5 research outputs found
Results of an early access treatment protocol of daratumumab monotherapy in spanish patients with relapsed or refractory multiple myeloma
Daratumumab is a human CD38-targeted monoclonal antibody approved as monotherapy for heavily pretreated relapsed and
refractory multiple myeloma. We report findings for the Spanish cohort of an open-label treatment protocol that provided early access
to daratumumab monotherapy and collected safety and patient-reported outcomes data for patients with relapsed or refractory
multiple myeloma. At 15 centers across Spain, intravenous daratumumab (16mg/kg) was administered to 73 patients who had ≥3
prior lines of therapy, including a proteasome inhibitor and an immunomodulatory drug, or who were double refractory to both. The
median duration of daratumumab treatment was 3.3 (range: 0.03–13.17) months, with a median number of 12 (range: 1–25)
infusions. Grade 3/4 treatment-emergent adverse events were reported in 74% of patients and included lymphopenia (28.8%),
thrombocytopenia (27.4%), neutropenia (21.9%), leukopenia (19.2%), and anemia (15.1%). Common (>5%) serious treatmentemergent adverse events included respiratory tract infection (9.6%), general physical health deterioration (6.8%), and back pain
(5.5%). Infusion-related reactions occurred in 45% of patients. The median change from baseline in all domains of the EQ-5D-5L and
EORTC QLQ-C30 was mostly 0. A total of 18 (24.7%) patients achieved a partial response or better, with 10 (13.7%) patients
achieving a very good partial response or better. Median progression-free survival was 3.98 months. The results of this early access
treatment protocol are consistent with previously reported trials of daratumumab monotherapy and confirm its safety and antitumoral
efficacy in Spanish patients with heavily treated relapsed or refractory multiple myeloma
Multiple myeloma and SARS-CoV-2 infection: clinical characteristics and prognostic factors of inpatient mortality
There is limited information on the characteristics, prognostic factors, and outcomes of patients with multiple
myeloma (MM) hospitalized with COVID-19. This retrospective case series investigated 167 patients reported from 73
hospitals within the Spanish Myeloma Collaborative Group network in March and April, 2020. Outcomes were
compared with 167 randomly selected, contemporary, age-/sex-matched noncancer patients with COVID-19 admitted
at six participating hospitals. Among MM and noncancer patients, median age was 71 years, and 57% of patients were
male; 75 and 77% of patients, respectively, had at least one comorbidity. COVID-19 clinical severity was
moderate–severe in 77 and 89% of patients and critical in 8 and 4%, respectively. Supplemental oxygen was required
by 47 and 55% of MM and noncancer patients, respectively, and 21%/9% vs 8%/6% required noninvasive/invasive
ventilation. Inpatient mortality was 34 and 23% in MM and noncancer patients, respectively. Among MM patients,
inpatient mortality was 41% in males, 42% in patients aged >65 years, 49% in patients with active/progressive MM at
hospitalization, and 59% in patients with comorbid renal disease at hospitalization, which were independent
prognostic factors on adjusted multivariate analysis. This case series demonstrates the increased risk and identifies
predictors of inpatient mortality among MM patients hospitalized with COVID-19
Results of an early access treatment protocol of daratumumab monotherapy in spanish patients with relapsed or refractory multiple myeloma
Daratumumab is a human CD38-targeted monoclonal antibody approved as monotherapy for heavily pretreated relapsed and
refractory multiple myeloma. We report findings for the Spanish cohort of an open-label treatment protocol that provided early access
to daratumumab monotherapy and collected safety and patient-reported outcomes data for patients with relapsed or refractory
multiple myeloma. At 15 centers across Spain, intravenous daratumumab (16mg/kg) was administered to 73 patients who had ≥3
prior lines of therapy, including a proteasome inhibitor and an immunomodulatory drug, or who were double refractory to both. The
median duration of daratumumab treatment was 3.3 (range: 0.03–13.17) months, with a median number of 12 (range: 1–25)
infusions. Grade 3/4 treatment-emergent adverse events were reported in 74% of patients and included lymphopenia (28.8%),
thrombocytopenia (27.4%), neutropenia (21.9%), leukopenia (19.2%), and anemia (15.1%). Common (>5%) serious treatmentemergent adverse events included respiratory tract infection (9.6%), general physical health deterioration (6.8%), and back pain
(5.5%). Infusion-related reactions occurred in 45% of patients. The median change from baseline in all domains of the EQ-5D-5L and
EORTC QLQ-C30 was mostly 0. A total of 18 (24.7%) patients achieved a partial response or better, with 10 (13.7%) patients
achieving a very good partial response or better. Median progression-free survival was 3.98 months. The results of this early access
treatment protocol are consistent with previously reported trials of daratumumab monotherapy and confirm its safety and antitumoral
efficacy in Spanish patients with heavily treated relapsed or refractory multiple myeloma
Prognostic value of serum paraprotein response kinetics in patients with newly diagnosed multiple myeloma
Introduction
Response kinetics is a well-established prognostic marker in acute lymphoblastic leukemia. The situation is not clear in multiple myeloma (MM) despite having a biomarker for response monitoring (monoclonal component [MC]).
Materials and Methods
We developed a mathematical model to assess the prognostic value of serum MC response kinetics during 6 induction cycles, in 373 NDMM transplanted patients treated in the GEM2012Menos65 clinical trial. The model calculated a “resistance” parameter that reflects the stagnation in the response after an initial descent.
Results
Two patient subgroups were defined based on low and high resistance, that respectively captured sensitive and refractory kinetics, with progression-free survival (PFS) at 5 years of 72% and 59% (HR 0.64, 95% CI 0.44-0.93; P = .02). Resistance significantly correlated with depth of response measured after consolidation (80.9% CR and 68.4% minimal residual disease negativity in patients with sensitive vs. 31% and 20% in those with refractory kinetics). Furthermore, it modulated the impact of reaching CR after consolidation; thus, within CR patients those with refractory kinetics had significantly shorter PFS than those with sensitive kinetics (median 54 months vs. NR; P = .02). Minimal residual disease negativity abrogated this effect. Our study also questions the benefit of rapid responders compared to late responders (5-year PFS 59.7% vs. 76.5%, respectively [P < .002]). Of note, 85% of patients considered as late responders were classified as having sensitive kinetics.
Conclusion
This semi-mechanistic modeling of M-component kinetics could be of great value to identify patients at risk of early treatment failure, who may benefit from early rescue intervention strategies
Multiple myeloma and SARS-CoV-2 infection: clinical characteristics and prognostic factors of inpatient mortality
There is limited information on the characteristics, prognostic factors, and outcomes of patients with multiple
myeloma (MM) hospitalized with COVID-19. This retrospective case series investigated 167 patients reported from 73
hospitals within the Spanish Myeloma Collaborative Group network in March and April, 2020. Outcomes were
compared with 167 randomly selected, contemporary, age-/sex-matched noncancer patients with COVID-19 admitted
at six participating hospitals. Among MM and noncancer patients, median age was 71 years, and 57% of patients were
male; 75 and 77% of patients, respectively, had at least one comorbidity. COVID-19 clinical severity was
moderate–severe in 77 and 89% of patients and critical in 8 and 4%, respectively. Supplemental oxygen was required
by 47 and 55% of MM and noncancer patients, respectively, and 21%/9% vs 8%/6% required noninvasive/invasive
ventilation. Inpatient mortality was 34 and 23% in MM and noncancer patients, respectively. Among MM patients,
inpatient mortality was 41% in males, 42% in patients aged >65 years, 49% in patients with active/progressive MM at
hospitalization, and 59% in patients with comorbid renal disease at hospitalization, which were independent
prognostic factors on adjusted multivariate analysis. This case series demonstrates the increased risk and identifies
predictors of inpatient mortality among MM patients hospitalized with COVID-19