An Open-Label, Phase 1b Study of Acalabrutinib With and Without Dexamethasone in Subjects With Multiple Myeloma

Completed · Phase 1

Conditions studied: Multiple Myeloma (MM)

In brief

To characterize the safety profile of acalabrutinib with and without dexamethasone in subjects with relapsed or refractory Multiple Myeloma (MM)

Key facts

Study ID

NCT02211014

Run by

Acerta Pharma BV

People needed

27

Starts

2015-02-01

Expected to finish

2019-04-26

Last updated by the study team

2020-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women ≥ 18 years of age.
• A confirmed diagnosis of MM, which has relapsed after, or been refractory to ≥ 1 prior therapy for MM, and is progressing at the time of study entry.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
• Agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children.

You may not qualify if…

• A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk
• Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
• Malabsorption syndrome, disease significantly affecting gastrointestinal function, gastric bypass, resection of the stomach or small bowel, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
• Breast feeding or pregnant

Where it is running

• Study site — Baltimore, Maryland, United States
• United Kingdom — Leicester, United Kingdom
• Guys and St Thomas' Hospital NHS Foundation Trust — London, United Kingdom

Full record on ClinicalTrials.gov

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