Phase III Trial for Low Risk Myeloma: Total Therapy 4B
Sponsor: University of Arkansas
ClinicalTrials ID:NCT00734877
This study is testing a treatment plan for patients with low-risk multiple myeloma to see if it can reduce treatment side effects while maintaining effectiveness. The trial is currently enrolling patients to receive the standard treatment plan.
Patient Parameters
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Program Overview
The aim of this study is to improve the treatment for low-risk multiple myeloma by reducing side effects while keeping the treatment effective. The trial compares a standard treatment plan (S-TT3) with a modified version (L-TT3) that uses fewer cycles of therapy to reduce side effects. However, the trial is now only enrolling patients for the standard treatment plan (S-TT3).
Description
This study focuses on improving treatment for low-risk multiple myeloma by reducing side effects associated with high-dose chemotherapy. The standard treatment (S-TT3) involves high-dose melphalan and tandem transplants, which can cause significant side effects like mouth sores. The modified treatment (L-TT3) aimed to reduce these side effects by using fewer cycles of therapy before and after transplants. However, the trial is now only enrolling patients for the standard treatment plan (S-TT3).
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed active multiple myeloma requiring 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 one cycle of systemic therapy, excluding bisphosphonates and localized radiation.
- Low-risk disease as defined by specific genetic and lab criteria.
- Zubrod performance status of 2 or less, unless due to bone disease symptoms.
- Age between 18 and 75 years.
- Adequate kidney function (serum creatinine < 3 mg/dL).
- Heart function with an ejection fraction of 40% or more.
- Adequate lung function, with exceptions for those unable to complete tests due to myeloma-related issues.
- Signed informed consent understanding the treatment and study approval.
Exclusion Criteria
- High-risk disease based on specific genetic features.
- Poorly controlled high blood pressure, diabetes, or other serious medical or psychiatric conditions.
- Low platelet count unless related to myeloma.
- Severe peripheral neuropathy.
- Allergies to specific drugs used in the treatment.
- Recent heart issues like heart attack or unstable heart conditions.
- Chronic lung diseases.
- Light chain deposition disease or poor kidney function (creatinine > 3 mg/dL).
- Recent or untreated cancer, except for certain skin cancers or cervical cancer.
- Pregnant or nursing women cannot participate. Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Arkansas for Medical Sciences, Myeloma Institute for Research and Therapy | 72205 | Little Rock | Arkansas |
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