Dexamethasone for Primary Amyloidosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Primary Amyloidosis+2 MoreDexamethasone - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is studying the side effects and best dose of daratumumab, ixazomib, and dexamethasone in treating patients with amyloid light chain amyloidosis.

Eligible Conditions
  • Primary Amyloidosis
  • Refractory Primary Amyloidosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Up to 24 months

Up to 24 months
Duration of response
Overall hematologic response rate
Overall survival
Progression free survival
Recommended phase 2 dose of daratumumab, ixazomib, and dexamethasone
Time to next therapy
Time to response
Up to 28 days
Dose limiting toxicity rate

Trial Safety

Safety Progress

1 of 3

Side Effects for

Ondansetron
2%Cerebrospinal fluid leak
2%Deep Vein Thrombosis
2%Fever
This histogram enumerates side effects from a completed 2013 Phase 4 trial (NCT01474915) in the Ondansetron ARM group. Side effects include: Cerebrospinal fluid leak with 2%, Deep Vein Thrombosis with 2%, Fever with 2%.

Trial Design

1 Treatment Group

Treatment (daratumumab, ixazomib, dexamethasone)
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Dexamethasone · No Placebo Group · Phase 1

Treatment (daratumumab, ixazomib, dexamethasone)Experimental Group · 3 Interventions: Ixazomib, Daratumumab, Dexamethasone · Intervention Types: Drug, Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ixazomib
FDA approved
Daratumumab
FDA approved
Dexamethasone
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months

Who is running the clinical trial?

Janssen PharmaceuticalsIndustry Sponsor
71 Previous Clinical Trials
16,458 Total Patients Enrolled
TakedaIndustry Sponsor
1,119 Previous Clinical Trials
4,054,313 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,805 Previous Clinical Trials
1,790,359 Total Patients Enrolled
Hans C LeePrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
100 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

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