A Phase II Trial of IPH2101 (Anti-KIR) in Smoldering Multiple Myeloma (SMM)
- Multiple myeloma (MM) is an incurable plasma cell neoplasm with a median survival of
- Smoldering multiple myeloma (SMM) is a premalignant plasma cell disorder characterized
by monoclonal protein greater than or equal to 3 g/dL or bone marrow plasma cells
greater than or equal to 10 percent in the absence of myeloma-related tissue impairment
with 51 percent progression to MM at 5 years.
- Current recommendations do not endorse treatment of SMM with chemotherapy.
- Transplanted Natural Killer (NK) Cells have anti-myeloma activity.
- Anti-KIR (IPH2101) is a monoclonal antibody that facilitates NK cell mediated killing
of myeloma cells by blocking inhibitory receptors (KIR) on NK cells.
- To assess the response rate of anti-KIR(IPH2101) in patients with SMM
- To evaluate the toxicity of anti-KIR(IPH2101) in patients with SMM
- To evaluate the pharmacokinetic parameters and biological activity of anti-KIR
- A confirmed diagnosis of SMM
- Age greater than or equal to 18 years
- ECOG performance status in the range of 0-1.
- Without serious co-morbidity that would interfere with receipt of anti-KIR(IPH2101)
- Single-arm Phase II trial of anti-KIR(IPH2101) for patients with SMM.
- All patients will have initial evaluation and confirmation of diagnosis.
- Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles.
- Patients will have routine blood work with SPEP and immunofixation monthly.
- Pre- and post-treatment bone marrow biopsies will be obtained for confirmation of
diagnosis and correlative studies.
- Patients may donate cellular products or tissues as appropriate for research purposes.
- Optimal two-stage phase II design will be employed, initially enrolling 9 patients. If
3 or more have a positive outcome, then a total of 21 patients will be enrolled in this
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective of the study is to assess the response rate of anti-KIR(IPH2101) in patients with SMM
Carl O Landgren, M.D.
National Cancer Institute (NCI)
United States: Federal Government
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|