A Phase II Trial of Anti-KIR in Smoldering Multiple Myeloma

Stopped early · Phase 2

Conditions studied: Multiple Myeloma, Myeloma, Smoldering Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT01248455

Run by

National Cancer Institute (NCI)

People needed

9

Starts

2010-11-01

Expected to finish

2015-04-01

Last updated by the study team

2019-11-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients with a diagnosis of multiple myeloma (MM) or a clinical suspicion of an ongoing progression into full-blown MM
• Patients without measurable disease defined as serum monoclonal protein (M-protein) less than 1 g/dL.
• Previous treatment having a proven or potential impact on myeloma cell proliferation or survival (including conventional chemotherapies, immunomodulatory drugs (IMiDs), or proteasome inhibitors).
• Use of any investigational agent within the last 3 months.
• Clinical laboratory values at screening:
• Platelet levels less than 75 times 10\^9/L
• Absolute neutrophil count (ANC) levels less than 1 times 10\^9/L
• Bilirubin levels greater than 1.5 upper limit of normal (ULN) ; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 3.0 ULN (grade 1 National Cancer Institute (NCI))
• Primary or associated amyloidosis
• Known abnormal cardiac status with any of the following:
• New York Heart Association (NYHA) stage III or IV congestive heart failure
• Myocardial infarction within the previous 6 months
• Symptomatic and/or treatment-refractory cardiac arrhythmia. Patients with controlled or asymptomatic arrhythmia are not excluded from this study.
• Current active infectious disease or positive serology for:
• Human Immunodeficiency Virus (HIV)
• Hepatitis C Virus (HCV)
• Hepatitis B Surface Antigen
• Severe type of autoimmune disease defined as:
• One which currently requires or previously required long-term systemic immunosuppressive or immunomodulatory therapy (including corticosteroids, administered by systemic route)
• And/or it has a substantial probability to cause an irreversible injury to any tissue (e.g. Hashimoto thyroiditis).
• And/or it is recent or unstable, or has a substantial risk to progress and cause severe complications (e.g. Graves disease)
• Enrollment of other non severe types of auto-immunes disease requiring topical therapy, or non-steroidal inflammatory drugs (NSAIDS) can be considered on a case by case basis by the Principal Investigator.
• History of a lymphoproliferative malignancy.
• History of other malignancy (apart from basal cell carcinoma of the skin or in situ cervical carcinoma) except if the patient has been free of symptoms and without active therapy during at least the previous 5 years.
• Serious concurrent uncontrolled medical disorder.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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