* Light chain MM without measurable M-protein in the serum or the urine: serum free light chain (sFLC) ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.
* For participants without measurable disease in the serum, urine, or involved FLC, presence of plasmacytomas (≥2 cm).
* Human immunodeficiency virus-positive participants are eligible if they meet all of the following:
* No detectable viral load (i.e., \<50 copies/mL) at screening
* CD4+ count \>300 cells/mm3 at screening
* No acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 6 months of screening
* Receivin…
What they're measuring
1
Incidence of CRS of any grade during the first two cycles
Timeframe: From first dose of teclistamab or talquetamab, from Day 1 first step-up dose to the end of Cycle 2 (each cycle is 28 days)