Bortezomib, Cyclophosphamide, Dexamethasone, and Thalidomide in Treating Patients With Newly Diag… (NCT00438841) | Clinical Trial Compass
UnknownPhase 2
Bortezomib, Cyclophosphamide, Dexamethasone, and Thalidomide in Treating Patients With Newly Diagnosed, Previously Untreated Multiple Myeloma
United States43 participantsStarted 2006-08
Plain-language summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving bortezomib together with cyclophosphamide, dexamethasone, and thalidomide may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with cyclophosphamide, dexamethasone, and thalidomide works in treating patients with newly diagnosed, previously untreated multiple myeloma.
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.
DISEASE CHARACTERISTICS:
* Diagnosis of multiple myeloma meeting 1 of the following criteria:
* Monoclonal immunoglobulin spike on serum electrophoresis (IgG \> 3.5 g/dL or IgA \> 2.0 g/dL) and kappa or lambda light chain excretion \> 1 g/day by 24-hour urine protein electrophoresis AND meets any of the following criteria:
* Bone marrow plasmacytosis (10-30% plasma cells)
* Lytic bone lesions
* Monoclonal immunoglobulin of lesser magnitude present and bone marrow plasmacytosis (10-30% plasma cells) AND meets any of the following criteria:
* Lytic bone lesions
* IgM \< 50 mg/dL, IgA \< 100 mg/dL, or IgG \< 600 mg/dL
* Bone marrow plasmacytosis (\> 30% plasma cells) or plasmacytoma on tissue biopsy AND meets any of the following criteria:
* Monoclonal immunoglobulin of lesser magnitude present
* Lytic bone lesions
* IgM \< 50 mg/dL, IgA \< 100 mg/dL, or IgG \< 600 mg/dL
* FreeLite testing abnormal and kappa:lambda light chain ratio abnormal
* Symptomatic disease requiring treatment
* Documented related organ or tissue involvement, if present
* Measurable disease, defined as 1 of the following:
* Monoclonal immunoglobulin spike on serum electrophoresis ≥ 1 g/dL and/or urine monoclonal immunoglobulin spike ≥ 200 mg/day
* Abnormal FreeLite testing (for nonsecretors)
* Patients with nonsecretory disease must meet either of the following criteria for measurability:
* Has measurable protein by FreeLite testing
* Untreated so…
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.