Immunoglobulin Light-chain Amyloidosis
Conditions
Brief summary
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.
Interventions
DRUGLive Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules combined with Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab
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).
DRUGBortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab
Naive al amyloidosis patients receive Bortezomib+Dexamethasone, Bortezomib+Dexamethasone+Daratumumab or single Daratumumab therapy without any probiotics (Blank Control).
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Biopsy-proven naive AL amyloidosis * Receive at least 1 course of treatment based on Bortezomib+Dexamethasone or Bortezomib+Dexamethasone+Daratumumab therapy * At least 1 organ (heart, kidney, liver, etc) involved * Agree to participate in the project and sign the informed consent.
Exclusion criteria
* Received antibiotics for 3 consecutive days and on in the past 2 months prior to the enrollment * Had history of probiotics, prebiotics, immunosuppressants, hormones, and other medications use in the past 3 months that influence the Gastrointestinal Microbiome * Had other underlying diseases（malignancy or immune system diseases, etc.） * Had history of clearly diagnosed chronic gastrointestinal disease * Secondary AL amyloidosis or local AL amyloidosis * Other conditions the researcher judged unsuitable for enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of diarrhea | Up to 3 months after enrollment | Increased stool frequency and/or loose or watery stools |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of the diarrhea | Up to 6 months after enrollment | The time between the start of diarrhea and the last diarrhea. |
| Hematological response at 3 and 6 months after enrollment | Up to 6 months after enrollment | Hematological response is evaluated according to the difference between Serum free light chains and immunofixation electrophoresis. |
| Involved organ response（heart）at 3 and 6 months after enrollment | Up to 6 months after enrollment | Involved organ response（heart）is evaluated according to the change of NT-proBNP. |
| SF-36 score at 1 month, 3 month and 6 month | Up to 6 months after enrollment | 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. |
| GSRS score at 1 month, 3 month and 6 month | Up to 6 months after enrollment | 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. |
| Time before diarrhea | Up to 3 months after enrollment | Time interval from the start of treatment to the first diarrhea |
| Survival status at study endpoints | From date of randomization until the date of death from any cause, assessed up to 36 months | Survival status（live or dead） |
| Changes of al amyloidosis patients' gut microbiome at 3 months and 6 months after enrollment | Up to 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.) |
| Severity of the diarrhea | Up to 6 months after enrollment | The severity of diarrhea was graded according to the CTCAE 5.0. |
| Involved organ response（kidney）at 3 and 6 months after enrollment | Up to 6 months after enrollment | Involved organ response（kidney）is evaluated according to the change of 24h proteinuria. |
| Other adverse events that occurred during the treatment | Up to 6 months after enrollment | Adverse events are evaluated according to the CTCAE 5.0. |
Contacts
Primary ContactShiren Sun, Doctor
Outcome results
None listed