Study on Melphalan, Prednisone, and Thalidomide or Lenalidomide for Newly Diagnosed Multiple Myeloma
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT00602641
This clinical trial is comparing two treatment combinations for patients with newly diagnosed multiple myeloma to see which is more effective. The study involves using chemotherapy drugs melphalan and prednisone with either thalidomide or lenalidomide to stop cancer growth.
Patient Parameters
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Program Overview
This study aims to find out if combining melphalan and prednisone with either thalidomide or lenalidomide is more effective in treating newly diagnosed multiple myeloma. These drugs work by stopping cancer cells from growing and spreading. Thalidomide and lenalidomide may also block blood flow to the cancer, helping to control the disease. The trial will compare how well each combination works in terms of stopping the disease from getting worse, overall survival, and side effects.
Description
The study is divided into two groups. In the first group, patients will receive melphalan and prednisone along with thalidomide. In the second group, patients will receive melphalan and prednisone with lenalidomide. Both groups will take these medications in cycles, with each cycle lasting 28 days. The treatment will continue for up to 12 cycles unless the disease progresses or side effects become too severe.
After the initial treatment, patients will continue with maintenance therapy. Those in the thalidomide group will keep taking thalidomide, while those in the lenalidomide group will continue with lenalidomide. The study will follow patients for up to 10 years to monitor their health and the effectiveness of the treatments.
The study will also look at the quality of life of patients during and after treatment, using a specific questionnaire to assess any changes. Researchers will gather data on how the treatments affect patients' daily lives and overall well-being.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of symptomatic multiple myeloma with specific criteria met at some point in their disease.
- Must be over 65 years old and have declined other treatments, or be between 18 and 65 and not eligible for a stem cell transplant.
- Must have a performance status score of 0 to 2, indicating they are fully active or have some limitations but can still care for themselves.
- Must have specific blood test results within normal ranges, including hemoglobin, platelet count, and kidney function.
- Must not have received prior treatment for myeloma, except for short-term use of prednisone or dexamethasone.
- Must be willing to take preventive measures against blood clots, such as aspirin or other medications.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control methods.
- Must not have uncontrolled health conditions that would interfere with the study, such as severe heart problems or psychiatric illness.
- Must not have significant nerve damage or active infections.
- Must not be pregnant or breastfeeding, and must agree to use birth control during and after the study.
- Must not have had another active cancer requiring treatment in the last two years, except for certain skin cancers.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Providence Hospital | 36608 | Mobile | Alabama |
| Mayo Clinic in Arizona | 85259 | Scottsdale | Arizona |
| Sparks Regional Medical Center | 72901 | Fort Smith | Arkansas |
| UC San Diego Moores Cancer Center | 92093 | La Jolla | California |
| Fremont - Rideout Cancer Center | 95901 | Marysville | California |
| Memorial Medical Center | 95355 | Modesto | California |
| University of California Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| UC San Diego Medical Center - Hillcrest | 92103 | San Diego | California |
| Kaiser Permanente-San Diego Mission | 92108 | San Diego | California |
| San Diego VA Medical Center | 92161 | San Diego | California |
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