HD Melphalan and SCT in Patients With IGDD or LCDD (NCT00681044) | Clinical Trial Compass
TerminatedPhase 2
HD Melphalan and SCT in Patients With IGDD or LCDD
Stopped: Poor accrual
United States5 participantsStarted 2006-10
Plain-language summary
RATIONALE: Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
PURPOSE: This phase II trial is studying the side effects of high-dose melphalan given together with stem cell transplant and to see how well it works in treating patients with immunoglobulin deposition disease or light-chain deposition disease.
Who can participate
Age range
18 Years – 120 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:
DISEASE CHARACTERISTICS:
* Histologically confirmed light-chain deposition disease based on the following criteria:
* Deposition of granular material containing free light-chain (FLC) immunoglobulins that did not bind Congo red
* Evidence of a plasma cell dyscrasia, as defined by any of the following:
* Monoclonal gammopathy in the serum or urine by immunofixation electrophoresis
* Clonal plasmacytosis on bone marrow biopsy by immuno-histochemical
* Elevated serum levels of FLC
* Patients may enroll after stem cell collection (SCC) if all prestudy requirements are completed prior to starting SCC (i.e., ≥ 2.5 x 10\^6 cells available for transplantation)
PRIOR CONCURRENT THERAPY:
* Prior chemotherapy with alkylating agent allowed provided there is no evidence of myelodysplastic syndromes
* Prior total dose of melphalan \< 300 mg
* More than 4 weeks since prior cytotoxic therapy and recovered
PATIENT CHARACTERISTICS:
* Performance status 0-2
* Left Ventricular Ejection Fraction (LVEF) ≥ 45% within the past 90 days
* diffusing capacity of lung for carbon monoxide (DLCO) ≥ 50%
Exclusion Criteria:
* No overt multiple myeloma, as defined by any of the following:
* Greater than 30% bone marrow plasmacytosis
* Extensive (i.e., \> 2) lytic lesions
* Hypercalcemia
* No myocardial infarction, congestive heart failure, or arrhythmia refractory to therapy within the past 6 months
* No prior malignancy except adequately treated basal cell…
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.