A Phase II Trial of Anti-KIR in Smoldering Multiple Myeloma
Status:
Terminated
Trial end date:
2015-04-01
Target enrollment:
Participant gender:
Summary
Background:
- Recent studies have shown that smoldering multiple myeloma has a high risk of
progressing to multiple myeloma, an aggressive type of bone marrow cancer, within 5
years of diagnosis. People with smoldering multiple myeloma have abnormal blood test
results that show a high level of monoclonal protein (M-protein) in the blood and of
plasma cells in the bone marrow. There are currently no known effective treatments to
prevent smoldering multiple myeloma from developing into multiple myeloma, and there are
no known tests for determining whether an individual with smoldering multiple myeloma
will develop multiple myeloma.
- Certain cells in the immune system, known as natural killer (NK) cells, are active
against multiple myeloma. The experimental drug anti-killer cell immunoglobulin-like
receptor (anti-KIR) has been shown to help NK cells kill multiple myeloma cells.
Researchers are interested in determining whether anti-KIR can be given to individuals
with smoldering multiple myeloma to improve their abnormal blood test results.
Objectives:
- To evaluate the safety and effectiveness of anti-KIR as a treatment for abnormal blood test
results related to smoldering multiple myeloma.
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with smoldering multiple
myeloma.
Design:
- Participants will be screened with a physical examination and medical history, and will
provide baseline blood, urine, and bone marrow samples before beginning the study drug.
- Participants will receive anti-KIR intravenously for 1 hour, and will be closely
monitored for 24 hours after receiving the first dose. If there are no serious side
effects, participants will receive five additional anti-KIR doses, one every other
month, for a total of six treatment cycles.
- Participants will have monthly visits to provide additional blood and urine samples, and
may have additional bone marrow biopsies as directed by the study researchers.
- Participants will have followup visits every 3 to 6 months for up to 5 years after
receiving anti-KIR treatment.