RecruitingMultiple Myeloma

Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma

Eligible age

18+ yrs

Accepts

All genders

Locations

12 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

This is a phase II study to evaluate the outpatient administration of Teclistamab or Talquetamab in Multiple Myeloma patients

Sponsor: SCRI Development Innovations, LLC

✓ 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

✕ Has a rapidly progressing disease per investigator assessment.
✕ Has plasma cell leukemia (\>2.0×10\^9/L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.
✕ Has known active CNS involvement or exhibits clinical signs of meningeal involvement of MM.
✕ Has risk factors for developing clinically significant TLS and requiring management with increased hydration, allopurinol, or rasburicase.
✕ Has myelodysplastic syndrome or active malignancies (ie, progressing or requiring treatment change in the last 12 months) other than RRMM. The only allowed exceptions are:
✕ Any malignancy that was not progressing nor requiring treatment change in the last 12 months.
✕ Malignancies treated within the last 12 months and considered at very low risk for recurrence:
✕ Non-muscle invasive bladder cancer (solitary Ta-PUNLMP or low grade, \<3 cm, no CIS).