Plasma Cell Disorders
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Name
Subtype
MGUS
Count4
1
SECURE
2
COSMOS: biology and genetics of smouldering myeloma
3
SEL PCD Registry
4
Ascelus-H
5
RADAR (UK-MRA Myeloma XV)
6
REVAMP
7
Linker-MM3
8
SUCCESSOR-1 (CA057-001)
9
M22-574 Cervino
10
MonumenTAL-6
11
RUDY
12
Ascelus-H
13
SEL PCD Registry
14
MoTD
15
Ascelus-H
16
SEL PCD Registry
17
COSMOS: biology and genetics of smouldering myeloma
Treatment stage
Pre-treatment
2
Treatment stage
Multiple stages
2
Subtype
Myeloma
Count10
Treatment stage
First line
2
Treatment stage
Relapsed / refractory
4
Treatment stage
Multiple stages
4
Subtype
Waldenstrom's
Count2
Treatment stage
Multiple stages
2
Subtype
Smouldering myeloma
Count1
Treatment stage
Pre-treatment
1
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Population
Description
ECOG
PI - Evelina
PI - KCH
PI - GSTT
PI - PRUH
PI - QEH
PI - UHL
Trial summary
Key Eligibility Criteria
Adults with monoclonal gammopathy of undetermined significance
Prospective long-term observational study
NA
Bowcock, S
Bowcock, S
Monoclonal gammopathy of undetermined significance (MGUS) is the distinct precursor to Multiple Myeloma (MM), a rare blood cancer affecting over 5000 people a year in the UK. Although Myeloma is the only clinical state offered therapy, a small number of MGUS patients suffer complications and these are referred to having monoclonal gammopathy of clinical significance (MGCS). Early detection is a high priority for Myeloma patients and drastically improves survival but has the longest diagnostic de

Any individual with a confirmed or suspected case of MGUS

Adults with MGUS or smouldering myeloma
Observational study, using blood and BM samples for laboratory projects
NA
Gunawan, A
Myeloma(MM) is a common bone marrow cancer with over 5,000 patients diagnosed annually in the UK. Patients with MM have cancerous cells in their bone marrow that grow in an uncontrolled fashion and although new treatments have been developed for MM in the last 5 years, it remains an incurable disease, with nearly 3000 deaths yearly. MM is always preceded by defined precursor conditions, known as monoclonal gammopathy of uncertain significance (MGUS) and smouldering myeloma (SMM). However, only 7

All patients with a diagnosis or suspected diagnosis of monoclonal gammopathy of uncertain significance (MGUS) or smouldering myeloma (sMM).

For adults with plasma cell disorders
Research database project
Not specified
Benjamin, R
Streetly, M
Bowcock, S
Patrick, H
Asher, S
The South East London Plasma Cell Disorders Registry is a research database collecting routine clinical data on all patients with myeloma and related disorders under the care of King's College Hospital and Lewisham and Greenwich Hospitals.
  • Patient has a diagnosis of myeloma or a related disorder, including MGUS, MGRS, MGCS, AL amyloidosis, POEMS syndrome, solitary plasmacytoma, and IgM neuropathy, and is under the care of one of the following participating Trusts:
For adults with stable CLL, Haemochromatosis, irron-deficient anaemia, MDS, MGUS, Smouldering myeloma, SCD, or Waldenstrom’s macroglobulinemia
Digital follow-up pathway monitoring long-term stable blood conditions
None
Benjamin, R.
This study has 5 arms: Arm 1 - Patient and carer co-design,collecting qualitative data on patient satisfaction and empowerment on follow-up pathways,via focus groups and individual interviews Arm 2 – Healthcare professionals co-design and feedback,collecting qualitative data on Healthcare professionals views and feedback of the digital follow-up pathways,via focus groups and interviews Arm 3 – Key Opinion Leader (KOL) interviews,investigating issues of implementation,scalability,and commercialis

Inclusion for Arm 1:

For transplant eligible adults with newly diagnosed myeloma
Phase 2/3 study: induction, transplant, consolidation, maintenance
0-2
Cuthill, K
Sachchinanantham, S
This study will investigate different treatment combinations for these two groups of patients. It will also investigate whether a third group of patients, who do respond well to initial treatment, can receive treatment for a shorter period of time without coming to harm. This study gives access to new treatments (the unlicensed drug isatuximab) and treatment combinations. All participants will receive the same initial induction treatment and ASCT. After induction participants will be allocated t
  • Previously untreated patients with multiple myeloma requiring therapy, defined as having myeloma defining events or with biomarkers of malignancy according to IMWG diagnostic criteria
For adults with newly diagnosed myeloma
Response evaluation in myeloma using 18F-FDG PET/MRI
Not specified
Yeghen, T
Yeghen, T
Myeloma, a form of blood cancer, is a debilitating disease affecting 4,800 patients per year [CRUK 2014]. Patients suffer from bone pain due to destructive bone lesions. Imaging plays an important role via lesion detection, therapy triage and response assessment. Skeletal survey, involving x-rays of the entire skeleton [Dimopoulos, Blood, 2011] has been the 'gold standard' but recent studies have shown it only has a sensitivity of 30% for lesion detection [Regelink et al, 2013]. Magnetic resonan

Patients newly diagnosed with myeloma and referred to our institution for further management.

For adults with relapsed myeloma, 1-4 prior lines incl. PI & len
Phase 3 randomised study: linvoseltamab vs EPd
0-1
Streetly, M
This is an open-label phase 3, randomized, active controlled study designed to evaluate the efficacy and safety of linvoseltamab monotherapy vs EPd in participants with relapsed/refractory multiple myeloma (RRMM) who have received 1 to 4 prior lines of therapy including a proteasome inhibitor and lenalidomide. Participants in the European Union (EU) and the United Kingdom (UK) must have previously received 2 to 4 prior lines of therapy, including a CD38 antibody. A total of approximately 300 eli
  • Age 18 years or older (or legal adult age in the country) at the time of the screening visit.
For adults with relapsed / refractory myeloma
Phase 3 randomised open-label study: CC-92480 / Bor / Dex vs Pom / Bor / Dex
0-2
Cuthill, K
Gardner, K
A Phase 3, Randomized, Multicenter, Open-Label Study, Comparing CC-92480, Bortezomib and Dexamethasone (480Vd), with Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects with Relapsed or Refractory Multiple Myeloma (RRMM)
  • Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
For adults with myeloma, after 2 or more lines of therapy
Phase 3 randomised study: ABBV-383
0-2
Streetly, M
This is a Phase 3, multicenter, randomized, open-label, parallel group study designed to evaluate the efficacy, safety, and tolerability of ABBV-383 monotherapy compared with SATs in subjects with RRMM who have received ≥ 2 prior lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb, and are refractory to or progressing on last line of treatment. The study will enroll approximately 380 subjects in the randomized portion of the trial. In China only, there will be a separate
  • Subjects must voluntarily sign and date an informed consent, approved by an IEC/IRB, prior to the initiation of any screening or study-specific procedures.
Adults with relapsed myeloma who have received 1-4 prior lines incl. Anti-CD38 Antibody and Lenalidomide
Phase 3 randomised study: Talquetamab with Pomalidomide (Tal-P) vs Talquetamab with Teclistamab (Tal-Tec) vs investigator choice (Elo/Pom/Dex or Pom/Bor/Dex)
Not specified
Bailey, K
A Phase 3 Randomized Study Comparing Talquetamab in Combination with Pomalidomide (Tal-P), Talquetamab in Combination with Teclistamab (Tal-Tec), and Investigator’s Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone (PVd) in Participants with Relapsed or Refractory Myeloma who Have Received 1 to 4 Prior Lines of Therapy Including an Anti-CD38 Antibody and Lenalidomide
  • ≥ 18 years of age at the time of informed consent
For adults with myeloma
Observational cohort study
Not specified
Bowcock, S
Bowcock, S
This is a prospective cohort study. It aims to develop a national cohort of participants with myeloma (smouldering and active multiple myeloma) using the rare diseases RUDY platform.. From this cohort we will characterize participants using their clinical history to describe the natural history of the disease, its effect on quality of life and improve our understanding across all aspects of myeloma. This is a patient centred study and much of the information will be reported directly by the pati
  • Age range 0 – 100 years
For adults with stable CLL, Haemochromatosis, irron-deficient anaemia, MDS, MGUS, Smouldering myeloma, SCD, or Waldenstrom’s macroglobulinemia
Digital follow-up pathway monitoring long-term stable blood conditions
None
Benjamin, R.
This study has 5 arms: Arm 1 - Patient and carer co-design,collecting qualitative data on patient satisfaction and empowerment on follow-up pathways,via focus groups and individual interviews Arm 2 – Healthcare professionals co-design and feedback,collecting qualitative data on Healthcare professionals views and feedback of the digital follow-up pathways,via focus groups and interviews Arm 3 – Key Opinion Leader (KOL) interviews,investigating issues of implementation,scalability,and commercialis

Inclusion for Arm 1:

For adults with plasma cell disorders
Research database project
Not specified
Benjamin, R
Streetly, M
Bowcock, S
Asher, S
The South East London Plasma Cell Disorders Registry is a research database collecting routine clinical data on all patients with myeloma and related disorders under the care of King's College Hospital and Lewisham and Greenwich Hospitals.
  • Patient has a diagnosis of myeloma or a related disorder, including MGUS, MGRS, MGCS, AL amyloidosis, POEMS syndrome, solitary plasmacytoma, and IgM neuropathy, and is under the care of one of the following participating Trusts:
For adults awaiting a planned allo-SCT
Phase 2 trial: Thymoglobulin vs. Calcineurin inhibitor or cyclophosphamide as GvHD prophylaxis
Not specified
Krishnamurthy, P
Stem cell transplantation from a matched sibling or unrelated donor (allo-SCT) is the only curative therapy for many children and adults with blood cancer. However allo-SCT remains associated with a number of life-threatening side effects, the most serious of which is ‘graftversus-host disease’ (GvHD). This complication occurs when donor immune cells (the ‘graft’) see the patient’s healthy skin, gut or liver (the ‘host’) as foreign and attacks them. Patients currently receive a combination of d
  • Availability of suitably matched unrelated donor (9/10 or 10/10)
For adults with stable CLL, Haemochromatosis, irron-deficient anaemia, MDS, MGUS, Smouldering myeloma, SCD, or Waldenstrom’s macroglobulinemia
Digital follow-up pathway monitoring long-term stable blood conditions
None
Benjamin, R.
This study has 5 arms: Arm 1 - Patient and carer co-design,collecting qualitative data on patient satisfaction and empowerment on follow-up pathways,via focus groups and individual interviews Arm 2 – Healthcare professionals co-design and feedback,collecting qualitative data on Healthcare professionals views and feedback of the digital follow-up pathways,via focus groups and interviews Arm 3 – Key Opinion Leader (KOL) interviews,investigating issues of implementation,scalability,and commercialis

Inclusion for Arm 1:

For adults with plasma cell disorders
Research database project
Not specified
Benjamin, R
Streetly, M
Bowcock, S
Patrick, H
Asher, S
The South East London Plasma Cell Disorders Registry is a research database collecting routine clinical data on all patients with myeloma and related disorders under the care of King's College Hospital and Lewisham and Greenwich Hospitals.
  • Patient has a diagnosis of myeloma or a related disorder, including MGUS, MGRS, MGCS, AL amyloidosis, POEMS syndrome, solitary plasmacytoma, and IgM neuropathy, and is under the care of one of the following participating Trusts:
Adults with MGUS or smouldering myeloma
Observational study, using blood and BM samples for laboratory projects
NA
Gunawan, A
Myeloma(MM) is a common bone marrow cancer with over 5,000 patients diagnosed annually in the UK. Patients with MM have cancerous cells in their bone marrow that grow in an uncontrolled fashion and although new treatments have been developed for MM in the last 5 years, it remains an incurable disease, with nearly 3000 deaths yearly. MM is always preceded by defined precursor conditions, known as monoclonal gammopathy of uncertain significance (MGUS) and smouldering myeloma (SMM). However, only 7

All patients with a diagnosis or suspected diagnosis of monoclonal gammopathy of uncertain significance (MGUS) or smouldering myeloma (sMM).

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