Clinical trial · Observational
This Study Aims to Clarify the Prevalence and Characteristics of Neuropathy, Along With Associated Paraclinical Findings in Patients With Waldenström's Macroglobulinemia (WM) in a Cohort of WM Patients to Optimize the Diagnostic Process
Neuropathy in Waldenström's Macroglobulinemia: Pathophysiology, Prognosis and Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Neuropathy severely reduces patients' quality of life due to sensory loss, chronic neuropathic pain, and loss of mobility of arms and legs. Given the diverse origins of neuropathy, it is critical to identify its specific causes, particularly when effective treatments are available. Neuropathy is a frequent morbidity in Waldenström's macroglobulinemia (WM), a specific type of lymphoma caused by infiltration of clonal lymphoplasmocytic B cells in the bone marrow with the presence of IgM paraprotein. WM associated neuropathy is largely undescribed. The few existing studies are mostly retrospective indicating the neuropathy has a heterogenic pathophysiology and diverse clinical appearance from mild sensory neuropathy to aggressive with loss of ambulation and development of chronic neuropathic pain within weeks to months. With treatment of WM the speed of the disease progression including the related neuropathy can be halted. Few studies and clinical experience indicate that the nerve damage induced by WM might remit if treatment is initiated early in the course of the disease. Thus, there is need for timely interventions to reduce chronic disabilities. However, even for an experienced neurologist, it can be difficult to identify whether the neuropathy is caused by WM or other causes where treatment is not indicated. This project aims to investigate the prevalence and underlying mechanisms of neuropathy in patients with WM to help speed up the diagnostic process and thus help slow down the irreversible nerve damage that these patients experience.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral Neuropathies | — | UNRESOLVED | — |
| Waldenstrom Macroglobulinaemia | Waldenstrom Macroglobulinemia | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Neuropathy associated to Waldenström's Macroglobulinemia
Primary outcomes (1)
- measure
- Prevalence of peripheral neuropathy associated to Waldenström Macroglobulinema (WM)
- timeFrame
- From enrollment from August 2024 and new diagnosed patients with WM and symptoms of neuropathy refered to the neuromuscular clinic until July 2025.
- description
- The prevalence will be calculated by screening WM patients with a questionnaire designed specific for the research project to identify possible peripheral neuropathy. Patients with possible peripheral neuropathy will be clinical examined to either positiv og negative for peripheral neuropathy and confirmed by nerve conduction study. The prevalence will be the amount of patient with polyneuropathy in the population of investigated patientes with WM.
Secondary outcomes (1)
- measure
- Disability of WM associated polyneuropathy
- timeFrame
- Investigation during one year with follow up for 3 years
- description
- The severity of WM associated neuropathy will be assesed by neuropathy scores - INCAT disability score (a scale of 0-10 with higher scores indicating greater disability.) * MRC 80 sum score (0-80. Lower score indicating more severe paralysis) * INCAT sensory sum score (0-20 with with higher scores indicating greater sensory abnormalities) * Modified Rankin scale: numbered 0 to 6, with higher scores indicating greater disability.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of Waldenström's Macroglobulinemia with symptoms of peripheral neuropathy for further clinical investigation. Exclusion Criteria: * Investigated with no sign of peripheral neuropathy
References
Publications (14)
- BACKGROUNDBuske C, Castillo JJ, Abeykoon JP, Advani R, Arulogun SO, Branagan AR, Cao X, D'Sa S, Hou J, Kapoor P, Kastritis E, Kersten MJ, LeBlond V, Leiba M, Matous JV, Paludo J, Qiu L, Tam CS, Tedeschi A, Thomas SK, Tohidi-Esfahani I, Varettoni M, Vos JM, Garcia-Sanz R, San-Miguel J, Dimopoulos MA, Treon SP, Trotman J. Report of consensus panel 1 from the 11th International Workshop on Waldenstrom's Macroglobulinemia on management of symptomatic, treatment-naive patients. Semin Hematol. 2023 Mar;60(2):73-79. doi: 10.1053/j.seminhematol.2023.03.005. Epub 2023 Mar 29. PMID 37099027
- BACKGROUNDD'Sa S, Kersten MJ, Castillo JJ, Dimopoulos M, Kastritis E, Laane E, Leblond V, Merlini G, Treon SP, Vos JM, Lunn MP. Investigation and management of IgM and Waldenstrom-associated peripheral neuropathies: recommendations from the IWWM-8 consensus panel. Br J Haematol. 2017 Mar;176(5):728-742. doi: 10.1111/bjh.14492. Epub 2017 Feb 15. PMID 28198999
- BACKGROUNDTreon SP, Hanzis CA, Ioakimidis LI, Patterson CJ, Hunter ZR, Brodsky PS, m.fl. Clinical characteristics and treatment outcome of disease-related peripheral neuropathy in Waldenstrom's macroglobulinemia (WM). J Clin Oncol. 20. maj 2010;28(15_suppl):8114-8114.
- BACKGROUNDHanewinckel R, Drenthen J, van Oijen M, Hofman A, van Doorn PA, Ikram MA. Prevalence of polyneuropathy in the general middle-aged and elderly population. Neurology. 2016 Nov 1;87(18):1892-1898. doi: 10.1212/WNL.0000000000003293. Epub 2016 Sep 28. PMID 27683845
- BACKGROUNDDimopoulos MA, Kastritis E, Owen RG, Kyle RA, Landgren O, Morra E, Leleu X, Garcia-Sanz R, Munshi N, Anderson KC, Terpos E, Ghobrial IM, Morel P, Maloney D, Rummel M, Leblond V, Advani RH, Gertz MA, Kyriakou C, Thomas SK, Barlogie B, Gregory SA, Kimby E, Merlini G, Treon SP. Treatment recommendations for patients with Waldenstrom macroglobulinemia (WM) and related disorders: IWWM-7 consensus. Blood. 2014 Aug 28;124(9):1404-11. doi: 10.1182/blood-2014-03-565135. Epub 2014 Jul 15. PMID 25027391
- BACKGROUNDCastillo JJ, D'Sa S, Lunn MP, Minnema MC, Tedeschi A, Lansigan F, Palomba ML, Varettoni M, Garcia-Sanz R, Nayak L, Lee EQ, Rinne ML, Norden AD, Ghobrial IM, Treon SP. Central nervous system involvement by Waldenstrom macroglobulinaemia (Bing-Neel syndrome): a multi-institutional retrospective study. Br J Haematol. 2016 Mar;172(5):709-15. doi: 10.1111/bjh.13883. Epub 2015 Dec 21.