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Alkylating Agent

Newly Diagnosed AL Amyloidosis for AL Amyloidosis

Phase 1 & 2
Waitlist Available
Led By Keren Osman, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is for people with a bone marrow disorder called light chain (AL) amyloidosis. The goal is to find the safest dose of a combination of three drugs—Ixazomib, cyclophosphamide, and dexamethasone—that can stop the growth of abnormal cells producing an abnormal protein.

Eligible Conditions
  • AL Amyloidosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD)
Secondary outcome measures
Frequency of organ response
Response Rate

Trial Design

1Treatment groups
Experimental Treatment
Group I: Newly Diagnosed AL AmyloidosisExperimental Treatment3 Interventions
Ixazomib/Cyclophosphamide/Dexamethasone. Treatment cycles will be repeated up to 6 cycles or until disease progression or until development of significant treatment-related toxicities.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ixazomib
FDA approved
Cyclophosphamide
FDA approved
Dexamethasone
FDA approved

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
861 Previous Clinical Trials
525,248 Total Patients Enrolled
Millennium Pharmaceuticals, Inc.Industry Sponsor
404 Previous Clinical Trials
46,886 Total Patients Enrolled
Keren Osman, MDPrincipal Investigator - Icahn School of Medicine at Mount Sinai
The Mount Sinai Hospital
Medical School - Icahn School of Medicine at Mount Sinai, Doctor of Medicine
The Mount Sinai Hospital, Residency in Internal Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Ixazomib In Combination With Cyclophosphamide And Dexamethasone for Newly Diagnosed AL Amyloidosis
Keren Osman 2017. "Ixazomib In Combination With Cyclophosphamide And Dexamethasone for Newly Diagnosed AL Amyloidosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03236792.
~4 spots leftby Apr 2025
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