Bortezomib, Melphalan, and Total-Body Irradiation Before Stem Cell Transplant in Treating Patient… (NCT01936090) | Clinical Trial Compass
CompletedPhase 1
Bortezomib, Melphalan, and Total-Body Irradiation Before Stem Cell Transplant in Treating Patients With Multiple Myeloma
United States11 participantsStarted 2013-08
Plain-language summary
This phase I/II trial studies the side effects and best dose of bortezomib when given together with melphalan, and total-body irradiation before stem cell transplant and to see how well it works in treating patients with multiple myeloma. Giving chemotherapy and total-body irradiation before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. The stem cells that were collected from the patient's blood or bone marrow are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and total-body irradiation.
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:
* Serum creatinine =\< 2 mg/dL
* Serum total bilirubin =\< 1.5 X upper limit of normal (ULN)
* Platelet count \>= 30,000/μL
* Hemoglobin \>= 8.0 g/dL
* Diagnosis of myeloma for which autologous stem cell transplant is being considered
* Measurable disease of multiple myeloma at the time of baseline values for disease assessment as defined by at least one of the following:
* Serum monoclonal protein \>= 1.0 g/dL
* \>= 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
* Bone marrow plasma cells \>= 30%
* NOTE:
* For patients with no relapse prior to transplant, measurable disease at the time of diagnosis
* For patients who have had a disease relapse prior to transplant, measurable disease at the time of the most recent relapse immediately prior to transplant.
* If the patient had treatment for the relapsed disease prior to transplant, the patient must have measurable disease at the time of relapse prior to this therapy
* Patient is considered for autologous stem cell transplantation with full dose melphalan (200 mg/m\^2)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
* Recovered from non-hematological toxicity of previous chemotherapy (excludes grade 1 neurotoxicity)
* Voluntary written informed consent before performance of any study-related procedure not part of norm…
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
MTD defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (phase I)
Timeframe: Day 36
2
The number and severity of all adverse events (phase I)
Timeframe: Up to 3 years
3
Proportion of complete responses (CR) defined as a CR noted as the objective status on two consecutive evaluations (phase II)