A Phase 1 interventional study of Carfilzomib and Dexamethasone in Lymphoma, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-09-19.
Sponsored by M.D. Anderson Cancer Center · Phase 1, Interventional, and Treatment
The goal of this clinical research study is to find the highest tolerable dose of carfilzomib that can be given to patients with lymphoma after a stem cell transplant. The safety of this drug will also be studied.
Carfilzomib is designed to block cancer cells from repairing themselves. If the cancer cells cannot repair themselves, this may cause them to die.
Study Groups:
If you agree to take part in this study, you will be assigned to a dose level of carfilzomib based on when you joined this study. Up to 4 dose levels of carfilzomib will be tested. Three (3) participants will be enrolled at each dose level until the highest tolerable dose level is found. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. When the highest tolerable dose is found, more participants may be enrolled at that dose level.
Study Treatment:
Each study cycle is 28 days.
On Days 1, 2, 15, and 16 of each cycle, you will receive carfilzomib by vein over 30 minutes. You will receive hydration by vein before and after each infusion of carfilzomib in Cycle 1. This may be repeated in Cycle 2, if your doctor thinks it is needed. On these days during Cycles 1 and 2, before you receive carfilzomib you will receive dexamethasone by vein or as a tablet by mouth. Dexamethasone may help prevent possible infusion reactions. You may continue to receive dexamethasone before each dose of each cycle depending how well you tolerate the infusion.
You will be monitored closely for at least 1 hour for possible infusion reactions after each dose during Cycle 1 and on Day 1 of Cycle 2. If you have an infusion reaction, your doctor may delay or stop the infusion, and you may receive drugs to help relieve the symptoms.
You will have about 12 days of "rest" between each cycle of treatment (during this time you will not receive carfilzomib).
Study Visits:
On Day 1 (+ or - 3 days) of Cycle 1 and on Day 1 of all other cycles, women who are able to become pregnant will have blood (about 1 teaspoon) drawn for a pregnancy test. To take part in this study, you must not be pregnant.
About 1 day before you receive carfilzomib in each cycle:
About 1 day and about 15 days before you receive carfilzomib in each cycle, blood (about 2 tablespoons) will be drawn for routine tests and to check your kidney and liver function.
At any point that your doctor thinks they are needed, you will have a bone marrow aspiration and computed tomography (CT) and/or positron emission tomography (PET) scans to check the status of the disease. To collect a bone marrow aspirate, an area of the hip or other site is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle.
End-of-Treatment Visit:
Within 30 days of your last dose of study drug, you will return to the clinic. The following tests and procedures will be performed:
During follow-up, the study staff may also contact you and your local doctor by telephone to ask about your health.
Length of Study:
You may remain in this study for about 2 years from the time of first dose. You may receive up to 6 cycles of treatment during this time, which will take about 7 months to complete. You will be taken off study early if the disease gets worse, you cannot keep appointments, you miss more than 2 doses of carfilzomib in a row, if intolerable side effects occur, or if you decide that you want to leave the study early.
This is an investigational study. Carfilzomib is FDA approved and commercially available for the treatment of multiple myeloma. The use of carfilzomib to treat lymphoma after a stem cell transplant is investigational.
Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.
5,623 studies on the registry are indexed under Lymphoma; 823 are open to participants now.
This study's enrollment of 2 is below the median of 40 across 4,534 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →M.D. Anderson Cancer Center is the lead sponsor of 3,044 studies on the registry; 578 are open to participants now.
Of its 608 completed or terminated interventional studies of FDA-regulated products, 407 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Carfilzomib given in four doses, days 1, 2, 15 and 16, every 28 days for 6 months starting within 6 months post ASCT. Doses given in an escalated phase 1 design, starting at 20/20 mg/m2, later increased to 20/27 mg/m2, 20/36 mg/m2 and 20/45 mg/m2. CFZ dose based on actual body surface area at baseline (cycle 1). Patients with a body surface area (BSA) greater than 2.2 m2 receive dose based upon a 2.2 m2 BSA. Adjustments are not made if weight gains or losses are less than or equal to 20% from baseline. Dexamethasone 4 mg by vein or mouth prior to each CFZ dose in cycle 1 and 2 to prevent infusion reactions. After dexamethasone is stopped, then it should be restarted and administered prior to subsequent doses for reactions.
Drug: Carfilzomib · Drug: Dexamethasone
Starting dose: 20/20 mg/m2 by vein on Days 1, 2, 15, and 16 of each 28 day cycle.
4 mg by vein or mouth prior to each Carfilzomib dose in Cycle 1 and 2 to prevent infusion reactions. After dexamethasone is stopped, it should be restarted and administered prior to subsequent doses for reactions.
Also known as: Decadron
Maximum Tolerated Dose (MTD) of Carfilzomib (CFZ) After Autologous Stem Cell Transplantation (ASCT)
Maximum tolerated dose (MTD) defined as dose with a posterior probability of treatment-related dose-limiting toxicity (DLT) during the first 56 days closest to the target of 30%. DLT defined as: equal or greater than Grade (G) 2 neuropathy with pain, equal or greater than G3 non-hematologic toxicity, G4 neutropenia greater than 7 days, febrile neutropenia, G4 thrombocytopenia lasting for more than 7 days despite withholding CFZ, G3/4 thrombocytopenia with bleeding, or equal or greater than Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal by day 56.
Time frame: 56 days
Efficacy of Carfilzomib (CFZ) After Autologous Stem Cell Transplantation (ASCT)
Efficacy assessed by progression free survival (PFS) and overall survival (OS) at 2 years. Assess progression rate and correlations with Ki67, and gene profiling. Distributions of PFS and OS estimated by Kaplan-Meier method, and distributions compared between groups by using the log-rank test. Cox proportional hazards regression models will be fit to assess the relationship between baseline covariates of interest and these survival parameters.
Time frame: 2 years
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Carfilzomib