Contributions
Abstract: EP1031
Type: E-Poster Presentation
Session title: Myeloma and other monoclonal gammopathies - Clinical
Background
Patients with relapsed/refractory multiple myeloma (RRMM) have a reduced health-related quality of life (HRQoL) compared with age- and sex-matched populations. In the phase 3 APOLLO study (NCT03180736), patients with RRMM who had received ≥1 prior line of therapy, including lenalidomide with a proteasome inhibitor, were treated with pomalidomide and dexamethasone (Pd) with or without subcutaneous daratumumab (D-Pd; 1800 mg, co-formulated with recombinant human hyaluronidase PH20 in 15 mL). The rate of progression or death was significantly lower with D-Pd (by 37%) vs Pd (median follow up, 16.9 months).
Aims
To present patient-reported outcomes (PROs) from the APOLLO study.
Methods
Patients were randomly assigned 1:1 to receive D-Pd or Pd in 28-day cycles until disease progression or unacceptable toxicity. Written informed consent was obtained from all patients. Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 item (EORTC QLQ-C30), EORTC QLQ Multiple Myeloma Module 20 item (MY20), and EQ 5D, PROs were assessed on Day 1 of each cycle. Intent-to-treat population with baseline and ≥1 postbaseline assessment were evaluated. Time to worsening was estimated using the Kaplan-Meier method, and treatment effect was evaluated using a mixed effects model with repeated measures.
Results
Overall, 304 patients (D-Pd: n=151, pd: n=153) were eligible. The median duration of treatment was 11.5 and 6.6 months in the D-Pd and Pd groups, respectively. At Cycle 16, 63 patients in the D-Pd group and 40 patients in the Pd group continued to be on treatment. The PRO compliance rates were similarly high in both groups. As measured with the EORTC QLQ-C30, pain reduced in D-Pd-treated patients (maximum improvement: 6.8 points at Cycle 12), and no mean change was observed in disease symptoms or treatment side effect subscales of the EORTC QLQ-MY20. Group mean physical and emotional functioning worsened from baseline in the Pd group (maximum worsening: 6.4 points at Cycle 4 and 9.1 points at Cycle 14) but was unaltered in the D-Pd group. A greater proportion of patients had a meaningful improvement from baseline with D-Pd vs Pd for disease symptoms (55.0% vs 49.0%), physical functioning (43.0% vs 35.3%), and emotional functioning (41.7% vs 31.4%). The median time to worsening was approximately 4 months, except for disease symptoms subscale, where the median time to worsening was approximately 10 months. No differences were observed between groups.
Conclusion
Combining daratumumab with Pd for the treatment of RRMM did not lead to any decrements in HRQoL. Some patients benefited from the combination through reduction in pain and clinically meaningful improvements in symptoms and emotional/physical function. These findings complement the clinical benefits of D-Pd in patients with RRMM and further support its use in this population
Keyword(s): Multiple myeloma, Progression
Abstract: EP1031
Type: E-Poster Presentation
Session title: Myeloma and other monoclonal gammopathies - Clinical
Background
Patients with relapsed/refractory multiple myeloma (RRMM) have a reduced health-related quality of life (HRQoL) compared with age- and sex-matched populations. In the phase 3 APOLLO study (NCT03180736), patients with RRMM who had received ≥1 prior line of therapy, including lenalidomide with a proteasome inhibitor, were treated with pomalidomide and dexamethasone (Pd) with or without subcutaneous daratumumab (D-Pd; 1800 mg, co-formulated with recombinant human hyaluronidase PH20 in 15 mL). The rate of progression or death was significantly lower with D-Pd (by 37%) vs Pd (median follow up, 16.9 months).
Aims
To present patient-reported outcomes (PROs) from the APOLLO study.
Methods
Patients were randomly assigned 1:1 to receive D-Pd or Pd in 28-day cycles until disease progression or unacceptable toxicity. Written informed consent was obtained from all patients. Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 item (EORTC QLQ-C30), EORTC QLQ Multiple Myeloma Module 20 item (MY20), and EQ 5D, PROs were assessed on Day 1 of each cycle. Intent-to-treat population with baseline and ≥1 postbaseline assessment were evaluated. Time to worsening was estimated using the Kaplan-Meier method, and treatment effect was evaluated using a mixed effects model with repeated measures.
Results
Overall, 304 patients (D-Pd: n=151, pd: n=153) were eligible. The median duration of treatment was 11.5 and 6.6 months in the D-Pd and Pd groups, respectively. At Cycle 16, 63 patients in the D-Pd group and 40 patients in the Pd group continued to be on treatment. The PRO compliance rates were similarly high in both groups. As measured with the EORTC QLQ-C30, pain reduced in D-Pd-treated patients (maximum improvement: 6.8 points at Cycle 12), and no mean change was observed in disease symptoms or treatment side effect subscales of the EORTC QLQ-MY20. Group mean physical and emotional functioning worsened from baseline in the Pd group (maximum worsening: 6.4 points at Cycle 4 and 9.1 points at Cycle 14) but was unaltered in the D-Pd group. A greater proportion of patients had a meaningful improvement from baseline with D-Pd vs Pd for disease symptoms (55.0% vs 49.0%), physical functioning (43.0% vs 35.3%), and emotional functioning (41.7% vs 31.4%). The median time to worsening was approximately 4 months, except for disease symptoms subscale, where the median time to worsening was approximately 10 months. No differences were observed between groups.
Conclusion
Combining daratumumab with Pd for the treatment of RRMM did not lead to any decrements in HRQoL. Some patients benefited from the combination through reduction in pain and clinically meaningful improvements in symptoms and emotional/physical function. These findings complement the clinical benefits of D-Pd in patients with RRMM and further support its use in this population
Keyword(s): Multiple myeloma, Progression