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NCT01421524 · ClinicalTrials.gov registry record · Phase 1
Study of CC-122 to Evaluate the Safety, Tolerability, and Effectiveness for Patients With Advanced Solid Tumors, Non-Hodgkin's Lymphoma, or Multiple Myeloma
A Phase 1 study of Multiple Myeloma and Lymphoma, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 271
- Enrollment target
- 20
- Study locations
NCT01421524: Completed Phase 1 study of Multiple Myeloma and Lymphoma, sponsored by Celgene.
NCT01421524 is a Phase 1 study of Multiple Myeloma and Lymphoma that has completed, run by Celgene. The registered enrollment target is 271 participants, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (50% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01421524, a Phase 1 study of Multiple Myeloma and Lymphoma, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 271 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main purpose of this first in human study with CC-122 is to assess the safety and action of a new class of experimental drug (Pleiotropic Pathway Modulator) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dosing level and regimen for later-stage clinical trials.
Primary Outcome
Dose-limiting toxicities (DLTs) will be evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE): * A clinically relevant AE that is suspected to be related to CC-122 and starts ≤ 30 days of first dose (Cycle 1) and ≥ grade (Gr) 3 except for Alopecia, Gr3 rash of the acneiform or maculopapular type \< 4 daysduration , Gr 3 diarrhea or vomiting lasting\< 72 hours * Clinically relevant laboratory abnormality suspected to be related to CC-122 and tha
Conditions Studied
Interventions
- DRUG CC-122
Study Locations (20)
California
- City of Hope Cancer Center - Duarte
- UCLA Neuro-Oncology Program - Los Angeles
- UCSF Helen Diller Medical Center at Parnassus Heights - San Francisco
Other
- Local Institution - 401 - Brussels
- Local Institution - 400 - Leuven
- Local Institution - 202 - Caen
Michigan
- University Of Michigan Comprehensive Cancer Center - Ann Arbor
- Henry Ford Medical Center - New Center One - Detroit
New York
- Mount Sinai Hospital - New York
- Local Institution - 020 - New York
South Carolina
- MUSC Rheumatology and Immunology Dept. - Charleston
- Greenville Hospital System - Greenville
Texas
- Texas Oncology, PA - Dallas 75246 - Dallas
- South Texas Accelerated Research Therapeutics (START) - San Antonio
Washington
- Swedish Medical Center Cancer Institute Research - Seattle
- Yakima Valley Memorial Hospital/ North Star Lodge - Yakima
Nevada
- Comprehensive Cancer Centers Of Nevada - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 271 participants |
| Start Date | 2011-09-12 |
| Est. Completion | 2023-11-21 |
| Phase | Phase 1 |
What the finished NCT01421524 record still lists
NCT01421524 is an interventional study that assigns participants to a tested intervention. The registered 271 participants enrollment target is mid-sized for trials with a published cap, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (50% lower).
The record links to 6 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 1 intervention - of which CC-122 is the first listed.
NCT01421524 names 20 study sites across 11 states, led by California, Other, Michigan.
Frequently Asked Questions
What is clinical trial NCT01421524 about?
NCT01421524 is a clinical study titled "Study of CC-122 to Evaluate the Safety, Tolerability, and Effectiveness for Patients With Advanced Solid Tumors, Non-Hodgkin's Lymphoma, or Multiple Myeloma". The main purpose of this first in human study with CC-122 is to assess the safety and action of a new class of experimental drug (Pleiotropic Pathway Modulator) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dosing level and regimen for later-sta...
What is the current status of trial NCT01421524?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 271 participants. The study started on 2011-09-12. Estimated completion is 2023-11-21.
What conditions does trial NCT01421524 study?
This clinical trial studies the following conditions: Multiple Myeloma, Lymphoma, Glioblastoma, Primary Central Nervous System Lymphoma, Lymphoma, Large B-Cell, Diffuse.
What interventions are being tested in trial NCT01421524?
The interventions under investigation include: CC-122 (DRUG).
Who is sponsoring clinical trial NCT01421524?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01421524 being conducted?
This trial has 20 study locations across California, Michigan, Nevada, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01421524's enrollment target sits among peer trials
271 84th of 438 higher than 355 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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