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Histone Deacetylase (HDAC) Inhibitor

ACY-241 + Pomalidomide + Dexamethasone for Multiple Myeloma

Q: Are there any other experiments that have utilized ACY-241?

<p>ACY-241 was first studied by Manitoba Blood &#x26; Marrow <a href="https://www.withpower.com/clinical-trials/transplant">Transplant</a> Program CancerCare Manitoba in 2002, with 1137 studies having been completed. Presently, 569 clinical trials are actively recruiting participants; a substantial amount of these being hosted in <a href="https://www.withpower.com/clinical-trials/new-york">New york</a> City.</p>

Phase 1

Waitlist Available

Led By Ruben Niesvizky, MD

Research Sponsored by Celgene

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 cycle 2 days 1, 2, 15, 16 and 22

Awards & highlights

Study Summary

This trial is testing a new drug for safety and effectiveness in patients with relapsed or relapsed-and-refractory multiple myeloma.

Who is the study for?

This trial is for patients with multiple myeloma who have relapsed after previous treatments. They must have had at least stable disease once, tried lenalidomide and proteasome inhibitors, and be able to take anticoagulants daily. People can't join if they've used HDAC inhibitors before or are very sensitive to similar drugs like thalidomide.Check my eligibility

What is being tested?

The study tests ACY-241 alone and combined with Pomalidomide and Dexamethasone in different doses to find the highest dose patients can tolerate without severe side effects (MTD). It's an early-phase trial looking at safety and how well these treatments work against multiple myeloma.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system, blood disorders such as low white cell counts which increase infection risk, fatigue, digestive issues, potential liver function changes indicated by enzyme levels in blood tests, and other drug-specific reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cycle 2 days 1, 2, 15, 16 and 22

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cycle 2 days 1, 2, 15, 16 and 22

This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 2 days 1, 2, 15, 16 and 22 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 of ACY-241 as monotherapy as assessed by dose limiting toxicities

Maximum tolerated dose of ACY-241 in combination with pomalidomide and low dose dexamethasone as assessed by dose limiting toxicities

Secondary outcome measures

ACY-241 metabolite concentration in blood samples

Change in acetylation of histone and tubulin as a measure of pharmacodynamics

Change in fetal hemoglobin expression as a measure of pharmacodynamics

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: ACY-241, Pomalidomide, and dexamethasoneExperimental Treatment3 Interventions

Open label dosing cohorts will evaluate oral ACY-241 (dosing ranging from 180 mg to 480 mg days 1-21) in combination with oral pomalidomide (4 mg days 1-21), and oral dexamethasone (40 mg qd on days 1, 8, 15, 22).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2590

ACY-241

2016

Completed Phase 1

~30

Pomalidomide

2011

Completed Phase 2

~1020

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor

636 Previous Clinical Trials

128,886 Total Patients Enrolled

142 Trials studying Multiple Myeloma

40,778 Patients Enrolled for Multiple Myeloma

Ruben Niesvizky, MDPrincipal InvestigatorWeill Medical College of Cornell University

7 Previous Clinical Trials

291 Total Patients Enrolled

7 Trials studying Multiple Myeloma

291 Patients Enrolled for Multiple Myeloma

Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb

1,506 Previous Clinical Trials

3,369,412 Total Patients Enrolled

72 Trials studying Multiple Myeloma

25,202 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

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

Are there any other experiments that have utilized ACY-241?

"ACY-241 was first studied by Manitoba Blood & Marrow Transplant Program CancerCare Manitoba in 2002, with 1137 studies having been completed. Presently, 569 clinical trials are actively recruiting participants; a substantial amount of these being hosted in New york City."

Answered by AI

Is enrollment for this experiment still open?

"The trial for this study is no longer accepting new patients, having first been posted on May 7th 2015 and last updated November 3rd 2022. For those looking to join a medical study, 807 trials featuring multiple myeloma are in progress, with 569 recruiting participants for ACY-241."

Answered by AI

For what therapeutic purpose is ACY-241 typically prescribed?

"ACY-241 is prescribed for ophthalmia, sympathetic and can also be utilized to manage eye conditions such as branch retinal vein occlusion or macular edema."

Answered by AI

How many participants are included in this research endeavor?

"The research team is no longer searching for participants in this trial, which was initially posted on May 7th 2015 and last updated November 3rd 2022. If you are still seeking to participate in clinical trials, there are 807 studies currently enrolling patients with multiple myeloma and 569 trails scrutinizing ACY-241's effects on human health."

Answered by AI

What have been the observed safety implications for individuals taking ACY-241?

"As this is an early-stage trial, with limited efficacy and safety data available to assess ACY-241's risk profile, it has been assigned a score of 1."

Answered by AI

In which areas is the experimental protocol being implemented?

"Fifteen distinct sites are included in the study, including Local Institution - 101 (New york), Colorado Blood Cancer Institute (Denver), and Local Institution- 108 (Tampa). Additional locations can be found elsewhere."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of ACY-241 Alone and in Combination With Pomalidomide and Dexamethasone in Multiple Myeloma

2015. "Study of ACY-241 Alone and in Combination With Pomalidomide and Dexamethasone in Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02400242.

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