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About
The purpose of this study is to see what effects, good and/or bad, the combination of ixazomib and dexamethasone has on the patient and the smoldering multiple myeloma.
Enrollment
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Inclusion criteria
Patients must have histologically or cytologically confirmed Smoldering Multiple Myeloma confirmed by Department of Pathology, based on the International Myeloma Working Group Criteria
Serum M-protein ≥3 g/dl and/or bone marrow plasma cells ≥10 %,
Absence of anemia attributed to the plasma cell disorder*: Hemoglobin >10 g/dl or not more than 2g/dL below the lower limit of normal
Absence of renal failure attributed to the plasma cell disorder*: calculated creatinine clearance (according to Cockcroft-Gault method, MDRD, or CKD-EPI formulae) > 30 mL/min (or alternatively based on standard creatinine level criteria of 2 mg/dl)
Absence of hypercalcemia attributed to the plasma cell disorder* (: Ca < 10.5 mg/dl or ≤ 2.5 mmol/L
Absence of lytic bone lesion
Absence of Clonal bone marrow plasma cell percentage ≥60%
Absence of Involved: uninvolved serum free light chain ratio ≥100
Absence >1 focal lesions on MRI studies
* To be determined based on clinical and laboratory assessment by the primary oncologist
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 (reference 0.26-1.65)
Absolute neutrophil count ≥1.0 K/μL
Platelets ≥ 75 K/μL (Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment.)
Hemoglobin > 10 g/dL(transfusions are not permissible)
Total bilirubin ≤1.5 X institutional upper limit of normal AST(SGOT)/ALT(SGPT) ≤ 3.0 X institutional upper limit of normal
Are postmenopausal for at least 24 months before the Screening visit, OR
Are surgically sterile, OR
If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR
Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR
Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
Exclusion criteria
Primary purpose
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14 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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