Study on Early and Late Consolidation/Maintenance Therapy for Multiple Myeloma
Sponsor: University of Arkansas
ClinicalTrials ID:NCT03004287
This clinical trial is exploring whether adding the new drug daratumumab to the Total Therapy approach can help patients with multiple myeloma live longer and experience fewer side effects.
Patient Parameters
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Program Overview
This study aims to find out if including daratumumab, a new treatment for multiple myeloma, in the Total Therapy approach can improve patient outcomes. Total Therapy involves using several chemotherapy drugs, followed by a stem cell transplant, and then additional treatments to maintain health. Daratumumab is a type of drug that targets a protein found on myeloma cells, helping the body to attack them. The study will also use other drugs like carfilzomib, bortezomib, thalidomide, lenalidomide, and dexamethasone to see if this combination can be more effective and cause fewer side effects.
Description
Previous research has shown that patients with high-risk multiple myeloma often have shorter periods without symptoms and do not live as long as those with low-risk myeloma. The Total Therapy approach, which includes multiple chemotherapy drugs, a stem cell transplant, and maintenance therapy, is currently the best treatment strategy. However, new treatments like daratumumab, which targets a specific protein on myeloma cells, may improve the effectiveness of this approach and reduce side effects. This study will use daratumumab along with other drugs such as carfilzomib, bortezomib, thalidomide, lenalidomide, dexamethasone, cisplatin, adriamycin, cyclophosphamide, and etoposide to see if this combination can help patients live longer and with fewer side effects.
Eligibility Criteria
Inclusion Criteria
- Must have newly diagnosed active multiple myeloma needing treatment. Patients with a history of smoldering myeloma can join if their disease has progressed and needs chemotherapy.
- Must be untreated or have had no more than four cycles of multiple myeloma therapy.
- Must have high-risk disease, shown by specific tests or conditions like a high MyPRS risk score, high LDH levels, or primary plasma cell leukemia.
- Must have a performance status score of 2 or less, unless due to bone disease from myeloma.
- Must have a platelet count of at least 50,000/μL, unless explained by bone marrow issues.
- Must be between 18 and 75 years old.
- Must have normal kidney and liver function as shown by specific blood tests.
- Must have a heart function of at least 45%.
- Must have adequate lung function, unless unable to complete tests due to myeloma-related pain.
- Must sign an informed consent form approved by the Institutional Review Board (IRB).
Exclusion Criteria
- No evidence of high-risk disease.
- Poorly controlled high blood pressure, diabetes, active hepatitis, or other serious medical or psychiatric conditions that could interfere with treatment.
- No prior cancer, except for certain skin cancers or cervical cancer, unless the patient has not been treated for it in the past year and has a life expectancy of more than five years.
- Pregnant or nursing women cannot participate. Women who can become pregnant must have a negative pregnancy test within one week of joining the study.
- Participants must agree to use effective birth control if they can have children.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Arkansas for Medical Sciences | 72205 | Little Rock | Arkansas |
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