Monoclonal gammopathy of undetermined significance (MGUS) and smoldering myeloma (SMM): a practical guide to management

Maciocia, Nicola; Wechalekar, Ashutosh; Yong, Kwee

doi:10.1002/hon.2345

Cited by 9 publications

(7 citation statements)

References 51 publications

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“…Few treatment studies, aiming to prevent or delay the development of manifest disease in SMM, have been conducted [ 6 , 21 – 31 ]. Up to the present, standard of care is close observation without treatment until progression [ 5 ]. Theoretically, targeted therapy with monoclonal antibodies, without expected long-term side effects, would be an attractive treatment strategy for patients with SMM.…”

Section: Discussionmentioning

confidence: 99%

“…The International Myeloma Working Group (IMWG) has defined smoldering multiple myeloma as a disorder where the patient has a serum monoclonal (M) protein (IgG or IgA) ≥3 g/100 ml and/or clonal bone marrow plasma cells (BMPCs) of ≥10%, but no CRAB symptoms (increased c alcium level, r enal failure, a nemia or destructive b one lesions) [ 4 ]. The current standard of care is observation without treatment until progression to symptomatic multiple myeloma [ 5 ]. Only one clinical trial so far has shown a benefit in overall survival for high-risk SMM patients on treatment with lenalidomide/dexamethasone compared to observation [ 6 ].…”

Section: Introductionmentioning

confidence: 99%

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A single-arm, open-label, phase 2 clinical trial evaluating disease response following treatment with BI-505, a human anti-intercellular adhesion molecule-1 monoclonal antibody, in patients with smoldering multiple myeloma

et al. 2017

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BackgroundSmoldering multiple myeloma (SMM) is an indolent disease stage, considered to represent the transition phase from the premalignant MGUS (Monoclonal Gammopathy of Undetermined Significance) state towards symptomatic multiple myeloma (MM). Even though this diagnosis provides an opportunity for early intervention, few treatment studies have been done and the current standard of care is observation until progression. BI-505, a monoclonal antibody directed against intercellular adhesion molecule 1 (ICAM-1) with promising anti-myeloma activity in preclinical trials, is a possible treatment approach for this patient category with potential to eliminate tumor cells with minimal long-term side effects. BI-505 was well tolerated in an earlier phase 1 trial.Methods and findingsIn this phase 2 trial the effects of BI-505 in patients with SMM were studied. Four patients were enrolled and three of them completed the first cycle of treatment defined as 5 doses of BI-505, a total of 43 mg/kg BW, over a 7-week period. In the three evaluable patients, BI-505 showed a benign safety profile. None of the patients achieved a response as defined per protocol. EudraCT number: 2012-004884-29.ConclusionsThe study was conducted to assess the efficacy, safety and pharmacodynamics of BI-505 in patients with SMM. BI-505 showed no clinically relevant efficacy on disease activity in these patients with SMM, even if well tolerated.Trial registrationClinicalTrials.gov Identifier: NCT01838369.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A single-arm, open-label, phase 2 clinical trial evaluating disease response following treatment with BI-505, a human anti-intercellular adhesion molecule-1 monoclonal antibody, in patients with smoldering multiple myeloma

et al. 2017

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“…24,98,99 Stratified models of monitoring have been proposed, based on risk of progression, although risk models continue to be refined. 100,101…”

Section: Mon Itor I Ng Of Patie N Ts W Ith Smou L Der I Ng M Y E Lom Amentioning

confidence: 99%

Diagnosis and management of smouldering myeloma: A British Society for Haematology Good Practice Paper

Hughes,

Yong,

Ramasamy

et al. 2024

Br J Haematol

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This good practice paper was compiled according to the British Society for Haematology (BSH) process at (https:// b-s-h. org. uk/ media/ 16732/ bsh-guida nce-devel opmen tproce ss-dec-5-18. pdf). The Grading of Recommendations Assessment, Development and Evaluation (GRADE) nomenclature was used to evaluate the levels of evidence and to assess the strength of recommendations. The BSH produces good practice papers to recommend good practice in areas where there is a limited evidence base, but for which a degree of consensus or uniformity is likely to be beneficial to patient care. Literature review detailsA literature search was performed using the EMBASE and MEDLINE databases using the following search terms: monoclonal gammopathy of undetermined significance, multiple myeloma, smouldering (smoldering) multiple myeloma; monoclonal gammopathy, MGUS. Review of the manuscriptReview of the manuscript was performed by the BSH Haemato-Oncology Task Force, the BSH Guidelines Committee and the Haemato-Oncology sounding board of BSH. It has also been reviewed by the UK Myeloma Society and Myeloma UK. I N TRODUC TIONMultiple myeloma (MM) is a clonal bone marrow disorder of plasma cells. MM is preceded by the precursor conditions monoclonal gammopathy of undetermined significance (MGUS) and smouldering myeloma (SMM). SMM sits between MGUS and MM, representing a plasma

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“…-serum monoclonal protein <30 g/L; -clonal BM plasma cells (PCs) <10%; and -absence of end-organ damage (hypercalcemia, renal insufficiency, anemia, and bone lesions) [Maciocia N. et al, 2016].…”

Section: Mgus Criteriamentioning

confidence: 99%

Plasma cell myeloma – therapeutic opportunities

Orzechowska

Karolina

Pawłowski

et al. 2022

J Educ Health Sport

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Introduction: Plasmocytic myeloma (PCM) is a neoplastic disease with a multistage course. Monoclonal plasmocytes undergo uncontrolled, multifocal growth in the bone marrow, which results in the production of monoclonal immunoglobulin or its fragments that damage the bone marrow. Aim: The aim of this study is to present selected therapeutic possibilities of multiple myeloma. Materials and methods: The work uses the method of non-systematic review and analysis of the available scientific literature. Databases such as PubMed, Google Scholar, Arianta, Scopus, Web of Science were searched. The years 2005-2022 were assumed as the review period. Discussion: Multiple myeloma accounts for 1-2% of all cancer cases, and 10-15% of all hematological cancers. It is the third most common lymphoid neoplasm after chronic lymphocytic leukemia and large B-cell lymphoma. The diagnosis of PCM requires the presence of a minimum of 10% clonal plasmocytes in the bone marrow or biopsy confirmed plasmocytoma. Moreover, the CRAB and SLiM CRAB criteria are also important. Treatment should be initiated in all symptomatic patients meeting the SLiM CRAB criteria. The first stage of treatment is to induce remission of the disease. Conclusions: Thanks to the progress of medicine, an increasing percentage of patients achieve permanent remissions. The success of the therapy is a component of the earliest possible detection of the disease and the use of appropriate, individually selected drugs.

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Monoclonal gammopathy of undetermined significance (MGUS) and smoldering myeloma (SMM): a practical guide to management

Cited by 9 publications

References 51 publications

A single-arm, open-label, phase 2 clinical trial evaluating disease response following treatment with BI-505, a human anti-intercellular adhesion molecule-1 monoclonal antibody, in patients with smoldering multiple myeloma

A single-arm, open-label, phase 2 clinical trial evaluating disease response following treatment with BI-505, a human anti-intercellular adhesion molecule-1 monoclonal antibody, in patients with smoldering multiple myeloma

Diagnosis and management of smouldering myeloma: A British Society for Haematology Good Practice Paper

Plasma cell myeloma – therapeutic opportunities

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