Carfilzomib and Lenalidomide With Dexamethasone Combination in Newly Diagnosed, Previously Untrea… (NCT01029054) | Clinical Trial Compass
CompletedPhase 1/2
Carfilzomib and Lenalidomide With Dexamethasone Combination in Newly Diagnosed, Previously Untreated Multiple Myeloma
United States53 participantsStarted 2009-09
Plain-language summary
This study is designed to evaluate the safety and to determine the maximum tolerated dose of carfilzomib + lenalidomide in combination with dexamethasone in newly diagnosed Multiple Myeloma patients who have not received treatment.
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
. Newly diagnosed, histologically confirmed, previously untreated Stage I, II, or III multiple myeloma requiring systemic chemotherapy
. Diagnosis of symptomatic multiple myeloma per IMWG uniform criteria within the past 90 days
. Measurable disease, per IMWG (International Myeloma Working Group) criteria (\>= one of the following) within the past 4 weeks:
. Life expectancy \> 3 months
. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
. Adequate hepatic function, with bilirubin \< 1.5 x the ULN, and AST (Aspartate Aminotransferase) and ALT (Alanine Transaminase) \< 2.5 x ULN
. Absolute neutrophil count (ANC) \>=1.0 x 109/L, hemoglobin \>= 8 g/dL, platelet count \>= 75 x 109/L
. Non-secretory or hyposecretory multiple myeloma, defined as \<0.5 g/dL M-protein in serum, \<200 mg/24 hr urine M-protein, or disease only measured by serum free light chain
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
The Maximum Tolerated Dose (MTD) of Carfilzomib
Timeframe: 6 Months
2
The Percentage of Patients That Achieve a Response to Treatment
. Radiotherapy to multiple sites or immunotherapy within 2 weeks before start of protocol treatment (localized radiotherapy to a single site at least 1 week before start is permissible)
. Patient must not have been previously treated with any prior systemic therapy for the treatment of multiple myeloma
. Participation in an investigational therapeutic study within 3 weeks or within 5 drug halflives (t1/2) prior to first dose, whichever time is greater