Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma
ConditionMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSCRI Development Innovations, LLC
About this trial
This is a phase II study to evaluate the outpatient administration of Teclistamab or Talquetamab in Multiple Myeloma patients
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Teclistamab
- Talquetamab
- Tocilizumab
- Oral Dexamethasone
Treatment groups
100 Participants
are divided into 3 treatment groupsSponsors and collaborators
SCRI Development Innovations, LLC
Lead sponsor
Johnson & Johnson
Collaborator
Source ClinicalTrials.gov