Actively Recruiting
Isatuximab and Iberdomide as Immunotherapy for High Risk in Smouldering Myeloma
Led by University College, London · Updated on 2025-08-01
63
Participants Needed
2
Research Sites
387 weeks
Total Duration
On this page
Sponsors
U
University College, London
Lead Sponsor
S
Sanofi
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Isatuximab and Iberdomide as Immunotherapy for High Risk in Smouldering Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent and follow study visits, treatment, and tests
- Age 18 years or older
- Diagnosed with smouldering myeloma within 5 years and classified as intermediate or high risk within 2 years of study registration
- Intermediate or high risk smouldering myeloma defined by IMWG criteria with at least two of these factors: bone marrow plasma cell infiltration over 20%, serum paraprotein over 20g/L, serum free light chain ratio over 20 but less than 100, or certain genetic abnormalities by FISH
- Measurable disease with paraprotein at least 5g/L, serum free light chains at least 100mg/L with abnormal ratio, or Bence Jones protein at least 200mg/24hr
- ECOG performance status of 0 to 2
- Total bilirubin less than or equal to 1.5 times the upper limit of normal
- ALT and/or AST less than or equal to 3 times the upper limit of normal
- Adequate marrow function with neutrophils at least 1.0 x109/L (or 0.75 if certain neutropenia diagnosed), hemoglobin at least 100g/L, and platelets at least 75 x109/L
- Creatinine clearance at least 30 mL/min after correcting reversible causes
- Willing to follow contraceptive requirements of the trial
You will not qualify if you...
- Multiple myeloma requiring treatment by IMWG criteria
- Monoclonal gammopathy of undetermined significance, solitary plasmacytoma, or primary amyloid light-chain amyloidosis
- Low or low-intermediate risk smouldering myeloma
- Previous treatment for myeloma, smouldering myeloma, or solitary plasmacytoma
- Treatment with any other anti-cancer therapy, including investigational therapy, within 4 weeks before registration
- Rapidly rising paraprotein or serum free light chains within 2 months
- Corticosteroid treatment over 10 mg prednisone or equivalent per day within 28 days before study drugs
- Unstable heart conditions or severe heart disease
- Prior or concurrent invasive cancers except certain treated skin, prostate, breast, cervical cancers or cancers disease-free for 3 years
- Major surgery within 21 days before registration
- Gastrointestinal disease or procedure affecting oral drug absorption or tolerance
- Active systemic infection
- Positive test for acute or chronic hepatitis B or C infection unless specific criteria met
- Positive HIV test unless stable on therapy with adequate immune status
- Other medical or psychiatric conditions that contraindicate participation
- Receipt of live vaccine within 30 days before registration and during study plus 3 months after last dose
- Contraindication to blood clot prevention treatment
- History or risk of seizures not well controlled
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Barts Health Trust
London, United Kingdom, EC1A 7BE
Actively Recruiting
2
Nottingham City Hospital
Nottingham, United Kingdom, NG5 1PB
Actively Recruiting
Research Team
M
MODIFY Trial Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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