Biology and Genetics of Smouldering Myeloma

NCT05047107 | Unknown DMC

• 1 other identifier: 129657
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Observational clinical trial recruiting Smouldering Myeloma patients (SMM) or potential SMM patients. Study involves collecting blood and bone marrow samples to determine the features of the tumour genome and BM microenvironment, including immune dysfunction that are key drivers of progression from precursor conditions (MGUS and SMM) to MM.

Conditions

Smouldering Myeloma; MGUS; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Genomic markers of progression

  To characterise genomic markers of progression by sequencing and studying the biology of bone marrow (BM) derived tumour cells.

  5 years

Secondary Outcomes (1)

• Immune biomarkers

  5 years

Interventions

No intervention OTHER

Non-interventional study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any individual with a confirmed or suspected diagnosis of MGUS, SMM, or MM.

You may qualify if:

• Any individual with a confirmed or suspected diagnosis of MGUS, SMM, or MM.

You may not qualify if:

• Patients under the age of 18
• Patients with active symptomatic myeloma at diagnosis
• Patients with no evidence of MGUS, sMM or MM

Sponsors & Collaborators

• University College, London: lead
• Cancer Research UK: collaborator

Study Sites (1)

University College London Hospitals

London, NW1 2PG, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

BM aspirates and blood samples will be processed to extract tumour and non-tumour cells, as well as plasma and sera. Mononuclear cells (MNCs) will be prepared from these samples by centrifugal sedimentation, or red cell lysis, and plasma cells will be selected using immuno-magnetic beads coupled to monoclonal antibody specific to the plasma cell marker, CD138. In some cases, purified MM cells will be isolated by negative selection using RosetteSep method, which depletes immature progenitors, T-lymphocytes and NK cells. Immune cells, including CD4 and CD8 T cells will be separated by similar means for further assessment. MM cells, immune cells and bulk MNCs will be frozen and stored for future DNA and RNA extraction. Cell lysates will be made for immuno-blotting and live cells will be frozen for use in functional assays.

MeSH Terms

Conditions

Smoldering Multiple Myeloma; Multiple Myeloma

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Hypergammaglobulinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Paraproteinemias; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders

Central Study Contacts

Kwee Yong, Prof

CONTACT

02076796233; kwee.yong@ucl.ac.uk

Louise Ainley, MD

CONTACT

02076796233; l.ainley@ucl.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: September 16, 2021
• Study Start: April 15, 2021
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)