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Venetoclax + Carfilzomib + Dexamethasone for Multiple Myeloma
Study Summary
This trial is testing a new combination of drugs to treat relapsed or refractory MM (multiple myeloma). They are testing to see if it is safe and effective.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 389 Patients • NCT02005471Trial Design
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Who is running the clinical trial?
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- You have a detectable amount of myeloma according to specific guidelines.I have a serious heart condition.I have severe nerve pain or damage in my hands or feet.I have been diagnosed with Waldenström's macroglobulinemia.I have not had major surgery in the last 4 weeks.I haven't needed antibiotics or antiviral drugs in the last 14 days.My recent blood tests meet the required levels for white blood cells, platelets, hemoglobin, and liver and kidney function.My multiple myeloma has worsened or not responded to my last treatment.I can take care of myself and am up and about more than half of my waking hours.You have an ongoing hepatitis B or C infection based on blood tests.My cancer has a specific genetic change known as t(11;14).I have active plasma cell leukemia.I have not had any other cancers, including MDS, in the last 3 years.I currently have an active COVID-19 infection.I have POEMS syndrome.My multiple myeloma does not produce high levels of M-protein.My diabetes or high blood pressure has been uncontrolled in the last 2 weeks.I have received at least one treatment for multiple myeloma.I have been diagnosed with primary amyloidosis.
- Group 1: Venetoclax + Carfilzomib + Dexamethasone
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are people still being recruited for this experiment?
"Yes, this trial is currently seeking patients. The original posting was on January 19th, 2017 with the most recent update being August 25th, 2022."
What are the primary health concerns that Venetoclax addresses?
"Venetoclax can be used as an ophthalmic medication to treat sympathetic, branch retinal vein occlusion, and macular edema."
What are the other uses that Venetoclax has been trialed for?
"Venetoclax was first studied in 2002 by the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. So far, 1184 studies have been completed with 802 trials still active. A large number of these trials are based in Dallas, Texas."
Are there any life-threatening risks associated with Venetoclax?
"Venetoclax's safety has been studied in a Phase 2 trial, which means that while there is some evidence supporting its safety, none exists for its efficacy. Our team at Power have given it a score of 2."
How many patients are part of this research project?
"That is correct, the online information does show that the trial is currently underway and looking for subjects. The study was originally posted on 1/19/2017 and updated as recently as 8/25/2022. There are a total of 120 spots available at 12 different locations."
What are the investigators of this trial hoping to find out?
"The primary objective of this two-year clinical trial is to evaluate the Objective Response Rate (ORR) of VenKd in Participants with Relapsed or Refractory Multiple myeloma (RRMM), specifically those with t(11;14)-positive RRMM. Additionally, researchers will be measuring the Terminal Phase Elimination Rate Constant (β) of Carfilzomib, Maximum Plasma Concentration (Cmax) of Venetoclax, and Area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) post-dose of Venetoclax as secondary objectives."
How many different locations are responsible for this study?
"This particular clinical trial is hosted at University of Texas Southwestern Medical Center /ID# 218336 in Dallas, Texas, University of Alabama at Birmingham - Main /ID# 151405 in Birmingham, Alabama, and University of Utah /ID# 151397 in Salt Lake City, Utah. There are also 12 other recruitment sites for this study."
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