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Proteasome Inhibitor

Venetoclax + Carfilzomib + Dexamethasone for Multiple Myeloma

Phase 2
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meets absolute neutrophil count, platelet count, hemoglobin, liver and kidney function laboratory values within 2 weeks prior to first dose of study drug
Documented relapsed or progressive Multiple Myeloma (MM) on or after any regimen or is refractory to the most recent line of therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 17 months
Awards & highlights

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.

Who is the study for?
This trial is for people with Multiple Myeloma who've had 1-3 prior treatments, can perform daily activities (ECOG score ≤2), and have a specific genetic marker (t(11;14) positive). They must have measurable disease, adequate blood counts, liver and kidney function. Excluded are those with certain MM types, other cancers within 3 years, severe infections including COVID-19 or hepatitis B/C, significant heart disease, recent major surgery or uncontrolled diabetes/hypertension.Check my eligibility
What is being tested?
The study tests Venetoclax combined with Carfilzomib and Dexamethasone in participants whose Multiple Myeloma has returned after treatment or didn't respond to the last therapy. It's an open-label Phase 2 trial where everyone knows what treatment they're getting. The goal is to find out how safe this combination is and how well it works.See study design
What are the potential side effects?
Possible side effects include low blood cell counts leading to increased infection risk or bleeding problems; nerve damage causing pain or numbness; liver issues; digestive symptoms like nausea/vomiting; fatigue; muscle weakness from steroids like dexamethasone; potential heart complications due to carfilzomib.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My recent blood tests meet the required levels for white blood cells, platelets, hemoglobin, and liver and kidney function.
Select...
My multiple myeloma has worsened or not responded to my last treatment.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My cancer has a specific genetic change known as t(11;14).
Select...
I have received at least one treatment for multiple myeloma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 17 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 17 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Multiple Myeloma
Number of Participants with Adverse Events
Multiple Myeloma
+1 more
Secondary outcome measures
AUC from 0 to Infinity (AUC∞) of Carfilzomib
AUC from Time 0 to the Time of the Last Measurable Concentration (AUCt) of Carfilzomib
Area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) post-dose of Venetoclax
+13 more

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471
33%
Neutropenia
11%
Anaemia
11%
Gastroenteritis
11%
Abdominal pain
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
Pneumonia pseudomonal
11%
Sepsis
11%
SARS-CoV-2 test positive
11%
Dermatitis
11%
Pneumonia
11%
Blood creatinine increased
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Neutrophil count decreased
11%
COVID-19
11%
Supraventricular tachycardia
11%
Hypokalaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study

Trial Design

1Treatment groups
Experimental Treatment
Group I: Venetoclax + Carfilzomib + DexamethasoneExperimental Treatment3 Interventions
Part 1: Evaluate the safety and pharmacokinetic profiles while providing information to determine the appropriate doses of venetoclax and carfilzomib (VenKd) to be used in the VenKd combination in approximately 18 participants. The dose levels are Venetoclax 400 mg or 800 mg; Carfilzomib 20/27 mg/m2, 20/70 mg/m2, and/or 20/56 mg/m2; Dexamethasone 40 mg Part 2: Further evaluate the safety and efficacy profile of the VenKd combination selected after completion of Part 1 in approximately 22 additional participants. Participants may discontinue Kd but may continue receiving venetoclax once daily (QD) as monotherapy. Part 3: Further evaluation of the efficacy of the VenKd combination after completion of Part 1 and Part 2 in 7 additional participants. Part 4, An additional 65 participants t(11;14) positive will receive varying doses of the VenKd combination or carfilzomib and dexamethasone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carfilzomib
2017
Completed Phase 3
~1440
Venetoclax
2019
Completed Phase 3
~1990
Dexamethasone
2007
Completed Phase 4
~2590

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
950 Previous Clinical Trials
496,808 Total Patients Enrolled
34 Trials studying Multiple Myeloma
5,271 Patients Enrolled for Multiple Myeloma
Genentech, Inc; Onyx Therapeutics, Inc.UNKNOWN
ABBVIE INC.Study DirectorAbbVie
390 Previous Clinical Trials
141,599 Total Patients Enrolled
14 Trials studying Multiple Myeloma
2,367 Patients Enrolled for Multiple Myeloma

Media Library

Carfilzomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02899052 — Phase 2
Multiple Myeloma Research Study Groups: Venetoclax + Carfilzomib + Dexamethasone
Multiple Myeloma Clinical Trial 2023: Carfilzomib Highlights & Side Effects. Trial Name: NCT02899052 — Phase 2
Carfilzomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02899052 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~41 spots leftby Dec 2027