C90.00
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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
Universitätsklinikum Heidelberg; Innere Medizin V – Hämatologie, Onkologie, Rheumatologie Sektion Multiples Myelom / Heidelberg Myeloma Center; GMMG Studiensekretariat