Daratumumab/Daratumumab and Hyaluronidase-fihj in Combination With Pomalidomide and Dexamethasone for the Treatment of Patients With Newly Diagnosed AL Amyloidosis: a Prospective, Multicenter, Single-arm Study
NCT Number: NCT06455748
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Amyloid Light-chain Amyloidosis
Interventions: DRUG: Daratumumab/daratumumab and hyaluronidase-fihj|DRUG: Pomalidomide|DRUG: Dexamethasone
Sponsor: Yongyong MA
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-03-01
Completion Date: 2025-03-01
Locations: The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325000, China

Summary:
This is a prospective and single arm clinical study. The goal of this clinical trial is to observe and evaluate the efficacy and safety of Daratumumab/daratumumab and hyaluronidase-fihj in combination with pomalidomide and dexamethasone in the treatment of patients with newly diagnosed AL amyloidosis.

Primary Outcome Measures: Hematologic Overall Remission Rate (ORR), ORR was defined as the proportion of subjects who achieved partial remission (PR) or better partial remission (VGPR) and complete response (CR) by Guideline 2021 Edition criteria., A follow-up is required 30 days (± 7 days) after the completion of all treatments, followed by a follow-up every 12 weeks (± 7 days) for a period of 1 year.
Secondary Outcome Measures: Hematologic complete remission (CR) rate, Negative blood/urine immunofixation electrophoresis and normal serum free light chain levels and ratios., A follow-up is required 30 days (± 7 days) after the completion of all treatments, followed by a follow-up every 12 weeks (± 7 days) for a period of 1 year.|Very good partial remission (VGPR) rate, dFLC decreased to \<40 mg/L, A follow-up is required 30 days (± 7 days) after the completion of all treatments, followed by a follow-up every 12 weeks (± 7 days) for a period of 1 year.|Overall survival (OS), OS: defined as the time from the start of the subject's randomization enrollment until death or final follow-up (time lost to follow-up)., A follow-up is required 30 days (± 7 days) after the completion of all treatments, followed by a follow-up every 12 weeks (± 7 days) for a period of 1 year.|Progression free survival （PFS）, PFS was defined as the period from the subject's randomization to enrollment to the date of the first documented disease progression (PD) (rated according to IMWG criteria, with or without continuation of treatment) or the date of death from any cause, whichever occurred first., A follow-up is required 30 days (± 7 days) after the completion of all treatments, followed by a follow-up every 12 weeks (± 7 days) for a period of 1 year.|Negative rate of microscopic residual disease (MRD), MRD level: MRD was detected using second-generation sequencing (NGS) for bone marrow MRD levels. MRD negative rate: MRD is only evaluated in patients who achieve CR or better., A follow-up is required 30 days (± 7 days) after the completion of all treatments, followed by a follow-up every 12 weeks (± 7 days) for a period of 1 year.|Time to response (TTR), TTR: defined as the period from randomization of subjects to the date of first recorded disease remission., A follow-up is required 30 days (± 7 days) after the completion of all treatments, followed by a follow-up every 12 weeks (± 7 days) for a period of 1 year.|Duration of response (DOR), DOR: defined as the date from the first recording of treatment response to the first recording of disease progression or the date of death from any cause., A follow-up is required 30 days (± 7 days) after the completion of all treatments, followed by a follow-up every 12 weeks (± 7 days) for a period of 1 year.
Other Outcome Measures: Adverse event, An adverse event is defined as an adverse medical event that occurs after a patient in a clinical trial has received treatment in this study, but is not necessarily causally related to the treatment. Any adverse medical event that occurred in this trial from the time the patient signed the informed consent form until 30 days after the final treatment was determined to be an adverse event, regardless of whether it was causally related to the study treatment., A follow-up is required 30 days (± 7 days) after the completion of all treatments, followed by a follow-up every 12 weeks (± 7 days) for a period of 1 year.|EORTC QLQ-C30, EORTC QLQ-C30 is the core scale developed by the European Organization for Research and Treatment (EORTC) for measuring the quality of life of cancer patients. It is used for measuring the common components of quality of life in all cancer patients, and on this basis, specific items (modules) for different cancers are added to form specific scales for different cancers., A follow-up is required 30 days (± 7 days) after the completion of all treatments, followed by a follow-up every 12 weeks (± 7 days) for a period of 1 year.