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NCT01575925 · ClinicalTrials.gov registry record · Phase 1
Study of Pomalidomide to Evaluate the Pharmacokinetics and Safety for Patients With Multiple Myeloma and Impaired Renal Function (POM Renal)
A Phase 1 study of Multiple Myeloma and Renal Impairment, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 9
- Study locations
NCT01575925 is a Phase 1 study of Multiple Myeloma and Renal Impairment that has completed, run by Celgene. The registered enrollment target is 25 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (95% lower). The trial reports 9 study locations across 9 states.
The verdict
NCT01575925, a Phase 1 study of Multiple Myeloma and Renal Impairment, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 9
- Study locations
Study 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 Studied
Interventions
- DRUG 4 mg Oral POM + 40 mg Oral DEX
- DRUG 2 mg Oral POM + 40 mg Oral DEX
Study Locations (9)
Colorado
- Colorado Blood Cancer Institute - Denver
Georgia
- Winship Cancer Institute of Emory University - Atlanta
Illinois
- Ingalls Cancer Research Center - Harvey
New Jersey
- Hackensack University Medical Center - Hackensack
New York
- Weill Cornell Medical College - New York
Ohio
- Cleveland Clinic - Cleveland
Texas
- MD Anderson Cancer Center - Houston
Nova Scotia
- Queen Elizabeth II Health Sciences Centre - Halifax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2012-06-01 |
| Est. Completion | 2018-08-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01575925
The ClinicalTrials.gov registry entry for NCT01575925 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (95% lower). The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 2 interventions - of which 4 mg Oral POM + 40 mg Oral DEX is the first listed.
NCT01575925 reports 9 study locations spanning 9 distinct geographic areas - top geographies include Colorado, Georgia, Illinois.
Frequently Asked Questions
What is clinical trial NCT01575925 about?
NCT01575925 is a clinical study titled "Study of Pomalidomide to Evaluate the Pharmacokinetics and Safety for Patients With Multiple Myeloma and Impaired Renal Function (POM Renal)". 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.
What is the current status of trial NCT01575925?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2012-06-01. Estimated completion is 2018-08-07.
What conditions does trial NCT01575925 study?
This clinical trial studies the following conditions: Multiple Myeloma, Renal Impairment.
What interventions are being tested in trial NCT01575925?
The interventions under investigation include: 4 mg Oral POM + 40 mg Oral DEX (DRUG), 2 mg Oral POM + 40 mg Oral DEX (DRUG).
Who is sponsoring clinical trial NCT01575925?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01575925 being conducted?
This trial has 9 study locations across Colorado, Georgia, Illinois, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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