At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Isatuximab (drug), Iberdomide (drug), Dexamethasone (drug)
- How long the study runs
- Study runs about 89 months (dates as stated)
- About the drug or intervention
- Isatuximab — drug: Subcutaneous isatuximab will be delivered using an unlicensed medical device (On Body Delivery System) · Iberdomide — drug: Oral iberdomide · Dexamethasone — drug: Oral dexamethasone
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 63
- Started
- 2025-06-02
- Last checked
- 2024-12
Plain English Summary
What is this study?
- • Testing a new treatment for smouldering myeloma
- • Phase2 - 63 participants
- • The study will test a new combination of 3 drugs: Isatuximab (Isa), Iberdomide (Iber) and Dexamethasone (Dex), in patients who have intermediate or high risk smouldering myeloma
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with smouldering myeloma
Where?
- • London - Barts Health Trust
- • Nottingham - Nottingham City Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The study will test a new combination of 3 drugs: Isatuximab (Isa), Iberdomide (Iber) and Dexamethasone (Dex), in patients who have intermediate or high risk smouldering myeloma. Smouldering myeloma is an early form of myeloma which may progress to active multiple myeloma, but at a slow rate. Patients with smouldering myeloma do not usually receive any treatment but will have regular check-ups and observation. Some patients have a diagnosis of smouldering myeloma which has a higher risk of progressing to active myeloma. The study will test if the combination of drugs is effective at preventing or delaying the disease progressing into active multiple myeloma. The study will also test if the combination is tolerated and accepted by patients.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Able and willing to provide written agreement to take part and comply with protocol-mandated visits, treatment plan,...
- ✓Age ≥ 18 years
- ✓Diagnosed with smouldering myeloma (SMM) within 5 years of study registration AND diagnosed with intermediate or...
- ✓i.e. patients may have been diagnosed de novo with intermediate or high risk smouldering myeloma within 2 years of...
- ✓BM plasma cell infiltrate \>20%
Who cannot take part
- ✗Multiple Myeloma requiring treatment, as defined by IMWG SLiM-CRAB or CRAB criteria.
- ✗Monoclonal gammopathy of undetermined significance (MGUS), solitary plasmacytoma, primary amyloid light-chain (AL)...
- ✗Low or Low-intermediate risk smouldering myeloma by IMWG criteria
- ✗Received previous treatment for myeloma, smouldering myeloma or solitary plasmacytoma.
- ✗Rapidly rising paraprotein or serum free light chains, defined as any of the following occurring within the space of...
See the full criteria
Where Is This Study? (2 UK sites)
Barts Health Trust
London EC1A 7BE, United Kingdom
Nottingham City Hospital
Nottingham NG5 1PB, United Kingdom
How to Get in Touch
MODIFY Trial Manager
Sponsor contactCONTACT
