Study on Carfilzomib, Clarithromycin, Lenalidomide, and Dexamethasone (Car-BiRD) Therapy for Multiple Myeloma
Sponsor: Weill Medical College of Cornell University
ClinicalTrials ID:NCT01559935
This clinical trial is testing a new treatment combination called Car-BiRD for patients with newly diagnosed multiple myeloma. The study aims to evaluate the safety and effectiveness of adding carfilzomib to a regimen that includes clarithromycin, lenalidomide, and dexamethasone.
Patient Parameters
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Program Overview
The purpose of this study is to see if a new combination of drugs, including carfilzomib, clarithromycin, lenalidomide, and dexamethasone, can safely and effectively treat patients with newly diagnosed multiple myeloma. The study will first use carfilzomib and dexamethasone, followed by a combination of clarithromycin, lenalidomide, and dexamethasone, and then lenalidomide alone. Researchers hope this approach will improve response rates and help patients achieve a better quality of life.
Description
Multiple myeloma is a type of cancer that affects plasma cells in the bone marrow. Although new treatments have been developed, it remains incurable. This study is exploring a new treatment combination called Car-BiRD, which includes carfilzomib, clarithromycin, lenalidomide, and dexamethasone. The goal is to improve the overall response rate and complete remission rate for patients with newly diagnosed multiple myeloma.
The study will measure how well patients respond to the treatment, how long they remain free from disease progression, and their overall survival. For patients eligible for stem cell transplantation, the study will also look at how carfilzomib affects stem cell collection.
Participants will receive carfilzomib and dexamethasone first, followed by the BiRD regimen (clarithromycin, lenalidomide, and dexamethasone), and then lenalidomide alone. The study will monitor for any side effects and assess the treatment's effectiveness in reducing tumor burden.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older and able to understand and sign a consent form.
- Must have a confirmed diagnosis of multiple myeloma that has not been treated before.
- Must not have received any anti-myeloma treatment within 14 days before starting the study, except for certain corticosteroids or routine care treatments.
- Must have measurable disease, such as specific levels of proteins in the blood or urine, or measurable tumors.
- Must have a performance status score of at least 60% (or 50% if due to bone involvement).
- Must be able to take preventive blood clot medication.
- Must be registered in the RevAssist® program and comply with its requirements.
- Women of childbearing potential must have a negative pregnancy test and agree to use two forms of birth control.
- Must meet specific blood and organ function criteria, including adequate blood cell counts and liver and kidney function.
Exclusion Criteria
- Cannot have unmeasurable multiple myeloma.
- Cannot have had another cancer unless disease-free for at least 5 years, except for certain skin, cervical, or prostate cancers.
- Cannot have had a heart attack within 6 months or severe heart conditions.
- Cannot be pregnant or breastfeeding.
- Cannot have known HIV or active hepatitis B or C infections.
- Cannot have active infections or medical conditions that increase treatment risks.
- Cannot have allergies to any of the study drugs.
- Cannot have had a recent blood clotting event.
- Cannot have any significant medical or psychiatric conditions that interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Weill Cornell Medical College | 10021 | New York | New York |
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