Carfilzomib, Lenalidomide, and Dexamethasone for Smoldering Multiple Myeloma
- Multiple myeloma is a blood cancer that affects the plasma cells. These cells help produce antibodies and fight infection. Smoldering multiple myeloma (SMM) is a related condition that may develop into multiple myeloma. The current standard of care for SMM is close follow-up without treatment until multiple myeloma develops. However, researchers are studying possible treatments for SMM itself. One possible treatment involves a combination of cancer treatment drugs.
- Lenalidomide is a drug that may help reduce or prevent the growth of cancer cells. Dexamethasone is a steroid that is often given with other anti-cancer drugs. These two drugs are an approved treatment for multiple myeloma that has not responded to at least one other treatment. Carfilzomib is an experimental drug that has been effective in treating multiple myeloma. Researchers want to combine these three drugs to see if they are a safe and effective treatment for SMM.
- To see if carfilzomib, lenalidomide, and dexamethasone are a safe and effective treatment for smoldering multiple myeloma.
- Individuals at least 18 years of age who have SMM that is likely to progress to multiple myeloma.
- Participants will be screened with a physical exam and medical history. They will also have blood and urine tests, and baseline bone marrow scans. Bone marrow samples will also be collected.
- Participants will have eight 28-day cycles of treatment with the three study drugs. The drugs will be given as tablets or as infusions. Treatment will be monitored with frequent blood tests and study visits.
- After the first four cycles, participants who are eligible for a stem cell transplant will have their stem cells collected and stored for future use.
- At the end of eight cycles, participants whose disease has not progressed will have up to 12 more cycles of treatment with lenalidomide tablets alone.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Carfilzomib, Lenalidomide, and Dexamethasone in High-Risk Smoldering Multiple Myeloma: A Clinical and Correlative Study|
- Assess the response rate of CRd in patients with high-risk SMM
- Determine progression free survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Determine duration of response. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Evaluate toxicity of combination therapy [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
- Correlative studies [ Time Frame: 4 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
SMM is a precursor condition to MM defined by the clinical parameters of M-protein greater than or equal to 3.0 g/dL or bone marrow plasma cells greater than or equal to 10% and absence of end organ disease.
Risk of progression of high risk SMM at 5 years is 72-75% with median time to progression < 2 years.
The current standard of care for SMM is close follow-up without treatment until symptomatic MM develops. However, IMWG states Preventive clinical trials need to be considered for patients with high risk smoldering myeloma .
Carfilzomib is a new proteasome inhibitor with potent anti-MM effects.
|Contact: Marcia Mulquin, R.N.||(301) email@example.com|
|Contact: Carl O Landgren, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Carl O Landgren, M.D.||National Cancer Institute (NCI)|