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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic group | Active Comparator | 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). |
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| Control group | Active Comparator | Naive al amyloidosis patients receive Bortezomib+Dexamethasone, Bortezomib+Dexamethasone+Daratumumab or single Daratumumab therapy without any probiotics. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules combined with Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of diarrhea | Increased stool frequency and/or loose or watery stools | Up to 3 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Time before diarrhea | Time interval from the start of treatment to the first diarrhea | Up to 3 months after enrollment |
| Duration of the diarrhea | The time between the start of diarrhea and the last diarrhea. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiren Sun, Doctor | Contact | 18520955728 | 1019282726@qq.com |
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| Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab | Drug | Naive al amyloidosis patients receive Bortezomib+Dexamethasone, Bortezomib+Dexamethasone+Daratumumab or single Daratumumab therapy without any probiotics (Blank Control). |
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| 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. | 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. | 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. | 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. | Up to 6 months after enrollment |
| Other adverse events that occurred during the treatment | Adverse events are evaluated according to the CTCAE 5.0. | Up to 6 months after enrollment |
| Survival status at study endpoints | Survival status（live or dead） | 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.) | Up to 6 months after enrollment. |
| Severity of the diarrhea | The severity of diarrhea was graded according to the CTCAE 5.0. | 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. | Up to 6 months after enrollment |
| ID | Term |
|---|---|
| D000075363 | Immunoglobulin Light-chain Amyloidosis |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000686 | Amyloidosis |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D010265 | Paraproteinemias |
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