Study of Pomalidomide to Evaluate the Pharmacokinetics and Safety for Patients With Multiple Myeloma and Impaired Renal Function (POM Renal)
NCT01575925 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2022-11-04
Summary
The purpose of this study is to determine the pharmacokinetics (PK) and safety for the combination of pomalidomide (POM) + low-dose dexamethasone (LD- DEX) in subjects with relapsed or refractory Multiple Myeloma (RRMM) and impaired renal function.
Conditions
- Multiple Myeloma
- Renal Impairment
Interventions
- DRUG
-
4 mg Oral POM + 40 mg Oral DEX
- DRUG
-
2 mg Oral POM + 40 mg Oral DEX
Sponsors & Collaborators
-
Celgene
lead INDUSTRY
Principal Investigators
-
Bristol Myers-Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-06-01
- Primary Completion
- 2018-08-07
- Completion
- 2018-08-07
Countries
- United States
- Canada
Study Locations
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