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ACY-241 for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Multiple MyelomaACY-241 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

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

Eligible Conditions
  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

2 Primary · 9 Secondary · Reporting Duration: Cycle 2 days 1, 2, 15, 16 and 22

Day 28
Frequency and severity of AEs as measured by safety and tolerability in combination
Cycle 1 (28 days)
Frequency and severity of AEs as measured by safety and tolerability
Maximum tolerated dose of ACY-241 as monotherapy as assessed by dose limiting toxicities
Day 1
Single- and multiple-dose peak-plasma concentration
Cycle 2 (28 days)
Maximum tolerated dose of ACY-241 in combination with pomalidomide and low dose dexamethasone as assessed by dose limiting toxicities
Day 2
Change in acetylation of histone and tubulin as a measure of pharmacodynamics
Change in fetal hemoglobin expression as a measure of pharmacodynamics
Day 2
Single- and multiple-dose area under the plasma concentration versus time curve
Day 1
ACY-241 metabolite concentration in blood samples
Exposure response analyses of potential biomarkers of response.
Day 1
Quantification of M-protein as a measure of anti-tumor activity

Trial Safety

Safety Progress

1 of 3

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1
Pioglitazone 30 mg
1
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2
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Trial Design

1 Treatment Group

ACY-241, Pomalidomide, and dexamethasone
1 of 1

Experimental Treatment

85 Total Participants · 1 Treatment Group

Primary Treatment: ACY-241 · No Placebo Group · Phase 1

ACY-241, Pomalidomide, and dexamethasoneExperimental Group · 3 Interventions: Dexamethasone, ACY-241, Pomalidomide · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
ACY-241
2016
Completed Phase 1
~30
Pomalidomide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: cycle 2 days 1, 2, 15, 16 and 22

Who is running the clinical trial?

CelgeneLead Sponsor
625 Previous Clinical Trials
173,064 Total Patients Enrolled
139 Trials studying Multiple Myeloma
39,235 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
1,407 Previous Clinical Trials
3,309,082 Total Patients Enrolled
62 Trials studying Multiple Myeloma
21,648 Patients Enrolled for Multiple Myeloma

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

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References

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