BridgeMD
New treatment option for Smouldering Myeloma
Official title Isatuximab and Iberdomide as Immunotherapy for High Risk in Smouldering Myeloma
ClinicalTrials.gov ID: NCT06762769
What this study is testing
What is Isatuximab?
Isatuximab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for smouldering myeloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Able and willing to provide written informed consent and comply with protocol-mandated visits, treatment plan, laboratory tests and other study...
- Age ≥ 18 years
- Diagnosed with smouldering myeloma (SMM) within 5 years of study registration AND diagnosed with intermediate or high risk SMM within 2 years of...
- i.e. patients may have been diagnosed de novo with intermediate or high risk smouldering myeloma within 2 years of study registration OR
- patients may have been diagnosed with low or low-intermediate smouldering myeloma within 5 years of study registration and then their risk...
You likely can't join if
- 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) amyloidosis.
- Low or Low-intermediate risk smouldering myeloma by IMWG criteria
- Received previous treatment for myeloma, smouldering myeloma or solitary plasmacytoma.
- Treatment with any other standard anti-cancer radiotherapy/chemotherapy/targeted therapy including investigational therapy (defined as treatment for...
- Rapidly rising paraprotein or serum free light chains, defined as any of the following occurring within the space of 2 months:
See the full eligibility criteria
Who can join
- Able and willing to provide written informed consent and comply with protocol-mandated visits, treatment plan, laboratory tests and other study procedures.
- Age ≥ 18 years
- Diagnosed with smouldering myeloma (SMM) within 5 years of study registration AND diagnosed with intermediate or high risk SMM within 2 years of registration.:
- i.e. patients may have been diagnosed de novo with intermediate or high risk smouldering myeloma within 2 years of study registration OR
- patients may have been diagnosed with low or low-intermediate smouldering myeloma within 5 years of study registration and then their risk classification has changed to intermediate or high risk within 2 years of study...
- Diagnosed with intermediate or high-risk SMM defined by IMWG diagnostic criteria and IMWG SMM risk stratification. Intermediate or high risk is defined by the presence of 2 or more of the following factors:
- BM plasma cell infiltrate \>20%
- Serum paraprotein \>20g/l
- Serum Free Light Chain (SFLC) Ratio \>20 (but \<100)
- Presence of t(4;14), t(14;16), del 17p, del 13q or 1q gain by fluorescence in situ hybridization (FISH) studies. Copy number abnormalities will be considered significant if present in ≥ 20% of cells.
- Measurable disease with at least one of the following:
- Paraprotein ≥5g/L
- Serum free light chains ≥100mg/L with abnormal light chain ratio
- Bence Jones protein ≥200mg/24hr
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 3 x ULN (if ALT and AST are tested, both must meet this criteria)
- Adequate marrow function:
- Neutrophils ≥1.0 x109/L (unless the participant has a known/suspected diagnosis of familial or racial neutropenia in which case an ANC ≥0.75 x 109/L is allowed),
- Haemoglobin (Hb) ≥ 100g/L
- Platelets ≥ 75 ×109/L
- Creatinine clearance (CrCl) ≥ 30 mL/minute, according to the Cockcroft-Gault formula, following correction of reversible causes (e.g. dehydration, hypercalcaemia, sepsis)
- Willing to comply with the contraceptive requirements of the trial
What rules you out
- 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) amyloidosis.
- Low or Low-intermediate risk smouldering myeloma by IMWG criteria
- Received previous treatment for myeloma, smouldering myeloma or solitary plasmacytoma.
- Treatment with any other standard anti-cancer radiotherapy/chemotherapy/targeted therapy including investigational therapy (defined as treatment for which there is currently no regulatory authority approved indication)...
- Rapidly rising paraprotein or serum free light chains, defined as any of the following occurring within the space of 2 months:
- doubling of serum M-protein (minimum rise 5g/l)
- increase of serum M-protein by ≥10 g/L
- increase of involved serum-free light chains (FLC) level by ≥200 mg/L (plus abnormal ratio)
- increase of Bence Jones protein by ≥500mg/24hr
- Corticosteroid treatment with a dose \>10 mg prednisone or equivalent per day within 28 days of initiation of study drugs.
- Unstable angina or myocardial infarction within 4 months prior to registration, NYHA Class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular...
- Prior or concurrent invasive malignancies except the following:
- Adequately treated basal cell or squamous cell skin cancer.
- Incidental finding of low grade (Gleason 3+3 or less) prostate cancer requiring no intervention. (Hormone monotherapy is permitted if overall survival is anticipated to be \>5 years).
- Adequately treated carcinoma in situ of the breast or cervix no longer requiring medical or surgical intervention.
- Any cancer from which the patient has been disease-free for at least 3 years.
- Any major surgery within 21 days prior to registration which in the investigator's opinion would compromise trial treatment and/or the patient's ability to comply with trial visits.
- Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of trial treatment, including difficulty swallowing.
- Active systemic infection
- Positive serologic and/or polymerase chain reaction (PCR) test results for acute or chronic hepatitis B virus (HBV) infection. (Note: Patients whose HBV infection status cannot be determined by serologic test results...
- Positive test results for hepatitis C virus (HCV). Note: Patients who are positive for HCV antibody must be negative for HCV by PCR to be eligible for study participation.
- Positive test results for human immunodeficiency virus (HIV). Note: Patients with a positive HIV test at screening are eligible provided they are stable on antiretroviral therapy, have a CD4 count ≥ 200/μL, and have an...
- Any other medical or psychiatric condition which, in the opinion of the investigator, contraindicates the participant's participation in this study.
- Receipt of live vaccination within 30 days prior to registration, for the duration of the study and for 3 months after the last dose of study drug.
- Contraindication to thromboprophylaxis.
- Participant has risk factors for seizures or seizures that are not well controlled on current medication.
- Women who are pregnant or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
- Nottingham, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom; Nottingham, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.