Study on the Dose, Safety, and Effectiveness of CC-220 Alone and with Other Treatments for Multiple Myeloma
Sponsor: Celgene
ClinicalTrials ID:NCT02773030
This clinical trial is exploring the safety and effectiveness of a new drug, CC-220, both on its own and in combination with other treatments for patients with multiple myeloma, a type of blood cancer. The study aims to find the best dose and see how well the treatment works.
Patient Parameters
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Program Overview
This study is being conducted in multiple centers across different countries and is divided into two parts. The first part focuses on finding the right dose of CC-220, both alone and in combination with other drugs like dexamethasone (DEX), daratumumab (DARA), bortezomib (BTZ), and carfilzomib (CFZ). The second part will expand on the best dose found in the first part to further test its effectiveness in patients with relapsed or newly diagnosed multiple myeloma.
Description
Participants in this study will receive CC-220 either alone or with other medications. If the cancer progresses while on CC-220 alone, patients may add dexamethasone to their treatment after consulting with the study doctor. The study will test different doses to find the safest and most effective one. Patients will be monitored for their response to the treatment every 28 days, or every 21 days for some groups, until the cancer progresses or they choose to leave the study. The study follows strict international guidelines to ensure patient safety and data accuracy. The second part of the study will begin once the best dose is determined in the first part, and all decisions will be made after careful review of safety and effectiveness data.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of multiple myeloma with measurable disease.
- Must have shown disease progression after previous myeloma treatments.
- Must have a performance status score of 0, 1, or 2, indicating good overall health.
- Must have a diagnosis of symptomatic multiple myeloma with specific criteria, such as high calcium levels, kidney issues, anemia, or bone lesions.
- Must have measurable disease as defined by specific protein levels in the blood or urine.
- For certain groups, must not be eligible for high-dose chemotherapy and stem cell transplant due to age or other health conditions.
- For other groups, must be eligible for high-dose chemotherapy and stem cell transplant based on health assessments.
Exclusion Criteria
- Cannot have nonsecretory multiple myeloma.
- Cannot have plasma cell leukemia or amyloidosis.
- Cannot have certain blood count or calcium level abnormalities.
- Cannot have serious liver or kidney issues.
- Cannot have significant nerve damage.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Local Institution - 102 | 85259 | Scottsdale | Arizona |
| Mayo Clinic | 85259 | Scottsdale | Arizona |
| Local Institution - 107 | 72205 | Little Rock | Arkansas |
| University of Arkansas for Medical Sciences | 72205 | Little Rock | Arkansas |
| Local Institution - 101 | 30322 | Atlanta | Georgia |
| Winship Cancer Institute of Emory University | 30322 | Atlanta | Georgia |
| Local Institution - 120 | 60611 | Chicago | Illinois |
| Robert H Lurie Comprehensive Cancer Center NW Univ | 60611 | Chicago | Illinois |
| Local Institution - 113 | 66205 | Fairway | Kansas |
| University of Kansas Cancer Center | 66205 | Fairway | Kansas |
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