Daratumumab for Patients With Light Chain Amyloidosis
ConditionLight Chain (AL) Amyloidosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNanjing University School of Medicine
About this trial
This is a prospective, single-center study exploratory clinical trial, aim to exploring the efficacy and safety of daratumumab in patients with AL amyloidosis, patients were divided into three groups: one group received long-term treatment with daratumumab based regimen, and the other group received autologous stem cell transplantation after two standard treatment courses with daratumumab based regimen, and the third group consists of newly diagnosed stage IIIb AL amyloidosis patients who plan to receive DPD treatment. The purpose of this study is to observe the efficacy and safety of Daratumumab, in the treatment of newly diagnosed systemic AL amyloidosis.
Eligibility criteria
Qualifiers
Participants must be aged ≥18 and ≤75 years;
Newly diagnosed AL amyloidosis ((confirmed by pathological examination with at least one major organ involvement (heart, kidney, or liver));
In group A and B, according to the Mayo 2004 staging system, the disease is classified as stage Ⅰ-ⅢA; In group C, according to the Mayo 2004 staging system, the disease is classified as stage IIIB: NT⁃proBNP>8500ng/L and cTnT>0.035μg/L or cTnI>0.01g/L;
Participants must personally sign an informed consent form approved by the Ethics Committee before the start of the study;
Disqualifiers
eGFR< 30ml/min/1.73m2;
Combined multiple myeloma;
Acute or chronic infection requiring treatment within 30 days prior to baseline;
Pregnant or breastfeeding women.
Trial design
Treatments tested in this trial
- Dratumumab / Hyaluronidase Injection [Darzalex Faspro]
- Pomalidomide 4 MG
- autologous stem cell transplantation (ASCT)
Treatment groups
100 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov