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| Overall Recruitment Status: Enrollment on hold |
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| Official Title |
| Randomized Phase III Trial of Bortezomib, Lenalidomide, and Dexamethasone (VRd) Versus Carfilzomib, Lenalidomide, and Dexamethasone (CRd) Followed by Limited or Indefinite Duration Lenalidomide Maintenance in Patients With Newly Diagnosed Symptomatic Multiple Myeloma (ENDURANCE)
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| Region |
Sponsors |
| California - Northern |
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| Acronym |
NCT No. |
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NCT01863550 |
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| Study Type |
Phase |
| INTERVENTIONAL |
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| Purpose |
| This randomized phase III trial studies bortezomib, lenalidomide, and dexamethasone to see how well they work compared to carfilzomib, lenalidomide, and dexamethasone in treating patients with newly diagnosed multiple myeloma. Bortezomib and carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether bortezomib, lenalidomide, and dexamethasone are more or less effective than carfilzomib, lenalidomide, and dexamethasone in treating patients with multiple myeloma |
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| Detailed Description |
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- Patients must have measurable or evaluable disease as defined by having one or more of the following, obtained within 28 days prior to randomization:
>= 1 g/dL monoclonal protein (M-protein) on serum protein electrophoresis
>= 200 mg/24 hours (hrs) of monoclonal protein on a 24 hour urine protein electrophoresis
Involved free light chain >= 10 mg/dL or >= 100 mg/L AND abnormal serum immunoglobulin kappa to lambda free light chain ratio (< 0.26 or > 1.65)
Monoclonal bone marrow plasmacytosis >= 30% (evaluable disease)
Serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), and serum free light chain (FLC) assay are required to be performed within 28 days prior to randomization
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- a bone marrow biopsy and/or aspirate is required within 28 days if bone marrow is being followed for response
NOTE: UPEP (on a 24-hour collection) is required, no substitute method is acceptable
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- urine must be followed monthly if the baseline urine M-spike is >= 200 mg/24 hr
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- please note that if both serum and urine M-components are present, both must be followed in order to evaluate response
NOTE: The serum free light chain test is required to be done if the patient does not have measurable disease in the serum or urine
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- measurable disease in the serum is defined as having a serum M-spike >= 1 g/dL
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- measurable disease in the urine is defined as having a urine M-spike >= 200 mg/24 hr
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- 16) by fluorescence in situ hybridization (FISH) testing on bone marrow
evidence of t(14:20) by FISH testing on bone marrow or not available
evidence of deletion 17p by FISH testing on bone marrow
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