Clinical Trial Information
Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.
- Age ≥ 18 years.
- Patients must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 12 months. High-risk is
defined by any one of the following factors:
• Abnormal serum free light chain ratio (≤ 0.125 or ≥ 8.0 and
involved chain < 100 mg/L) by serum FLC assay
• Serum M-protein level ≥ 3 gm/dL
• Presence of t(4;14) or del 17p or 1q gain by conventional
cytogenetics or FISH studies
- Bone marrow aspirate and/or biopsy is required to be performed within 28 days prior to randomization and must demonstrate 10-59%
clonal plasma cells.
- Patients must have measureable disease as defined by having one or
more of the following, obtained within 28 days prior to randomization:
• ≥ 1 g/dL on serum protein electrophoresis AND ≥ 200 mg of monoclonal protein on a 24 hour urine protein electrophoresis
NOTE: In the rare situation where the SPEP is felt to be unreliable,
then quantitative immunoglobulin levels on nephelometry or
turbidometry can be accepted. Please refer to Section 6.1.2
for more information.
- SPEP, UPEP, and serum FLC are required to be performed within 28 days prior to randomization.
- Patients must have no lytic lesions, no known plasmacytoma, and no unexplained hypercalcemia (i.e., > 11 mg/dL or 1mg/dL above ULN).
- Patients must not have any prior or concurrent systemic or radiation therapy for the treatment of myeloma. Patients must also not have
contraindication to DVT prophylaxis/aspirin.
- Patients must not have more than one focal marrow lesion on MRI of either pelvis or spine.
- Concurrent use of erythropoietin is not allowed while on study therapy.