Study on Carfilzomib, Lenalidomide, Vorinostat, and Dexamethasone for Treating Relapsed or Resistant Multiple Myeloma
Sponsor: Hackensack Meridian Health
ClinicalTrials ID:NCT01297764
This clinical trial is testing a combination of four drugs to see if they can effectively treat multiple myeloma that has returned or not responded to previous treatments. The study aims to find out if this combination can work well together and reduce side effects.
Patient Parameters
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Program Overview
The purpose of this study is to test a new combination of four drugs—Carfilzomib, Lenalidomide, Vorinostat, and Dexamethasone—to see if they can effectively treat multiple myeloma that has come back or is resistant to other treatments. Researchers want to see if these drugs can work together to fight the cancer while minimizing side effects like nerve damage and stomach issues.
Description
This study involves testing a combination of four drugs to treat multiple myeloma, a type of blood cancer. Carfilzomib is a drug that has shown promise in treating advanced multiple myeloma, especially in patients who did not respond to another drug called bortezomib. Carfilzomib tends to have fewer side effects related to nerves and the stomach. Vorinostat is another drug that has shown some activity against multiple myeloma on its own, but it works better when combined with other drugs like Lenalidomide and Dexamethasone. These combinations have been effective even in patients who did not respond to previous treatments. The goal of this study is to see if combining these four drugs can maximize their effectiveness while reducing side effects, particularly nerve damage and stomach issues.
Eligibility Criteria
Inclusion Criteria
- Have symptomatic multiple myeloma that has returned or not responded after at least one previous treatment.
- Have been treated before with drugs like immunomodulators, proteasome inhibitors, and histone deacetylase inhibitors.
- Have measurable disease, such as specific levels of proteins in the blood or urine.
- Be 18 years or older.
- Have a life expectancy of more than three months.
- Be in relatively good health with a performance status score of 0 to 2.
- Have adequate liver function and blood cell counts.
- Have normal kidney function.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control.
- Men must agree to use a condom during sexual contact with women of childbearing potential.
- Be willing to follow the study's requirements and attend all appointments.
- Agree to take daily aspirin or other blood thinners if needed.
Exclusion Criteria
- Have a type of multiple myeloma that does not produce measurable proteins.
- Have used certain steroids or other experimental drugs recently.
- Have certain other medical conditions like POEMS syndrome or Waldenström's macroglobulinemia.
- Have had recent chemotherapy, radiation, or immunotherapy.
- Be pregnant or breastfeeding.
- Have allergies to certain components of the study drugs.
- Have serious heart conditions or uncontrolled high blood pressure.
- Have active infections or certain viral infections like HIV or hepatitis.
- Have significant nerve damage or other medical conditions that could interfere with the study.
- Have conditions that prevent the use of required medications or treatments.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Hackensack University Medical Center | 07601 | Hackensack | New Jersey |
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