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BCL-2 Inhibitor
Venetoclax + Dexamethasone for AL Amyloidosis
Phase 1 & 2
Recruiting
Research Sponsored by Rajshekhar Chakraborty, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years at time of signing Informed Consent Form
Has received ≥1 prior lines of therapy, including an anti-cluster of differentiation 38 (CD 38) monoclonal antibody
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is testing a new drug to see if it's safe and effective for people with a certain type of blood cancer that has come back or didn't get better with previous treatment.
Who is the study for?
This trial is for adults over 18 with relapsed or refractory AL amyloidosis, a condition where abnormal proteins build up in organs. Participants must have had prior treatments including an anti-CD38 antibody and be able to follow the study plan. They can't join if they're on dialysis, have certain infections like HIV without effective treatment, severe heart failure, previous use of BCL-2 inhibitors, or other serious health issues.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of venetoclax combined with dexamethasone in patients whose amyloidosis has returned or didn't respond to treatment. It aims to find the safest dose and see how well it works against this disease that affects organ function by protein accumulation.See study design
What are the potential side effects?
Potential side effects may include nausea, diarrhea, low blood cell counts leading to increased infection risk or bleeding problems, fatigue, and possible allergic reactions to medication components.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years or older.
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I have been treated with an anti-CD38 drug before.
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My tests show I have the t(11;14) genetic marker.
Select...
I have recovered from any side effects of my stem cell transplant.
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I can take care of myself and am up and about more than half of my waking hours.
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My diagnosis of AL amyloidosis was confirmed by a biopsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hematologic ≥ Very Good Partial Response (VGPR) Rate (Phase 2)
Number of Participants with Dose Limiting Toxicities (DLT) (Phase 1)
Secondary outcome measures
Duration of Hematologic Response (DOHR) (Phase 2)
Major Organ Deterioration-Progression Free Survival (MOD-PFS) (Phase 2)
Overall Hematologic Response Rate (HRR) (Phase 2)
+6 moreTrial Design
6Treatment groups
Experimental Treatment
Active Control
Group I: Phase 2: Venetoclax MTD with DexamethasoneExperimental Treatment1 Intervention
Venetoclax MTD (200 mg or 400 mg) with Dexamethasone (10 mg or 20 mg) as determined by the phase I results
Group II: Phase 1: Venetoclax 400mg + Dexamethasone 20 mgExperimental Treatment3 Interventions
Cohort 4: Venetoclax 400 mg tablet, once daily and Dexamethasone 20 mg tablet once weekly, for up to 2 cycles after achieving best response, for a maximum of 6 cycles (1 cycle = 28 days)
Group III: Phase 1: Venetoclax 400mg + Dexamethasone 10 mgExperimental Treatment3 Interventions
Cohort 3: Venetoclax 400 mg tablet, once daily and Dexamethasone 10 mg tablet once weekly, for up to 2 cycles after achieving best response, for a maximum of 6 cycles (1 cycle = 28 days)
Group IV: Phase 1: Venetoclax 400mgExperimental Treatment2 Interventions
Cohort 2: Venetoclax 400 mg tablet, once daily for up to 2 cycles after achieving best response, for a maximum of 6 cycles (1 cycle = 28 days)
Group V: Phase 1: Venetoclax 200 mgExperimental Treatment2 Interventions
Cohort 1: Venetoclax 200 mg tablet, once daily for up to 2 cycles after achieving best response, for a maximum of 6 cycles (1 cycle = 28 days)
Group VI: Phase 2: Control Arm (Investigator's Choice)Active Control5 Interventions
Participants will receive one of the following as determined by the investigator:
Daratumumab, Pomalidomide, Bendamustine, or Ixazomib (+/- dexamethasone)
Find a Location
Who is running the clinical trial?
Rajshekhar Chakraborty, MDLead Sponsor
1 Previous Clinical Trials
88 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,636 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years or older.I have been treated with an anti-CD38 drug before.I have HIV but am not on HAART, or I have active hepatitis A, B, or C.My heart condition is at stage IIIB with high NT-Pro BNP levels.My tests show I have the t(11;14) genetic marker.I had cancer before, but it's either been treated successfully or has been in remission for over 2 years.I have been treated with BCL-2 inhibitors before.I have symptoms of multiple myeloma such as bone damage, a tumor from plasma cells, high calcium levels, or more than 60% of my bone marrow is plasma cells.I am on dialysis.I have recovered from any side effects of my stem cell transplant.I have a GI condition or had a procedure that affects how I absorb pills.I have severe heart failure.I can take care of myself and am up and about more than half of my waking hours.My diagnosis of AL amyloidosis was confirmed by a biopsy.I do not have any uncontrolled infections or significant health conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1: Venetoclax 200 mg
- Group 2: Phase 1: Venetoclax 400mg
- Group 3: Phase 1: Venetoclax 400mg + Dexamethasone 10 mg
- Group 4: Phase 1: Venetoclax 400mg + Dexamethasone 20 mg
- Group 5: Phase 2: Control Arm (Investigator's Choice)
- Group 6: Phase 2: Venetoclax MTD with Dexamethasone
Awards:
This trial has 3 awards, including:- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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 is the primary focus of this trial's research agenda?
"The primary purpose of this 6-month medical investigation is to evaluate the Very Good Partial Response (VGPR) rate for hematologic issues. Secondary goals encompass assessing Overall Organ Response Rate, Duration of Hematologic Response, and Major Organ Deterioration Progression Free Survival."
Answered by AI
Are there vacant slots remaining in this research trial?
"The latest information posted on clinicaltrials.gov indicates that this investigation is actively seeking subjects, with the initial post being published on October 26th 2022 and recently updated to reflect new changes."
Answered by AI
How many individuals are actively participating in this medical experiment?
"Affirmative. The information hosted on clinicaltrials.gov verifies that this medical study is currently recruiting participants, with 53 patients needed from a single trial site. This research was initially initiated and most recently edited on October 26th 2022."
Answered by AI
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