Study on Improving Remission in High-Risk Multiple Myeloma Patients
Sponsor: University of Arkansas
ClinicalTrials ID:NCT00869232
This clinical trial is exploring a new approach to treating high-risk multiple myeloma by using lower doses of chemotherapy more frequently to prevent cancer cells from regrowing between treatments. The goal is to achieve longer remission and improve survival rates.
Patient Parameters
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Program Overview
This study aims to improve outcomes for patients with high-risk multiple myeloma by using a new treatment approach. Previous research has shown that patients with high-risk features often have shorter remissions and do not live as long as those with low-risk myeloma. Researchers believe this is because myeloma cells can regrow during recovery periods between high-dose chemotherapy treatments. In this study, patients will receive several chemotherapy drugs in lower doses and shorter cycles to prevent regrowth of myeloma cells, potentially leading to longer remissions and better survival rates.
Description
The study has several goals:
- To see if giving multiple chemotherapy drugs in lower, more frequent doses can lead to better treatment results.
- To find out if changing how drugs are given during the transplant phase can reduce side effects while still being effective.
- To determine if providing treatment between transplants (called "inter-transplant therapy") can stop myeloma from regrowing.
- To see if long-term maintenance therapy can lead to longer remissions.
- To understand the effects, both good and bad, of this overall treatment approach.
- To learn more about the biology and genetics of multiple myeloma by performing imaging tests and collecting samples for research.
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 be untreated or have had no more than one cycle of systemic MM therapy, excluding bisphosphonates and localized radiation.
- Must have high-risk disease, defined by specific criteria such as a GEP risk score of 0.66 or higher, or LDH levels of 360 U/L or higher.
- Must have a Zubrod performance status of 2 or lower, unless due to MM-related bone disease symptoms.
- Must have a platelet count of 50,000/uL or higher, unless lower levels are due to extensive bone marrow involvement.
- Must be between 18 and 75 years old.
- Must have good kidney function, with a serum creatinine level below 3 mg/dL.
- Must have a heart ejection fraction of 45% or higher.
- Must have adequate lung function, with specific test results of 50% or higher. Exceptions may be made if pain or condition related to MM prevents testing, with documentation from the investigator.
- Must sign an informed consent form approved by the Institutional Review Board (IRB).
Exclusion Criteria
- Does not have high-risk disease.
- Has poorly controlled high blood pressure, diabetes, or other serious medical or psychiatric conditions that could interfere with treatment.
- Has had another cancer, except for certain skin cancers or cervical cancer, unless the patient has not received treatment for it in the past year. Other cancers are acceptable if the patient's life expectancy is over five years.
- Pregnant or nursing women cannot participate. Women of childbearing potential must have a negative pregnancy test within one week of joining the study. Participants of reproductive potential must agree to use effective contraception.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Arkansas for Medical Sciences | 72205 | Little Rock | Arkansas |
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