was 21 days (mean, 35.1 days; range, 2-253 days), and the median duration of the first dose interruption was 22 days (mean, 28.5 days; range, 2-265 days). A second dose reduction or interruption due to adverse events was required in 50 (33.8%) of the 148 patients. The median interval between the first and second dose reduction or interruption was 51 days (mean, 59.7 days; range, 15-205 days) and the median duration of the second dose interruption was 21 days (mean, 26 days; range, 2-148 days).
14.3 Mantle Cell Lymphoma
A multicenter, single-arm, open-label trial of single-agent lenalidomide was conducted to eva luate the safety and efficacy of lenalidomide in patients with mantle cell lymphoma who have relapsed after or were refractory to bortezomib or a bortezomib-containing regimen. Patients with a creatinine clearance ≥60 mL/min were given lenalidomide at a dose of 25 mg once daily for 21 days every 28 days. Patients with a creatinine clearance ≥30 mL/min and <60 mL/min were given lenalidomide at a dose of 10 mg once daily for 21 days every 28 days. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent.
The trial included patients who were at least 18 years of age with biopsy-proven MCL with measurable disease by CT scan. Patients were required to have received prior treatment with an anthracycline or mitoxantrone, cyclophosphamide, rituximab, and bortezomib, alone or in combination. Patients were required to have documented refractory disease (defined as without any response of PR or better during treatment with bortezomib or a bortezomib-containing regimen), or relapsed disease (defined as progression within one year after treatment with bortezomib or a bortezomib-containing regimen). At enrollment patients were to have an absolute neutrophil counts (ANC) ≥1500/ mm3, platelet counts ≥ 60,000/mm3, serum SGOT/AST or SGPT/ALT ≤3x upper limit of normal (ULN) unless there was documented evidence of liver involvement by lymphoma, serum total bilirubin ≤1.5 x ULN except in cases of Gilbert’s syndrome or documented liver involvement by lymphoma, and calculated creatinine clearance (Cockcroft-Gault formula) ≥30 mL/min.
The median age was 67 years (43-83), 81% were male and 96% were Caucasian. The table below summarizes the baseline disease-related characteristics and prior anti-lymphoma therapy in the Mantle Cell Lymphoma trial.
Table 18: Baseline Disease-related Characteristics and Prior Anti –Lymphoma Therapy in Mantle Cell Lymphoma Trial
a) ECOG = Eastern Cooperative Oncology Group
b) MIPI = MCL International Prognostic Index
c) High tumor burden is defined as at least one lesion that is ≥5 cm in diameter or 3 lesions that are ≥3 cm in diameter
d) Bulky disease is defined as at least one lesion that is ≥7cm in the longest diameter
Baseline Disease Characteristics and Prior Anti -
Lymphoma Treatment Total Patients
(N=134)
ECOG Performance Statusa n (%)
0
1
2
3 43 (32)
73 (54)
17 (13)
1 (<1)
Advanced MCL Stage, n (%)
III
IV 27 (20)
97 (72)
High or Intermediate MIPI Score b, n (%) 90 (67)
High Tumor Burdenc, n (%) 77 (57)
Bulky Diseased, n (%) 44 (33)
Extranodal Disease, n (%) 101 (75)
Number of Prior Syst
