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Proteasome Inhibitor

bortezomib for Systemic Amyloidosis

Phase 2
Waitlist Available
Led By Jeffrey A. Zonder, MD
Research Sponsored by Barbara Ann Karmanos Cancer Institute
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 start of treatment until 72 months
Awards & highlights

Study Summary

This trial is studying bortezomib in combination with melphalan and dexamethasone to treat patients with primary amyloidosis or light chain deposition disease.

Eligible Conditions
  • Systemic Amyloidosis
  • Light Chain Deposition Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start of treatment until 72 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and start of treatment until 72 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Hematologic Response
Secondary outcome measures
Organ Response Rate (OrR)
Overall Hematologic Response Rate (OHR)
Overall Survival
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Melphalan, Dexamethasone, Bortezomib,Experimental Treatment7 Interventions
Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
bortezomib
2011
Completed Phase 3
~850
dexamethasone
1995
Completed Phase 3
~9860
melphalan
1994
Completed Phase 3
~3530
microarray analysis
2006
Completed Phase 3
~3600
quality-of-life assessment
2012
Completed Phase 3
~2780

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,819 Total Patients Enrolled
Barbara Ann Karmanos Cancer InstituteLead Sponsor
163 Previous Clinical Trials
9,221 Total Patients Enrolled
Jeffrey A. Zonder, MDPrincipal InvestigatorBarbara Ann Karmanos Cancer Institute
5 Previous Clinical Trials
241 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does your research group have an age limit for participants?

"This study allows for a wide age range of participants, with the youngest being 18 years old and the oldest being 120 years old."

Answered by AI

Are new participants still being accepted for this research project?

"Unfortunately, this study is no longer looking for participants. It was last updated on August 24th, 2022 after being posted on September 1st, 2007. There are currently 915 trials related to multiple myeloma and 721 trials investigating dexamethasone that are actively recruiting patients."

Answered by AI

Could you please provide a list of dexamethasone's past and present clinical trials?

"City of Hope Comprehensive Cancer Center published the first study on dexamethasone in 1997 and, since then, 2409 trials have been completed. As of right now, there are 721 ongoing clinical trials with many taking place in Durham, North carolina."

Answered by AI

How many study subjects are you testing this medication on?

"Recruitment for this trial is currently closed. The opening posting date was September 1st, 2007, with the most recent edit taking place on August 24th, 2022. For patients looking for other trials, 915 studies concerning multiple myeloma and 721 trials studying dexamethasone are still open and actively recruiting participants."

Answered by AI

For what sorts of medical ailments is dexamethasone typically prescribed?

"Dexamethasone is an effective medical intervention for ophthalmia, sympathetic, branch retinal vein occlusion, and macular edema."

Answered by AI

If I am willing to be a test subject, am I eligible for this clinical trial?

"The ideal candidate for this clinical trial would be someone with multiple myeloma who is also between 18 and 120 years old. Right now, the study is looking to recruit a total of 35 patients that meet these qualifications."

Answered by AI

In how many different areas is this trial taking place?

"Currently, this clinical trial is taking place at Duke Comprehensive Cancer Center in Durham, Providence Cancer Institute at Providence Hospital - Southfield Campus in Southfield, and UPMC Cancer Centers in Pittsburgh. Additionally, there are 7 other sites running this trial."

Answered by AI

What are the FDA's thoughts on dexamethasone?

"Dexamethasone falls into Phase 2 of clinical trials, so there is some evidence suggesting it is safe but not yet any for efficacy. Our team rates its safety as a 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Bortezomib, Melphalan, and Dexamethasone in Treating Patients With Primary Amyloidosis or Light Chain Deposition Disease
Jeffrey Zonder 2007. "Bortezomib, Melphalan, and Dexamethasone in Treating Patients With Primary Amyloidosis or Light Chain Deposition Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00520767.
~2 spots leftby Apr 2025
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