Heidelberg University Hospital, Heidelberg, Germany
Hartmut Goldschmidt , Ravi Vij , David Kuter , David Cella , Teresa Maria Zyczynski , Catherine C. Davis , Sergey Popov , Gordon Cook
Background: PREAMBLE (Prospective REsearch Assessment in multiple Myeloma: an oBservationaL Evaluation; NCT01838512) is an observational cohort study on the real-world effectiveness of immunomodulatory drugs (IMiDs), proteasome inhibitors (PIs), and combination therapy for RRMM. We report preliminary data on HCRU on the overall study population (US and Europe). Methods: Eligibility criteria: patients (pts) aged ≥ 18 y with RRMM ( ≥ 1 prior therapy) who initiated treatment with an IMiD, PI, or IMiD+PI 90 days prior/30 days after study enrollment. Pt data collected at each healthcare provider (HCP) visit included number of clinic/physician office visits, home healthcare, hospital outpatient and emergency room visits, and hospitalizations. Results: At data cut-off (Dec 2015), 764 treated pts (median age 68 y, 55% male) were enrolled; 599 (78%) relapsed, 161 (21%) refractory. Median time from diagnosis to index MM therapy was 41 mo (range 24–71). Of the 764 pts, 365 (48%) had prior transplantation experience. Forty-eight percent (n = 368) received an IMiD (lenalidomide 81%, n = 297), 45% (n = 347) received a PI (bortezomib 80%, n = 278), and 6% (n = 49) received an IMiD+PI. Majority of pts had 1 prior line of therapy (43%, n = 325), 27% (n = 203) had 2, 31% (n = 234) ≥ 3. Median follow-up: 15.1 mo (Q1–Q3 8–24). Median (Q1–Q3) number of HCP visits per relapsed pt during yr 1 was 4.5 (0–20) and 7 (0–20) per refractory pt. Median (Q1–Q3) number of HCP visits in Yrs 2 and 3 were 2 (0–12). Of 6804 total HCP visits, 3017 (44%) were hospital outpatients, 2779 (41%) clinic/physician, 371 (6%) hospitalizations. The main reason for visit (90%, 6143/6804) and hospitalization (66%, 276/417) was management of MM and its sequelae. The overall number of HCP visits and hospitalizations for management of treatment-related AEs was 9% (619/6804) and 33% (137/417), respectively. Surgical interventions accounted for 0.6% (42/6804) of resource use. Conclusions: Routine management and disease progression continues to drive HCRU in MM, regardless of lines of prior therapy. Early use of novel therapies with potential to provide durable responses could improve management of MM and pt outcomes. Additional analyses to apply costs are ongoing. Clinical trial information: NCT01838512
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Abstract Disclosures
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