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OPTIMIZING THE MANAGEMENT OF NON-HEMATOLOGICAL ADVERSE EFFECTS RELATED TO LENALIDOMIDE IN RELAPSED MULTIPLE MYELOMA PATIENTS. ONE CENTER EXPERIENCE.
Author(s): ,
María Moya-Arnao
Affiliations:
Hematology,Hospital Clínico Universitario Virgen de la Arrixaca,El Palmar,Spain
,
Valentin Cabanas-Perianes
Affiliations:
Hematology,Hospital Clínico Universitario Virgen de la Arrixaca,El Palmar,Spain
,
Maria Jose Moreno Belmonte
Affiliations:
Hematology,Hospital Clínico Universitario Virgen de la Arrixaca,El Palmar,Spain
,
Mercedes Berenguer
Affiliations:
Hematology,Hospital Clínico Universitario Virgen de la Arrixaca,El Palmar,Spain
,
Amelia Martínez Marin
Affiliations:
Hematology,Hospital Clínico Universitario Virgen de la Arrixaca,El Palmar,Spain
,
Elena Fernandez Poveda
Affiliations:
Hematology,Hospital Clínico Universitario Virgen de la Arrixaca,El Palmar,Spain
,
Raúl Pérez López
Affiliations:
Hematology,Hospital Clínico Universitario Virgen de la Arrixaca,El Palmar,Spain
,
Eduardo Salido Fierrez
Affiliations:
Hematology,Hospital Clínico Universitario Virgen de la Arrixaca,El Palmar,Spain
Jose Maria Moraleda Jimenez
Affiliations:
Hematology,Hospital Clínico Universitario Virgen de la Arrixaca,El Palmar,Spain
(Abstract release date: 05/18/17) EHA Library. M. 05/18/17; 182683; PB1969
María
María
Contributions
Abstract

Abstract: PB1969

Type: Publication Only

Background
During many years, the combination of lenalidomide and dexamethasone (Rd) has been an effective treatment for patients with relapsed or refractory Multiple Myeloma (RRMM). On the basis of the available evidence, treatment with Rd may continue in responding patients until progression or unacceptable toxic effects. The data suggest full dose lenalidomide is important for optimal efficacy and to improve the progression free survival (PFS). Approaches to achieve higher doses of lenalidomide could include continuing therapy in responding patients and proactive adverse effects (AEs) management.

Aims
The main aim was to evaluate the incidence of two of most common non-hematologic AEs related to lenalidomide (rash and dystonia) in patients who received treatment with Rd. The second end points were to evaluate the response of rash after switching the enoxaparin to bemiparin and to evaluate the response of the dystonia after treatment with clonazepam, instead of lenalidomide dose reduction.

Methods
We retrospectively reviewed a consecutive cohort of patients with RRMM receiving Rd (R: 25 mg on days 1 through 21. d: 40 mg on days 1, 8, 15, and 22) in 28-day cycles until progression or unacceptable adverse effects, from 2011-2016. All patients received thromboprophylaxis with low-molecular-weight-heparin (LMWH) (Enoxaparin 40 mg subcutaneous daily) the first 4 cycles; thereafter, patients were switched to aspirin 100 mg in a day prophylaxis. Bemiparin 7500 anti-Xa IU once-daily dose was employed if enoxaparin was suspended. Clonazepam dose to treat dystonia was 0,5 mg twice daily. Data were analyzed with SPSS statistical v 22.0.

Results
Between 2011 and 2016 a total of 65 patients received Rd in our center. Baseline characteristics are shown in Table 1. Patients received a median of 2 previous regimens (range 1-6). 51,5% of the patients had undergone one previous autologous stem-cell transplant (ASCT). Rash occurring in 12,3% of patients (grade 2), all of them were concurrently reciving enoxaparine. All rashes resolved switching the enoxaparine to bemiparine, maintaining same dose of lenalidomide. Neither treatment with esteroids or antihistaminic were administrated. Dystonias were reported in 23,1% of patients (grade 2), all of them dissapeared after treatment with clonazepam without lenalidomide dose reduction.

Conclusion
Rash and dystonias are frequent adverse effects of immunomodulatory drugs (IMiDs), particularly lenalidomide, often leading to treatment discontinuation and decreasing the potential benefits to patients.

According to our data, the rash could be due to synergism between enoxaparin and lenalidomide. In most cases, switch LWHM letting not to reduce lenalidomide dose in order to optimize the benefit of the treatment. Clonazepam, a benzodiazepine, is useful to treat dystonias related to lenalidomide.

Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical

Keyword(s): Myeloma, Immunomodulatory thalidomide analog, Adverse reaction

Abstract: PB1969

Type: Publication Only

Background
During many years, the combination of lenalidomide and dexamethasone (Rd) has been an effective treatment for patients with relapsed or refractory Multiple Myeloma (RRMM). On the basis of the available evidence, treatment with Rd may continue in responding patients until progression or unacceptable toxic effects. The data suggest full dose lenalidomide is important for optimal efficacy and to improve the progression free survival (PFS). Approaches to achieve higher doses of lenalidomide could include continuing therapy in responding patients and proactive adverse effects (AEs) management.

Aims
The main aim was to evaluate the incidence of two of most common non-hematologic AEs related to lenalidomide (rash and dystonia) in patients who received treatment with Rd. The second end points were to evaluate the response of rash after switching the enoxaparin to bemiparin and to evaluate the response of the dystonia after treatment with clonazepam, instead of lenalidomide dose reduction.

Methods
We retrospectively reviewed a consecutive cohort of patients with RRMM receiving Rd (R: 25 mg on days 1 through 21. d: 40 mg on days 1, 8, 15, and 22) in 28-day cycles until progression or unacceptable adverse effects, from 2011-2016. All patients received thromboprophylaxis with low-molecular-weight-heparin (LMWH) (Enoxaparin 40 mg subcutaneous daily) the first 4 cycles; thereafter, patients were switched to aspirin 100 mg in a day prophylaxis. Bemiparin 7500 anti-Xa IU once-daily dose was employed if enoxaparin was suspended. Clonazepam dose to treat dystonia was 0,5 mg twice daily. Data were analyzed with SPSS statistical v 22.0.

Results
Between 2011 and 2016 a total of 65 patients received Rd in our center. Baseline characteristics are shown in Table 1. Patients received a median of 2 previous regimens (range 1-6). 51,5% of the patients had undergone one previous autologous stem-cell transplant (ASCT). Rash occurring in 12,3% of patients (grade 2), all of them were concurrently reciving enoxaparine. All rashes resolved switching the enoxaparine to bemiparine, maintaining same dose of lenalidomide. Neither treatment with esteroids or antihistaminic were administrated. Dystonias were reported in 23,1% of patients (grade 2), all of them dissapeared after treatment with clonazepam without lenalidomide dose reduction.

Conclusion
Rash and dystonias are frequent adverse effects of immunomodulatory drugs (IMiDs), particularly lenalidomide, often leading to treatment discontinuation and decreasing the potential benefits to patients.

According to our data, the rash could be due to synergism between enoxaparin and lenalidomide. In most cases, switch LWHM letting not to reduce lenalidomide dose in order to optimize the benefit of the treatment. Clonazepam, a benzodiazepine, is useful to treat dystonias related to lenalidomide.

Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical

Keyword(s): Myeloma, Immunomodulatory thalidomide analog, Adverse reaction

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