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Investigation of the impact of peripheral neuropathic symptoms on the quality of life of patients with smouldering multiple myeloma.

Investigation of the impact of peripheral neuropathic symptoms on the quality of life of patients with smouldering multiple myeloma.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00037503
Enrollment
140
Registered
2025-07-24
Start date
2025-07-28
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C90.00

Interventions

Group 1: Patients without peripheral neuropathic symptoms are interviewed once about their quality of life using the questionnaires: QLQ-C30, QLQ-MY20, QLQ-CIPN "Quality of Life Questionnaire C30, Qua

Sponsors

Universitätsklinikum Heidelberg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: patient at the Multiple Myeloma Section at Heidelberg University Hospital, confirmed smoldering multiple myeloma diagnosis, participation in the Heidelberg Myeloma Registry

Exclusion criteria

Exclusion criteria: Multiple myeloma requiring therapy, Ongoing neoplastic therapy for smoldering multiple myeloma or multiple myeloma, Gammopathy-associated clinically already diagnosed neuropathies (POEMS syndrome, anti-MAG neuropathy, AL amyloidosis, CANOMAD syndrome, cryoglobulinemia)

Design outcomes

Primary

MeasureTime frame
The primary endpoint of the study is the investigation of differences in the quality of life of treatment-naive patients with SMM between potential or diagnosed peripheral neuropathy and patients without peripheral neuropathy. For this purpose, the subjective quality of life of the patients is recorded once using the questionnaires: QLQ-C30, QLQ-MY20, QLQ-CIPN "Quality of Life Questionnaire C30, Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Module, Quality of Life Questionnaire, Multiple Myeloma Module".

Secondary

MeasureTime frame
Frequency distribution of peripheral neuropathy, Possible correlations of quality of life and the basic data collected, such as concomitant diseases, age, date of initial diagnosis and clinical parameters or risk scores relevant to SMM disease for the presence of neuropathic symptoms

Countries

Germany

Contacts

Public ContactEileen Kurre

Universitätsklinikum Heidelberg; Innere Medizin V – Hämatologie, Onkologie, Rheumatologie Sektion Multiples Myelom / Heidelberg Myeloma Center; GMMG Studiensekretariat

eileen.kurre@med.uni-heidelberg.de+49 6221/ 56-8246

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026