TY - JOUR
T1 - Analysis of Efficacy and Prognostic Factors of Lenalidomide Treatment as Part of a Dutch Compassionate Use Program
AU - Kneppers, Evelien
AU - Lokhorst, Henk M.
AU - Eeltink, Corien M.
AU - Huls, Gerwin
AU - Kersten, Marie José
AU - Koedam, Jan
AU - Minnema, Monique C.
AU - van Oers, Marinus H. J.
AU - Raymakers, Reinier A. P.
AU - Schaafsma, Martijn R.
AU - Vellenga, Edo
AU - Wijermans, Pierre W.
AU - Wittebol, Shulamiet
AU - Sonneveld, Pieter
AU - Zweegman, Sonja
PY - 2010
Y1 - 2010
N2 - Background and Methods: To obtain efficacy and safety data on lenalidomide treatment outside of clinical trials, we analyzed the clinical data of 114 patients with refractory or relapsed multiple myeloma treated with lenalidomide on a compassionate use basis. The recommended treatment consisted of lenalidomide 25 mg given on days 1-21 of a 28-day cycle, in combination with dexamethasone. A median of 3 previous lines of therapy were given, including thalidomide in 91%. Most patients were treated until progression or intolerable toxicity. Results: The median number of cycles was 7 (range, 1-21 + cycles) with a maximum response after a median of 3 cycles (range, 1-10 cycles). The overall response rate was 69%, including complete response in 6%, very good partial response in 19%, and partial response in 44%. The response rate was not influenced by previous thalidomide and/or bortezomib treatment. The median time to progression (TTP) was 9 months and the median overall survival (OS) was 22 months. A significantly longer TTP was observed in patients who previously underwent allogeneic stem cell transplantation (12.5 months vs. 8 months; P = .036). Overall survival was significantly affected by performance status (P <.0001). Lenalidomide toxicity was predominantly hematologic (37%; Common Toxicity Criteria >= 3) and the incidence of venous thrombotic events was low (5%) using the recommended prophylaxis. Conclusion: This analysis confirms that, outside clinical prospective trials, treatment with lenalidomide is highly effective and feasible in heavily pretreated patients with multiple myeloma
AB - Background and Methods: To obtain efficacy and safety data on lenalidomide treatment outside of clinical trials, we analyzed the clinical data of 114 patients with refractory or relapsed multiple myeloma treated with lenalidomide on a compassionate use basis. The recommended treatment consisted of lenalidomide 25 mg given on days 1-21 of a 28-day cycle, in combination with dexamethasone. A median of 3 previous lines of therapy were given, including thalidomide in 91%. Most patients were treated until progression or intolerable toxicity. Results: The median number of cycles was 7 (range, 1-21 + cycles) with a maximum response after a median of 3 cycles (range, 1-10 cycles). The overall response rate was 69%, including complete response in 6%, very good partial response in 19%, and partial response in 44%. The response rate was not influenced by previous thalidomide and/or bortezomib treatment. The median time to progression (TTP) was 9 months and the median overall survival (OS) was 22 months. A significantly longer TTP was observed in patients who previously underwent allogeneic stem cell transplantation (12.5 months vs. 8 months; P = .036). Overall survival was significantly affected by performance status (P <.0001). Lenalidomide toxicity was predominantly hematologic (37%; Common Toxicity Criteria >= 3) and the incidence of venous thrombotic events was low (5%) using the recommended prophylaxis. Conclusion: This analysis confirms that, outside clinical prospective trials, treatment with lenalidomide is highly effective and feasible in heavily pretreated patients with multiple myeloma
U2 - https://doi.org/10.3816/CLML.2010.n.020
DO - https://doi.org/10.3816/CLML.2010.n.020
M3 - Article
C2 - 20371448
SN - 2152-2650
VL - 10
SP - 138
EP - 143
JO - Clinical lymphoma, myeloma & leukemia
JF - Clinical lymphoma, myeloma & leukemia
IS - 2
ER -