Carfilzomib, Lenalidomide, and Dexamethasone in New Multiple Myeloma Patients
- Carfilzomib is an experimental anti-cancer drug that has not yet been approved for treating multiple myeloma. Lenalidomide is a drug that may stop tumor growth and help the immune system kill cancer cells. Dexamethasone is a drug that helps stop inflammation. It is sometimes used to treat (alone or with other drugs) certain types of cancer, especially multiple myeloma. This combination of drugs has not been tested in people with multiple myeloma. Researchers want to see whether it is safe and effective for this group.
- To test the effectiveness of combined carfilzomib, lenalidomide, and dexamethasone in treating multiple myeloma.
- People at least 18 years of age who have multiple myeloma that has not been treated.
- Participants will be screened with a medical history and physical exam. They will also have blood and urine tests, a bone marrow sample, and molecular imaging studies.
- Participants will have eight 28-day cycles of treatment. The combined study drugs will be given as tablets and injections. Those in the study will be monitored with frequent blood tests, bone marrow samples, and molecular imaging studies. In addition to current standard measures to determine clinical responses, molecular tests will be conducted to define evidence of minimal residual disease.
- After the first four cycles of therapy, those who are eligible for a stem cell transplant will have stem cells collected and stored for use if the cancer returns.
After stem cell collection, participants will have the second four treatment cycles.
-, If the disease has improved or is stable at the end of eight cycles, those in the study may have another 12 cycles of low-dose (maintenance) lenalidomide alone.
- Participants will have regular follow-up visits after the end of the study chemotherapy.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Carfilzomib, Lenalidomide, and Dexamethasone in Newly Diagnosed Multiple Myeloma: Clinical and Correlative Phase II Study|
- Evaluate toxicity [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
- Best Response [ Time Frame: 4 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Patients will receive 8 cycles of induction combination therapy of CRd. Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year
Cycle 1: 20 mg/m2 IV infusion over 30 minutes on days 1 and 2, then 36 mg/m2 IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m2 IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16Drug: Lenalidomide
Cycle 1: 25 mg oral days 2-21 of 28-day cycle Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycleDrug: Dexamethasone
Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22, and 23 Cycle 2-4: 20 mg oral or IV on days 1, 2, 8, 9, 15, 16, 22, and 23 Cycle 5-8: 10 mg oral or IV on days 1, 2, 8, 9, 15, 16, 22, and 23
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01402284
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Mark J Roschewski, M.D.||National Cancer Institute (NCI)|