Study on Total Therapy 3B: An Extension of Total Therapy for Multiple Myeloma
Sponsor: University of Arkansas
ClinicalTrials ID:NCT00572169
This study aims to build on previous research to understand how chromosome abnormalities in multiple myeloma patients affect their response to treatment. It seeks to improve outcomes for patients with and without these abnormalities.
Patient Parameters
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Program Overview
This study, called Total Therapy IIIB, is an extension of earlier research efforts to understand and improve treatment for multiple myeloma, a type of blood cancer. Researchers are focusing on why certain chromosome abnormalities in patients can make the disease more aggressive and harder to treat. By learning from past studies, they hope to develop better strategies to help all patients, especially those with these high-risk chromosome changes.
Description
Patients with multiple myeloma who have chromosome abnormalities often face a more aggressive form of the disease that doesn't respond well to treatment. Previous studies, Total Therapy I and II, showed that while patients with these abnormalities had better outcomes than those on standard chemotherapy, there was still room for improvement. This new study aims to specifically target patients with these high-risk chromosome changes, while also benefiting those without them. The goal is to find more effective treatment strategies for all patients involved.
Eligibility Criteria
Inclusion Criteria
- Must have newly diagnosed active multiple myeloma (MM) that needs treatment. Patients with a history of smoldering myeloma can join if their disease has progressed and requires chemotherapy.
- Must have specific protein markers in the blood or urine to evaluate treatment response. Non-secretory patients can join if they have certain levels of plasma cells or specific findings on MRI scans.
- Must not have received more than one cycle or month of prior chemotherapy for MM. Previous radiotherapy is allowed with approval.
- Must be under 75 years old at the time of joining the study.
- Must have a heart ejection fraction of 40% or higher from a recent heart test.
- Must have adequate lung function from recent tests, unless unable to complete due to MM-related issues, with approval from the principal investigator.
- Must have a performance status score of 0-2, or 3-4 if due to bone pain only.
- Must be informed about the study and sign a consent form.
Exclusion Criteria
- Platelet count below 30 x 10^9/L, unless related to myeloma.
- Severe nerve damage (Grade > 2 peripheral neuropathy).
- Allergies to specific drugs used in the study.
- Uncontrolled diabetes.
- Recent serious heart issues, such as heart attack or unstable heart conditions.
- Chronic lung diseases.
- Severe kidney issues or light chain deposition disease.
- History of other cancers, unless treated and in remission for over a year, or with a life expectancy over five years.
- Significant other medical conditions or uncontrolled infections.
- Pregnant or nursing women. Women of childbearing potential must have a negative pregnancy test before joining. Participants must agree to use effective birth control.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Arkansas for Medical Sciences/Myeloma Institute | 72205 | Little Rock | Arkansas |
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