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

NCT02400242 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2024-07-09

No results posted yet for this study

Summary

This is a phase 1a/1b, multicenter, single-arm, open-label, dose escalation study to determine the maximum tolerated dose (MTD) and evaluate the safety and preliminary antitumor activity of ACY-241 for oral administration as monotherapy and in combination therapy with orally administered pomalidomide and low-dose dexamethasone in eligible patients with relapsed or relapsed-and-refractory multiple myeloma (MM).

Conditions

Interventions

DRUG

ACY-241

Dose escalation up to 480 mg administered orally on Days 1-21 of a 28 day cycle.

DRUG

Pomalidomide

4 mg qd dosed on days 1-21 of a 28 day cycle

DRUG

Dexamethasone

40 mg qd on days 1, 8, 15, 22

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-07
Primary Completion
2024-06-03
Completion
2024-06-03

Countries

  • United States
  • France
  • Germany
  • Greece
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02400242 on ClinicalTrials.gov