DARA RVD For High Risk SMM (NCT04775550) | Clinical Trial Compass
Active — Not RecruitingPhase 2
DARA RVD For High Risk SMM
United States61 participantsStarted 2021-03-08
Plain-language summary
The purpose of this research study is to learn whether the combination of daratumumab SC ( Darzalex Faspro), lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone works in treating smoldering multiple myeloma and preventing progression to active or symptomatic multiple myeloma.
The names of the study drugs involved in this study are:
* Daratumumab (also called Darzalex Faspro)
* Bortezomib (also called Velcade)
* Lenalidomide (also called Revlimid)
* 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:
* Age ≥ 18 years.
* Must meet criteria of high-risk smoldering MM as described with one of the below criteria:
* Bone marrow clonal plasma cells ≥10% and any one or more of the following:
* Serum M protein ≥3.0 gm/dL
* Immunoparesis with reduction of two uninvolved immunoglobulin isotypes
* Serum involved/uninvolved free light chain ratio ≥8 (but less than 100)
* Free Light Chain Smoldering Myeloma patients are not excluded
* Progressive increase in M protein level (Evolving type of SMM)\*\*\* Increase in serum monoclonal protein by ≥10% on two successive evaluations within a 6-month period
* Bone marrow clonal plasma cells 50-60%
* Abnormal plasma cell immunophenotype (≥95% of bone marrow plasma cells are clonal) and reduction of one or more uninvolved immunoglobulin isotypes
* High Risk FISH defined as any one or several of the following: t(4;14), t(14;16), t(14;20), del 17p or 1q gain
* MRI with diffuse abnormalities or 1 focal lesion (≥5mm)
* PET-CT with one focal lesion (≥5mm) with increased uptake without underlying osteolytic bone destruction
* OR High-risk per IMWG/Mayo 2018 "20-2-20" Criteria (at least 2 of the following)
* Bone marrow plasmacytosis ≥20%
* ≥ 2g/dl M protein
* 20 involved: uninvolved serum free light chain ratio
* No evidence of CRAB criteria\* or new criteria of active MM which including the following:
* Increased calcium levels: Corrected serum calcium \>0.25 mmol/…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
Proportion of high risk smoldering multiple myeloma (SMM) patients who are MRD negative (MRD-)