Study on Bortezomib or Carfilzomib with Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma
Sponsor: ECOG-ACRIN Cancer Research Group
ClinicalTrials ID:NCT01863550
This clinical trial is comparing two different treatment combinations to see which is more effective for patients with newly diagnosed multiple myeloma. The study aims to determine if bortezomib or carfilzomib, when combined with lenalidomide and dexamethasone, can better control the disease.
Patient Parameters
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Program Overview
This study is testing two different combinations of drugs to treat newly diagnosed multiple myeloma, a type of blood cancer. The trial compares bortezomib, lenalidomide, and dexamethasone against carfilzomib, lenalidomide, and dexamethasone to see which combination works better at stopping cancer growth. Bortezomib and carfilzomib are drugs that may block cancer cell growth, while lenalidomide helps the immune system fight cancer cells. Dexamethasone is a chemotherapy drug that helps stop cancer cells from growing and spreading. The study will help determine which combination is more effective for patients.
Description
The study is divided into two main parts: induction and maintenance.
Induction Phase:
- Group A: Patients receive bortezomib, lenalidomide, and dexamethasone in cycles over 12 courses, each lasting 3 weeks, unless the disease progresses or side effects become too severe.
- Group B: Patients receive carfilzomib, lenalidomide, and dexamethasone in cycles over 9 courses, each lasting 4 weeks, unless the disease progresses or side effects become too severe.
Maintenance Phase: After completing the induction phase, patients are assigned to one of two maintenance groups:
- Group C: Patients take lenalidomide daily for 21 days in a 4-week cycle for up to 24 cycles, unless the disease progresses or side effects become too severe.
- Group D: Patients take lenalidomide daily for 21 days in a 4-week cycle continuously, unless the disease progresses or side effects become too severe.
Patients will be monitored regularly after treatment to assess their health and the effectiveness of the treatment. Follow-up visits will occur every 3 months for 2 years, every 6 months for 3 years, and then annually for 10 years.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with symptomatic standard-risk multiple myeloma.
- No specific genetic abnormalities in cancer cells as determined by tests.
- Have measurable disease based on specific medical tests.
- Adequate blood cell counts and organ function.
- Have not received more than one cycle of prior chemotherapy or certain drugs for myeloma.
- No active, uncontrolled health issues like seizures or infections.
- Women of childbearing potential must use effective birth control and have negative pregnancy tests.
- Men must use condoms and agree not to donate sperm during and after treatment.
- Agree to participate in the RevAssist program for lenalidomide use.
- Meet specific health criteria for blood counts and organ function before starting the maintenance phase.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Mayo Clinic in Arizona | 85259 | Scottsdale | Arizona |
| CHI Saint Vincent Cancer Center Hot Springs | 71913 | Hot Springs | Arkansas |
| Veteran's Administration Medical Center | 72205 | Little Rock | Arkansas |
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