OncoMatch/Clinical Trials/NCT04847453
Venetoclax, MLN9708 (Ixazomib Citrate) and Dexamethasone for the Treatment of Relapsed or Refractory Light Chain Amyloidosis
Is NCT04847453 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Dexamethasone and Ixazomib Citrate for recurrent al amyloidosis.
Treatment: Dexamethasone · Ixazomib Citrate · Venetoclax — This phase I/Ia trial finds the best dose and side effects of venetoclax given in combination with ixazomib citrate and dexamethasone in treating patients with light chain amyloidosis that has come back (relapsed) or does not respond to treatment (refractory) and who have an abnormal genetic change \[translocation t(11;14)\]. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Ixazomib citrate is in a class of medications called proteasome inhibitors. It works by helping to kill cancer cells. Anti-inflammatory drugs such as dexamethasone reduce inflammation by lowering the body's immune response and are used with other drugs in the treatment of some types of cancer. Combination therapy with venetoclax, ixazomib citrate and dexamethasone may be effective in treatment of relapsed or refractory light chain amyloidosis.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Disease stage
Required: Stage CARDIAC RISK STAGE I, CARDIAC RISK STAGE II, CARDIAC RISK STAGE IIIA (2013 European Modification of the 2004 Standard Mayo Clinic Staging)
Excluded: Stage CARDIAC RISK STAGE IIIB, NEW YORK HEART ASSOCIATION CLASSIFICATION III, NEW YORK HEART ASSOCIATION CLASSIFICATION IV
AL Amyloidosis Cardiac Risk stage I, II or IIIa disease based on the 2013 European Modification of the 2004 Standard Mayo Clinic Staging
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: MLN9708 (ixazomib citrate) (MLN9708, ixazomib citrate)
Patients that have previously been treated with MLN9708 (ixazomib citrate)
Cannot have received: venetoclax (venetoclax)
Patients who have received prior treatment with venetoclax
Cannot have received: anti-plasma cell therapy
Exception: nitrosoureas or mitomycin C require 6 weeks
Patients who have had anti-plasma cell therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
Cannot have received: investigational agents
Patients who are receiving any other investigational agents, within 30 days of the start of this trial and throughout the duration of this trial
Lab requirements
Blood counts
Leukocytes >= 3,000/mcL; ANC >= 1,000/mcL (independent of G-CSF/GM-CSF support for at least 1 week and of pegylated G-CSF for at least 2 weeks); Platelets >= 75,000/mcL (no platelet transfusions within 2 weeks before study enrollment)
Kidney function
Creatinine Calculated clearance >= 15 mL/min using Cockcroft-Gault equation
Liver function
Total bilirubin <= 1.5 x institutional ULN; AST/ALT <= 3 x institutional ULN
Cardiac function
Left ventricular ejection fraction >= 35% by echocardiogram
Leukocytes >= 3,000/mcL; ANC >= 1,000/mcL...Platelets >= 75,000/mcL...Total bilirubin <= 1.5 x institutional ULN; AST/ALT <= 3 x institutional ULN; Creatinine Calculated clearance >= 15 mL/min...Left ventricular ejection fraction >= 35% by echocardiogram
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Comprehensive Cancer Center · Duarte, California
- University of California Davis Comprehensive Cancer Center · Sacramento, California
- Emory University Hospital/Winship Cancer Institute · Atlanta, Georgia
- Johns Hopkins University/Sidney Kimmel Cancer Center · Baltimore, Maryland
- Boston Medical Center · Boston, Massachusetts
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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