An international, multicenter, prospective, observational study of neutropenia in patients being treated with lenalidomide + dexamethasone for relapsed or relapsed/refractory multiple myeloma (RR‐MM)

Abstract

Neutropenia is a well‐known dose‐limiting toxicity associated with lenalidomide plus dexamethasone treatment in patients with multiple myeloma; however, little is known about its management and associated outcomes in the real world setting. The present prospective, multicenter, observational study evaluated the incidence, management, and outcomes of grade 3/4 neutropenia in patients with relapsed or relapsed/refractory multiple myeloma who initiated treatment with lenalidomide plus dexamethasone. Of 198 patients, 62 (31%, 95% CI: 25, 38) experienced grade 3/4 neutropenia, and half of these patients experienced 3 or more events during the 12‐month observational period. Grade 3/4 neutropenia occurred throughout lenalidomide treatment, with a median time to first event of 8.8 weeks (Q1, Q3: 5.9, 17.3). In a multivariate analysis, diagnosis of relapsed and refractory disease was associated with grade 3/4 neutropenia. Lenalidomide exposure reduction, use of G‐CSF, unplanned hospitalization, and outpatient clinic visits were more common in patients who experienced grade 3/4 neutropenia than in those who did not. In conclusion, grade 3/4 neutropenia is a common toxicity and patients are at continued risk throughout treatment with lenalidomide and dexamethasone. Further efforts should be made to improve the recommendations for neutropenia management in this population. Am. J. Hematol. 91:806–811, 2016. © 2016 Wiley Periodicals, Inc.

Real World Experience of Daratumumab: Evaluating Lymphopenia and Adverse Events in Multiple Myeloma Patients

“…The median lowest ANC value was 950 neutrophils/μl (range: 110 to 4320) in patients treated with daratumumab in combination with IMIDs while was 1900 neutrophils/μl (range: 100 to 5700) in patients treated with daratumumab in combination with PIs or as single agent (p-value = 0.003). Indeed, it is well known that IMIDs can cause neutropenia ( 10 ).…”

Incidence of neutropenia and use of granulocyte colony-stimulating factors in multiple myeloma: is current clinical practice adequate?

“…In the observational study by Leleu et al, 31% of patients experienced neutropenia and 23% received G-CSF, which the authors noted was probably reactive. Dose reductions and interruptions with neutropenia as the primary cause were rare [ 42 ]. In the retrospective analysis of patients on the MM-016 extended access programme by Sun et al, intermittent G-CSF (4–6 doses per cycle) was used reactively in 49% of patients and as secondary prophylaxis in 5%.…”

“…Two of these studies used pegfilgrastim in lenalidomide-based regimens. An observational study of patients with RRMM found that pegfilgrastim was given to 8% of patients receiving RD [ 42 ]. Daily G-CSF was used more frequently (16% of patients).…”

“…The prospective cohort study of sequential filgrastim and pegfilgrastim treatment reported that the main AEs following pegfilgrastim administration were mild fever and bone pain, which were experienced by 12% of patients [ 83 ]. In the observational IMPACT study, no adverse drug reactions to any G-CSF were reported [ 42 ]. Another study assessing pegfilgrastim with and without cyclophosphamide reported no hospitalizations due to toxicity in the pegfilgrastim group [ 84 ].…”

“…In the observational study by Leleu et al of patients with RRMM receiving RD, those who received pegfilgrastim were more likely to have International Staging System stage III at diagnosis, more than four previous treatments and more comorbidities than those who were given daily G-CSFs [ 42 ]. They were also more likely to be younger and to be receiving the recommended 25 mg dose of lenalidomide [ 42 ]. This suggests that pegfilgrastim may be reserved for patients with a high risk of neutropenia.…”