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Histone Deacetylase Inhibitor

ACY-1215 (Ricolinostat) in combination with pomalidomide and dexamethasone for Multiple Myeloma

Phase 1 & 2

Waitlist Available

Led By Noopur Raje, 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 duration on study, estimated average of 4 months

Awards & highlights

Study Summary

This trial is testing a new drug combination for patients with relapsed-and-refractory multiple myeloma. The first part of the trial (phase 1b) will evaluate side effects and determine the best dose to use. The second part of the trial (phase 2) will look at the overall response rate to the new drug combination.

Who is the study for?

This trial is for adults with relapsed-and-refractory multiple myeloma who have tried at least two prior therapies, including lenalidomide and a proteasome inhibitor. They must not be eligible or interested in stem cell transplant and should have adequate organ function. Women of childbearing age must test negative for pregnancy and use effective birth control; men must also agree to use contraception.Check my eligibility

What is being tested?

The study tests ACY-1215 (Ricolinostat) combined with pomalidomide and low-dose dexamethasone. Phase 1b aims to find the safest dose with the fewest side effects, while Phase 2 evaluates how well this combination works in treating patients whose myeloma has returned after previous treatment.See study design

What are the potential side effects?

Possible side effects include reactions related to blood counts like anemia or bleeding risks, liver issues indicated by elevated enzymes, potential nerve damage causing numbness or pain, gastrointestinal symptoms such as nausea or diarrhea, fatigue, increased risk of infections due to immune suppression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ duration on study, estimated average of 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~duration on study, estimated average of 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and duration on study, estimated average of 4 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

Phase 1b: MTD and dosing schedule of ACY-1215 administered in combination with pomalidomide and low-dose dexamethasone in patients with MM

Phase 2: Overall response rate of ACY-1215 in combination with pomalidomide and dexamethasone in patients with relapsed-and-refractory multiple myeloma

Secondary outcome measures

Phase 1b & 2: Safety assessed by type, frequency and severity of AEs and relationship of AEs to study drug

Phase 1b and 2: Efficacy assessed by time to response, duration of response, time to progression, progression free survival, and objective response as assessed by a central adjudication committee

Phase 1b: Exposure response of treatment including biomarkers relating to intracellular protein acetylation, protein levels, mRNA and microRA expression profiles.

+1 more

Other outcome measures

Phase 2: Relationship between response to treatment and any cytogenetic abnormalities

Trial Design

1Treatment groups

Experimental Treatment

Group I: ACY-1215 in combination with pomalidomide and dexamethasoneExperimental Treatment1 Intervention

ACY-1215 (Ricolinostat) in combination with pomalidomide and dexamethasone

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor

636 Previous Clinical Trials

128,868 Total Patients Enrolled

142 Trials studying Multiple Myeloma

40,760 Patients Enrolled for Multiple Myeloma

Noopur Raje, MDPrincipal InvestigatorMassachusetts General Hospital

6 Previous Clinical Trials

165 Total Patients Enrolled

6 Trials studying Multiple Myeloma

165 Patients Enrolled for Multiple Myeloma

Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb

1,506 Previous Clinical Trials

3,369,427 Total Patients Enrolled

72 Trials studying Multiple Myeloma

25,184 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.

Can more people still enroll in this clinical trial?

"This study has since concluded its recruitment period. It was originally posted on March 1st, 2014 but the last update occurred on August 31st, 2022. There are 827 other trials involving multiple myeloma and 599 clinical studies ACY-1215 (Ricolinostat) in combination with pomalidomide and dexamethasone that are still looking for participants."

Answered by AI

Does previous research suggest that ACY-1215 (Ricolinostat) is effective when used in tandem with pomalidomide and dexamethasone?

"ACY-1215 (Ricolinostat), when used in tandem with pomalidomide and dexamethasone, was first studied in 2002 at the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. As of now, 1128 studies have been completed while 599 are still ongoing. A large portion of these active trials are taking place in Lafayette, Indiana."

Answered by AI

What does ACY-1215 (Ricolinostat) do when mixed with pomalidomide and dexamethasone?

"ACY-1215 (Ricolinostat) can be used in combination with pomalidomide and dexamethasone to mitigate the symptoms of ophthalmia, sympathetic eye disorders, and branch retinal vein occlusions."

Answered by AI

How many test subjects are you studying in this clinical trial?

"This study is not enrolling patients at the moment. However, it was first posted on March 1st, 2014 and edited as recently as August 31st, 2022. For those still looking to participate in clinical trials, there are 827 different studies recruiting multiple myeloma patients and 599 more that are recruiting participants for ACY-1215 (Ricolinostat) in combination with pomalidomide and dexamethasone."

Answered by AI

At how many different locations is this trial currently being conducted?

"Patients are currently being accepted at the following medical institutions: Local Institution - 207 in Lafayette, Indiana; Local Institution - 209 in Saint Louis, Missouri; Local Institution - 301 in Toronto, Ontario. In addition, there are 20 other centres across North America where patients can participate."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ACY-1215 (Ricolinostat) in Combination With Pomalidomide and Low-dose Dex in Relapsed-and-Refractory Multiple Myeloma

2014. "ACY-1215 (Ricolinostat) in Combination With Pomalidomide and Low-dose Dex in Relapsed-and-Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01997840.

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