Thalidomide and Prednisone After Autologous Stem Cell Transplantation Multiple Myeloma (NCT00049673) | Clinical Trial Compass
CompletedPhase 3
Thalidomide and Prednisone After Autologous Stem Cell Transplantation Multiple Myeloma
Canada332 participantsStarted 2002-10-15
Plain-language summary
RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor. It is not yet known whether combining thalidomide with prednisone and giving them after autologous stem cell transplantation may be effective in treating multiple myeloma.
PURPOSE: This randomized phase III trial is studying thalidomide and prednisone to see how well they work compared to observation in treating patients who have undergone stem cell transplantation for multiple myeloma.
Who can participate
Age range
16 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:
* Histologically confirmed multiple myeloma as evidenced by one of the following:
* Biopsy of an osteolytic lesion or soft tissue tumor composed of plasma cells
* Bone marrow aspirate and/or biopsy demonstrating at least 10% plasmacytosis
* Bone marrow less than 10% plasma cells with at least 1 bony lesion and meets the M-protein criteria as below
* Detectable serum M-component of IgG, IgA, IgD, or IgE at initial diagnosis OR
* Urinary excretion of light chain (Bence Jones) protein at least 1.0 gm/24 hrs if only light chain disease (urine M-protein) was present at initial diagnosis
* Previously treated with autologous stem cell transplantation after high-dose melphalan (200 mg/m\^2) within the past 60-100 days
* Received transplantation within 1 year of the beginning of initial chemotherapy for multiple myeloma
* No evidence of disease progression
PATIENT CHARACTERISTICS:
Age
* 16 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 6 months
Hematopoietic
* No prior hereditary hypercoaguable disorder
* Granulocyte count at least 1,000/mm\^3
* Platelet count at least 75,000/mm\^3
Hepatic
* Bilirubin no greater than 2 times upper limit of normal (ULN)
* AST and/or ALT no greater than 2 times ULN
* Alkaline phosphatase no greater than 2 times ULN
Renal
* Creatinine no greater than 3 times ULN
Cardiovascular
* No prior spontaneous deep vein thrombosis within the past 5 years
* Catheter-associated thrombus allowe…
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.