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Corticosteroid

Venetoclax + Ixazomib + Dexamethasone for AL Amyloidosis

Phase 1
Recruiting
Led By Michael A Rosenzweig
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >= 18 years
Measurable disease of AL amyloidosis as defined by at least one of the following: 1) serum or urine monoclonal protein >= 500 mg/dL by protein electrophoresis, or 2) serum free light chain >= 20 mg/L with an abnormal kappa:lambda ratio or the difference between involved and uninvolved free light chains (dFLC) >= 20 mg/L
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2.5 years
Awards & highlights

Study Summary

This trial is testing a combination of drugs to treat light chain amyloidosis that has come back or does not respond to treatment. The drugs are venetoclax, ixazomib citrate, and dexamethasone.

Who is the study for?
Adults with relapsed or refractory light chain amyloidosis, specifically those who have a genetic change known as translocation t(11;14). They should be in relatively good health (ECOG <=2), not HIV positive unless undetectable viral load on therapy, and without major organ damage from multiple myeloma. Prior cancer treatments must be completed at certain intervals before joining.Check my eligibility
What is being tested?
The trial is testing the combination of venetoclax, ixazomib citrate, and dexamethasone to find the safest dose with the fewest side effects for treating light chain amyloidosis that has returned or isn't responding to treatment. Venetoclax blocks proteins cancer cells need to survive, while ixazomib helps kill them and dexamethasone reduces inflammation.See study design
What are the potential side effects?
Potential side effects include nausea, diarrhea, fatigue, risk of infection due to low blood counts, liver issues reflected by changes in blood tests results. There may also be risks related to heart function given the nature of amyloidosis affecting different organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My AL amyloidosis shows through specific blood or urine tests.
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My white blood cell count is healthy without needing medication for at least 1-2 weeks.
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I need treatment after trying at least one other therapy.
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I don't have bone lesions or organ damage from multiple myeloma.
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My bone marrow biopsy shows I have the t(11;14) genetic marker.
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I have another cancer type, but it won't affect this trial's treatment.
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I can understand and am willing to sign the consent form, or I have someone who can do it for me.
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I can take care of myself but might not be able to do heavy physical work.
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My AL amyloidosis is at a cardiac risk stage of I, II, or IIIa.
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My condition is confirmed AL amyloidosis needing treatment.
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I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.
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I had hepatitis C but have been treated and cured.
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My kidneys work well enough, with a clearance rate of at least 15 mL/min.
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My hepatitis B virus load is undetectable with treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Maximum tolerated dose
Recommended phase 2 dose (RP2D)
Secondary outcome measures
Overall response rate (complete hematologic response)
Other outcome measures
Characterization of CD138+ plasma cell with t(11;14)
Expression of BCL-2, BCL-XL, BAX, BAK, BIM, NOXA, and MCL-1
Hematologic response rates
+2 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: Treatment (venetoclax, ixazomib citrate, dexamethasone)Experimental Treatment10 Interventions
Patients receive venetoclax PO QD on days 1-28, ixazomib citrate PO on days 1, 8 and 15, and dexamethasone PO on days 1, 8, 15 and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may undergo x-ray imaging and abdominal ultrasound during screening. Patients undergo bone marrow biopsy and/or aspiration as well as blood sample collection throughout the study. Patients may undergo CT scans, and/or MRI, and/or PET scans throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Biospecimen Collection
2004
Completed Phase 2
~1920
Computed Tomography
2017
Completed Phase 2
~2790
Ixazomib Citrate
2012
Completed Phase 2
~200
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Positron Emission Tomography
2008
Completed Phase 2
~2260
Transabdominal Ultrasound
2020
N/A
~50
Venetoclax
2019
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,626 Previous Clinical Trials
40,927,611 Total Patients Enrolled
2 Trials studying AL Amyloidosis
363 Patients Enrolled for AL Amyloidosis
Michael A RosenzweigPrincipal InvestigatorCity of Hope Comprehensive Cancer Center LAO
3 Previous Clinical Trials
50 Total Patients Enrolled

Media Library

Dexamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04847453 — Phase 1
AL Amyloidosis Research Study Groups: Treatment (venetoclax, ixazomib citrate, dexamethasone)
AL Amyloidosis Clinical Trial 2023: Dexamethasone Highlights & Side Effects. Trial Name: NCT04847453 — Phase 1
Dexamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04847453 — Phase 1

Frequently Asked Questions

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

How is Venetoclax usually prescribed for therapeutic purposes?

"Venetoclax is frequently prescribed to treat ophthalmia and sympathetic eye disorders. It has also been known to be beneficial in treating branch retinal vein occlusion and macular edema."

Answered by AI

Are there any open recruitment opportunities for this experiment?

"Affirmative. According to clinicaltrials.gov, this medical trial commenced recruitment on September 14th 2021 and is still in need of participants as of November 18th 2022. 6 people are required for the experiment across 10 different sites."

Answered by AI

What is the current size of the cohort participating in this research?

"This study requires the recruitment of 6 suitable candidates. These individuals can join from Montefiore Medical Center-Einstein Campus in Bronx, New york or Montefiore Medical Center-Weiler Hospital in Charlottesville, Virginia."

Answered by AI

How many locations are participating in conducting this trial?

"Currently, 10 different medical facilities are enrolling participants. These sites span from Bronx to Baltimore and everywhere in between; therefore it is advisable to select the one that requires minimal travel for your own convenience."

Answered by AI

What other investigations with Venetoclax have been initiated?

"Venetoclax was initially studied in 2002 by Manitoba Blood & Marrow Transplant Program CancerCare Manitoba and 1184 trials have been successfully concluded. Presently, 778 studies are active with a considerable portion originating from Bronx, New york."

Answered by AI

What adverse effects has Venetoclax been known to cause in patients?

"Due to the limited data on Venetoclax's efficacy and safety, a score of 1 was assigned by Power professionals. This is in keeping with its Phase 1 trial status."

Answered by AI
~6 spots leftby Sep 2024