TMI With HD Mel in ASCT for R/R Multiple Myeloma (BMT-03) (NCT02043847) | Clinical Trial Compass
CompletedPhase 1
TMI With HD Mel in ASCT for R/R Multiple Myeloma (BMT-03)
United States12 participantsStarted 2014-01-14
Plain-language summary
In this phase I trial, patients with relapsed or refractory multiple myeloma will receive standard autologous stem cell transplant conditioned with high dose melphalan. In addition to Melphalan, the conditioning will include targeted total marrow irradiation (TMI). This is a conventional 3+3 phase I trial with increasing doses of TMI from minimum 3Gy to Maximum 9Gy.
Who can participate
Age range
18 Years – 75 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
. Patients meeting criteria for symptomatic myeloma
. Patients who have progressive myeloma following initial induction (patients may have received any number of treatment regimens including prior autologous transplant)
. Patient age 18-75 years at time of enrollment
. Karnofsky performance status of ≥70
. Cardiac function: LVEF \>40%
. Hepatic: Bilirubin \<2x upper limit of normal and ALT and AST \< 2.5x the upper limit of normal
. Renal: Creatinine clearance of \>30mL/min, estimated or calculated
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.
. Pulmonary: DLCO, FEV1, FVC \>50% of predicted (after correction for hemoglobin)
Exclusion criteria
. Patients with diagnosis of plasma cell leukemia
. Patients with truly non secretory myeloma (patients with light chain disease are eligible)
. Pregnant or breast-feeding
. Uncontrolled viral, fungal or bacterial infection Note: Infection is permitted if there is evidence of response to medication. Eligibility of HIV infected patients will be determined on a case-by-case basis.
. Patients who have undergone prior allogeneic stem cell transplant
. Prior solid organ transplant
. Patients receiving prior radiation to more than 20% of bone marrow containing areas