All > Waldenstrom Macroglobulinemia

Rifaximin for Monoclonal Gammopathy

Emory University Hospital/Winship Cancer Institute, Atlanta, GA
Monoclonal Gammopathy+7 More ConditionsRifaximin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing how well rifaximin works to treat patients with monoclonal gammopathy by reducing the abnormal protein or cells in patients.

Eligible Conditions
  • Monoclonal Gammopathy
  • Waldenstrom Macroglobulinemia
  • Smoldering Waldenstrom Macroglobulinemia
  • Monoclonal Gammopathy of Undetermined Significance (MGUS)
  • Light Chain Deposition Disease
  • Immunoglobulin A Monoclonal Gammopathy

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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1
LP-168
1
TAA-specific CTLs
1
Dasatinib

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 2 weeks after study start

Week 12
Changes in gammopathy
Changes in stool microbiota
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Week 2
Clinical response rate defined as a reduction in clonal immunoglobulin (Ig) by > 25%

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
LP-168
1
TAA-specific CTLs
1
Dasatinib

Side Effects for

Rifaximin 550 mg BID
19%Hepatic encephalopathy
17%Oedema peripheral
16%Constipation
14%Nausea
14%Fatigue
12%Insomnia
11%Urinary tract infection
10%Pruritus generalised
8%Muscle spasms
7%Abdominal pain
7%Decreased appetite
6%Ascites
6%Headache
6%Dyspnoea
5%Renal failure acute
5%Anaemia
5%Vomiting
5%Asthenia
5%Anxiety
5%Cough
4%Diarrhoea
4%Jaundice
3%Cellulitis
3%Abdominal distension
3%Depression
2%Peritonitis bacterial
2%Bronchitis
2%Hyperkalaemia
2%Liver transplant
1%Chest pain
1%Pneumococcal bacteraemia
1%Non-cardiac chest pain
1%Septic shock
1%Pneumonia
1%Sepsis
1%Thrombocytopenia
1%Cardiac failure congestive
1%Gastrointestinal haemorrhage
1%Haematemesis
1%Haematochezia
1%Upper gastrointestinal haemorrhage
1%Systemic inflammatory response syndrome
1%Chronic hepatic failure
1%Hepatic failure
1%Hepatitis
1%Hepatorenal syndrome
1%Herpes zoster
1%Craniocerebral injury
1%Subdural haematoma
1%Dehydration
1%Fluid overload
1%Hyperglycaemia
1%Alcoholic seizure
1%Cerebrovascular accident
1%Subarachnoid haemorrhage
1%Toxic encephalopathy
1%Anxiety disorder
1%Suicidal ideation
1%Calculus ureteric
1%Oliguria
1%Renal failure
1%Acute respiratory failure
1%Pleural effusion
1%Hypovolaemic shock
1%Flatulence
This histogram enumerates side effects from a completed 2014 Phase 4 trial (NCT01842581) in the Rifaximin 550 mg BID ARM group. Side effects include: Hepatic encephalopathy with 19%, Oedema peripheral with 17%, Constipation with 16%, Nausea with 14%, Fatigue with 14%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

1 Treatment Group

Treatment (rifaximin)
1 of 1

Experimental Treatment

48 Total Participants · 1 Treatment Group

Primary Treatment: Rifaximin · No Placebo Group · Phase 1

Treatment (rifaximin)
Drug
Experimental Group · 1 Intervention: Rifaximin · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rifaximin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 weeks after study start

Who is running the clinical trial?

The Leukemia and Lymphoma SocietyOTHER
75 Previous Clinical Trials
16,752 Total Patients Enrolled
1 Trials studying Monoclonal Gammopathy
42 Patients Enrolled for Monoclonal Gammopathy
Emory UniversityLead Sponsor
1,558 Previous Clinical Trials
2,765,693 Total Patients Enrolled
Madhav Dhodapkar, MDPrincipal Investigator - Emory University
Emory University Hospital, Emory University Hospital Midtown
All India Inst Of Medical Sci (Medical School)
Mayo Grad School Med/Mayo Fndn (Residency)
4 Previous Clinical Trials
390 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Indiana100.0%
How old are they?
65+100.0%
What site did they apply to?
Emory University Hospital/Winship Cancer Institute100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Typically responds via
Email100.0%
Most responsive sites:
  1. Emory University Hospital/Winship Cancer Institute: < 48 hours
Average response time
  • < 2 Days
References

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