A Study of Lenalidomide and CC-486 With Radiation Therapy in Patients With Plasmacytoma (NCT04174196) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Lenalidomide and CC-486 With Radiation Therapy in Patients With Plasmacytoma
United States21 participantsStarted 2019-11-19
Plain-language summary
The purpose of this study is to investigate if the combination of CC-486 with lenalidomide and radiation therapy is a safe and effective treatment for plasmacytoma.
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:
Cohort 1: Must meet all the following 3 criteria:
* Histologically confirmed newly diagnosed or recurrent solitary plasmacytoma/lytic lesion (recurrent solitary plasmacytomas will be considered based on treating physician discretion for cases where they clinically plan to treat with RT alone) - Minimal marrow involvement (Detectable clonal bone marrow plasma cells by multicolor flow cytometry and \</= 10% clonal plasma cells in a bone marrow biopsy by immunohistochemistry, morphology, or flow cytometry)
* Secretory M protein \< 3 g/dL
Cohort 2: Must meet all the following criteria:
* Relapsed multiple myeloma with plasmacytomas/lytic lesion appropriate for RT on imaging
* Relapsed (reappearance of M-spike/serum FLC) or progressive myeloma defined by a 25% increase from nadir in M-spike or involved serum FLB on 2 separate measurements; or with bone marrow involvement by clonal plasma cells detectable by IHC or flow cytometry.
* Any prior number of therapies is permitted, including prior radiation therapy
* Allogeneic transplant patients are permitted
All Cohorts:
* Age \>/= 18 years
* Surgical resection of plasmacytoma or stabilization surgery is permitted if necessary based on physician judgement
* ECOG performance status of 0-1
* Anticipated lifespan greater than 3 months
* Able and willing to give valid written informed consent
* Creatinine clearance \>/=30ml/min by Cockroft-Gault method. See section below, "Dosing Regimen", regarding lenalidomide …
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
Measure Complete Response
Timeframe: At the end of Cycle 6 (each cycle is 28 days)