Efficacy, safety, and health-related quality of life in transplant-ineligible newly diagnosed multiple myeloma patients receiving bortezomib maintenance therapy - a study of the Korean Multiple Myeloma Working Party KMMWP-174 study

Q: Who were the participants in the KMMWP-174 study?

The study enrolled 78 transplant-ineligible newly diagnosed multiple myeloma patients who achieved partial response or better after induction chemotherapy. Transplant-ineligible status reflected older age, high comorbidity burden, or poor performance status.

Q: How was HRQoL assessed during maintenance therapy?

HRQoL was assessed at baseline (cycle 1, day 1) and on day 1 of each subsequent maintenance cycle. A 10-point or higher change was considered clinically significant, and multi-item scales were scored per the EORTC manual.

Sep 29, 2026

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Letter to the editor describing a prospective multicenter single-arm observational study evaluating bortezomib maintenance therapy in transplant-ineligible newly diagnosed multiple myeloma patients. Conducted across 14 Korean Multiple Myeloma Working Party institutions (May 2017–Dec 2021), it enrolled 78 patients receiving subcutaneous bortezomib weekly and assessed progression-free survival, toxicity, and health-related quality of life. Findings reported effective disease control with manageable safety and clinically relevant HRQoL changes measured by EORTC-QLQ-C30 and QLQ-MY20 through maintenance cycles.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages6

Reading Time15 min

AccessFree to download

Study design and endpoints

Treatment regimen and follow-up

Patient characteristics

Baseline disease and risk features

Efficacy outcomes

PFS, PFS2, and OS

Safety and HRQoL outcomes

EORTC-QLQ-C30 and QLQ-MY20 results

LETTER TO THE EDITOR Efficacy, safety, and health-related quality of life in transplant-ineligible newly diagnosed multiple myeloma patients receiving bortezomib maintenance therapy: a study of the Korean Multiple Myeloma Working Party KMMWP-174 study Multiple myeloma (MM) remains incurable with inevitable relapse, requiring effective long-term treatment strategies for transplant-ineligible patients who make up a significant proportion of MM patients due to advanced age and comorbidities.1,2 Maintenance therapy (MT) has emerged as a cornerstone strategy to sustain treatment responses, delay progression, and improve survival outcomes.3-5 While lenalidomide maintenance is well-established, evidence supporting bortezomib MT in transplant-ineligible patients remains limited. This prospective multicenter single-arm observational study evaluated the impact of bortezomib MT on clinical efficacy, safety, and health-related quality of life (HRQoL) in real-world transplant-ineligible newly diagnosed MM (NDMM) patients, demonstrating effective disease control with an acceptable safety profile and manageable HRQoL outcomes. This study was conducted across 14 institutions affiliated with the Korean Multiple Myeloma Working Party (KMMWP) between May 2017 and December 2021. Seventy-eight transplant-ineligible patients with NDMM who achieved partial response (PR) or better after induction chemotherapy were enrolled. The transplant-ineligible group refers to patients who, due to older age, high comorbid burden, or poor performance status, are at increased risk of treatment-related toxicities.6 Ethics committees or institutional review boards at all study sites approved the study, which was carried out in accordance with the principles of the Declaration of Helsinki and the guidelines for Good Clinical Practice. All patients provided written informed consent. The primary endpoint was progression-free survival (PFS), with secondary endpoints including secondary PFS (PFS2), overall survival (OS), toxicity, and HRQoL. Events of PFS were defined as progression or death. PFS2 was defined as the duration from the start of first-line treatment to the second relapse, progression, or death. OS was defined as the time from initiation of induction chemotherapy to death from any cause. Bortezomib MT was administered subcutaneously at 1.3 mg/m² once weekly for three weeks (days 1, 8, 15) at 28-day intervals7 until disease progression or unacceptable toxicity. Patients without disease progression or significant adverse events (AE) received MT for up to 24 months before discontinuation. Dose reductions were applied based on toxicity severity. HRQoL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30)8 and its MM-specific module (QLQ-MY20)9 validated tools at baseline (cycle 1, day 1 of MT) and on day 1 of each subsequent cycle throughout maintenance. A 10-point change or higher was considered clinically significant. All multi-item scales were scored according to the EORTC scoring manual. Statistical analyses included Kaplan-Meier survival estimates and paired t tests for HRQoL changes, with P<0.05 considered statistically significant. The median age was 71.0 years (range: 56-83), with 23.1% aged ≥75 years. IgG MM was most prevalent (52.6%), followed by IgA (25.6%) and light chain (17.9%) MM. Most patients had an Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (98.7%) and International Staging System (ISS) stage II-III (71.8%) . High-risk cytogenetics were present in 25.6% of patients. Moderate to severe renal impairment (glomerular filtration rate [GFR] <60 mL / minute [min] / 1.73 m²) occurred in 35. 9%(Table 1) . The majority (93.6%) received bortezomib + melphalan + prednisone (VMP) induction therapy. Median bortezomib MT cycles was 9.5 (range: 1-26) with a median duration of 9.4 months ( Online Supplementary Table S1) . With median follow-up of 44.5 months,

FAQs

Who were the participants in the KMMWP-174 study?

The study enrolled 78 transplant-ineligible newly diagnosed multiple myeloma patients who achieved partial response or better after induction chemotherapy. Transplant-ineligible status reflected older age, high comorbidity burden, or poor performance status.

What outcomes were evaluated to assess bortezomib maintenance therapy?

The primary endpoint was progression-free survival (PFS), with secondary endpoints including PFS2, overall survival (OS), toxicity, and health-related quality of life (HRQoL). HRQoL was measured using EORTC-QLQ-C30 and the myeloma module QLQ-MY20.

How was HRQoL assessed during maintenance therapy?

HRQoL was assessed at baseline (cycle 1, day 1) and on day 1 of each subsequent maintenance cycle. A 10-point or higher change was considered clinically significant, and multi-item scales were scored per the EORTC manual.

Sep 29, 2026

Upload by Miles