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Iceland Screens Treats or Prevents Multiple Myeloma (iStopMM): A nationwide phase 2 trial of patients with smoldering and active multiple myeloma (MM)
EU CTIS ID: 2024-519353-11-00
What this study is testing
This is a phase II study to assess the efficacy of treating patients with intermediate-risk SMM with combinational therapy with dexamethasone and lenalidomide and treating patients with high risk SMM with combinational therapy with dexamethasone, lenalidomide, and carfilzomib. The primary objective is to determine MRD negativity rate at three years after study enrollment.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Active MM or SMM which is untreated
- Willing to follow strict birth control measures as outlined in the protocol
- Patients must be willing and able to adhere to the study schedule and other protocol requirement
- At least 18 years of age, with at least 6 months of expected survival
- Active MM or SMM (defined as measurable M spike OR pathological FLC ratio AND bone marrow PC% > 10%) which is untreated
- Laboratory values, see protocol
You likely can't join if
- MGUS or low risk smoldering myeloma
- Known hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection
- Any medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol
- Known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients or known sensitivity to mammalian-derived products
- Inability to comply with protocol/procedures
- Diagnosed or treated for another malignancy ≤ 2 years before trial enrollment or previously diagnosed with another malignancy and have any evidence of residual disease
See the full eligibility criteria
- Active MM or SMM which is untreated
- Willing to follow strict birth control measures as outlined in the protocol
- Patients must be willing and able to adhere to the study schedule and other protocol requirement
- At least 18 years of age, with at least 6 months of expected survival
- Active MM or SMM (defined as measurable M spike OR pathological FLC ratio AND bone marrow PC% > 10%) which is untreated
- Laboratory values, see protocol
- Prior therapy for the treatment of solitary plasmacytoma is permitted, but >7 days should have elapsed from the last day of radiation.
- Measurable disease as defined by at least ONE of the following: Serum monoclonal protein >1.0 g/L, >200 mg of monoclonal protein in the urine on 24 hour electrophoresis , Serum immunoglobulin free light chain ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
- ECOG performance status (PS) 0, 1 or 2
- Provide informed written consent
- Negative pregnancy test done ≤7 days prior to entry, for women of childbearing potential only
- MGUS or low risk smoldering myeloma
- Known hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection
- Any medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol
- Known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients or known sensitivity to mammalian-derived products
- Inability to comply with protocol/procedures
- Diagnosed or treated for another malignancy ≤ 2 years before trial enrollment or previously diagnosed with another malignancy and have any evidence of residual disease
- Pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception
- Other co-morbidity which would interfere with subject's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
- Other concurrent chemotherapy, or any ancillary therapy considered investigational
- Peripheral neuropathy > Grade 3 on clinical examination or grade 2 with pain within 30 days prior to C1D1
- Major surgery ≤14 days prior to C1D1
- Evidence of current uncontrolled cardiovascular conditions, including hypertension, cardiac arrhythmias, congestive heart failure, unstable angina, or myocardial infarction within the past 6 months
- Known human immunodeficiency virus (HIV) positive
The study team makes the final eligibility decision.
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, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.