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Investigator(s):
C. Ola Landgren, M.D., Ph.D. Principal Investigator Phone: 301-496-0670 Fax: 301-402-0172 landgreo@mail.nih.gov
Referral Contact(s):
Marcia L. Mulquin, R.N., B.S.N. Research Nurse Phone: 301-435-5613 mmulquin@mail.nih.gov	Diamond Zuchlinski, R.N., B.S.N., O.C.N. Research Nurse Phone: 301-435-9227 zuchlinskid@mail.nih.gov

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Key Eligibility Criteria:

• Histologically or cytologically confirmed diagnosis of smoldering multiple myeloma (SMM) based on the International Myeloma Working Group Criteria:
• Serum M-protein ≥ 3 g/dl and/or bone marrow plasma cells ≥ 10 percent
• Absence of anemia: hemoglobin > 10 g/dl
• Absence of renal failure: serum creatinine < 2.0 mg/dL
• Absence of hypercalcemia: Ca < 10.5 mg/dl
• Absence of lytic bone lesion
• High-risk SMM per Mayo Clinic or Spanish PETHEMA criteria
• Measurable disease within the past 4 weeks defined by any one of the following:
• Serum monoclonal protein ≥ 1.0 g/dl
• Urine monoclonal protein > 200 mg/24 hour
• Serum immunoglobulin free light chain > 10 mg/dL AND abnormal kappa/lambda ratio
• ≥ 18 years of age
• ECOG ≤ 1
• Able to swallow whole pills
• Not pregnant or nursing
• Normal organ and marrow function
• No serious illness that would preclude study participation

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Study Outline:

• Screening physical examination; blood and tumor samples; bone marrow biopsy and imaging studies to determine eligibility for the study
• Participants will take oral MLN9708 and oral dexamethasone on a regular schedule for 28 days (1 cycle)
• Up to 12 cycles of MLN9708 and dexamethasone
• Participants may continue to take MLN9708 in the absence of disease progression or unacceptable side effects
• Treatment will be monitored with frequent blood tests and imaging studies

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/6/12
Updated: 8/16/12