The purpose of this clinical trial is to evaluate whether specific probiotic can reduce gastrointestinal symptoms and improves therapeutic response, on a background of Bortezomib+dexamethasone or Bortezomib+dexamethasone combined with daratumumab therapy, for naive AL amyloidosis patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
116
Naive al amyloidosis patients receive Bortezomib+Dexamethasone, Bortezomib+Dexamethasone+Daratumumab or single Daratumumab therapy combined with Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules(250mg/time, bid,up to 3 months).
Naive al amyloidosis patients receive Bortezomib+Dexamethasone, Bortezomib+Dexamethasone+Daratumumab or single Daratumumab therapy without any probiotics (Blank Control).
Occurrence of diarrhea
Increased stool frequency and/or loose or watery stools
Time frame: Up to 3 months after enrollment
Time before diarrhea
Time interval from the start of treatment to the first diarrhea
Time frame: Up to 3 months after enrollment
Duration of the diarrhea
The time between the start of diarrhea and the last diarrhea.
Time frame: Up to 6 months after enrollment
Hematological response at 3 and 6 months after enrollment
Hematological response is evaluated according to the difference between Serum free light chains and immunofixation electrophoresis.
Time frame: Up to 6 months after enrollment
Involved organ response（heart）at 3 and 6 months after enrollment
Involved organ response（heart）is evaluated according to the change of NT-proBNP.
Time frame: Up to 6 months after enrollment
SF-36 score at 1 month, 3 month and 6 month
The general health condition is evaluated by the 36-item Short-Form. The SF-36 measure consists of 36 items that address the following 8 dimensions: physical pain, mental health, general health, emotional role functioning, social functioning, vitality, and physical and role functioning. Each dimension receives a final score between 0 and 100, with 100 representing the best performance.
Time frame: Up to 6 months after enrollment
GSRS score at 1 month, 3 month and 6 month
The Gastrointestinal Symptoms are evaluated by Gastrointestinal Symptom Rating Scale. The minimum and maximum values is 15 and 105, respectively. The scores are calculated by taking the mean of the items completed within an individual scale, with higher scores indicating greater severity of symptoms.
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Time frame: Up to 6 months after enrollment
Other adverse events that occurred during the treatment
Adverse events are evaluated according to the CTCAE 5.0.
Time frame: Up to 6 months after enrollment
Survival status at study endpoints
Survival status（live or dead）
Time frame: From date of randomization until the date of death from any cause, assessed up to 36 months
Changes of al amyloidosis patients' gut microbiome at 3 months and 6 months after enrollment
The changes of gut microbiome are evaluated by 16sRNA (such as Microbiota α-diversity and β-diversity、Changes in gut microbiota at the phylum and the genus levels、Phylogenetic profiles of the gut microbial communities、Microbial functional alteration、Correlations between significantly different ASVs and clinical characteristics in AL amyloidosis patients.etc.)
Time frame: Up to 6 months after enrollment.
Severity of the diarrhea
The severity of diarrhea was graded according to the CTCAE 5.0.
Time frame: Up to 6 months after enrollment
Involved organ response（kidney）at 3 and 6 months after enrollment
Involved organ response（kidney）is evaluated according to the change of 24h proteinuria.
Time frame: Up to 6 months after enrollment