Probiotic Supplementation Reduces Gastrointestinal Symptoms During the Therapy and Improves Therapeutic Response in AL Amyloidosis

Air Force Military Medical University of People's Liberation Army

Status and phase: Not yet enrolling; Phase 3

Conditions: Immunoglobulin Light-chain Amyloidosis

Treatments: Drug: Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab; Drug: Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules combined with Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05776940

Probiotic in AL amyloidosis

Details and patient eligibility

About

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.

Enrollment: 116 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

Probiotic group

Active Comparator group

Description:

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).

Treatment:

Drug: Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules combined with Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab

Control group

Active Comparator group

Description:

Naive al amyloidosis patients receive Bortezomib+Dexamethasone, Bortezomib+Dexamethasone+Daratumumab or single Daratumumab therapy without any probiotics.

Treatment:

Drug: Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab