NCT05776940

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2023

Typical duration for phase_3

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

March 31, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

March 20, 2023

Status Verified

March 1, 2023

Enrollment Period

3 years

First QC Date

February 8, 2023

Last Update Submit

March 18, 2023

Conditions

Immunoglobulin Light-chain Amyloidosis

Outcome Measures

Primary Outcomes (1)

  • Occurrence of diarrhea

    Increased stool frequency and/or loose or watery stools

    Up to 3 months after enrollment

Secondary Outcomes (11)

  • Time before diarrhea

    Up to 3 months after enrollment

  • Duration of the diarrhea

    Up to 6 months after enrollment

  • Hematological response at 3 and 6 months after enrollment

    Up to 6 months after enrollment

  • Involved organ response（heart）at 3 and 6 months after enrollment

    Up to 6 months after enrollment

  • SF-36 score at 1 month, 3 month and 6 month

    Up to 6 months after enrollment

  • +6 more secondary outcomes

Study Arms (2)

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).

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

Control group

ACTIVE COMPARATOR

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

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

Interventions

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

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).

Also known as: Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules + Routine therapy
Probiotic group
Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single DaratumumabDRUG

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

Also known as: Routine therapy
Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Immunoglobulin Light-chain Amyloidosis

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesParaproteinemias

Central Study Contacts

Shiren Sun, Doctor

CONTACT

185209557281019282726@qq.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 8, 2023

First Posted

March 20, 2023

Study Start

March 31, 2023

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

March 20, 2023

Record last verified: 2023-03