Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma - ECOG E3A06

ICORG-the All Ireland Co-operative Oncology Research Group0 sites40 target enrollmentSeptember 6, 2012

Overview

No summary available.

Registry

who.int

Start Date

September 6, 2012

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

ICORG-the All Ireland Co-operative Oncology Research Group

•\- Age \= 18 years.
•\- Patients must be diagnosed with asymptomatic high\-risk smoldering multiple myeloma (SMM) within the past 60 months, as confirmed by both of the following: 1\) Bone marrow plasmacytosis or
•2\) Abnormal serum free light chain ratio
•\- Patients must have measurable levels of monoclonal protein (M\-protein): \=1g/dL on serum protein electrophoresis or \=200 mg of monoclonal protein on a 24 hour urine protein electrophoresis
•\- Patients must have no lytic lesions on skeletal surveys and no hypercalcemia (i.e., \> 11 mg/dL).
•\- The following laboratory levels must be obtained within four weeks prior to randomization:
•Hemoglobin \= 11 g/dL / Platelet count \= 100,000 cells/mm3 / Absolute neutrophil count \= 1500 cells/mm3 / Calculated creatinine clearance \= 30 mL/min / Bilirubin \= 1\.5 mg/dL / SGPT (ALT) and SGOT (AST) \= 2\.5 times the upper limit of normal.
•\- Prior systemic glucocorticosteroid use for the treatment of non\-malignant disorders is permitted; concurrent use after registration on the study should be restricted to the equivalent of prednisone 10 mg per day.
•\- Prior or concurrent topical or localized glucocorticosteroid therapy to treat non\-malignant comorbid disorders is permitted.
•\- ECOG performance status 0, 1, or 2\.

•\- No prior or concurrent systemic or radiation therapy for the treatment of myeloma.
•\- Concurrent use of bisphosphonates is not permitted. However, prior bisphosphonates or once\-a\-year intravenous bisphosphonate given for the treatment of osteoporosis is permitted.
•\- Prior or concurrent use of erythropoietin is disallowed.
•\- Prior glucocorticosteroid therapy for the treatment of multiple myeloma is not permitted.
•\- Patients must not have active, uncontrolled seizure disorder. Patients must have had no seizures in the last 6 months.
•\- Patients must not have uncontrolled intercurrent illness including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation that would limit compliance with the study, or a prior history of Stevens Johnson Syndrome.
•\- Patients must not have baseline bone lesions or plasmacytomas.
•\- Patients with monoclonal gammopathy of undetermined significance are not eligible.
•\- Patients must not have Grade 2 or higher peripheral neuropathy.
•\- Patients must not have active, uncontrolled infection.