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Monoclonal Antibodies
Venetoclax + Daratumumab + Dexamethasone for Amyloidosis
Phase 1 & 2
Recruiting
Led By Sandy W Wong, MD
Research Sponsored by Alfred Chung, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of a combination of drugs to treat light-chain amyloidosis, a rare disease where abnormal proteins build up in tissues and organs.
Who is the study for?
Adults with systemic light-chain amyloidosis and a specific DNA abnormality (t(11;14)) can join this trial. They must have certain levels of blood components, no prior CD38-directed antibody treatment, at least one organ affected by the disease, measurable disease indicators, and be able to use birth control if necessary. People are excluded if they have other medical conditions that could interfere or have had recent vaccinations or surgeries.Check my eligibility
What is being tested?
The trial is testing the combination of Venetoclax, Daratumumab, and Dexamethasone for treating systemic light-chain amyloidosis in patients with t(11;14). It aims to find out the safest doses and observe side effects. Venetoclax targets cancer cells by binding to Bcl-2 protein; Daratumumab attaches to CD38 on cancer cells aiding immune destruction; Dexamethasone helps reduce inflammation.See study design
What are the potential side effects?
Potential side effects include reactions where drugs are infused into the body, fatigue, digestive issues like upset stomach or diarrhea, changes in blood counts leading to increased infection risk or bleeding problems. Specific side effects will depend on individual patient responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) (Phase 1)
Proportion of participants who achieve a complete hematologic response (CHR) (Phase 2)
Proportion of participants with reported dose limiting toxicities (Phase 1)
+1 moreSecondary outcome measures
Median Duration of response (DOR) (Phase 2)
Median Major Organ Deterioration Progression-Free Survival (MOD-PFS) (Phase 2)
Median Overall Survival (OS) (Phase 2)
+11 moreSide effects data
From 2022 Phase 3 trial • 389 Patients • NCT0200547133%
Neutropenia
11%
Neutrophil count decreased
11%
Blood creatinine increased
11%
Hypokalaemia
11%
Dermatitis
11%
Pneumonia pseudomonal
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Pneumonia
11%
Abdominal pain
11%
Anaemia
11%
Sepsis
11%
Gastroenteritis
11%
SARS-CoV-2 test positive
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
COVID-19
11%
Supraventricular tachycardia
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
2Treatment groups
Experimental Treatment
Group I: Phase II (venetoclax, dexamethasone, daratumumab)Experimental Treatment4 Interventions
Participants will receive the RP2D of venetoclax QD on days 1-28 of each cycle, dexamethasone on days 1, 8, 15, and 22 of each cycle, and daratumumab on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, then on day 1 of cycles thereafter. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity
Group II: Phase I (venetoclax, dexamethasone, daratumumab)Experimental Treatment4 Interventions
All participants receive 400 mg venetoclax once a day (QD) on days 1-28 of each cycle. Depending on the number of DLTs reported for this dose-level, participants may also receive dexamethasone on days 1, 8, 15, and 22 of each cycle with or without daratumumab on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, then on day 1 of cycles thereafter. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Dexamethasone
2007
Completed Phase 4
~2590
Daratumumab
2014
Completed Phase 3
~1860
Find a Location
Who is running the clinical trial?
Alfred Chung, MDLead Sponsor
1 Previous Clinical Trials
3 Total Patients Enrolled
AbbVieIndustry Sponsor
958 Previous Clinical Trials
502,344 Total Patients Enrolled
2 Trials studying Amyloidosis
76 Patients Enrolled for Amyloidosis
Janssen PharmaceuticalsIndustry Sponsor
80 Previous Clinical Trials
205,025 Total Patients Enrolled
2 Trials studying Amyloidosis
43 Patients Enrolled for Amyloidosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition is AL amyloidosis caused by lymphoma.My condition is a type of amyloidosis that is not AL amyloidosis.I am scheduled for a stem cell transplant.I have had severe asthma recently or it's currently not under control.I have not had major surgery in the last 2 weeks.My tests show I have measurable light chain amyloidosis.One of my organs is affected by AL amyloidosis.I can take care of myself and perform daily activities.I haven't taken certain medications in the last 7 days.I am using reliable birth control methods.I have had at least one treatment for AL amyloidosis.I have never had CD38 antibody treatment or I responded well to it without my condition worsening.I have serious heart-related conditions.I am not pregnant, breastfeeding, nor planning to become pregnant soon.I have not taken any restricted medications or substances within the last 3 days.I have been treated with BCL-2 inhibitors before.I have not had any cancer other than AL amyloidosis in the past 3 years.My blood cancer worsened while on or soon after CD38 antibody therapy.I cannot tolerate certain antibody or enzyme treatments.I am 18 years old or older.I haven't taken any anti-amyloid drugs or supplements in the last 14 days.My diagnosis of amyloidosis was confirmed through specific tissue staining and microscopy techniques.I have been diagnosed with multiple myeloma.I finished my last cancer treatment or surgery more than 2 weeks ago, and any stem cell transplant over 100 days ago.I have not received any live vaccines in the last 4 weeks.My test shows I have t(11;14) in my bone marrow cells, confirmed by UCSF.My lung function is not severely reduced (FEV1 is 50% or more of the predicted normal).
Research Study Groups:
This trial has the following groups:- Group 1: Phase II (venetoclax, dexamethasone, daratumumab)
- Group 2: Phase I (venetoclax, dexamethasone, daratumumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What objectives does this exploration intend to fulfill?
"The primary metric of this trial, evaluated over a two-year period, is the proportion of participants who experience dose limiting toxicities in Phase 1a. Additional outcomes include number of treatment related mortalities (Phase 2), median major organ deterioration progression-free survival (MOD-PFS) (Phases 1b/2), and median overall survival time (OS) (Phases 1b/2). All results will be provided with 95% confidence intervals calculated using Brookmeyer and Crowley's 1982 methodology."
Answered by AI
Is this research effort presently open to recruitment?
"As per clinicaltrials.gov, this investigation is not currently seeking patients; the trail was initiated on January 15th 2023 and last updated September 14th 2022. Although no longer recruiting participants, a large number of trials are actively enrolling individuals at this time - 97 in total."
Answered by AI
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