Teclistamab-Daratumumab in AL Amyloidosis
ConditionAmyloid Light-chain Amyloidosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorRajshekhar Chakraborty, MD
About this trial
The purpose of this study is to investigate whether teclistamab-daratumumab combination is effective and safe in AL amyloidosis.
The study treatment is divided into cycles (C) and each cycle is 28 days (D). Study treatment is expected to last 6 months.
Eligibility criteria
Qualifiers
Age >18 years and able to sign Informed Consent Form (ICF). If the individual being considered for participation in this study is unable to provide informed consent due to medical, cognitive, or other conditions, a legally authorized representative (LAR) may consent on their behalf.
Ability to comply with the study protocol, in the investigator's judgment.
Confirmed histopathological diagnosis of systemic AL amyloidosis by mass spectrometry or immunohistochemistry (IHC) or Immunofluorescence (IF) on a tissue biopsy that is positive for Congo Red.
Patient must not have received any prior plasma cell clone-directed therapy.
Disqualifiers
Prior therapy for AL amyloidosis or multiple myeloma with the exception of 160 mg dexamethasone (or equivalent corticosteroid) maximum exposure prior to C1D0.
Patients meeting criteria for symptomatic multiple myeloma by any one of the following: (a) Lytic lesions on imaging (Skeletal survey, whole body CT or MRI, or PET/CT) (b) Plasmacytoma, (c) Hypercalcemia without any alternate etiology, (d) Bone marrow plasma cell infiltrate of greater than 60%.
NT-Pro BNP > 8500 pg/mL, and/or
NYHA Class IIIb or IV functional class
Trial design
Treatments tested in this trial
- Teclistamab
- Daratumumab and Hyaluronidase-fihj
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Rajshekhar Chakraborty, MD
Lead sponsor
Columbia University
Sponsor institution
Janssen Pharmaceuticals
Collaborator
Source ClinicalTrials.gov