KRDI in Transplant-Eligible MM (NCT04430894) | Clinical Trial Compass
Active — Not RecruitingPhase 2
KRDI in Transplant-Eligible MM
United States50 participantsStarted 2020-07-10
Plain-language summary
This research study is testing the efficacy of an experimental drug combination for people with newly diagnosed multiple myeloma that are eligible for a stem cell transplant.
The names of the study drugs involved in this study are:
* Carfilzomib
* Isatuximab
* Lenalidomide
* Dexamethasone
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject must be at least 18 years of age.
* Subject must have documented multiple myeloma satisfying the CRAB criteria and measurable disease defined as:
* Monoclonal plasma cells in the bone marrow ≥10% or presence of a biopsy-proven Plasmacytoma.
* Measurable disease as defined by any of the following:
* IgG myeloma: Serum monoclonal paraprotein (M-protein) level ≥.5 g/dL or urine M-protein level ≥200 mg/24 hours; or
* IgA, IgM, or IgD multiple myeloma: serum M-protein level ≥0.25 g/dL or urine M-protein level ≥200 mg/24 hours; or
* Light chain multiple myeloma: Serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.
* Sixty percent or greater clonal plasma cells on bone marrow examination.
* Serum involved / uninvolved free light chain ratio of 100 or greater, provided the absolute level of the involved free light chain is at least 100 mg/L (a patient's "involved" free light chain - either kappa or lambda - is the one that is above the normal reference range; the uninvolved light chain is the one that typically is in, or below, the normal range).
* More than one focal lesion on magnetic resonance image (MRI) that is at least 5 mm or greater in size.
* Newly diagnosed and considered candidate for high-dose chemotherapy with stem cell transplant.
* Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
* Subject must have pret…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Phase 2 and is actively enrolling patients — but it's no longer recruiting, so could I still potentially access this treatment approach outside the trial, or are there other similar studies I should look into?
2The trial is specifically for transplant-eligible multiple myeloma patients — does my current health status and disease profile actually make me a candidate for transplant, and how does that affect whether this kind of regimen would even be relevant for me?
3The main thing this trial is measuring is complete response rate, meaning how many patients' myeloma becomes undetectable — based on what my doctor knows so far, how likely is it that I could achieve that kind of deep response, and does it change my long-term outlook?
4Since this is a Phase 2 trial, the full safety and long-term benefit data aren't yet established — how does the risk profile of this combination compare to the standard induction regimens my doctor would normally recommend before a transplant?
5If this trial is no longer enrolling, what is the standard-of-care treatment path my doctor would recommend for a transplant-eligible patient like me right now, and how does it compare to what this trial was testing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.