Place title here, using this font

1. Place title here, using this font Place authorship here, using this font and using superscript for institutional affiliation1, etc. Place institutional affiliation here, using this font METHODS BACKGROUND RESULTS Response • Response seen in 17/27 patients, resulting in an overall response rate of 63%: – CR was seen in 2 (7%) – VGPR in 3 (11%) – PR in 12 (44%) – SD for 9 (33%) – Unevaluable in 1 (3%) • 3 patients have not yet had a disease evaluation • 1 patient was unevaluable (died before disease evaluation) • With median follow-up of 24 months, median progression-free survival is 9.8 months and median overall survival is 31.5 months. • Lenalidomide is a highly effective treatment in relapsed multiple myeloma (MM), particularly when used in combination with weekly oral dexamethasone • Over 30% of patients with myeloma have renal insufficiency • As lenalidomide is renally excreted, little information is available about the optimal use of lenalidomide in myeloma patients with impaired kidney function • Defining a safe and effective dose of lenalidomide in this context is critical • Eligible patients had previously treated MM with renal impairment defined as creatinine clearance <60 mL/min measured within 21 days prior to registration • Patients previously treated with lenalidomide were required to demonstrate clinical response (any duration) or stable disease with progression-free interval of >6 months from start of that therapy • All patients received dexamethasone 40 mg orally on days 1, 8, 15 and 22 of a 28-day cycle • Prophylactic anticoagulation consisted of either 81 mg or 325 mg per day of aspirin • Patients also received lenalidomide orally every 1 or 2 days on days 1-21 of a 28-day cycle (Table 1) – Starting doses were as in U.S. Product Insert – Dose escalation follows a standard 3+3 design • 30 patients have been enrolled to the study – Groups, cohorts and dosing is outlined in Table 1 – Patient characteristics are summarized in Table 2 – The regimen was well tolerated» MTD has not been reached in any group » No DLTs have occurred to date Toxicity • The most commonly reported clinical adverse events (all grades, independent of attribution) across all patients included infections, hyperglycemia, constipation, dizziness, hyponatremia, hypocalcemiaand tremor • Hematological toxicities (grade 3-4) occurred in 13/21 (62%) patients, mostly neutropenia and thrombocytopenia • Grade 3-4 events at least possibly related to the regimen occurred in 70% and included pneumonia (26%) and otitismedia (9%) Table 1 Sample text sample text sample text sample text sample text sample text sample text sample text sample text sample text. Sample text sample text sample text sample text sample text sample text sample text sample text sample text sample text Sample text sample text sample text sample text sample text sample text sample text sample text sample text sample text Sample text sample text sample text sample text sample text sample text sample text sample text sample text Sample text sample text sample text sample text sample text sample text sample text sample text sample text Sample text sample text sample text sample text sample text sample text sample text sample text sample text • CONCLUSIONS • Lenalidomide and dexamethasone is a safe and effective regimen in patients with MM and renal insufficiency • • This regimen is very well tolerated; cytopenias are common but manageable • • MTD has yet to be reached in each group, allowing for higher doses to be given than previously thought: • – 25 mg daily (for 21/28 days) in patients with CrCl 30-60 mL/min • – 25 mg every other day (for 21/28 days) in patients with CrCl <30 (for 21/28 days) in patients with CrCl <30 mL/min on dialysis • • Phase II has opened for group A (CrCl 30-60 mL/min) at full dose lenalidomide 25 mg daily (21/28) • • Response rates are 63% despite advanced disease • • These results will provide needed, clinically relevant dosing for lenalidomide in MM patients with renal insufficiency OBJECTIVES • To establish the maximum tolerated dose of lenalidomide in three cohorts of patients with different levels of impaired renal function: – Group A: Creatinine clearance (CrCl) between 30-60 mL/min – Group B: CrCl <30 mL/min not on dialysis – Group C: CrCl < 30mL/min who are on dialysis • Secondary endpoints included response rate, progression free survival (PFS) and overall survival (OS) Aim 1 Number One– sample text sample text sample text sample text sample sample text sample text Number Two– sample text sample text sample text sample text sample sample text sample text. Aim 2 Number One– sample text sample text sample text sample text sample sample text sample text Number Two– sample text sample text sample text sample text sample sample text sample text. Aim 2 Number One– sample text sample text sample text sample text sample sample text sample text Number Two– sample text sample text sample text sample text sample sample text sample text. • REFERENCES • Sample text sample text sample text sample text sample text sample text sample text sample text sample text sample text. • Sample text sample text sample text sample text sample text sample text sample text sample text sample text sample text • Sample text sample text sample text sample text sample text sample text sample text sample text sample text sample text • Sample text sample text sample text sample text sample text sample text sample text sample text sample text sample text Abstract #