Carfilzomib, Lenalidomide, and Dexamethasone for Smoldering Multiple Myeloma
Status:
Active, not recruiting
Trial end date:
2025-06-01
Target enrollment:
Participant gender:
Summary
Background:
- 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.
Objectives:
- To see if carfilzomib, lenalidomide, and dexamethasone are a safe and effective treatment
for smoldering multiple myeloma.
Eligibility:
- Individuals at least 18 years of age who have SMM that is likely to progress to multiple
myeloma.
Design:
- 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.