Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis
ConditionAL Amyloidosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital
About this trial
This is a phase II study in patients with newly diagnosed Mayo stage IIIB immunoglobulin light-chain (AL) Amyloidosis to evaluate the efficacy and safety of teclistamab
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Biopsy confirmed AL amyloidosis
Mayo 2004 stage IIIB
dFLC ≥ 50mg/L
Disqualifiers
Co-morbidity of uncontrolled infection
Co-morbidity of other active malignancy
Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia
Co-morbidity of grade 2 Mobitz II or grade 3 atrioventricular block (expect for those with implanted pacemaker)
Trial design
Design model
Single group
Treatments tested in this trial
Teclistamab (Tec)
DrugTeclistamab will be administered via a subcutaneous injection
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: TeclistamabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Stringent difference in involved and uninvolved free light chains (dFLC) response at 1 months after treatment initiation
Stringent dFLC response is defined as dFLC \< 10 mg/L or involved free light chain (FLC) ≤ 20 mg/L, and FLC will be tested using FreeLite assay (Binding Site).
Time frame
at 1 months after treatment initiationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov