Lenalidomide (Page 9 of 12)

14.3 Mantle Cell Lymphoma

A multicenter, single-arm, open-label trial of single-agent lenalidomide was conducted to evaluate 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 to 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 19: Baseline Disease-related Characteristics and Prior Anti–Lymphoma Therapy in Mantle Cell Lymphoma Trial

Baseline Disease Characteristics and Prior Anti-Lymphoma Treatment

Total Patients


ECOG Performance Statusa n (%)


43 (32)


73 (54)


17 (13)


1 (<1)

Advanced MCL Stage, n (%)


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 Systemic Anti-Lymphoma Therapies, n (%)

Median (range)

4 (2, 10)


0 (0)


29 (22)


34 (25)

≥ 4

71 (53)

Number of Subjects Who Received Prior Regimen Containing, n (%):


133 (99)


133 (99)


134 (100)


134 (100)

Refractory to Prior Bortezomib, n (%)

81 (60)

Refractory to Last Prior Therapy, n (%)

74 (55)

Prior Autologous Bone Marrow or Stem Cell Transplant, n (%)

39 (29)

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 ≥7 cm in the longest diameter.

The efficacy endpoints in the MCL trial were overall response rate (ORR) and duration of response (DOR). Response was determined based on review of radiographic scans by an independent review committee according to a modified version of the International Workshop Lymphoma Response Criteria (Cheson, 1999). The DOR is defined as the time from the initial response (at least PR) to documented disease progression. The efficacy results for the MCL population were based on all evaluable patients who received at least one dose of study drug and are presented in Table 20. The median time to response was 2.2 months (range 1.8 to 13 months).

Table 20: Response Outcomes in the Pivotal Mantle Cell Lymphoma Trial

Response Analyses (N = 133)

N (%)

95% CI

Overall Response Rate (IWRC) (CR + CRu +PR)

34 (26)

(18.4, 33.9)

Complete Response (CR + CRu)

9 (7)

(3.1, 12.5)


1 (1)


8 (6)

Partial Response (PR)

25 (19)

Duration of Response (months)


95% CI

Duration of Overall Response (CR + CRu + PR) (N = 34)


(7.7, 26.7)

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