Study Details

Open

Venetoclax, MLN9708 and Dexamethasone for Relapsed or Refractory Light Chain Amyloidosis

This study is being done to answer the following question: What is the dose of venetoclax, MLN9708 (ixazomib citrate), and dexamethasone in combination that can be safely and tolerably taken by patients with amyloidosis? We are doing this study because we want to find out if this approach is better or worse than the usual approach for amyloidosis. The usual approach is defined as care most people get for amyloidosis.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

Before you begin the study, your doctor will review the results of your exams, tests, and procedures. This helps your doctor decide if it is safe for you to take part in the study. If you join the study, you will have more exams, tests, and procedures to closely monitor your safety and health. Most of these are included in the usual care you would get even if you were not in a study. The tests and procedures that need to be done as part of this study to monitor your safety and health, but may not be included in the usual care are as follows: pregnancy test (for women of childbearing potential), blood counts, tests for immunoglobulins, physical exams, kidney function testing, and liver function testing. Procedures that will be done for research purposes only are as follows: blood samples and bone marrow samples (aspirate and biopsy). Venetoclax, MLN9708 (ixazomib citrate) and Dexamethasone are oral medications. You will be asked to keep a diary of when you take these study drugs.

Incentives

You or your insurance provider will not have to pay for the venetoclax or MLN9708 (ixazomib citrate) while you take part in this study.

Total length of participation:
Length of participation will depend on when your disease gets worse, side effects, or if your doctor thinks it's no longer best for you.

Looking for Specific Volunteers

Able to participate:

You have histologically-proven systemic light chain amyloidosis.
You have an abnormal chromosome called t(11:14).
You require therapy after receiving at least one prior line of treatment.
You have adequate organ and bone marrow function per labwork required by protocol.
You have measurable disease of light chain amyloidosis as defined by certain criteria.

Not eligible if:

You have had major surgery or radiotherapy within 14 days prior to entering the study.
You have not recovered from adverse events due to prior anti-cancer therapy.
You are receiving any other investigational agents, within 30 days of the start of this trial and throughout the duriation of this trial.
You have central nervous system involvement.
You have known gastrointestinal disease or gastrointestinal procedure that could interfere with the oral absorption or tolerance of ixazomib citate, including difficulty swallowing.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Trials Office
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Secondary Visit Location

UNC Hospitals Hillsborough Campus
460 Waterstone Dr, Hillsborough, NC 27278, USA

Additional Study Information

Principal Investigator

Samuel Rubinstein
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Blood Conditions
Cancer (Other Cancers)

IRB Number

24-1432

ClinicalTrials.gov

NCT04847453